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The Affixus® Tibial Nailing System is indicated for temporary stabilization and fixation of tibial fractures and osteotomies including proximal. metaphyseal. and distal shaft fractures. closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus® Antegrade Femoral Nailing System is indicated for temporary stabilization and fixation of femoral fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, trochanteric and subtrochanteric fractures, closed fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nailing System and the Affixus Antegrade Femoral (AF) Nailing System are long bone nailing systems that offer implants designed to treat a range of tibial and femoral fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality.

This is a 510(k) premarket notification for a medical device, specifically the Affixus Tibial and Antegrade Femoral Nailing System. These notifications are submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is at least as safe and effective.

The provided text does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device. This document is for a traditional medical implant, not an AI software as a medical device (SaMD).

Therefore, many of the requested fields are not applicable or cannot be extracted from the given text. However, I can provide information based on what is available.

Here's the breakdown of what can be inferred and what is missing:

Acceptance Criteria and Device Performance Study

As this is a 510(k) for a physical medical implant (intramedullary fixation rod), the concept of "acceptance criteria" and "device performance" in the context of an AI/algorithm is not directly applicable in the same way. Instead, the "acceptance criteria" can be interpreted as demonstrating substantial equivalence to predicate devices through various non-clinical tests. The "device performance" is demonstrated by meeting the standards and benchmarks set by these tests.

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

Explanation of Performance: The document explicitly states: "The information provided herein demonstrates that: any differences do not raise different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." This is the ultimate "performance" metric for a 510(k) submission, achieved by passing the listed non-clinical tests and demonstrating material, design, packaging, and sterilization similarity to predicate devices. The specific values or pass/fail thresholds for each test are not provided in this summary, but the successful submission implies they were met.

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

• Sample Size: Not specified in the provided text. For mechanical testing of implants, sample sizes typically adhere to relevant ASTM standards.
• Data Provenance: Not specified in the provided text. These are non-clinical lab tests, so country of origin for "data" is typically the testing lab's location. The tests are prospective in the sense that they are specifically conducted for the submission.

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. This is a physical implant, not an AI/algorithm requiring expert-established ground truth on image data or other patient data. The "ground truth" for these tests are the defined mechanical properties and physical characteristics as per the ASTM standards.

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

• Not Applicable. This is a physical implant. The mechanical tests are objective measurements, not subject to adjudication by human interpreters.

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

• Not Applicable. This is for a physical implant. No AI component is mentioned, and therefore, no MRMC study or human reader improvement with AI assistance is relevant.

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

• Not Applicable. This is for a physical implant. No algorithm is mentioned.

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

• Mechanical Test Standards: The "ground truth" for the non-clinical tests are the specified mechanical properties and performance requirements outlined in the referenced ASTM standards (e.g., ASTM F1264, ASTM F543, ASTM F2182, etc.). These standards define acceptable ranges for strength, fatigue, torque, etc., which the device must meet or exceed.

8. The sample size for the training set

• Not Applicable. This is for a physical implant; there is no "training set" in the context of an AI/machine learning model.

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

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

Summary of what the document does indicate for this physical device:

The submission highlights that the Affixus Tibial and Antegrade Femoral Nailing System is deemed substantially equivalent to predicate devices based on:

• Similar indications for use.
• Similar technological characteristics (materials, design features, packaging, sterilization).
• Successful completion of a battery of non-clinical mechanical and MR compatibility tests.

The goal of this 510(k) is to demonstrate that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicate devices. The listed non-clinical tests are the evidence used to support this claim.

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The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.

The PRECICE Intramedullary Limb Lengthening (IMLL) System is composed of the PRECICE Nail. locking screws, end cap, surgical instruments, and an External Remote Controller (ERC or ERC 2P). The nail is available in tibial and femoral models; with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and thread styles. The PRECICE Nail is supplied sterile by gamma radiation; the locking screws and surgical instruments are supplied non sterile, and must be sterilized prior to use.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria with specific numerical targets. The "acceptance criteria" here are implied to be that the new device components (new screw thread styles) maintain the same or similar performance characteristics as the predicate device's existing components.

Study Information

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

   • Test Set Sample Size: Not explicitly stated as a separate "test set" for this submission. The document states that testing was previously performed on the predicate components and on the same screws used in a reference device (K160267). The specific number of screws or nails tested in those prior studies is not mentioned.
   • Data Provenance: Not explicitly stated. The document refers to prior testing, but doesn't specify the country of origin or if the data was retrospective or prospective.

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

   • Not applicable/Not mentioned. This submission focuses on engineering and biocompatibility testing (mechanical, pyrogen), not on clinical performance evaluated by experts with patient data.

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

   • Not applicable/None. As this is not a clinical study involving expert interpretation, there is no adjudication method.

4. 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:

   • Not applicable. This is a medical device for bone lengthening, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

   • Not applicable. This is a physical implantable device, not an algorithm.

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

   • Ground Truth for Mechanical Testing: Adherence to established ASTM standards (material properties, strength, fatigue resistance, etc.) defining acceptable performance for orthopedic implants and screws.
   • Ground Truth for Pyrogen Testing: Compliance with ANSI/AAMI ST72:2011 specifications for bacterial endotoxins.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not a machine learning model that requires a training set.

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

   • Not applicable.

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