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Double Medical Femoral Nail System is intended for femoral fracture fixation and promoting femoral fracture healing.

Indications for use of the Proximal Femoral Nail, Anti-rotation, short; and Anatomical Proximal Femoral Nail (APFN ), short (Length 170 mm - 240 mm) include:

• Pertrochanteric fractures (31-A1 and 31-A2);
• Intertrochanteric fractures (31-A3);
• High subtrochanteric fractures (32-A1).

Indications for use of the Proximal Femoral Nail. Anti-rotation. long (Length 300 mm - 420 mm), Anatomical Proximal Femoral Nail (APFN ), long (Length 300 mm - 480 mm) include:

• Low and extended subtrochanteric fractures;
• Ipsilateral trochanteric fractures;
• Combination fractures (in the proximal femur);
• Pathological fractures.

Indications for use of the Universal Femoral Nail, Cannulated (UFN I) include:

• Femoral shaft fractures.

Indications for use of the Universal Femeral Nail II, Cannulated (UFN II) include:

• Standard Locking UFN II: femoral shaft fractures;
• Reconstruction Locking UFN II : femoral shaft combined with femoral neck fractures, subtrochanteric fractures.

Double Medical Femoral Nail System consists of a series of nails, spiral blades, locking screws, end caps and related instrument. The implants are provided in a variety of lengths and anatomical designs to accommodate the medullary canal of femur. All of the implants in the Double Medical Femoral Nail System are made of made of Ti-6AI-4V following ISO 5832-3 or Ti-6Al-4V ELI following ASTM F 136, which are widely used for surgical implants with well-known biocompatibility. Double Medical Femoral Nail System is provided as non-sterile.

The provided text is a 510(k) summary for the Double Medical Femoral Nail System, which is a medical device for femoral fracture fixation. The document details the device's indications for use, comparison with predicate devices, and non-clinical performance data. It explicitly states, "No clinical performance data is included in this submission."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria related to a clinical study with algorithms, human readers, or ground truth. The device's clearance is based on substantial equivalence to predicate devices, supported by non-clinical bench testing.

Here's a breakdown of the information available based on your request, highlighting where data is not present:

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

Since no clinical study evaluating algorithmic or human reader performance is mentioned, there are no acceptance criteria or reported device performance for such a study. The document focuses on performance relative to engineering standards.

Non-Clinical Performance Data is reported as:
"The test results demonstrated that the proposed device conforms to ASTM F1264-16e1 Standard Specification and Test Methods for Intramedullary Fixation Devices, ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices, including:

• Static Four-point Bending Test of Nail
• Dynamic Four-point Bending Test of Nail
• Static Torsion Test of Nail
• Static Three-point Bending Test of Locking Screw
• Dynamic Three-point Bending Test of Locking Screw
• Insertion/removal Test of Locking Screw
• Pullout Test of Locking Screw
• Torsion Test of Locking Screw.
• Cantilever Bending Test
• Insertion/removal test, static torsion and axial pullout test of Lag Screw
• Cut-out Test"

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

Not applicable, as no clinical or algorithmic test set is described. The non-clinical tests would have involved specific numbers of physical device samples for mechanical testing, but these details (sample size, provenance) are not provided in the 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)

Not applicable, as no clinical or algorithmic test set requiring expert-established ground truth is described.

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

Not applicable, as no clinical or algorithmic test set requiring adjudication is described.

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

No MRMC comparative effectiveness study was done or mentioned. The submission explicitly states, "No clinical performance data is included in this submission."

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

No standalone algorithmic performance study was done or mentioned. The submission explicitly states, "No clinical performance data is included in this submission."

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

Not applicable, as no clinical or algorithmic performance data requiring ground truth is described.

8. The sample size for the training set

Not applicable, as no algorithm or training set is mentioned.

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

Not applicable, as no algorithm or training set is mentioned.

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