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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.

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The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System that has already been cleared by FDA (K983058) for use in the following dental indications: draining fistulas, coagulation and decontamination of extraction sites, frenectomy, excisional biopsy, operculectomy, implant uncovering, gingivectomy, gingivoplasty, degranulation of infrabony defects, enucleate apical troughing for crown and bridge, apthus ulcers, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, exposure of enamel for orthodontic brackets, and surgical exposure to aid in eruption. The purpose of this submission is to expand the indications for use to include pulpotomy and pulpotomy as an adjunct to root canal therapy.

The Cerals D Diode Laser operates with a power range of 1-15W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.

Here's an analysis of the provided text regarding the Ceralas Diode Laser System and its performance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Performance Data: None required." This indicates that no new empirical test set data was used to demonstrate performance for this particular 510(k) submission. The device relies on demonstrating substantial equivalence to a predicate device and technological identity to a previously cleared version of itself for the expanded indications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no performance data was required or submitted, there was no test set for which ground truth needed to be established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Performance Data: None required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a hardware laser system, not an algorithm. Therefore, a standalone performance study in the context of AI algorithms is not applicable.

7. The Type of Ground Truth Used

No new ground truth was established or used for this 510(k) submission as no performance data was submitted. The grounds for approval are based on predicate device comparison and the lack of technological differences from a previously cleared device.

8. The Sample Size for the Training Set

Not applicable. As a hardware device, there is no "training set" in the context of machine learning. The device's design and operating parameters would have been established through engineering and potentially prior clinical testing, but this 510(k) does not detail such information.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in this context. The core assertion is that the device, being technologically identical to a previously cleared one and similar to a predicate, is safe and effective for the expanded indications without requiring new performance data.

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