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The Smith & Nephew Cabling System of the Smith & Nephew ACCORD™ Cable System is indicated for general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below:

• Primary total hip arthroplasty. .
• Revision total hip arthroplasty. .
• . Any procedure using anterolateral or lateral approaches.

The ACCORD™ Titanium Plates of the Smith & Nephew ACCORD™ Cable System are indicated for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.

The purpose of this Traditional 510(k) is to add MR safety information to the labeling and update the information within the labeling, including the package insert for the subject Smith & Nephew ACCORD™ Cable System. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the materials, sterilization, or the manufacturing processes of the previously cleared devices due tothe addition of MR labeling for this subject 510(k). The Smith & Nephew ACCORD™ Cable System consists of the following previously cleared devices:

• . The ACCORD™ Titanium Plates: Bone plates of various sizes to accommodate the individual requirements of patient anatomy, cleared under K993106.
• The Smith & Nephew Cabling System: Cables with or without clamps and . trochanteric grips, cleared under K031162.

This document does not contain information about acceptance criteria and a study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification for the Smith & Nephew ACCORD™ Cable System, focusing on adding MR safety information to the labeling and updating existing information.

The key points from the provided text are:

• Device: Smith & Nephew ACCORD™ Cable System.
• Purpose of Submission: To add MR safety information to the labeling and update other labeling information.
• No Changes to Core Device: The technological characteristics, function, materials, packaging, sterilization, and manufacturing processes of the device remain unchanged from previous clearances.
• Predicate Devices: The device is deemed substantially equivalent to two previously cleared Smith & Nephew devices: the Bone Plate System (K993106) and the Orthopaedic Cabling System (K031162).
• Performance Data: Performance data is mentioned only in the context of Magnetic Resonance Imaging (MRI) compatibility testing, conducted according to specific ASTM standards and FDA guidance.
• Engineering Analysis: Engineering analysis and dynamic tensile strength testing were performed to demonstrate substantial equivalent mechanical performance of the plates and cables to the predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, sample sizes for test/training sets, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided text. The document is a regulatory filing for an update, not a clinical study report or a detailed performance and validation study.

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1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   The ANTHEM PS Total Knee System is indicated for use only with cement and is a single use device.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed: and

4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

9. Rheumatoid arthritis.

10. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

11. Failed osteotomies, unicompartmental replacement, or total knee replacement.

12. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;
2. Correction of functional deformity;
3. Revision procedures where other treatments or devices have failed; and
4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:
· Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
· Correction of functional deformity;
· Revision procedures where other treatments or devices have failed; and
· Treatment of fractures that are unmanageable using other techniques.
Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

1. Degenerative arthritis in the distal femur and patella;
2. A history of patellar dislocation or patellar fracture; and
3. Failed previous surgery (arthroplasty, tibial tubercule elevation, lateral release) where pain, deformity or dysfunction persists.
   The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis;

2. Correction of functional deformity;

3. Revision procedures where other treatments or devices have failed; and

4. Treatment of fractures that are unmanageable using other techniques
   Unicompartmental knee implants are single use only and are intended for implantation only with bone cement. HA coated unicompartmental knee implants are available outside the US for use without bone cement.

5. Rheumatoid arthritis.

6. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

7. Failed osteotomies, unicompartmental replacement, or total knee replacement.

8. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

9. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

10. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent.
    The Legion Hinge Knee System is for Cemented Use Only.

11. Rheumatoid arthritis.

12. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

13. Failed osteotomies, unicompartmental replacement, or total knee replacement.

14. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

15. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incompetent.

16. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent.
    The LEGION Knee System - Finned Tibial Wedges are for single use only and are intended for implantation with bone cement.

These devices are indicated for patients with:

1. Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
2. Previous tibial condyle or plateu fractures with loss of anatomy or function.
3. Varus or Valgus deformities.
4. Revision of previous arthroplasty procedures.
   The devices are indicated for cemented use only.
   The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Engage™ Partial Knee System is intended for medial unicompartmental knee arthroplasty to treat one or more of the following conditions:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
• Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty
• As an alternative to tibial osteotomy in patients with Unicompartmental osteoarthritis.
  The femoral component and tibial tray are intented fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. When the tibial tray is implanted without the use of bone cement, the tibial anchor should be used. When the tibial tray is implanted with bone cement, the tibial anchor should not be used.

