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The ADAPT for Gamma3 System, when used with the Stryker Navigation System, assists the surgeon to determine the needed size and position of orthopedic implants during femur fracture surgery using the Gamma3 System.

When used in operation, the system should be operated only by trained personnel such as surgeons and clinic staff.

The Trochanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail indication may include fractures resulting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures.

The ADAPT for Gamma3 System consists of a software (ADAPT 2.0 for Gamma3 SW) and is compatible with hardware platforms, reference devices as well as Gamma3® implants and instruments. The software is designed to operate on the Stryker Navigation platforms (hardware platforms) and assists the surgeon to intraoperatively determine the size and position of Gamma3 implants during femur fracture surgery.

The Gamma3 Nail System is a family of intramedullary nails for basilar neck, intertrochanteric neck, peritrochanteric, subtrochanteric and femoral shaft fractures. The system consists of nails, lag screws, locking screws and screw sets.

The provided document is an FDA 510(k) clearance letter for the "ADAPT for Gamma3" system, which is a software and hardware system designed to assist surgeons in determining the size and position of orthopedic implants during femur fracture surgery.

Based on the document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum accuracy percentages or specific error tolerances) for the ADAPT for Gamma3 system's performance. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device (ADAPT for Gamma3 System K173946).

The reported device performance section primarily focuses on non-clinical testing results and the conclusion of substantial equivalence.

• Electrical safety and system safety per IEC 60601-1
• Electromagnetic Compatibility per IEC 60601-1-2 |
  | Usability | Compliance with usability engineering standards. | Non-clinical testing included:
• Formative and summative usability evaluation per IEC 62366-1 and IEC 60601-1-6 |
  | Reliability | Demonstrated reliability over its lifetime. | Non-clinical testing included:
• Reliability over lifetime for the ADAPT mobile PC Unit and the ADAPT mobile Operating System |
  | Performance (Equivalence)| The new ADAPT mobile platform must perform equivalently to the predicate ADAPT for Gamma3 System (K173946) regarding intended use, material, design, and operational principles. | Conclusion: "Testing demonstrated that ADAPT mobile is equivalent in performance to the predicate ADAPT for Gamma3 System (K173946)." The summary explicitly states: "A comparison of the systems demonstrated that the subject ADAPT for Gamma3 System and Gamma3 System are substantially equivalent to the predicate ADAPT for Gamma3 System (K173946) and Gamma3 System (K123401) regarding intended use, material, design, and operational principles." |

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

The document states, "Clinical data is not required in support of this submission." This indicates that no clinical test set of patient data was used to prove the device meets acceptance criteria, at least in the traditional sense of evaluating diagnostic or treatment outcomes on patients. The evaluation was primarily based on non-clinical testing and comparison to a predicate device.

Therefore, information on data provenance (country of origin, retrospective/prospective) and sample size for a test set of clinical data is not applicable here.

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

Since no clinical test set was used, no experts were explicitly mentioned as being used to establish ground truth for a clinical test set in this submission. The "ground truth" for the device's performance was established through engineering tests, usability evaluations, and comparison to the predicate device, rather than clinical outcomes or diagnoses.

4. Adjudication Method for the Test Set

Given that no clinical test set was used for performance evaluation, an adjudication method for a test set is not applicable.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers improving with AI vs. without AI assistance. The ADAPT for Gamma3 system is described as a "computer controlled stereotaxic image guided surgery system" that "assists the surgeon," implying it's a tool used by the surgeon, rather than a standalone diagnostic AI or an AI that directly enhances human interpretation in a comparative reader study.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

The document does not describe a standalone performance study for the algorithm without human-in-the-loop performance. The device is referred to as assisting the surgeon and being used with the Stryker Navigation System. The "intended use" specifies "assists the surgeon to determine the needed size and position." This indicates it's designed as an assistive tool, not a standalone diagnostic or treatment algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance was:

• Engineering specifications and regulatory standards: For electrical safety, EMC, usability, and reliability.
• Performance of the predicate device (ADAPT for Gamma3 System K173946): The core of the 510(k) clearance is demonstrating substantial equivalence to this previously cleared device. The predicate device's performance, safety profile, and intended use effectively serve as the "ground truth" or benchmark for the new device.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data being used as ground truth in this submission for the purpose of demonstrating substantial equivalence.

8. Sample Size for the Training Set

The document is a 510(k) clearance letter and does not provide information regarding a training set sample size. As it primarily describes a navigation system software update and hardware platform for an existing device, it's unlikely to involve a deep learning model that requires a large training set of annotated images in the typical sense. If internal algorithms were "trained," the details are not disclosed here.

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

Since no information on a training set is provided, how its ground truth was established is not detailed in this document.

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