Search Results

The OsteoCentric Integrated Hip Fastener System is indicated for stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

The OsteoCentric Integrated Hip Fastener System is indicated for femoral neck fractures including intracapsular, transcervical, and subcapital fractures.

The OsteoCentric Integrated Hip Fastener System is internal fixation of intertrochanteric and femoral neck fractures of the proximal femur. The OsteoCentric Integrated Hip Fastener System consists of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. Integrated Hip Fasteners which are lag screws implanted through the femoral neck and head are offered in Ø11, Ø13, & Ø15mm sizes with lengths ranging from 50 – 140mm in 5mm increments. Hip side plates are offered in 1-hole to 19-hole configurations (48 – 330mm length). 6.0mm support fasteners are offered in 55 – 125mm lengths. 5.2mm shaft fasteners are offered in 28 – 46mm locking fasteners for the trochanter plate are offered in 16 – 40mm lengths. Compression and attachment screws are also available. Devices are provided non-sterile. All implantable devices are manufactured from stainless steel per ASTM F138.

This document is a 510(k) Premarket Notification from the FDA regarding the OsteoCentric Integrated Hip Fastener System. It does not describe an AI/ML medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it concerns a traditional medical device (metallic bone fixation appliances) and its substantial equivalence to previously cleared predicate devices.

Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and reader performance for an AI/ML device is not present in the provided text. The document focuses on the physical characteristics of the hip fastener system (e.g., sizes, materials) and its intended use for treating hip fractures.

To answer your request, if this were an AI/ML device submission, the FDA would require detailed information on its performance, typically including:

1. Acceptance Criteria and Performance Table: This would outline the metrics (e.g., sensitivity, specificity, AUC) the device needed to achieve and the reported performance.
2. Sample Size and Data Provenance: Details on the number of cases in the test set, their origin (e.g., multi-site, geographical distribution), and whether the data was collected retrospectively or prospectively.
3. Ground Truth Experts: The number and qualifications of clinicians who established the definitive diagnosis for the test cases.
4. Adjudication Method: How disagreements among experts were resolved to form the ground truth (e.g., majority vote, senior expert arbitration).
5. MRMC Study: If applicable, a human-in-the-loop study comparing diagnostic accuracy with and without AI assistance, quantifying the improvement.
6. Standalone Performance: The algorithm's performance without human interaction.
7. Type of Ground Truth: Whether the ground truth was based on expert consensus, pathology, long-term outcomes, or other definitive sources.
8. Training Set Sample Size: The number of cases used to train the AI model.
9. Training Set Ground Truth: How the ground truth for the training data was established.

Since this document pertains to a mechanical medical device, none of this information is relevant or provided within the text.

Ask a specific question about this device

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.

Ask a specific question about this device

The OsteoCentric Integrated Hip Fastener System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

The OsteoCentric Integrated Hip Fastener System is intended for use in internal fixation of femoral neck fractures. The OsteoCentric Integrated Hip Fastem consist of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided non-sterile. All implantable devices are manufactured from Stainless Steel per ASTM F138.

The provided document is a 510(k) premarket notification for a medical device called the "OsteoCentric Integrated Hip Fastener System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with strict acceptance criteria and performance metrics.

Therefore, the document does not contain the kind of information typically requested for AI/ML device studies, such as:

• A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, AUC, etc.)
• Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
• Number of experts and their qualifications used to establish ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm-only) performance
• Type of ground truth used (pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

Instead, this document describes an engineering analysis for a mechanical device.

Here's what the document does provide regarding the "study" that proves the device meets the "acceptance criteria" (using these terms loosely in the context of a mechanical device submission):

1. Acceptance Criteria and Reported Device Performance (Mechanical Context):

The acceptance criteria here are implicitly demonstrating substantial equivalence to predicate devices in terms of mechanical properties for the intended use.

2. Sample size used for the test set and the data provenance:

• Test Set: No discrete "test set" in the context of an AI/ML algorithm is mentioned. The assessment was based on an "engineering analysis" comparing physical properties and design features of the subject device to predicate devices. This involves material properties, moment of inertia, screw types/sizes, and thread profiles.
• Data Provenance: Not applicable in the context of an engineering analysis of mechanical components. The data would come from specifications, material testing standards (e.g., ASTM F138), and design comparisons.