Total Knee components are indicated for:

1. Rheumatoid arthritis
2. Post- traumatic arthritis, osteoarthritis, or degenerative arthritis
3. Failed osteotomies, unicompartmental replacement, or total knee replacement
4. The posterior stabilized knee system is designed for use in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
   The Porous Patella and the Porous Tibia Baseplate are indicated for use with or without bone cement, and are single use devices.

The purpose of this Traditional 510(k) is to add MR safety information to the labeling (instructions for use, product labeling and patient implant card) of the subject Smith & Nephew Knee Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. As these products have been in distribution for several years, some parts have undergone changes in the technological characteristics that were assessed in compliance with the FDA's guidanceon "Deciding When to Submit a 510(k) for a Change to an Existing Device" or the FDA predecessor guidance on how to review changes to an existing device. These are not cumulative changes for all Smith & Nephew Knee Systems, but are rather specific changes that only affect certain parts. In the context of this submission, no modifications have been made to the device design, materials, sterilization, or the manufacturing process of the previously cleared devices due to the addition of MR Labeling for this 510(k).

The provided text describes a 510(k) premarket notification for various Smith & Nephew knee systems. The purpose of this submission is not to introduce a new device or significantly change an existing one that would require a new performance study to demonstrate clinical effectiveness or safety based on patient outcomes. Instead, the core of this submission is to add MR safety information to the labeling of existing, already cleared devices.

Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic or AI-driven devices (which you are asking about) are not applicable to this 510(k) submission.

The "performance data" section in the document, despite its heading, refers specifically to Magnetic Resonance Imaging (MRI) compatibility testing, not clinical performance of the knee implants themselves. This testing aims to demonstrate that the presence of the knee implants does not pose an undue risk or create excessive artifacts during MRI scans.

Here's why the questions you asked cannot be fully answered or are not relevant to this specific regulatory submission:

• No new device performance for clinical outcomes: This submission isn't about proving a device (like an AI algorithm) is effective at diagnosing or treating a condition. It's about ensuring an existing physical implant is safe in an MRI environment.
• No diagnostic or AI algorithm: The "device" in question here is a knee implant, not a software algorithm that generates clinical insights or diagnoses. Therefore, terms like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth," or "training set" are not applicable.

However, I can extract the relevant information regarding the MR safety testing which serves as the "study" for this particular 510(k) submission:

Acceptance Criteria and Study for MR Safety Labeling (as described in the document):

Since this 510(k) is specifically for adding MR safety information to the labeling of already cleared devices, the "acceptance criteria" and "study" revolve around demonstrating the device's compatibility with MRI environments, not its clinical performance as a knee implant.

1. Table of Acceptance Criteria and Reported Device Performance (for MR Safety)

Summary of Device Performance: The document states that "MR Safety testing/assessments support the appropriate MR parameters and symbols found in the subject device labeling." This implies that the devices met the requirements of the referenced ASTM and IEC standards for MR compatibility, allowing defined MR conditions (e.g., specific field strengths, gradients, RF levels) for imaging patients with these implants.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the sample size for the MR safety testing. These tests are typically conducted on representative samples of the implant devices themselves, not on human patients.
• Data Provenance: The testing references industry standards (ASTM, IEC, ISO/TS), indicating that the tests were performed in a controlled laboratory environment in accordance with these established protocols. The country of origin of the data is not specified but is presumed to be where Smith & Nephew conducted their R&D and testing. Since it's device testing, not patient data, the retrospective/prospective distinction is not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable: For MR safety testing of physical implants, "ground truth" as established by human experts (like radiologists interpreting images) is not the primary method. The "ground truth" for MR safety is determined by the physical properties of the materials and the design of the device, measured against established engineering and safety standards. The experts involved would be engineers and physicists specializing in MRI safety and material science.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods (like 2+1 or 3+1 for clinical interpretations) are not relevant here. The results of MR safety testing are quantitative measurements (e.g., temperature rise, displacement force, torque, artifact size) subject to direct measurement and comparison against defined thresholds in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No: This is not applicable. MRMC studies are used to assess the impact of a diagnostic tool (like an AI algorithm) on human reader performance. This submission is about the physical safety of an implant in an MRI scanner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No: This is not applicable as there is no algorithm being tested in this submission.

