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The TRIGEN INTERTAN Nails are indicated for fractures of the femur including:

• Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures: and intracapsular fractures
• · Polytrauma and multiple fractures
• · Prophylactic nailing of impending pathologic fractures
• · Reconstruction following tumor resection and grafting

The TRIGEN INTERTAN 10S Nail System consists of metallic implants including femur nails, leg screw, compression screw, Subtrochanteric lag screw, locking screw, Set Screw, and nail caps.

TRIGEN INTERTAN 10S nail is designed to have a slightly different neck taper from the existing neck design of the predicate TRIGEN INTERTAN 10mm Nail (K040212, SE 02/20/2004). The neck taper of the subject devices has been modified to accommodate the different patient population.

The TRIGEN INTERTAN 10S system is intended to provide a solution for treatment of proximal femoral fractures with one nail product. The INTERTAN nail includes two interlocking screws near the proximal end that form a worm gear, which is designed to provide stability for hip fracture cases.

The subject TRIGEN INTERTAN 10S nails are made of Titanium-6 Aluminum-4 Vanadium (Ti-6Al-4V). The 10S nails are available in both long and short nails. The "S" stands for shey are the smallest diameter nails offered. Design wise, the small diameter and a change to the subject INTERTAN 10S Nail implants are avallable in the 10mm diameter size, with lengths from 18cm to 46cm in 2cm increments, in both 125° or 130° neck angle versions. The INTERTAN 10S nails are single-use and are Gamma sterilized.

The provided text is a 510(k) premarket notification FDA clearance letter for a medical device called the "TRIGEN INTERTAN 10S Nail System." This documentation focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or an AI algorithm's standalone performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information for an AI/algorithm-driven device.

The document states:

• "No clinical tests were performed to support safety and effectiveness of the subject devices."
• "The performance bench tests were used as a basis for the determination of substantial equivalence."

The "acceptance criteria" referred to in the document relate to a pre-market clearance process demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, primarily through bench testing to show similar performance characteristics.

In the context of the provided document, the "study that proves the device meets the acceptance criteria" refers to non-clinical bench tests. These tests assess the mechanical and physical properties of the device, rather than its clinical performance or the performance of an AI algorithm.

Here's what can be extracted from the document, though it won't fulfill all aspects of your request:

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

The document mentions "performance bench tests" but does not provide a table of specific acceptance criteria (e.g., minimum tensile strength, fatigue cycles) or the exact reported device performance values. It generalistically states: "The results of these tests show that the substantially equivalent to the predicate device."

• Mentioned Bench Tests:
  • Proximal Shaft Fracture Construct Fatigue Testing
  • MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013)

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for the bench tests.
• Data Provenance: Not applicable in the context of clinical data for a 510(k) of this nature. The "data" would be the results of mechanical and material tests conducted on the device components, typically in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth in the context of mechanical bench testing refers to the physical measurements and standards of the materials and device. Expert consensus as you might see in image interpretation for AI is not relevant here.

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

• Not applicable. No human interpretation or adjudication method is described for generating "ground truth" for the bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states: "No clinical tests were performed to support safety and effectiveness of the subject devices." MRMC studies are clinical studies involving human readers, which were not conducted.

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

• No. This device is a physical orthopedic implant, not an AI/algorithm. No algorithm performance was assessed.

7. The type of ground truth used:

• Bench Test Results/Standard Specifications: The "ground truth" for demonstrating substantial equivalence for an orthopedic implant through bench testing is typically based on established industry standards (e.g., ASTM standards for mechanical properties) and comparison to the performance of the predicate device.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set was used.

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InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. InterTAN nail is for single use only.

Intramedullary Nail and Accessories

The provided text describes a 510(k) premarket notification for the "TriGen InterTAN" intramedullary nail. For medical devices undergoing 510(k) clearance, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device, rather than performance against pre-defined numerical thresholds or the kind of study typically associated with AI/software devices.

This document focuses on the mechanical and clinical data supporting substantial equivalence, not a standalone performance study as would be seen for an AI diagnostic.

Here's a breakdown of the requested information based on the provided text, recognizing the context of a 510(k) for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission for a physical orthopedic implant. The "test" here refers to mechanical testing, not a clinical trial with a patient sample.
• Data Provenance: The mechanical test data would be generated in a lab setting, likely in the US, by Smith & Nephew, Inc. This is not patient data, so "retrospective or prospective" does not apply.

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

• Number of Experts: Not applicable. The "ground truth" for mechanical testing is based on engineering specifications and physical measurements, not expert consensus on diagnostic images.
• Qualifications of Experts: The data would have been reviewed by engineers and potentially clinicians to interpret mechanical test results in the context of clinical relevance, but the text doesn't specify these individuals or their qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

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

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance of human readers, often with and without AI assistance, which is not applicable to a physical orthopedic implant like the TriGen InterTAN nail.

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

• Standalone Performance: No, a standalone performance study was not done. This concept is applicable to AI algorithms, not a physical medical device. The "standalone" performance here refers to the mechanical integrity of the nail itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for demonstrating the equivalence of the TriGen InterTAN nail is primarily based on mechanical test data demonstrating its ability to withstand "expected in vivo loading without failure," compared to established performance of predicate devices. This is an engineering standard, not clinical pathology, expert consensus, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI model, so there is no "training set."

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this device.

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