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

The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional sizes of the bone plates to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for singleuse. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

This document, K193029, is a 510(k) premarket notification for a medical device called CONQUEST FN, specifically an additional size of the bone plate (CONQUEST FN 3 Hole Small Stature Plate). The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain information about studies involving AI or human readers, expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies. The acceptance criteria discussed refer to engineering and biocompatibility testing for a physical implant, not an AI/software device.

Therefore, I cannot provide a response filling in the requested information about AI device acceptance criteria and performance studies. The document describes a traditional medical device (metallic bone fixation appliance) and its mechanical and material testing.

The "Summary of Pre-Clinical Testing" section discusses:

• Construct Fatigue Testing: This is a mechanical test to assess the device's durability under repeated stress.
• Bacterial Endotoxin Testing: This is a biocompatibility test to ensure the device is safe from endotoxin contamination.

The acceptance criteria for these tests are described in terms of meeting specific standards and showing similar stability to the predicate device.

If your request was based on the assumption that this document detailed an AI/software device, please note that it does not.

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The Smith & Nephew Conquest FN is indicated for displaced intracapsular femoral neck fractures.

The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional lengths of the proximal locking compression screws to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The provided document is a 510(k) premarket notification for a medical device called CONQUEST FN, which is an internal fracture fixation device. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing (axial pullout strength).

It does not contain information related to a study proving the device meets acceptance criteria based on its performance in interpreting medical images or diagnosing conditions. The acceptance criteria described are for mechanical properties of the device (e.g., pullout strength), not for AI/ML performance metrics like sensitivity, specificity, or AUC which would be relevant to an imaging-based AI device.

Therefore, I cannot provide a response that includes the requested information regarding:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample size used for the test set and data provenance (as no such test set is described for diagnostic performance).
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study.
• Standalone performance.
• Type of ground truth used (clinical outcomes, pathology, expert consensus).
• Sample size for the training set.
• How ground truth for the training set was established.

The document is primarily a regulatory submission for a physical orthopedic implant, not an AI/ML-driven diagnostic imaging device. The "acceptance criteria" mentioned in the document refer to engineering/biomechanical performance standards for the implant itself, such as axial pullout strength, and bacterial endotoxin limits for sterility.

Summary of relevant information from the document (limited to what is present):

Acceptance Criteria and Performance (related to the physical device):

• Acceptance Criteria for Axial Pullout Strength: Not explicitly quantified in the provided text, but stated as "met the acceptance criteria" for two different tests. These criteria likely refer to specific biomechanical standards or comparisons to predicate devices.
• Reported Device Performance for Axial Pullout Strength:
  • OR-17-111: "Result concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior axial pullout strength compared to the predicate device [Targon FN Titanium System]."
  • OR-17-164: "Results of the test concluded that the CONQUEST FN proximal locking screws met the acceptance criteria and exhibited similar or superior axial pullout strength as compared to the predicate device [cannulated screws]."
• Acceptance Criteria for Sterility: "Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance, 'Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile,' 'Pyrogen and Endotoxin Testing: Questions and Answers,' and ANSI/AAMI ST72."
• Reported Device Performance for Sterility: "met the acceptable endotoxin limits."

Other information:

• Sample size for testing pullout strength: Not specified.
• Nature of data: Pre-clinical (mechanical testing in a lab setting), not human patient data.
• Ground truth: For mechanical tests, the "ground truth" is the measured physical property (axial pullout strength) compared against a defined standard or predicate performance. For sterility, it is the endotoxin level measurement compared to the standard. This is not "ground truth" in the diagnostic sense.
• No information on AI/ML components or studies for diagnostic performance is present in this document.

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The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The provided text describes mechanical testing conducted for the CONQUEST FN device to demonstrate its substantial equivalence to predicate devices. However, it does not contain information about a study involving human readers or AI assistance. Therefore, questions related to MRMC studies, human reader improvement with AI, and standalone AI performance cannot be answered from the provided text.

Here's the information extracted from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes pre-clinical mechanical testing. Typically, for such tests, "sample size" refers to the number of devices or constructs tested. The specific number of samples for each test (e.g., how many screws for pullout strength, how many constructs for fatigue) is not provided in the given text.

The data provenance is from pre-clinical mechanical testing conducted by Smith & Nephew, Inc. The country of origin is not explicitly stated for the testing, but Smith & Nephew is based in Memphis, Tennessee, USA. The data is prospective as it was generated specifically for the 510(k) submission to compare the new device against predicates.

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

This question is not applicable to this type of mechanical testing. Ground truth in this context is established by the physical testing methods and the measured mechanical properties, not by expert consensus on images or pathology.

4. Adjudication Method for the Test Set:

This question is not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert reviews, typically in image interpretation or clinical trials, not for direct physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

No, an MRMC comparative effectiveness study was not done. The provided text focuses exclusively on pre-clinical mechanical testing of a bone fixation device, not on AI-assisted diagnostic or interpretative tasks. Therefore, there is no information on human reader improvement with or without AI.

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. The device being described is a physical medical implant (bone fixation system), not a software algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these tests is mechanical performance metrics derived from standardized or accepted pre-clinical testing methods (e.g., axial pullout strength, insertion torque, torsional strength, fatigue life). The comparison is against established predicate device performance as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. The CONQUEST FN is a physical implant, not an AI model requiring a "training set."

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

This question is not applicable as there is no training set for a physical implant device.

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