7. The Type of Ground Truth Used:

• Technical Standards and Physical Measurements: The "ground truth" for MR safety is established by international and national technical standards (ASTM, IEC, ISO/TS) that define acceptable limits for magnetic force, torque, heating, and image artifact. The studies involve physical measurements of these parameters using specialized testing equipment.

8. The Sample Size for the Training Set:

• Not Applicable: There is no "training set" in the context of MR safety testing of physical implants, as this is not an AI/machine learning submission.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable: As there is no training set, this question is not relevant.

In summary, this 510(k) submission is a prime example of a regulatory clearance based on engineering and performance testing against recognized standards for physical device properties (MR compatibility), rather than clinical efficacy studies or AI performance metrics.

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Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.

In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).

Indications for the TRIGEN Hindfoot Fusion Nail (HFN) include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.

The TRIGEN Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The TRIGEN InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures.

Knee Fusion Nails are intended for intramedullary knee arthrodesis.

The purpose of this Traditional 510(k) is to add the MR safety information to the labeling and update the information within the package insert for the Smith & Nephew Intramedullary Nail Systems. The Smith & Nephew Intramedullary Nail Systems consist of the following previously cleared devices:

• Trigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. . 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006)
• Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998, , K040929 S.E. 5/25/2004, ● and K111025 S.E. 7/1/2011)
• Trigen Hindfoot Fusion Nail System (K043052 S.E. 11/24/2004) .
• . Trigen Humeral Nail System (K032722 S.E. 10/1/2003)
• Trigen Intertan Intertrochanteric Antegrade Nail System (K040212 S.E. 2/20/2004) ●
• . Trigen Knee Fusion Nail System (K050938 S.E. 5/4/2005)
  The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices as a part of this subject 510(k).

The provided text describes a 510(k) premarket notification for Smith & Nephew Intramedullary Nail Systems. The primary purpose of this submission is to add MR safety information to the labeling and update the information within the package insert for existing, previously cleared devices. This means the device itself has not changed in design, material, sterilization, or manufacturing processes. Therefore, the "study that proves the device meets the acceptance criteria" is focused on Magnetic Resonance Imaging (MRI) compatibility testing.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a tabular format with specific performance metrics for the device itself (e.g., fracture healing rates, strength). Instead, the acceptance criteria relate to MRI compatibility, which is assessed against established standards and guidance documents. The "reported device performance" in this context refers to the successful completion of these tests.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not detail the specific sample size of devices tested for MRI compatibility. The testing information is generic, referring to "MRI compatibility testing was conducted." Given the nature of medical device MR safety testing, it typically involves a representative sample of device configurations (e.g., different sizes, materials, locking mechanisms) rather than a large "dataset" of patient data.

The data provenance is implied to be laboratory testing conducted according to the listed ASTM and IEC standards. There is no mention of patient data (retrospective or prospective) from any specific country of origin, as the submission is about changes to labeling based on technical testing, not clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This question is not applicable to this submission. The "ground truth" for MRI compatibility testing is established by the scientific principles and methodologies outlined in the referenced international standards (ASTM, IEC, ISO/TS) and FDA guidance documents, not by expert consensus on clinical cases. Testing engineers and MR safety specialists would be involved in conducting and interpreting these tests, but they are not "experts establishing ground truth" in the way radiologists might for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human reviewers assess the same case and discrepancies need to be resolved. This submission is about technical testing of device properties, not clinical assessment by human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study involves human readers (e.g., radiologists) assessing cases, often with and without AI assistance, to measure the impact of AI on their performance. This submission does not involve an AI component or the assessment of human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This submission is for physical intramedullary nail systems, not a software algorithm or AI device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is derived from the established physical and electromagnetic principles and measurement standards for MRI compatibility. The tests measure physical parameters like temperature rise, displacement force, torque, and artifact generation under defined MR conditions, with the standards themselves defining acceptable limits and testing methodologies.

