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The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.

The OSCAR Bone Resector consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable handpiece and a range of single use cutting blades. OSCAR Bone Resector employs longitudinal mode ultrasound in conjunction with a low frequency reciprocating motion to cut and remove bone.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that it's a 510(k) summary and therefore only provides a high-level overview of the testing conducted for substantial equivalence.

It's important to note that 510(k) summaries are not designed to be comprehensive clinical study reports. They aim to demonstrate substantial equivalence to a legally marketed predicate device, often relying on non-clinical performance testing rather than extensive human clinical trials for devices like surgical instruments. Therefore, many of the requested details (like sample size for test sets, number of experts, MRMC studies, training set details) are typically not found in a 510(k) summary if they don't directly relate to demonstrating equivalence through specific design or performance comparisons.

Acceptance Criteria and Device Performance (Based on available information)

Note on "Reported Device Performance": For a 510(k), explicit numerical performance metrics against specific acceptance criteria are often not detailed in the summary itself, particularly for non-clinical performance. The "reported performance" here is largely based on the claims made for "substantial equivalence" and the comparative advantages stated against predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided 510(k) summary. This document primarily focuses on asserting substantial equivalence based on technological characteristics and the types of testing performed or committed to. For a device like a surgical instrument, non-clinical performance testing (e.g., in vitro bone cutting, temperature measurements) is common, but the sample sizes for such tests are not detailed here.
   • Data Provenance: Not specified. It's safe to assume any performance testing would be non-clinical (laboratory-based), as no human-subject studies are mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. The testing described (FCC, UL, and comparative performance claims) does not indicate a need for expert-adjudicated "ground truth" in the way a diagnostic imaging study would. The focus is on technical compliance and direct performance comparisons.

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

   • Not applicable/None. This type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads), which is not described for this device.

4. 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 study is not mentioned and would be irrelevant for this type of surgical instrument. This device is not an AI-assisted diagnostic tool for human readers.

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

   • Yes, in the sense that the device's technical characteristics and performance claims (e.g., quicker cut, cooler operation, reduced soft tissue damage) are assessed independently of a human operator's skill level. The device itself is the "algorithm" and its performance is tested. However, it's not "algorithm-only" in the AI sense, but rather a standalone physical device. The tests mentioned (FCC, UL, and comparative performance) assess the device's inherent characteristics.

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

   • For the non-clinical performance testing (e.g., bone cutting), the "ground truth" would be objective measurements (e.g., cutting speed, temperature, tissue damage assessment via established laboratory methods). For regulatory compliance (FCC, UL), the ground truth is adherence to the specified technical standards. No "expert consensus" or "pathology" in a diagnostic sense is mentioned.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is a mechanical surgical instrument, not an AI or machine learning model that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no training set for this device.

Summary of Limitations due to 510(k) Context:

This 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" to predicate devices, not a detailed scientific publication of a clinical trial. As such, it highlights the types of testing done (e.g., electrical, EMC, and some unspecified "performance testing") and claims of performance improvements (quicker, cooler cut, reduced collateral damage) without providing the granular data, methodology, or specific sample sizes that would be present in a comprehensive study report or clinical trial. The "acceptance criteria" are largely implied by the need to meet regulatory standards (FCC, UL) and to perform "as well as or better than" predicate devices in key areas relevant to its intended use.

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