(89 days)
The MegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.
The MegaBeam Reusable Fiber Optic Delivery System for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K980838 for Biolitec Inc.
The provided text describes a 510(k) summary for the MegaBeam Reusable Fiber Optic Delivery System. It explicitly states that no performance testing was included in this submission because the performance of the device "is well established and documented on soft tissue."
Therefore, based on the provided text, I cannot complete a table of acceptance criteria or describe a study that proves the device meets specific criteria, as such information is not present in the document.
Here's an attempt to answer the questions based on the absence of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable, as no new performance testing was conducted for this submission.
- Data Provenance: Not applicable, as no new performance testing was conducted for this submission.
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, as no new performance testing with a test set requiring ground truth establishment was conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new performance testing with a test set requiring adjudication was conducted for this submission.
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-powered diagnostic tool, and 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 fiber optic delivery system, not an algorithm, and no standalone performance study was mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no new performance testing with a test set requiring ground truth was conducted for this submission.
8. The sample size for the training set
Not applicable, as this is a medical device, not an AI model, and no training set was mentioned.
9. How the ground truth for the training set was established
Not applicable, as this is a medical device, not an AI model, and no training set with ground truth establishment was mentioned.
Summary based on the provided text:
The submission for the MegaBeam Reusable Fiber Optic Delivery System (K113688) relies on a substantial equivalence pathway. The document explicitly states: "Since the performance of the MagaBeam Reusable Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission." Therefore, there is no information in the provided text regarding acceptance criteria or a study proving the device meets them because new performance data was not presented. The device's safety and efficacy are asserted through its identical nature to its predicate device (K980838).
§ 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.