Search Results

Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck; trochanteric or subtrochanteric fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Smith & Nephew, Inc. Intramedullary Hip Screws are for single use only.

Intramedullary Hip Screw

The provided text does not describe a study to prove acceptance criteria for a device using an AI algorithm.

Instead, it is a 510(k) premarket notification summary for a medical device called an "Intramedullary Hip Screw" manufactured by Smith & Nephew, Inc. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design features, indications for use, and material composition.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the information is not present in the provided text.

Here's a breakdown of what the document does provide:

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

The document states:

• Acceptance Criteria (Implied): Mechanical test data showed the device is "capable of withstanding expected in vivo loading without failure."
• Reported Device Performance: "A review of the mechanical test data indicated that the Intramedullary Hip Screw is equivalent to predicate devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

Missing Information (as per your request, because it's an AI-related prompt and this document is not AI-related):

2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, insilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

The AOS Trochanteric Nail is femoral intramedullary nail that is design to enter through the greater trochanter. It consists of an intramedullary nail, sliding lag screw, anti-rotation screws and end cap. The Trochanteric Nail is a cannulated nail with proximal diameter of 15mm. The short Trochanteric Nails are18cm in length and the long Trochanteric Nails are 30cm, 36cm and 42cm in length. The nails are produced in diameters of 9mm, and 11mm. The proximal end of the nail has two holes; one to accept the 11mm lag screw and one to accept the optional 5.0mm anti-rotation screw. There are two nail configurations with the proximal holes angled at 125° or 130°. The proximal holes in the long nails having 10° of anteversion and are in a left and a right configuration. The proximal end of the nail is threaded to accept an end can. The distal end of the nail contains one cross locking hole and one cross locking slot. The distal hole and the slot are design to accept 5.0mm screws.

The provided text is a 510(k) summary for the AOS Trochanteric Nail, an intramedullary fixation rod for treating femoral fractures. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial for a diagnostic device would.

Therefore, the requested information components related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets are not applicable (N/A) in this context.

This 510(k) summary is for a Class II medical device (intramedullary fixation rod) and relies on demonstrating an equivalence to legally marketed predicate devices, not on a performance study against specific acceptance criteria.

Summary of available information:

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

   • N/A. The document is a 510(k) summary for a medical device seeking market clearance based on substantial equivalence, not a performance study with explicit acceptance criteria. The "performance" is implicitly demonstrated through comparison to predicate devices' design and intended use.

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

   • N/A. No test set or clinical data is presented for performance evaluation in this 510(k) summary.

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):

   • N/A. No ground truth establishment by experts is mentioned, as there is no specific performance study.

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

   • N/A. No adjudication method is mentioned, as there is no specific performance study.

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:

   • N/A. This device is a physical implant (intramedullary nail), not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

   • N/A. This is a physical medical device, not an algorithm.

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

   • N/A. No performance study necessitating ground truth is presented.

8. The sample size for the training set:

   • N/A. Not a machine learning or AI device.

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

   • N/A. Not a machine learning or AI device.

Key information from the document that is relevant:

• Device Name: AOS Trochanteric Nail
• Intended Use: To treat stable and unstable proximal fractures of the femur (pertrochanteric, intertrochanteric, high subtrochanteric, combinations) and, for the long nail, subtrochanteric fractures, pertrochanteric fractures with shaft fractures, pathologic fractures (prophylactic use) in osteoporotic bone, long subtrochanteric fracture, insilateral femoral fractures, proximal and distal non-unions and malunions, and revision procedures.
• Device Description: A femoral intramedullary nail designed to enter through the greater trochanter, consisting of an intramedullary nail, sliding lag screw, anti-rotation screws, and end cap. It is cannulated with various lengths (18cm for short, 30cm, 36cm, 42cm for long) and diameters (9mm, 11mm).
• Substantial Equivalence Rationales: The device was shown to be substantially equivalent to the following predicate devices:
  • DePuy ACE, Trochanteric Nails (K010780 and K013563)
  • Howmedica Osteonics, Gamma Nails (K993670, K012158 and K013524)
  • Smith and Nephew, Intramedullary Hip Screw (K 912162, K921786 and K954712)
• Regulatory Class: Class II
• Product Code: HSB (Intramedullary fixation rod)

Ask a specific question about this device