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Futura Biomedical Classic Great Toe Implant is indicated for:

• Hallux limitus or hallux rigidus
• Painful rheumatoid arthritis
• Hallux abducto valgus associated with arthritis
• Unstable or painful joint from previous surgery

The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Futura Biomedical Classic Great Toe Implant:

Observation: The provided text is a 510(k) summary for a medical device (toe implant). It describes the device, its intended use, and argues for its substantial equivalence to a previously marketed device. Crucially, it does not contain information about acceptance criteria or a study proving device performance against such criteria. It's a regulatory submission focused on demonstrating equivalence and safety, not on a performance study with specific metrics and acceptance thresholds.

Therefore, the following points cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance results.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a performance study.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the text focuses on demonstrating substantial equivalence to a predicate device.

Here's what can be inferred or stated based on the provided document:

Summary of Device and Regulatory Context (Based on the provided text):

The document is a 510(k) Pre-market Notification for the Futura Biomedical Classic Great Toe Implant, specifically introducing a new, larger size (size 60) for an existing line of implants. The notification aims to demonstrate substantial equivalence to the original Futura Biomedical Classic Great Toe Implant (K023086).

1. Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria or performance study results are reported in this 510(k) submission. The submission's purpose is to demonstrate substantial equivalence to a predicate device, not to present a new performance study with pass/fail criteria.
• The argument for equivalence is based on the new device (larger size) having similar design characteristics, materials, intended use, and mechanism of action as the predicate device.

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

• Not applicable. This document does not describe a performance study involving a test set of data. It is a regulatory submission for a physical implant.

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

• Not applicable. No such "ground truth" establishment in the context of a performance study is described.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This document does not mention or present an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not for physical implants in a 510(k) of this nature.

6. Standalone (Algorithm Only) Performance Study:

• No. This device is a physical toe implant, not an algorithm. Therefore, a standalone performance study in that context is not relevant and not discussed.

7. Type of Ground Truth Used:

• Not applicable. No performance study employing a "ground truth" (expert consensus, pathology, outcomes data) is described in this submission. The "truth" in this context is the comparison of the new device's characteristics against the predicate device.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical implant, not an AI algorithm that requires a "training set."

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

• Not applicable. As above, there is no AI algorithm or training set described.

Conclusion from the provided text:

The 510(k) submission for the Classic Great Toe Implant (size 60) does not contain information about acceptance criteria for a performance study or details of such a study. Instead, it focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (the original Classic Great Toe Implant, with sizes 20, 30, 40, 50). This equivalence is reasoned based on identical intended use, materials, basic design principles (double-stemmed silicone prosthesis, constrained, intramedullary canal fixation), and manufacturing processes. The only difference highlighted is the addition of a new, larger size (size 60) to the existing product line.

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