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The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 4 diameter sizes of 2.0mm, 2.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°.

The system instruments include guide wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants.

The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

The provided text describes the regulatory clearance for the "OSTEOMED ExtremiFuse System" and does not contain information about an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable.

However, based on the provided text, I can infer the "acceptance criteria" and "study" in the context of a medical device submission for substantial equivalence, which is a different type of evaluation from an AI/ML model.

Here's the information based on the document:

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

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

The document does not specify a "sample size" for a traditional clinical "test set" in the context of an AI/ML device. Instead, it refers to mechanical testing.

• Sample Size for Mechanical Testing: Not explicitly stated. The document mentions "The ExtremiFuse implants underwent verification..." and references "pullout test, and bending test." It does not provide the number of implants tested.
• Data Provenance: Not applicable in the context of clinical data. This refers to mechanical performance testing of the device itself.

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. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images or diagnoses) was not established for this type of device submission. The "ground truth" here is adherence to mechanical performance standards and achieving substantial equivalence to predicate devices.

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

Not applicable. There was no clinical assessment requiring adjudication by multiple experts. The evaluation was based on mechanical testing and comparison to predicate devices.

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. An MRMC comparative effectiveness study is designed for AI/ML devices involving human readers. This submission is for a physical orthopedic implant and does not involve AI/ML or human readers in that capacity.

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

Not applicable. This device is not an algorithm or AI system. It is a physical implant.

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

The "ground truth" for this device's evaluation was based on:

• Mechanical performance standards: The device's physical properties (e.g., strength, durability in pullout and bending tests) were verified against established criteria for its intended use.
• Comparison to predicate devices: The device's design, materials, function, and performance were compared to already legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

Not applicable. No AI/ML model was trained.

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

Not applicable. No AI/ML model was trained.

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The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 3 diameter sizes of 2.4mm, 3.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°. The system instruments include wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants. The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

The provided text describes a 510(k) submission for the OsteoMed ExtremiFuse System, a medical device for foot surgery. It focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding a study proving acceptance criteria is not present in the provided text.

However, I can extract the available information and highlight what is missing.

Here's a breakdown based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format that the device was tested against. Instead, it states that the device "underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." The performance is reported in terms of "substantial equivalence" to predicate devices based on specific mechanical tests.

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

This information is not provided in the text. The document refers to "verification evaluation" and "pullout test, torque test, and bending test," but does not specify the sample sizes (number of implants tested) for these mechanical tests. There is no mention of human subject data, and therefore no information on data provenance (country of origin, retrospective/prospective).

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

This information is not provided in the text. As this was a mechanical device rather than, for example, an AI diagnostic tool, "ground truth" as typically understood in AI/medical imaging studies (e.g., expert consensus on pathology) is not applicable here. The "truth" in this context would be engineering specifications and mechanical test results, which do not involve expert interpretation in the same way.

4. Adjudication Method for the Test Set

This information is not provided in the text. Adjudication methods (like 2+1 or 3+1) are typically used for clinical endpoints or expert interpretation, which are not detailed in this mechanical equivalence submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems where human readers interpret medical images or data. The OsteoMed ExtremiFuse System is a physical surgical implant, not an AI or diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

A standalone performance study, as typically understood for algorithms without human-in-the-loop, was not done. The "performance" assessment was based on physical mechanical testing of the implant itself, and its comparison to predicate devices, not on an algorithm's output.

7. The Type of Ground Truth Used

For this mechanical device, the "ground truth" used for performance assessment would inherently be the results of established engineering and biocompatibility tests (e.g., precise measurements of pullout strength, torque resistance, bending deflection as per industry standards like ASTM F136 for material or specific test methods for mechanical properties). The text refers to "mechanical strength criteria" and confirms the material (Ti6Al4V) is "biocompatible."

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The OsteoMed ExtremiFuse System is a physical surgical implant, not a data-driven model or algorithm that requires a "training set."

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

This information is not applicable and therefore not provided, as there is no training set for this type of medical device.

Summary of Device Performance and Study:

The OsteoMed ExtremiFuse System's performance was assessed through mechanical testing (pullout, torque, and bending tests) to demonstrate substantial equivalence to legally marketed predicate devices (Pro-Toe VO HammerToe Implant System, OsteoMed Cannulated Screw System, OsteoMed Foot Plating System, K-Wires). The submission states that the device "meets the required mechanical strength criteria for their intended use" and "performs as well or better" than the predicate devices. Clinical testing was explicitly stated as "not required to support substantial equivalence." This means that the assessment relies entirely on engineering principles and comparative mechanical data, rather than clinical efficacy studies or deep statistical analysis of AI model performance.

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