The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:

• Pertrochanteric femoral fractures .
• Subtrochanteric femoral fractures and .
• Lateral femoral neck fractures .
  Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

The SLIM Gliding Nail Systems designed for internal fixation in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. The system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

This document is a 510(k) summary for the SLIM Gliding Nail System. It describes a medical device, specifically an orthopedic nail system for internal fixation of femoral fractures. The focus of the 510(k) is to demonstrate substantial equivalence to a predicate device (K020240, also a SLIM Gliding Nail System) after a minor design modification.

Based on the provided text, the device in question is a physical orthopedic implant. The 510(k) summary does not contain information related to software, artificial intelligence, or any performance study that would involve acceptance criteria, test sets, expert ground truth, or MRMC studies. The substantial equivalence is based on the device's design, materials, and intended use being nearly identical to a previously cleared predicate device, with the only modification being the "removal of the collar from the gliding blade."

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving device performance in the context of AI/software as the document pertains to a physical orthopedic implant and its substantial equivalence to a predicate device, not a novel AI-driven diagnostic or treatment tool.

In summary, the provided document does not contain the information required to answer your questions about acceptance criteria for AI/software, test sets, ground truth establishment, or clinical performance studies involving human readers and AI.

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The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:

• pertrochanteric femoral fractures
• subtrochanteric femoral fractures and
• lateral femoral neck fractures.
  Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.

We added the following smaller nails to our predicate device (FRIEDL Gliding Nail System, K974409):

• 132071 Slim Gliding Nail, 125°, 220 mm, 17 mm / 11 mm Ø

• 132072 Slim Gliding Nail, 135°, 220 mm, 17 mm / 11 mm Ø

• 132073 Slim Gliding Nail, 125°, 180 mm, 17 mm / 11 mm Ø,

These 3 nails are narrower than the conventional nails, which 19 mm diameter proximally and 12 mm distally.

• 132140 Femoral Neck Blade, 75 mm length

In addition, this 75 mm long femoral neck blade has been added to the existing range from 80 mm to 125 mm.

This document describes a Special 510(k) Device Modification for the SLIM Gliding Nail System. The modification involves the addition of smaller nails and a shorter femoral neck blade to the existing system. The primary study described is a biomechanical fatigue test.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "Biomechanical fatigue tests have been performed on the worst-case model." It does not specify the number of components or repetitions used in these tests.
• Data Provenance: The study is reported by PLUS ORTHOPEDICS to the FDA, suggesting it was conducted by the manufacturer for regulatory submission. The country of origin for the testing itself is not specified, nor is whether the data is retrospective or prospective, though for a biomechanical test, it's typically a prospective laboratory study.

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

• Not Applicable. This is a biomechanical engineering study, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" is established by the physical testing and engineering principles. The FDA reviewer (Celia M. Witten, Ph.D., M.D.) made the final determination of substantial equivalence, but not of the underlying biomechanical 'ground truth'.

4. Adjudication Method for the Test Set

• Not Applicable. As a biomechanical study, there isn't an adjudication method for reconciling different expert opinions on a test set in the way there would be for a diagnostic study. The determination of whether the test results "equal or better" the predicate would be based on quantitative measurements and engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This document describes a biomechanical engineering study of an orthopedic implant, not a diagnostic device or a study involving human readers or cases. Therefore, an MRMC study is not relevant or included.

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

• Not Applicable. This is a physical device, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The biomechanical testing is inherently "standalone" in that it tests the device properties directly.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to the objective physical properties and performance characteristics of the device under stress, as measured through biomechanical fatigue testing. This is compared against established engineering standards and the performance of predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This is a biomechanical engineering study, not a machine learning or AI study. There is no "training set" in this context. The study focuses on evaluating the physical properties of the manufactured device.

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

• Not Applicable. Since there is no training set, this question is not relevant.

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