(44 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, 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 contains the same basic components and design as the cleared Megabeam Radial fiber and theCeralas diode laser family is substantially similar in performance and technology to the cleared Nd: YAG laser.
The provided document is a 510(k) summary for the Radial-Emitting Shaped Fiber Optic Delivery System. It explicitly states that no performance testing was included in the submission because "the performance... is well established and documented on soft tissue."
Therefore, based on the provided text, it is not possible to provide a table of acceptance criteria or details about a study proving the device meets acceptance criteria. The submission relies on substantial equivalence to predicate devices, rather than new performance data.
Here's an attempt to answer the questions based only on the provided information, noting the lack of specific study data:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| The device is "as safe and effective" as predicate devices for its Indications for Use. | The Radial-Emitting Shaped Fiber Optic Delivery System is stated to be "as safe and effective for these Indication for Use as the Megabeam Radial-Emitting Shaped Fiber Optic Delivery System." |
| Substantial equivalence to predicate devices in "intended uses, indications, technological characteristics, and principles of operation." | The document states the device "contains the same basic components and design as the cleared Megabeam Radial fiber" and the Ceralas diode laser family is "substantially similar in performance and technology to the cleared Nd: YAG laser." It also notes: "Any minor differences in technology do not raise any new questions on safety or efficacy." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The submission explicitly states: "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." Therefore, no new test set was used or data provenance specified.
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 provided. No new test set requiring expert ground truth establishment was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No new test set requiring adjudication was described.
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
- No. This is a medical device (fiber optic delivery system), not an AI-based diagnostic tool. No MRMC study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (fiber optic delivery system), not an algorithm. No standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The submission relies on substantial equivalence to predicate devices whose performance is "well established and documented on soft tissue," rather than new studies with a defined ground truth.
8. The sample size for the training set
- Not applicable / Not provided. This is a medical device. There is no mention of a "training set" as would be used for AI/ML models.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set for this type of device submission, this question is not relevant.
§ 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.