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The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The modified device allows for placement of the implant with 3 lag screws. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Extremity Medical Calcaneal Osteotomy Device.

This document describes a 510(k) premarket notification for a medical device. For such submissions, the acceptance criteria and study data are primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Pull-out, torque and bending strength was assessed compared to the predicate device and worse case constructs have been tested to demonstrate equivalence."

• Sample Size: The exact number of samples tested for pull-out, torque, and bending strength is not specified in this document. It mentions "worse case constructs," implying a targeted selection of samples that represent the most challenging scenarios for the device's mechanical integrity.
• Data Provenance: The testing appears to be retrospective (or in-vitro testing for regulatory submission) and conducted by the manufacturer, Extremity Medical, LLC. The country of origin for the data is not explicitly stated but can be inferred as the United States, where the company is located and where the submission was made to the FDA.

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

This type of information is not applicable to this submission. The "ground truth" for demonstrating substantial equivalence here is based on engineering and mechanical testing standards, not expert clinical consensus or interpretation of patient data. The mechanical tests compare the new device's performance to the known performance of the predicate device.

4. Adjudication Method for the Test Set

This is not applicable. The "adjudication method" primarily applies to human interpretation tasks, such as in clinical trials or diagnostic image readings where multiple experts might disagree. For mechanical testing, the results are typically quantitative and assessed against predefined engineering specifications or direct comparison to predicate device performance.

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 is not applicable. An MRMC study is relevant to diagnostic or screening devices, often involving AI, to assess the impact on human reader performance. This device is a surgical implant (bone fixation fastener) and does not involve human readers or AI in its direct application or evaluation for this submission.

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

This is not applicable. This device is a physical surgical implant, not an algorithm or an AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for this regulatory submission is established through:

• Mechanical Testing Results: Data from pull-out, torque, and bending strength tests.
• Engineering Specifications and Benchmarking: Comparison of the device's performance against the predicate device and relevant industry standards for mechanical properties.
• Material Characterization: Verification of the material properties to be equivalent to the predicate device.
• Design Review: Comparison of the design features to the predicate device.

8. The Sample Size for the Training Set

This is not applicable. This device does not use an algorithm that requires a "training set" in the context of machine learning. The "training" for the device's development would involve engineering design, prototyping, and iterative mechanical testing.

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

This is not applicable for the same reason as point 8. No "training set" in the AI sense exists for this device. The development process relies on engineering principles and verification against established mechanical and material standards.

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The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

The provided document describes the FDA 510(k) premarket notification for the Extremity Medical Calcaneal Osteotomy Device. This device is a bone fixation device, not an AI/ML medical device, and therefore the concepts of acceptance criteria, device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in the context of AI regulatory submissions.

The document indicates that the device's substantial equivalence was based on non-clinical testing, specifically bench testing for static and dynamic bending, which was performed and compared to a predicate device. No clinical testing was performed.

The relevant information regarding this device's "acceptance criteria" (though not explicitly stated as such in the AI/ML context) would be its ability to demonstrate substantial equivalence to legally marketed predicate devices through its design, material mechanical properties, indications for use, and performance in these non-clinical bench tests.

To answer your request based on the provided document and keeping in mind it's for a physical bone fixation device:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied): Substantial equivalence to predicate device in terms of design, material mechanical properties, indications for use, and performance in static and dynamic bending bench tests.
   • Reported Device Performance: "Bench testing static and dynamic bending were performed and compared to the predicate device." (Specific numerical performance data is not provided in this summary document.)

2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device and no "test set" in the context of data for AI/ML is mentioned. The testing refers to physical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here.

4. Adjudication method for the test set: Not applicable.

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, this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for this physical device's performance would be its mechanical properties measured in bench tests and compared to the predicate device.

8. The sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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