(37 days)
The Radial Emitting Shaped Fiber Optic Delivery System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.
The Radial Emitting Shaped Fiber Optic Delivery System for Biolitec Medical Devices. Inc. contains the identical same components and design as the device cleared under K110080 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.
The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it's a 510(k) premarket notification for a medical device (Radial-Emitting Shaped Fiber Optic Delivery System). The key takeaway from the "Performance Data" section (Page 1) is:
"Since the performance of the Radial-Emitting Shaped Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission."
This statement indicates that the submission relies on the established performance of a predicate device (K110080) and asserts that the new device has "identical same components and design" and "no differences in technology." Therefore, it raises no "new questions on safety or efficacy" and is considered "substantially equivalent" to the predicate device.
Given this, I cannot fill out the requested table or answer most of your detailed questions about acceptance criteria and a study.
However, I can extract what limited information is available related to the request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. The submission states that performance is "well established and documented on soft tissue" for the predicate device. | The device has "identical same components and design as the device cleared under K110080" (the predicate device). It has "no differences in technology" and is "as safe and effective" as the predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not applicable. No new performance testing was conducted for this submission.
- Data provenance: Not applicable. The submission relies on the established performance of a predicate device, but no specific data or its provenance is detailed.
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. No new performance testing was conducted that would require establishing ground truth by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance testing was conducted.
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. This device is a fiber optic delivery system, not an AI or imaging device involving human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (fiber optic delivery system), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No new performance testing or ground truth establishment was conducted for this submission. The submission relies on the performance of a predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would have a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
In summary, this 510(k) submission leverages the concept of "substantial equivalence" to a predicate device. It explicitly states that no new performance testing was conducted or included in the submission because the device is identical in components and design to a previously cleared device, and its performance is considered "well established."
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.