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The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® Nail: the product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.

The existing Long Length Gamma® Nail is an intramedually rod intended to be used in the fixation of femoral fractures 'occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. The current design is cannulated, with a medial/lateral and anterior/posterior curve. The design modification involves changing the radius of curvature in the A-P plane. The modified device will allow the surgeon greater intraoperative flexibility in treating a variety of femoral The modified Long Length Gamma® Nails are substantially equivalent to the fractures. existing design of Long Length Gamma® Nails, which were cleared for marketing via the The materials used in the manufacture of the modified device are identical to 510(k) process. those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product.

This document is a Special 510(k) Summary for a device modification, not a study report detailing acceptance criteria and performance data from a clinical or analytical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

The document explicitly states: "This Special 510(k) submission is intended to address a design modification to the predicate Long Length Gamma® Nail." and "The modified Long Length Gamma® Nails are substantially equivalent to the existing design of Long Length Gamma® Nails, which were cleared for marketing via the 510(k) process. The materials used in the manufacture of the modified device are identical to those of the predicate. There is no change in intended use for the modified device when compared to the previously cleared product."

This indicates that the submission is based on substantial equivalence to a previously cleared device, meaning a comprehensive new study with defined acceptance criteria for device performance was likely not required or performed for this specific modification. Instead, the focus is on demonstrating that the design modification of the radius of curvature in the A-P plane does not alter the essential safety and effectiveness of the device as previously established by its predicate.

Here's a breakdown of the information that can be extracted or inferred, and what is absent:

1. A table of acceptance criteria and the reported device performance

   • Not present in the document. This submission is for a design modification and relies on substantial equivalence. It does not detail specific performance metrics or acceptance criteria for the modified device in a clinical or analytical study.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable/Not present. No specific test set or study data is presented for the modified device. The submission focuses on the modification itself and its equivalence to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable/Not present. No test set or ground truth establishment relevant to an AI/diagnostic device is discussed.

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

   • Not applicable/Not present.

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/Not present. This is hardware (intramedullary nail), not an AI/diagnostic device.

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

   • Not applicable/Not present. This is hardware, not an algorithm.

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

   • Not applicable/Not present.

8. The sample size for the training set

   • Not applicable/Not present. No AI algorithm is being described.

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

   • Not applicable/Not present. No AI algorithm is being described.

Summary of what the document does provide:

• Device: Modified Long Length Gamma® Nail
• Modification: Change in the radius of curvature in the A-P plane.
• Purpose of Modification: To allow the surgeon greater intraoperative flexibility in treating a variety of femoral fractures.
• Basis for Clearance: Substantial equivalence to the existing Long Length Gamma® Nail.
• Materials: Identical to the predicate device.
• Intended Use: Identical to the predicate device (fixation of femoral fractures from the base of the femoral neck to ~10 cm proximal to the intercondylar notch; fracture types include basilar neck, intertrochanteric, subtrochanteric, and femoral shaft fractures; for trauma, non-unions, mal-unions, pathological fractures, and impending pathological fractures).
• Regulatory Information:
  • Proprietary Name: Long Length Gamma® Nail
  • Common Name: Intramedullary Rod
  • Classification Name and Reference: 21 CFR 888.3020 Intramedullary Fixation Rod
  • Proposed Regulatory Class: Class II
  • Device Product Code: 87 HSB
  • 510(k) Number: K993670
  • Date of Submission: October 29, 1999
  • Date of Clearance: November 16, 1999

In conclusion, this document is a regulatory notice of substantial equivalence for a hardware modification, not a study report demonstrating meeting acceptance criteria through quantitative performance data.

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