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The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

The iFUSE Hammertoe System by OrthoPro is a single piece metal implant that is surgically inserted into the intramedullary canal of the bones in the toe, finger or small bones, designed to create a fusion.

The provided text does not contain information about a study proving the device meets acceptance criteria in the way typically required for AI/ML device submissions (i.e., with performance metrics, ground truth establishment, or human-in-the-loop studies).

Instead, this document is a 510(k) summary for a medical device (iFUSE Hammertoe System), which is a premarket submission to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. For this type of device (a bone fixation screw), substantial equivalence is primarily demonstrated through non-clinical testing (mechanical properties) and comparison to predicate devices, rather than clinical studies or performance against acceptance criteria derived from a complex AI/ML algorithm.

Here's why the provided text doesn't fit the requested criteria and what it does say:

1. Acceptance Criteria & Device Performance Table: Not applicable. The submission focuses on demonstrating substantial equivalence through mechanical testing rather than meeting specific performance thresholds against a diagnostic benchmark. The non-clinical tests performed are:

   • Pullout strength
   • Four-point bending and fatigue strength
     The document states: "The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices." This is the "performance" relative to the "acceptance criteria" of being equivalent to predicates for mechanical properties.

2. Sample Size for Test Set & Data Provenance: Not applicable for a clinical test set. The "testing" refers to mechanical properties of the device itself (hardware), not observational data.

3. Number of Experts & Qualifications / Adjudication Method: Not applicable. There was no clinical study involving human readers or expert radiologists for establishing ground truth from medical images.

4. MRMC Comparative Effectiveness Study: Not applicable. This device is a surgical implant, not an AI diagnostic tool.

5. Standalone (Algorithm Only) Performance: Not applicable. There is no algorithm.

6. Type of Ground Truth Used: Not applicable for a clinical study. For the mechanical tests, the ground truth would be the established engineering standards for strength and fatigue, and data from the predicate devices.

7. Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There's no AI/ML algorithm requiring training data.

Key Information from the Document that Relates to "Proof" of Meeting "Acceptance Criteria" for this specific device:

• Acceptance Criteria (Implicit): The primary "acceptance criterion" for this 510(k) submission is that the iFUSE Hammertoe System is substantially equivalent to legally marketed predicate devices (Stayfuse, Pioneer Surgical Technology, K990804 and OthoPro Stemman Pins and Kirschner Wires, OrthoPro LLC, K070555) in terms of:
  • Intended use
  • Design
  • Materials used
  • Mechanical safety
  • Performance
• Study Proving Device Meets Acceptance Criteria: The "study" was non-clinical testing:
  • Tests Performed: Pullout strength; Four-point bending and fatigue strength.
  • Results/Conclusion: "The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices." And "The conclusions drawn from the comparison between the devices demonstrate that the iFUSE Hammertoe System is as safe, as effective, and performs as well as the predicate devices."
  • Clinical Studies: "No clinical studies were performed."

In summary, the provided text describes the submission for a Class II metallic bone fixation fastener, where "acceptance criteria" and "proof" primarily revolve around demonstrating mechanical equivalence to existing devices through non-clinical laboratory testing, not through clinical trials or performance metrics of an AI/ML system.

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The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.

The provided text describes the 510(k) summary for the Apex Kirschner Wires and Steinmann Pins. It does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in performance testing sections for AI/ML-driven devices. Instead, it focuses on substantial equivalence to predicate devices based on design and materials.

However, I can extract the relevant information that is present and explain where the requested details are absent.

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

   This information is not provided in the document. The submission is a 510(k) for orthopedic fixation devices (Kirschner Wires and Steinmann Pins), which typically rely on material properties, mechanical strength, and biocompatibility rather than "performance" in the sense of an algorithm's output metrics like sensitivity or specificity.
   The document states: "The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters." This implies that the 'acceptance criteria' are implicitly met if these characteristics are equivalent to legally marketed predicate devices, which are presumed safe and effective.

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

   This information is not applicable/provided for this type of device submission. There is no 'test set' in the context of an algorithm or diagnostic device. The evaluation is based on engineering specifications and comparison to predicate devices, not data from a clinical trial or dataset.

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)

   This information is not applicable/provided. There is no ground truth established by experts for a test set, as this is a medical device (orthopedic pins) and not a diagnostic or AI-based product.

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

   This information is not applicable/provided. No adjudication method for a test set is mentioned because there is no such test set.

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

   This information is not applicable/provided. An MRMC study is relevant for AI-assisted diagnostic devices. This submission concerns orthopedic hardware, not an AI system.

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

   This information is not applicable/provided. This device is a physical medical implant, not an algorithm.

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

   This information is not applicable/provided. Ground truth, as defined for algorithm performance, is not relevant here. The "truth" for this device lies in its material properties, manufacturing quality, and successful physical fixation as per its intended use, established through engineering standards and comparison to predicate devices.

8. The sample size for the training set

   This information is not applicable/provided. There is no 'training set' for this physical medical device.

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

   This information is not applicable/provided. There is no ground truth or training set for this device.

Summary of available information regarding the "study" proving device meets "acceptance criteria":

Based on the provided document, the "study" demonstrating the device meets "acceptance criteria" is a substantive equivalence comparison with legally marketed predicate devices.

• Study Design: A comparison of physical dimensions, materials, and technological characteristics of the Apex Kirschner Wires and Steinmann Pins to identified predicate devices:

  • Evergreen Orthopedics Research Lab, Kirschner wires and Steinmann Pins (K102215)
  • DePuy Inc. Sterile Kirschner Wires and Steinmann Pins (K960385)
  • OrthoPro, LLC OrthoPro Steinman Pins and Kirschner Wires (K070555)
  • Treu-Instrumente GmbH Treu Bone Fixation Screws and Pins (K083912)

• Acceptance Criteria (Implied): The device is considered to meet acceptance criteria if its physical dimensions, materials, and technological characteristics are "similar" or equivalent to the identified predicate devices, thereby establishing substantial equivalence in terms of safety and effectiveness for its intended use.

• Reported Device Performance: The document explicitly states: "The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters." This statement serves as the 'reported performance' for the 510(k) process, indicating that the device design and materials are comparable to existing, approved devices.

• Data Provenance/Sample Size: Not applicable in the context of an AI/ML study. The 'data' consists of the specifications and characteristics of the Apex device and the predicate devices.

The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets regulatory requirements based on the comparative assessment.

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