8. The Sample Size for the Training Set:

Not applicable. This submission does not involve a training set as it pertains to physical devices and their MRI compatibility testing, not machine learning algorithms.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set.

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The Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.

The Smith & Nephew INTELLIO 4K CCU is a part of the Smith & Nephew visualization system. It is an all-in-one 4K imaging console and LED light source designed for endoscopic surgical procedures. The CCU is compatible with the LENS 4K Camera Head. The functional system level architecture of this device demonstrates multiple functions, that includes the illumination of surgical space and capturing of raw imaging data from the camera sensors. It also processes the imaging data and transfers it to the attached monitor for display. Apart from capturing still images and video during the procedure, the device also adjusts the visualization settings (brightness, line enhancement, color saturation/hue and image zoom) and allows optional communication to a medical tablet to facilitate centralized control of all tower devices from the tablet. The device contains of a Wi-Fi board that supports communication frequency of 2.4 GHz and 5.0 GHz. The device uses a LED light engine to illuminate the surgical space. The User Interface (UI) consists of buttons and LEDs that can be accessed on the front panel, which also contain the ports for camera head connector and USB slots for medical tablet and flash drive.

The provided text is a 510(k) summary for the Smith & Nephew Intellio 4K Camera Control Unit. It outlines the device description, indications for use, comparison to a predicate device, and non-clinical performance data.

However, the document does not contain any information regarding acceptance criteria, study details, or performance metrics in the context of device performance meeting acceptance criteria as typically seen for AI/ML device clearances. The "Non-Clinical Performance Data" section lists various engineering tests (Shock and Vibration, EMI/EMC, Safety, Packaging Design Verification) that were performed and states they "passed all acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the reported performance data for these tests.

Furthermore, it explicitly states: "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence." This indicates that no human-in-the-loop or standalone performance study, as described in your request (e.g., MRMC study, ground truth establishment, expert adjudication), was performed or provided for this 510(k) submission.

Therefore,Based on the provided text, I cannot fulfill your request for the following reasons:

• No Acceptance Criteria or Performance Data for "Device Performance" (as in clinical/diagnostic performance): The document refers to acceptance criteria for engineering tests (e.g., shock, vibration, safety), stating they passed, but it does not provide specific acceptance criteria or performance results for these tests. Crucially, it does not describe any clinical or diagnostic performance criteria or studies that would involve AI/ML components or human-in-the-loop performance.
• No Clinical Study Data: The document explicitly states "Clinical testing was not necessary for the determination of substantial equivalence." This means there is no data on:
  • Sample size for test sets
  • Data provenance
  • Number or qualifications of experts for ground truth
  • Adjudication methods
  • MRMC studies or effect sizes
  • Standalone algorithm performance
  • Type of ground truth used (clinical, pathology, outcomes)
  • Training set sample size or ground truth establishment for a training set (as no AI/ML component seeking performance clearance is mentioned).

This 510(k) focuses on substantial equivalence to a predicate device for a camera control unit and its accessories, primarily based on technological similarities and non-clinical engineering performance, not on a device that utilizes AI/ML requiring clinical performance validation as implied by your detailed request.

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The EVOS MINI Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, and clavicle. The EVOS Partial Articular and Anti-Glide Plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula. The EVOS Wrist Fracture Plating System is indicated for adult and pediatic patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna. The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

The PERI-LOC Plate and Screw System can be used for adult and pediativ patients with osteopenic bone. PERI-LOC bone plates and bone screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, humerus, ulna, radius, calcaneus, and clavicle. PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatic patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and for fracture fixation of the firstion of the firstilula. PERI-LOC VLP One-Third Tubular Locking Plates are indicated for, but not limited to, fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals. PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures of the proximal femur including metastatic fractures: proximal fenur osteotonies: fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures. The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot. The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus. The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The VLP MINI-MOD Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot. The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.

The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius.

Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatic as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.) 2. Trochanteric or subtrochanteric fractures with appropriate additional precautions about weight bearing and more than sedentary activity. 3. Osteotomies for patients with diseases or deformities of the hip. 4. Hip arthrodesis. 5. Supracondylar fractures and distal femoral fractures using a supracondylar plate. 6. Ipsilateral femoral shaft/neck fractures.

CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metatarsals, patella, ultar styloid, capitellum, radial head and radial styloid. The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle. The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bone fragments; arthrodeses of small ioints; bunionectomies and osteotomies; scaphoid and other carpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The Smith & Nephew 2.0mm OFX Screw is indicated for osteotomies of the lesser metatarsals, such as Well osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.

The purpose of this Traditional 510(k) is to update the MR safety information for the Smith & Nephew Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices.

The provided document is a 510(k) premarket notification for various orthopedic plates and screws systems from Smith & Nephew. The purpose of this submission is solely to update the MR safety information for these devices. The document explicitly states that no modifications have been made to the device design, material, sterilization, and manufacturing processes.

Therefore, this document does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria. The performance data mentioned (Magnetically induced displacement force, Magnetically induced torque, Radiofrequency (RF) induced heating, MR image artifact) relates to MRI compatibility testing, not the primary clinical performance of the orthopedic fixation devices themselves.

Given this, the requested information about acceptance criteria and a study demonstrating device performance cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices based on unchanged technological characteristics and updated MR safety information.

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The Smith+Nephew INTELLIO Tablet is indicated for use to provide wired or wireless remote control of Smith+Nephew compatible surgical and endoscopic devices within the operating room including camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.

The INTELLIO Tablet application software is pre-installed upon a medical grade tablet that is used with compatible Smith + Nephew surgical and endoscopic device allows for control of parameters within the operating room, including camera control system, patient information system, mechanical resection system, Fluid Management system and RF Coblation system. The device also connects to the MY.INTELLIO™ cloud and provides access to medical device status, settings, images/videos, and reports before, during and after surgical procedures. Additionally, software updates are manually downloaded from the MY.INTELLIO cloud account via secured link and can be installed via the administrator account. The device is able to set parameters remotely for the Fluid management pumps, Mechanical Resection controller and RF Coblation controller by connecting to the Wifi connect device either separate (LINK box) or integrated with the individual pump or controller. It also provides a secondary control mechanism for all of these devices forming a connected system. The primary control for setting parameters are on the individual devices.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this document is a 510(k) premarket notification letter from the FDA for a device called the "Smith+Nephew INTELLIO Tablet." It focuses on demonstrating "substantial equivalence" to a predicate device (Smith+Nephew Tablet Application cleared in K203566), rather than presenting a performance study with detailed acceptance criteria.

The "Performance Data" section (H) merely lists the types of testing performed:

• Physical Verification
• Software Verification and Validation
• Emissions and Immunity Testing
• Electrical Safety Testing

It states that "Testing demonstrated that the Smith+Nephew INTELLIO Tablet has met the performance specifications," but it does not specify what those performance specifications (acceptance criteria) were or what the reported device performance was. It also doesn't describe any clinical study or any study involving human readers or ground truth.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, reported performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided document.

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The components are indicated for the following:

1. Non-inflammatory degenerative joint disease including osteonecrosis, avascular necrosis and post traumatic arthritis;
2. Rheumatoid arthritis;
3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
4. Revision procedures where other treatment or devices have failed; and
5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The indications for use in total hip arthoplasty include rheumatoid arthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.

1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
2. Fracture or avascular necrosis of the femoral head
3. Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
4. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
5. Fracture or avascular necrosis of the femoral head
6. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
7. All forms of osteoarthritis
8. Patients with hips at risk of dislocation
9. Femoral neck fracture or proximal fracture to hip joint
   The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only.
   The components are intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.
   The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.

The purpose of this Traditional 510(k) is to add "MR Conditional" labeling to the subject Smith & Nephew Hip Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the devices' design, material, sterilization and the manufacturing processes of the previously cleared devices.