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

• Not applicable. Ground truth for mechanical properties is established through engineering principles, material science, and testing standards, not expert consensus in the medical imaging sense. The submission was prepared by Nathan Wright MS, an Engineer & Regulatory Specialist at Empirical Testing Corp.

4. Adjudication method for the test set:

• Not applicable. There was no clinical or interpretative "test set" requiring adjudication.

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:

• Not applicable. This is a mechanical bone fixation device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is a mechanical device.

7. The type of ground truth used:

• Engineering specifications and standards: The "ground truth" for this device's performance relies on established engineering principles, material science (e.g., Stainless Steel per ASTM F138 specifications), and comparative analysis against the known mechanical properties of legally marketed predicate devices. The aim is to show that the new device's mechanical integrity is equivalent or superior to existing devices for the same indications.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this type of mechanical device submission.

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

• Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

The THP™ Hip Fracture Plating System is indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures.

THP Hip Fracture Plating System is a set of metal plates and associated screws designed to affix to the lateral aspect of the proximal femur and provide fracture stabilization for femoral neck fractures and intertrochanteric fractures. The THP 5.0mm Cortical Screws are both locking and non-locking. The locking screws contain external threads that can be used to lock the threaded holes on the plate body, while the non-locking screws do not include the external threads to complete this task.

The provided document is a 510(k) premarket notification for the "THP™ Hip Fracture Plating System" by Biomet, Inc. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily addressing design modifications (specifically related to 5.0mm cortical screws and plate modifications) and confirming that these changes do not adversely affect the device's safety and effectiveness.

Crucially, this document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the typical performance metrics of sensitivity, specificity, or reader studies. Instead, it describes mechanical and biocompatibility testing of a physical implantable medical device.

Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this submission.

Here's how to address the request based on the provided document:

Acceptance Criteria and Study for the "THP™ Hip Fracture Plating System"

This 510(k) submission for the THP™ Hip Fracture Plating System focuses on demonstrating substantial equivalence to predicate devices, particularly in light of design modifications to address a head breakage issue in previously cleared screws and enhancements to the plates. The "acceptance criteria" in this context are primarily related to the mechanical performance and biocompatibility of the revised components being equivalent or superior to the predicate devices, ensuring no new safety or effectiveness concerns are introduced.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of screws or plates) used for each mechanical test. This level of detail is typically found in the full test reports, which are part of the detailed submission but not typically summarized in the 510(k) summary. However, the studies were sufficient for the FDA to draw conclusions of substantial equivalence.
• Data Provenance: The data is non-clinical performance data generated through mechanical and chemical testing of the device components (screws and plates). The location of the testing is not specified, but it would have been conducted under controlled laboratory conditions, likely by or for the manufacturer (Biomet, Inc., Warsaw, Indiana, USA). This is retrospective testing in the sense that it evaluates manufactured device components against predefined standards or predicate device performance. It is not human clinical data or patient data.

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

• Not Applicable. This is not a diagnostic device or an AI/ML device requiring human expert annotation or ground truth derived from clinical interpretation. The "ground truth" for these mechanical tests is established by published ISO standards (e.g., ISO 11137-2:2013 for sterilization, ISO 10993-1 for biocompatibility) and direct physical measurements/testing against specified engineering parameters or predicate device performance.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication method is relevant for these non-clinical, objective mechanical and chemical tests. The results are quantitative measurements interpreted against pre-defined performance criteria.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This submission is for a physical implantable orthopedic device, not a diagnostic imaging device or an AI component.

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

• Not Applicable. This is not an algorithm or an AI device. The "performance" discussed is the physical, mechanical, and biological performance of an implantable metallic device.

