(28 days)
The components of the MosaicPlasty System are intended to be used for drilling bone, harvesting osteochondral bone grafts and transferring grafts to the drilled site.
The MosaicPlasty System is a kit composed of several orthopedic manual surgical instruments. These instruments include a drill guide plugs, drill bits, tubular chisels, trephines, tamps, transfer tibes, bone block compressor, drill bit adapters and a sterilizing tray. All instruments are composed of stainless steel. The instruments range in diameter from 2.7 mm to 4.5 mm.
The provided text is a 510(k) summary for the MosaicPlasty® System, which describes surgical instruments. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through clinical studies or detailed standalone performance evaluations typically conducted for AI/software-as-a-medical-device (SaMD) products.
Therefore, most of the information requested in your prompt (acceptance criteria, specific study details with sample sizes, expert involvement, adjudication, MRMC studies, specific ground truth methods, and training set details) is not applicable or available in this document.
Here's an breakdown based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic or AI device. The acceptance criteria for this type of submission involve demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of design, function, materials, and intended use, and that it does not raise new questions of safety or effectiveness.
- Reported Device Performance: No specific quantitative performance metrics are reported. The performance is implied to be equivalent to the predicate devices for their respective intended uses (e.g., drilling bone, harvesting grafts).
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Sample size used for the test set and the data provenance: Not applicable. This is a surgical instrument kit, not a diagnostic or AI device tested on a dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant for this device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This device is not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a set of manual surgical instruments.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable. This device does not involve a training set.
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How the ground truth for the training set was established: Not applicable.
Summary based on the document:
The document establishes "substantial equivalence" as its primary acceptance criterion. The study implicitly performed to meet this criterion is a comparison of the MosaicPlasty System components against existing, legally marketed predicate devices. The document asserts that "The components are similar in design, function, materials and intended use as other devices currently in commercial distribution." and that "Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations." No specific performance numbers or detailed study results of the type requested are present, as this is typical for a 510(k) submission for manual surgical instruments.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.