(61 days)
The LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX) is indicated for the softening of bone cement to facilitate the removal of implants, including pedicle screws and other spinal implants, during revision surgery.
The USCIX consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable implant removal handpiece, a reusable acoustic coupler and a range of single use adaptors. USCIX employs longitudinal mode ultrasound at nominally 29kHz (Range 28.00-30.00kHz) to remove cemented implants for revision.
The provided text describes a 510(k) summary for the LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX). However, it does not contain details about specific acceptance criteria, a study proving performance against those criteria, or the methodology typically associated with such studies (like sample size, ground truth establishment, expert qualifications, or MRMC studies).
The "Testing" section (G) briefly mentions:
- "Testing to FCC Part 18 has been carried out at EMC Network (SW) Ltd, Devon UK, refer to Section 17 for data."
- "Electrical testing to UL 60601-1 has been successfully carried out by Underwriters Laboratories and the Certificate of Compliance is included in Section 17."
These refer to electrical and electromagnetic compatibility (EMC) safety and performance standards, which are general requirements for medical devices but not specific performance or clinical efficacy metrics for the intended use described (softening bone cement). The document states that "performance testing was carried out for some characteristics" due to descriptive characteristics not being "sufficiently precise to assure substantial equivalence" and that "The data from this testing are available and are presented in this 510(k)." However, the actual performance data, acceptance criteria, or the study details are not present in this excerpt.
Therefore, I cannot fully complete the requested table and answer all questions. I can only provide what little is mentioned about testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance criteria for softening bone cement or facilitating implant removal (e.g., time to soften, completeness of removal, safety metrics related to surrounding tissue) | Not provided in the excerpt. The document states "performance testing was carried out for some characteristics" but does not detail the criteria or results of this testing. |
| Compliance with FCC Part 18 | Successfully carried out (data in Section 17, not provided here). |
| Compliance with UL 60601-1 (Electrical Safety) | Successfully carried out (Certificate of Compliance in Section 17, not provided here). |
Missing Information (Not Available in the Provided Text):
- 2. Sample size used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. This device is an ultrasonic surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study would generally not be applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This refers to typical AI/software performance studies, which are not relevant for this type of physical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- 8. The sample size for the training set: Not mentioned.
- 9. How the ground truth for the training set was established: Not mentioned.
Conclusion based on the provided text:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general safety/electrical testing. It explicitly states that "performance testing was carried out for some characteristics" to assure substantial equivalence where descriptive characteristics were not sufficient, and that this data is available in the full 510(k) submission. However, this specific excerpt does not detail the nature of this performance testing, the acceptance criteria, or the results, nor does it describe any clinical or comparative efficacy studies.
§ 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.