(70 days)
The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.
The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range of single use and reusable probes. The generator is effectively an integration of the OSCAR OE3000DB and OSCAR Bone Resector generators. It comprises 3 channels, 2 of which are designed to provide power to the handsets from OSCAR OE3000DB and the third channel is dedicated to provide power to the handset from the OSCAR Bone Resector. The handsets and probes are identical to those of the predicate devices.
The provided 510(k) summary for the OSCAR 3 ultrasonic surgical instrument does not describe acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices (Orthosonics OSCAR OE3000DB and OSCAR Bone Resector).
Here's an analysis based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
- Not present in the document. The 510(k) summary states that "performance testing was carried out for some characteristics" but does not provide a table of acceptance criteria or the specific performance results in terms of metrics. It only generally concludes that "The data do in fact demonstrate equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present in the document. There is no mention of sample sizes for any test sets, nor the provenance of any data (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not present. Since a specific performance study with a "test set" and "ground truth" to evaluate diagnostic or therapeutic accuracy is not described, there's no information on experts or their qualifications for establishing ground truth. The device is a surgical instrument for cutting bone and cement, not a diagnostic tool requiring expert interpretation as ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not present. As there's no diagnostic or interpretative "test set" described, adjudication methods are not relevant or discussed.
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
- Not applicable. The device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not present. Given the nature of a surgical instrument for cutting, the concept of "ground truth" in the diagnostic sense is not directly applicable. The "testing" mentioned is likely related to engineering performance (e.g., cutting efficiency, material compatibility, electrical safety), not diagnostic accuracy. The document states "performance testing was carried out for some characteristics," but does not elaborate on the specific nature of these characteristics or how "ground truth" would be established for them.
8. The sample size for the training set
- Not applicable/Not present. This device is not an AI/ML algorithm that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not present. Same as above, not relevant for an ultrasonic surgical instrument.
Summary of what is present regarding "testing":
The document mentions two types of testing that will be carried out or have been carried out:
- G. TESTING:
- FCC Part 18: "Testing to FCC Part 18 will be carried out prior to marketing the device in the USA." (Electrical emissions/interference)
- UL 60601-1: "Electrical testing to UL 60601-1 will be carried out by Underwriters Laboratories before marketing the device in the USA." (Medical electrical equipment safety)
- Performance Testing for Substantial Equivalence: "performance testing was carried out for some characteristics. The data from this testing are available and are presented in this 510(k). The data do in fact demonstrate equivalence." However, the details of this performance testing, including specific acceptance criteria and results, are not included in this summary. The purpose of this testing was to confirm substantial equivalence to predicate devices, implying that the OSCAR 3 performs comparably to the devices it is replacing or integrating.
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.