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The Synthes modified PFN is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The Long PFN is additionally indicated for pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) in both trochanteric and diaphyseal areas, long subtrochanteric fractures, proximal or distal non-unions and malunions and revision procedures.

Synthes modified PFN System is a cannulated intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. The following components make up the PFN system: proximal femoral nails, hip pins, femoral neck screws, locking bolts, and end caps. Synthes modified PFNs are available in lengths of 240 mm (short) and 340, 380, and 420 mm (long). The nails allow for both proximal and distal locking options. Synthes modified PFN System is manufactured from titanium alloy.

The provided text is a 510(k) Summary for the Synthes (USA) Proximal Femoral Nail System, concerning modifications to an existing device (K970097). This document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through a clinical trial or AI algorithm validation.

This document is a regulatory submission demonstrating substantial equivalence to a predicate device. It focuses on device description, intended use, and regulatory classification, not on detailed performance study results with specific acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as no such test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to seek FDA clearance for market entry based on substantial equivalence, not to present a detailed performance study against specific acceptance criteria.

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The Synthes PFN System is intended to treat stable and unstable proximal fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures.

Synthes PFN System is an intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. Distal interlocking is performed with an aiming arm and can be either static or dynamic. The following components makeup the PFN system: proximal femoral nails, hip pins, femoral neck screws, 4.9 mm locking bolts, and 17 mm end caps.

The PFN has a 17 mm proximal diameter, and is 240 mm in length. The PFN features an angle between femoral neck / shaft ranging from 125° - 140°. It has two proximal holes: one is 6.5 mm in diameter and the other is 11 mm in diameter. Two distal holes accept the 4.9 mm locking bolts. The hip pin, femoral neck screws, and 4.9 mm locking bolts are used to lock the PFN into place. The hip pin is 6.5 mm in diameter and is available in lengths ranging from 75 mm to 120 mm. The femoral neck screw is 11 mm in diameter and is available in lengths ranging from 80 mm to 120 mm. The 4.9 mm locking bolts have a 4.9 mm diameter and are available in lengths ranging from 26 mm to 100 mm. The proximal end of the PFN accepts a 17 mm end cap. The end cap is 17 mm in diameter and is available in 0 to 15 mm extensions. Synthes PFN System is manufactured from a titanium alloy and stainless steel.

The provided document is a 510(k) summary for the Synthes Proximal Femoral Nail (PFN) system, comparing it to Howmedica's Gamma Locking Nail (GLN). However, it does not describe an acceptance criteria and study that fits the requested format for device performance based on a test set, ground truth, or an AI/human-in-the-loop scenario.

The document primarily focuses on:

• Intended Use: What the PFN system is designed to treat (proximal femoral fractures).
• Device Description: Detailed specifications of the PFN components (dimensions, materials, locking mechanisms).
• Comparison to a Predicate Device: Stating that the PFN is "at least equivalent to the GLN" based on "mechanical test results."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details of efficacy studies as this information is not present in the provided text.

The document is about a medical device (a surgical nail), not a diagnostic or AI-driven device with clearly defined performance metrics like sensitivity, specificity, or reader improvement. It speaks to mechanical equivalence, not a clinical trial design with patient outcomes or expert reads.

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