This document is a 510(k) Premarket Notification from Smith & Nephew, Inc. for various Hip Systems. The purpose of this submission is to add "MR Conditional" labeling to these hip systems.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes MR Conditional labeling, meaning the devices have been tested and found to be safe for use in specific MRI environments. The acceptance criteria are based on established standards for MRI compatibility.

Key takeaway: The document confirms that "Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance and the Standards listed" to support the "MR Conditional" labeling. However, it does not provide specific data points (e.g., maximum temperature rise, angular deflection, or translational force metrics) for each test. Instead, it makes a general statement that the testing supports the MR Conditional claim.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in terms of patient data or clinical images, as the study is focused on the physical devices' compatibility with MRI environments, not clinical performance or diagnostic accuracy.

The studies were conducted on the devices themselves (hip systems and their components). The provenance is implied to be laboratory testing based on the referenced ASTM and ISO standards for MRI compatibility. The data is prospective in the sense that the tests were performed to demonstrate compliance for new labeling.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this type of submission. The "ground truth" here is established by the scientifically validated test methods and established standards (e.g., ASTM, ISO, IEC) for MRI compatibility, not by expert consensus on clinical cases. The tests themselves define the "ground truth" for the physical properties being measured (e.g., magnetic susceptibility, RF heating).

4. Adjudication Method for the Test Set:

This is not applicable as the studies are physical/engineering tests against objective standards, not interpretation of clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is used to assess the diagnostic performance of an AI algorithm in comparison to or in conjunction with human readers. This submission is for the "MR Conditional" labeling of hip systems, which is a safety and functional characteristic of the physical implant, not a diagnostic AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This submission is not for an algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these "MR Conditional" studies is objective physical measurements conducted according to recognized international consensus standards (ASTM, ISO, IEC) and FDA guidance documents. These standards define the acceptable limits for parameters like magnetically induced displacement, torque, and RF-induced heating.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/machine learning device requiring a training set. The "training" for the hip systems refers to their design and manufacturing to meet performance specifications.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as this is not an AI/machine learning device. The "ground truth" for the design and manufacturing of the hip systems is established through engineering principles, material science, biomechanical testing, and adherence to quality systems and regulatory requirements, which are inherent to their previous clearances. The ground truth for the MR Conditional labeling is established by the referenced MRI compatibility test standards.

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Compression Hip Screw (CHS):
Adult Indications:

1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
2. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
3. Osteotomies for patients with diseases or deformities of the hip.
4. Hip arthrodesis.
5. Supracondylar fractures and distal femoral fractures using a supracondylar plate.
6. Ipsilateral femoral shaft/neck fractures.
   Pediatric Indications:
7. Congenital coxa vara.
8. Congenital dislocation of the hip.
9. Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
10. Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.

CONQUEST FN:
CONOUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

D-Rad:
The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius.

EVOS:
The EVOS MINI Plating System is indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.
The EVOS Partial Articular and Anti-Glide Plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula.
The EVOS Wrist Fracture Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.

PERI-LOC:
The PERI-LOC Plate and Screw System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and bone screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AQ/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC VLP One-Third Tubular Locking Plates are indicated for, but not limited to, fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.
PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multifragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot. midfoot and hindfoot.
The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation. arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The VLP MINI-MOD Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.

TC-100:
Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

Cannulated Screws:
Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.
The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 5.5mm. 6.5mm. 7.0mm. and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and nonunions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies, Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.

The purpose of this Traditional 510(k) is to add the MR safety information to the labeling, and update the information within the package insert for the Smith & Nephew Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices.

This document describes the Smith & Nephew Plates and Screws Systems, which encompasses several product lines: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws.

Acceptance Criteria and Device Performance:

The document states that the purpose of this 510(k) submission is to add MR safety information to the labeling and update information within the package inserts for the listed devices. It explicitly states: "The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices."

Therefore, the acceptance criteria for this specific submission are not focused on clinical performance metrics of the device for fracture fixation, but rather on the safety and compatibility of the implants within a Magnetic Resonance (MR) environment, as well as ensuring that the updated labeling and package insert information is accurate and appropriate.