7. The Type of Ground Truth Used:

• Engineering Specifications / Predicate Device Performance / ISO Standards. The "ground truth" for the mechanical tests is the measured performance of the predicate devices or established engineering specifications for strength and fatigue resistance. For biocompatibility and sterilization, the ground truth is adherence to international standards (ISO 10993-1, ISO 11137-2:2013) and cGMP (21 CFR 58 for GLP). It is not expert consensus, pathology, or outcomes data in the sense of clinical studies.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm here. The device itself is the product under evaluation, and its properties are tested directly.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary, the provided FDA 510(k) document is for a traditional physical medical device (an orthopedic implant) and primarily demonstrates substantial equivalence through non-clinical mechanical and biocompatibility testing. The questions posed in the prompt are largely designed for AI/Machine Learning diagnostic devices and therefore do not directly apply to this specific submission.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies.

The TSP Hip Fracture Plating System consists of a series of side specific fracture plates designed to treat femoral neck, intertrochanteric and subtrochanteric fractures.

The TSP Hip Fracture Plating System incorporates fracture plates with multiple cortical screw hole configurations, three 7.5mm telescoping lag screws in lengths from 70mm to 130mm that are inserted into the femoral head and lock into the fracture plate, and 4.5mm cortical screws in lengths ranging from 14mm to 95mm with either locking or non-locking head designs. The plates, lag screws and cortical screws are all made of Ti-6A1-4V titanium alloy with a TiMax® Type II anodized finish.

Limited collapse sleeves are also available in 5mm, 10mm, 15mm and 20mm lengths to limit the amount of distraction of the telescoping lag screws.

The provided document is a 510(k) summary for the TSP Hip Fracture Plating System, which is a medical device for fixing bone fractures. This type of regulatory submission generally focuses on demonstrating substantial equivalence to a predicate device through non-clinical (e.g., benchtop) testing, rather than detailed clinical trials with acceptance criteria and statistical analysis of performance metrics typically seen for AI/ML devices.

Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are highly relevant for AI/ML device evaluations, are not applicable or available in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

This document does not specify quantitative acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity for a diagnostic or prognostic device. Instead, it concludes that the device performs "as well as the predicate hip screw systems" based on non-clinical tests.

Table of Acceptance Criteria and Reported Device Performance (Not Applicable in the traditional sense for this device):

Study Details

• 1. Sample size used for the test set and the data provenance:
  • Not Applicable. No clinical test set data from human subjects is mentioned. The testing focused on the physical device components.
• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  • Not Applicable. As no clinical data was used, no expert ground truth establishment for a test set was conducted.
• 3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
  • Not Applicable. No clinical test set.
• 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:
  • Not Applicable. This is not an AI-enabled device; therefore, no MRMC study, human readers, or AI assistance is relevant.
• 5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
  • Not Applicable. This is a physical orthopedic implant system, not an algorithm, so standalone performance is not relevant in this context.
• 6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  • Not Applicable. For non-clinical testing, "ground truth" would refer to engineering specifications, material properties, and established test standards for mechanical devices. The document implies comparison to industry standards and predicate device performance.
• 7. The sample size for the training set:
  • Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
• 8. How the ground truth for the training set was established:
  • Not Applicable. No training set exists for this type of device.

Conclusion from the Document

The 510(k) submission for the TSP Hip Fracture Plating System states that:
"Non-Clinical Testing: Testing of the TSP Hip Fracture Plating System included static and cyclic fatigue tests. Additionally, the lag screws and cortical screws were tested for torsional properties, insertion and removal torques and pullout strength. Testing indicated that the system would perform as well as the predicate hip screw systems."

"Clinical Testing: Clinical testing was not determined to be necessary to demonstrate substantial equivalence of the TSP Hip Fracture Plating System to the predicate hip fracture plating systems."

This clearly indicates that the substantial equivalence was demonstrated solely through benchtop, non-clinical testing, comparing the device's mechanical properties to those of existing, legally marketed predicate devices. The "acceptance criteria" were implicitly met by demonstrating comparable performance in these non-clinical tests to the predicate devices.

Ask a specific question about this device

Indications for the HipLOC™ Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

The HipLOC™ Compression Hip Screw is designed as an internal fixation device to provide alignment and strong stabilization for fractures of the proximal femur.

The provided text is a 510(k) summary for the HipLOC™ Compression Hip Screw, an internal fracture fixation device. The document states that no clinical testing was performed as a basis for substantial equivalence. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document focuses on demonstrating substantial equivalence to predicate devices (Biomet® Compression Hip Screw System, K781389; DHS® System, Synthes, K981757) based on technological characteristics and non-clinical laboratory testing.

