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The DePuy Synthes Static Staples are indicated for extra-articular closing-wedge osteotomies of the 1st ray of the forefoot.

The DePuy Synthes Static Staple is an implant for bone fixation designed for extra-articular closing wedge osteotomies of the 1st ray of the forefoot. The implant is offered in two (2) configurations of 26° and 90° to address varying patient anatomy of the foot, particularly the 1st ray of the forefoot. The Static Staple implant is delivered to the operating room in a disposable, sterile kit, preloaded onto a handheld inserter along with drill guide and K-wires.

This appears to be a 510(k) premarket notification for a medical device, specifically the DePuy Synthes Static Staples. For such medical devices, "acceptance criteria" and "device performance" are typically related to mechanical and material properties, rather than diagnostic accuracy or clinical outcomes as might be found for AI/imaging devices.

Based on the provided document, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific "reported device performance" values in a pass/fail format. However, it states that the following non-clinical performance analysis were conducted and implies that the device met acceptable standards as substantial equivalence was claimed:

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

• Sample Size for Test Set: Not applicable as this is not a study focused on a diagnostic algorithm but rather a mechanical device. The "test set" here refers to the physical staples subjected to mechanical testing. The exact number of staples tested for each non-clinical analysis is not specified in this summary.
• Data Provenance: The studies were non-clinical (mechanical testing, MRI conditional testing). The location where these tests were performed is not specified, but the sponsor is DePuy Synthes, located in West Chester, PA, USA. The data is retrospective in the sense that the tests were performed on manufactured devices.

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

Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology in AI/imaging studies. For this mechanical device, the "ground truth" for the tests are the established standards (ASTM F564) and the physical properties of the materials and design. The testing would be performed by engineers and technicians, not clinical experts, and the results interpreted against defined specifications.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication by experts. The results of the mechanical tests are quantitative measurements compared against established standards or predicate device performance.

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 relevant for diagnostic or AI-assisted interpretation devices, not for a bone fixation staple. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a bone fixation staple, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data (mechanical testing and MRI conditional testing) is based on established engineering standards (e.g., ASTM F564) and material science principles, aiming to demonstrate the physical integrity and functional safety of the device. For substantial equivalence, the "ground truth" for comparison is the performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:

• Open reduction and internal fixation of fractures, mal-unions, and non-unions
• Following excision of benign bone tumors
• Replantations and reconstructions
• Arthrodeses of joints involving small bones
• Osteotomies, including deformity correction such as rotation, lengthening, shortening
• Pathological fractures, including impending pathologic fractures

The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. Generally, the system consists of plates, screws, and instruments which feature variable angle locking technology. The plates contained in the DePuy Synthes Variable Angle Locking Hand System are offered in a range of configurations to accommodate patient anatomy and surgical need. The plates are designed to accept existing 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screws at the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new 1.5mm VA Locking Screws feature existing variable angle locking technology (K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of the subject plates.

The provided text is a 510(k) premarket notification for a medical device (DePuy Synthes Variable Angle Locking Hand System). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance as would be seen in a PMA or De Novo submission.

Therefore, the document does not contain information typically found in acceptance criteria and study reports for software/AI devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details).

However, it does describe the non-clinical testing performed to demonstrate the substantial equivalence of the mechanical aspects of the device.

Here's an analysis of what information is available in the provided text, structured to address your request as much as possible given the limitations of the document:

Acceptance Criteria and Study to Prove Device Performance

This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing rather than clinical performance metrics with specific acceptance criteria typically associated with software or AI devices. The information below reflects the mechanical performance testing mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the non-clinical tests in the format of a table, nor does it provide the quantitative results of these tests. Instead, it lists the types of tests performed to support the device's performance and substantial equivalence to predicates.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not specified for the mechanical tests. For non-clinical mechanical testing, sample sizes are typically determined by relevant ASTM standards or internal validation protocols, often involving a small number of representative samples.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted by the manufacturer (DePuy Synthes). Country of origin is implied to be within the manufacturer's operational locations (e.g., USA, as the submitting entity is Synthes USA). The data is by nature "prospective" in the sense that the tests were designed and executed to evaluate this specific device configuration.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a mechanical implant, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" for mechanical testing is established by the physical properties of the materials and designs under standardized test conditions.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for clinical image interpretation or diagnostic decisions, not for mechanical testing of orthopedic implants.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a mechanical orthopedic implant, not an imaging device or AI diagnostic tool that would typically involve human readers.

6. Standalone Performance

The "standalone performance" in this context refers to the device's mechanical performance in laboratory settings, independent of human interaction during the test itself. The non-clinical tests (Dynamic Fatigue, Torsional, Pullout, Insertion Torque, FEA) evaluate the device in this standalone capacity.

7. Type of Ground Truth Used

For the mechanical tests, the "ground truth" is defined by:

• Standard ASTM methodologies: (e.g., ASTM F543 for screw properties).
• Engineering principles and material properties: Used in Finite Element Analysis.
• Physical measurements under controlled laboratory conditions.

This differs significantly from a "ground truth" for a diagnostic medical device which would involve expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set

Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm involved in the primary function or evaluation of this mechanical device.

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