Table of Acceptance Criteria and Reported Device Performance:

Since the submission is primarily for adding MR safety information and updating labeling, the "acceptance criteria" here relate to meeting specific MR safety testing standards rather than clinical efficacy metrics.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is Magnetic Resonance Imaging (MRI) compatibility testing.

1. Sample Size used for the test set and data provenance:

   • The document does not explicitly state the sample size (number of devices or configurations tested) for the MRI compatibility testing.
   • Data Provenance: The testing was conducted "as per the FDA's guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment', December 11, 2014 and the standards listed below." This implies the testing was likely prospective, conducted specifically for this submission, and likely performed in a controlled laboratory environment. The country of origin of the data is not specified but would typically be where the testing facility is located (presumably in the US or a country with recognized testing standards for FDA submissions).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For MRI compatibility testing of passive implants, "ground truth" is established by the adherence to and results of standardized tests (ASTM F2052, F2213, F2182, F2119). These tests have defined methodologies for measuring physical properties related to MR safety.
   • The document does not mention the use of human experts (e.g., radiologists) for subjective evaluation in this context, as the evaluation is based on objective measurements according to the specified ASTM standards. The "experts" implied are those who developed and validated these ASTM standards and the technical personnel who perform the tests according to the standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable for this type of testing. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical image interpretation, not for objective physical property measurements in MRI compatibility testing. The results of the ASTM tests are quantitative measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for surgical implants (bone plates and screws), not for an AI-powered diagnostic device. The study described is MRI compatibility testing.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this is not an AI algorithm. The testing performed is for physical device properties in an MR environment.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for MRI compatibility is based on objective, quantitative measurements obtained by following established industry standards (ASTM F2052, F2213, F2182, F2119), as outlined in FDA guidance. These standards define the limits and acceptable performance for implants in an MR environment.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The study is a series of physical tests on the manufactured devices.

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set for this type of device and submission.

Summary of Conclusion:

The conclusion is that the Smith & Nephew Plates and Screws Systems are substantially equivalent to the predicate devices because the only changes are the addition of MR safety information to the labeling and updates to the package insert. The fundamental device design, material, sterilization, manufacturing processes, and operational principles remain unchanged. The MRI compatibility testing confirms that the devices are safe for use in an MR environment under specified conditions, meeting the relevant ASTM standards and FDA guidance for passive implants.

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The Smith+Nephew Arthroscopes is indicated to provide illumination and visualization in:

· Diagnostic and Operative arthroscopic procedures for the hip, knee, shoulder, wrist, ankle, elbow, and feet.

In addition, Smith+Nephew 4 mm diameter rigid athroscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

The proposed Smith+Nephew 4KO Direct View/Video Arthroscopes are a line extension to the previously cleared K971253 and are surgical instruments used for illumination and visualization of surgical sites within articular cavities, body cavities, hollow organs and canals.

The Arthroscopes are designed with various angle specifications for directions of view and working lengths for access to various locations. The Arthroscopes are shipped non-sterile and must be cleaned, inspected and sterilized prior to each use. Both designs consist of a long tube containing a series of rod lenses that work to transfer the image of the patient's anatomy, through an associated visualization camera system, to a central monitor for clinical use in treatment.

The direct view scopes require attachment to an endocoupler and the VideoEndoscopes are attached to a Smith+Nephew C-Mount camera head.

Illumination is provided through a bundle of optical fibers internal to the Endoscope that transmits light from an external source to illuminate the image.

This inquiry pertains to a 510(k) premarket notification for the "Smith+Nephew Arthroscopes" (K201349). The provided documentation describes a medical device, specifically an arthroscope, which is a type of endoscope used for visualization during diagnostic and operative arthroscopic procedures.

The information provided does not describe an AI/ML powered device, nor does it detail a study that proves the device meets specific acceptance criteria in the manner one would typically expect for an AI/ML product. The document instead focuses on demonstrating substantial equivalence to a predicate device through performance testing of the physical arthroscope.

Therefore, many of the requested fields cannot be filled as they are explicitly related to AI/ML device testing and evaluation.