Specifically, the following sections cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance results from a clinical study are provided.
2. Sample size used for the test set and the data provenance: No test set from a clinical study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth from a clinical study is mentioned.
4. Adjudication method for the test set: Not applicable as there is no clinical test set.
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: Not applicable as this is not an AI/imaging device and no clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
7. The type of ground truth used: Not applicable as there is no clinical study with ground truth.
8. The sample size for the training set: Not applicable as there is no training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable as there is no training set for an algorithm.

The document explicitly states under "Non-Clinical Testing": "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." And under "Clinical Testing": "None provided as a basis for substantial equivalence."

Ask a specific question about this device

1. ) Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head). 2.) Intertrochanteric fractures. 3.) Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored. 4.) Hip osteotomy Components in the InterTANTM CHS Plating System are for single use only.

The design of the InterTAN™ CHS Plating System is based on design features of the following currently marketed products: PERJ-IJOC™ Periarticular Locked Plating System, TriGen InterTAN Nail and CHS. InterTAN™CHS System is designed to address fractures of the proximal femur. System components include bone plates, lag screws, compression screws, and associated accessories. Like the predicate devices listed below, the subject components include various hole configurations and barrel angles of the contoured locking bone plates and various lengths of the lag/compression screws made from stainless steel and titanium. Further InterTAN™ CHS femoral locking bone plates, incorporate a screw-to-plate locking feature along the shaft of the plate which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text is a 510(k) summary for a medical device (InterTAN™ CHS Plating System) seeking clearance from the FDA. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than conducting new clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) application would.

Therefore, the typical metrics and study designs used to demonstrate device performance in a clinical or diagnostic context (like sensitivity, specificity, expert consensus, MRMC studies, etc.) are not applicable to this document.

Instead, the "acceptance criteria" for a 510(k) in this context are primarily related to demonstrating equivalence in design, materials, and intended use as compared to already legally marketed predicate devices. The "study" that proves the device meets these criteria is typically a comparison of technological characteristics and design features, supported by engineering analyses (e.g., mechanical testing not detailed in this summary but common to such submissions) rather than patient-based clinical trials.

Below is an attempt to structure the information based on your request, but with the understanding that many fields will be "Not Applicable" or interpreted differently for a 510(k) of this nature.

Acceptance Criteria and Study for InterTAN™ CHS Plating System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable in the context of a clinical test set with patient data for this 510(k) summary. The "test set" in this case would refer to the specific designs, materials, and potentially mechanical test samples used for comparison. This document does not specify the number of test articles (e.g., plates, screws) tested in any engineering verification.
• Data Provenance: Not applicable for a clinical test set. The data presented here is related to the device's design, materials, and a comparison to predicate devices, not data from human subjects.

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

• Not applicable. "Ground truth" in the clinical/diagnostic sense (e.g., confirmed diagnosis by a panel) is not established or discussed for this 510(k) summary. The "ground truth" here is the established design and performance of the predicate devices. Design expertise (e.g., engineers, orthopedic surgeons involved in design) would have been utilized during development, but this isn't detailed as "ground truth experts" for a test set.

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

• Not applicable. This concept is relevant for clinical or diagnostic studies involving human assessment, not for a 510(k) focused on design and material equivalence of a mechanical device.

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:

• Not applicable. This describes a specific type of clinical study for diagnostic devices, particularly those involving AI. The InterTAN™ CHS Plating System is an orthopedic implant and does not involve AI or "human readers" in its direct use or evaluation documented here.

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

• Not applicable. This device is a physical orthopedic implant, not a software algorithm.

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

• Type of Ground Truth: For a 510(k) of this nature, the "ground truth" against which the new device is compared is primarily the established safety and efficacy profile of the legally marketed predicate devices. This "ground truth" is derived from decades of clinical use and regulatory clearance of these predicate devices. The new device demonstrates substantial equivalence rather than proving de novo safety and efficacy with independent ground truth data.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of machine learning for this orthopedic implant.

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

• Not applicable. As there is no training set mentioned, this question is not relevant.

Ask a specific question about this device