(90 days)
The biolitec, Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece is intended to be used as a fiberoptic laser delivery accessory with the CeralasD 980nm Diode Laser for the dental indications that the laser has already been cleared for in K983058, K991891 and K993002. Please refer to the Laser User Manual for the specific list of indications.
The Mega Beam / Ceralas Collimating Handpiece consists of a 3 meter quartz optical fiber encased in a handpiece. The handpiece has lenses that collimate the beam to create a 7mm beam and resulting 7mm spot size.
I am sorry, but based on the provided text, there is no specific acceptance criteria or detailed study information to fulfill your request. The document is a 510(k) summary for a medical device (Mega Beam/Ceralas Nonsterile Collimating Handpiece) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results with acceptance criteria.
The "Performance Data" section states that:
"biolitec conducted testing comparing the Mega Beam Ceralas Collimating Handpiece's and the Mega Beam Bare Fiber's handpiece efficiency, energy density and divergent half angle. These performance tests demonstrate that the Mega Beam/Ceralas Collimating Handpiece is as safe and effective as the bare fiber optic delivery system."
However, it does not provide any of the following crucial details you requested:
- Specific Acceptance Criteria: There are no defined numerical or qualitative thresholds for "handpiece efficiency, energy density, and divergent half angle."
- Reported Device Performance: No actual values or ranges for these parameters are provided for either the new device or the predicate.
- Sample Size: No information on the number of units tested.
- Data Provenance: No details on where or when the testing was performed.
- Number of Experts/Qualifications: These are irrelevant for this type of performance testing on a laser accessory.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable to a performance study of a device accessory.
- Standalone Performance: While performance testing was done, the results are not presented in a quantitative way to determine "standalone" performance against specific criteria.
- Type of Ground Truth: Not applicable for engineering performance tests.
- Training Set Sample Size/Ground Truth for Training Set: These relate to AI/machine learning models, which are not involved in this device's performance evaluation as described.
In summary, the document states that tests were performed and that the new device is "as safe and effective" as the predicate based on these tests, but it does not disclose the specific data or criteria necessary to complete your table and answer your detailed questions.
§ 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.