Here's a breakdown of the available information and why other fields cannot be completed:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Performance Testing" in general terms for the physical device but does not specify sample sizes for these tests, nor the origin or nature of the data (e.g., patient data, in-vitro testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a physical arthroscope, not an AI/ML diagnostic or image analysis tool requiring expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the reasons stated above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as this is not an AI/ML device, and no MRMC study is detailed for its comparison or human-in-the-loop performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable for the reasons stated above. The "ground truth" for a physical arthroscope's performance would relate to physical specifications and functional tests, not clinical diagnostic ground truth.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device and therefore does not have a "training set."

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/ML device and therefore does not have a "training set" or associated ground truth establishment process.

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Smith & Nephew's VISIONAIRE Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. Knee Systems and their cleared indications for use:

• Genesis II Knee System
• Legion Knee System
• Journey BCS Knee System
• Journey II Knee System

The Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks are intended for single use only.

The subject of this premarket notification is to seek FDA clearance of software components to be used in the design and manufacture of the VISIONAIRE Patient Matched Cutting Blocks. Patient Matched Cutting Blocks were previously cleared for market via premarket notifications- K183010. The blocks are designed utilizing the VISIONAIRE Patient Matched Technology software components and patient imaging data (MRI, X-Ray). The blocks are intended to be used as patient-specific surgical instruments to assist in the positioning of total knee replacement implant components intra-operatively and in guiding the marking of bone before cutting.

The provided document, K200826, describes a 510(k) premarket notification for the "Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks." This submission focuses on seeking FDA clearance for software components used in the design and manufacture of these cutting blocks, rather than the blocks themselves or a new AI algorithm for medical image analysis.

The document explicitly states:

• "No new mechanical testing was performed. No implants or new blocks are being introduced in this premarket notification." (Page 4)
• "There are no changes to the block design, packaging, material composition or manufacturing of Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks as a result of these changes described in the premarket notification." (Page 4)
• "Clinical data was not needed to support the safety and effectiveness of the subject device(s)." (Page 4)
• "Software verification and validation testing was completed in line with FDA's guidance document entitled, 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff,' dated January 11, 2002." (Page 4)

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning the performance of an AI-powered diagnostic or decision-support system. The information requested (e.g., acceptance criteria tables, sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, ground truth types) is typical for the validation of AI/ML medical devices that perform tasks like image analysis or diagnosis.

This 510(k) submission is for software changes related to the design and manufacturing process of previously cleared devices (K183010), not for a new AI algorithm that uses medical imaging directly for diagnostic or assistance purposes in the way implied by the questions. The software validation mentioned is general software validation (e.g., unit testing, integration testing, system testing) to ensure the software performs its intended function in designing the blocks correctly, not a clinical performance study with human readers or an AI-only performance study against ground truth established by experts.

To answer your request, if this were an AI medical device, the following information would be expected:

1. A table of acceptance criteria and the reported device performance: This would typically define metrics like sensitivity, specificity, AUC, or accuracy, along with objective thresholds that the device's performance must meet.
2. Sample sizes used for the test set and the data provenance: Details on the number of cases (e.g., scans, patients) in the test set, where the data came from (e.g., specific hospitals, demographics), and whether it was retrospectively collected or prospectively collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications: How many domain experts (e.g., board-certified radiologists) reviewed the test cases to establish the definitive diagnosis or finding, and their experience levels.
4. Adjudication method for the test set: How disagreements among experts in establishing ground truth were resolved (e.g., majority vote, consensus meeting, senior expert review).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Whether human readers were evaluated with and without the AI assistance, and the statistical significance of any improvement in their performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The performance metrics of the AI algorithm operating independently of human review.
7. The type of ground truth used: Whether ground truth was derived from expert consensus, histopathology, long-term patient outcomes, or another definitive method.
8. The sample size for the training set: The number of cases used to train the AI model.
9. How the ground truth for the training set was established: The process by which the training data was labeled and verified.

Since the provided document is not for an AI diagnostic device in the traditional sense, it lacks these specific details. The software in question essentially aids in the manufacturing design of a physical device, based on patient imaging data, rather than performing an interpretive or diagnostic function on the imaging itself.

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