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Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is indicated for:

• Partial or complete dislocation of the lesser metatarsophalangeal joint
• Pain Associated with rheumatoid or osteoarthritis
• Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint .
• Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• Kohler's disease
• Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state

The Lesser Metatarsal Phalangeal Joint Implant is a double-stemmed silicone prosthesis, intended to supplement lesser metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the metatarsal and base of the proximal phalanx.

This document is a 510(k) summary for a medical device called the "Lesser Metatarsal Phalangeal Joint Implant." It's a submission to the FDA (Food and Drug Administration) to demonstrate that this new device is substantially equivalent to a legally marketed predicate device, the "Sutter Lesser Metatarsal Phalangeal Joint Prosthesis."

The regulatory path for this device is based on substantial equivalence, not on meeting specific acceptance criteria derived from a performance study against a predefined standard. Therefore, many of the requested items, such as a table of acceptance criteria with reported device performance, sample sizes for test/training sets, expert qualifications, and study designs (MRMC, standalone), are typically associated with performance-based regulatory clearances or approvals (like de novo classification or PMA applications) rather than 510(k) submissions demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. This submission is for a medical device seeking 510(k) clearance based on substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria from a clinical or analytical study. The "acceptance criteria" here implicitly refer to demonstrating equivalence in design, materials, indications for use, and technological characteristics to the predicate device.

  The comparison provided is qualitative, highlighting similarities between the proposed device and the predicate:

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

• Not Applicable. No "test set" in the context of a clinical performance study is described. The submission focuses on comparing the proposed device's characteristics to a predicate device.

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

• Not Applicable. No expert-adjudicated test set is described. The "ground truth" for this 510(k) is the demonstrated similarity to the predicate device's design and intended use, as reviewed by the FDA.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or associated adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• Not Applicable. This is a device for surgical implantation, not an imaging diagnostic device that would typically undergo an MRMC study.

6. 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.

7. The Type of Ground Truth Used:

• For this 510(k) submission, the "ground truth" for the substantial equivalence determination is the characteristics and performance of the legally marketed predicate device (Sutter Lesser Metatarsal Phalangeal Joint Prosthesis) combined with the design specifications and intended use of the proposed device. The evaluation relies on demonstrating that the new device does not raise different questions of safety and effectiveness compared to the predicate.

8. The Sample Size for the Training Set:

• Not Applicable. No "training set" in the context of an AI/ML algorithm is described.

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

• Not Applicable. No training set is described.

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