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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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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.

In the scope of this 510(k), two medical devices are introduced:

• ADAPT 2.0 for Gamma3 SW – Software (stored on a USB stick as a data carrier) for Gamma3® surgery assistance
• ADAPT Gamma3 DTS Clip – Reference body enabling distal locking assistance with ADAPT 2.0 for Gamma3 SW

ADAPT 2.0 for Gamma3 SW is a software which is designed to be run on the existing Stryker ADAPT® Platform (K141551) and Stryker NAV3 Platform (K162937). The software is based on the existing FluoroMap® 1.0 software which belongs to the predicate device FluoroMap Computer Assisted Surgery System (K103400).

ADAPT 2.0 for Gamma3 SW (when using with specific reference bodies: FluoroDiscs [K103400], ADAPT Clip [K103400], ADAPT Gamma3 DTS Clip [in the scope of this submission]) assists the surgeon with implant alignment, lag screw length determination, lag screw positioning and distal locking during Gamma3® surgery.

ADAPT 2.0 for Gamma3 SW uses fluoroscopic X-ray images taken during the surgical procedure. The software uses the reference bodies to perform registration of the surgical site and to assist the surgeon in the selection and placement of orthopedic implants. The registration is based on the geometry of embedded metal marker beads in the reference bodies. The software detects radiopaque implants and instruments such as nails, K-wires, lag screws and drill sleeves and displays positional information to the surgeon to provide assistance in positioning of implants during Gamma3® surgery.

The ADAPT Gamma3 DTS Clip is used as a reference body enabling distal locking assistance (for Gamma3® Long Nails) with ADAPT 2.0 for Gamma3 SW. The ADAPT Gamma3 DTS Clip consists of a PEEK body and contains radiopaque metal marker beads (DIN 5401 - 2 G20 – 1.3541). For assembly on the Gamma3® Distal Targeting Adjusting Device (part of Gamma3® Distal Targeting System), a specific assembly mechanism is integrated. The software (ADAPT 2.0 for Gamma3 SW) detects the metal marker beads of the assembled ADAPT Gamma3 DTS Clip on X-ray images to enable assistance.

The provided FDA 510(k) clearance letter for "ADAPT for Gamma3" primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria, particularly for performance metrics like accuracy, sensitivity, or specificity.

The document states:

• "Different simulated use case scenarios – to verify a system accuracy of 2 mm. These scenarios include saw bone tests and simulated use tests."
• "Testing demonstrated that ADAPT for Gamma3 is equivalent in performance to the predicate device (K103400)."
• "No clinical testing of the ADAPT for Gamma3 System has been conducted."

This implies that the primary performance validation was non-clinical, focusing on achieving a 2mm accuracy in simulated environments and demonstrating equivalence to a predicate device. However, the details of the study design, sample sizes, ground truth establishment, or expert involvement for these performance claims are not provided in this document.

Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to address the points based only on the provided information, noting where information is missing.

Acceptance Criteria and Study for ADAPT for Gamma3

Based on the provided FDA 510(k) clearance letter, the primary acceptance criterion and the study proving it is rooted in non-clinical testing for system accuracy and equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The document mentions "Different simulated use case scenarios" and "saw bone tests and simulated use tests" but does not quantify the number of tests or samples.
• Data Provenance: The origin of the data (country, retrospective/prospective) is not specified. It is non-clinical, based on "simulated use case scenarios" and "saw bone tests."

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

• This information is not provided. The ground truth for the 2mm accuracy claim in simulated tests would likely be established through precise measurements in the lab rather than expert human interpretation.

4. Adjudication Method for the Test Set

• Not applicable as the testing appears to be objective, physical measurements (e.g., assessing 2mm accuracy) rather than subjective expert interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing of the ADAPT for Gamma3 System has been conducted." This implies no studies involving human readers or their improvement with AI assistance were performed and submitted.

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

• The document implies that standalone performance (e.g., accuracy) was evaluated through "simulated use case scenarios" and "saw bone tests" verifying a 2 mm accuracy. However, this is for the system's underlying capabilities, not necessarily a formal "standalone study" akin to an AI diagnostic device's performance evaluation. The device assists the surgeon, suggesting a human-in-the-loop context for its intended use, but the core 2mm accuracy appears to be a technical, system-centric metric.

7. The Type of Ground Truth Used

• For the 2mm system accuracy, the ground truth would be precise physical measurements from the "saw bone tests and simulated use tests." This is not an expert consensus, pathology, or outcomes data, but rather a directly measured physical accuracy.

8. The Sample Size for the Training Set

• The document does not provide information regarding a training set sample size. This is a 510(k) clearance based on substantial equivalence and non-clinical performance; details on internal development, including AI/software training, are typically not part of the public 510(k) letter unless specifically requested by FDA for novel AI components, which doesn't appear to be the case here. The software is noted to be "based on the existing FluoroMap® 1.0 software."

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

• This information is not provided. (See point 8).

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