(88 days)
The company's MegaBeam/Ceralas NonSterile Collimating Handpiece is intended to be used as a fiber optic delivery accessory to a laser device. Please refer to the Laser User Manual for a complete list of indications.
The Mega Beam/Ceralas Collimating Handpiece consists of a 3 meter quartz optical fiber encased in an anodized aluminum handpiece. The aluminum handpiece has lenses that collimate the beam to create a 7mm beam and resulting 7mm spot size.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ceralas Diode Laser System's MegaBeam/Ceralas Non Sterile Collimating Handpiece:
The provided document, K013193, is a 510(k) summary for the MegaBeam/Ceralas Non Sterile Collimating Handpiece. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a comprehensive clinical study with specific acceptance criteria in the context of typical AI/software device submissions.
Therefore, many of the requested categories (like number of experts, adjudication methods, MRMC studies, specific ground truth types) are not applicable or explicitly mentioned in the provided text, as this is a traditional medical device submission for an accessory.
Here's what can be extracted and inferred based on the provided information:
Acceptance Criteria and Device Performance for MegaBeam/Ceralas Non Sterile Collimating Handpiece
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (MegaBeam/Ceralas Handpiece) |
|---|---|
| Functional Equivalence: | Handpiece Efficiency: Comparable to predicate. |
| - Similar handpiece efficiency to predicate devices. | Energy Density: Comparable to predicate. |
| - Similar energy density to predicate devices. | Divergent Half Angle: Comparable to predicate. |
| - Similar divergent half angle to predicate devices. | Maximum Power Output: Less than predicate devices. (Not a new safety concern due to overall performance). |
| - No new questions of safety and effectiveness raised by technological differences. | Technological differences (lower max power, less divergence) do not raise new safety/effectiveness questions. |
| Intended Use: | Same intended use as all three predicate devices. |
| Indications for Use: | Same indications as one predicate, except no endoscopic applications. |
| Principle of Operation: | Very similar to predicate collimating handpieces. |
| Technical Characteristics: | Similar to a combination of predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical trial. The "testing" refers to comparative engineering/performance measurements. The sample sizes for these measurements (e.g., how many handpieces were tested, how many individual measurements per handpiece) are not provided.
- Data Provenance: The device performance data was "Biolitec conducted testing." This indicates in-house engineering and laboratory testing. The country of origin for this testing is implied to be within the US (where Biolitec, Inc. is located). The data is prospective in the sense that the testing was performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. This type of information is relevant for studies involving human interpretation or clinical outcomes, which is not the nature of the testing described for this device accessory. The "truth" here is based on physical scientific measurements of the device's optical and power characteristics.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 3.
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 is not an AI/software device. The product is a physical fiber optic delivery accessory for a laser.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
- The ground truth for the performance claims appears to be based on direct physical measurements of the device's characteristics (efficiency, energy density, divergent half angle, maximum power output) using established scientific and engineering methodologies, compared against the known specifications or measured performance of the predicate devices.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" in the context of this type of device submission. This is not an AI/machine learning product.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See point 8.
Summary of the Study Proving Device Meets Acceptance Criteria:
Biolitec conducted performance tests to compare the MegaBeam/Ceralas Collimating Handpiece's:
- Handpiece efficiency
- Energy density
- Divergent half angle
These tests were performed against the company's own MegaBeam Bare Fiber's handpiece (acting as a predicate/comparator). The results of these comparative tests demonstrated that the MegaBeam/Ceralas Collimating Handpiece is "as safe and effective" as the predicate Fiber Optic Delivery System's Bare Fiber.
The argument for meeting the acceptance criteria (which are largely implicit in demonstrating substantial equivalence) relies on showing that while there are minor technological differences (e.g., maximum power output is less, divergence angle is less than predicates), these differences:
- Do not raise new questions of safety and effectiveness.
- The device performs comparably in key optical and power delivery metrics.
- It has the same intended use and very similar principles of operation to the predicate devices.
The FDA's decision to grant 510(k) clearance signifies that they agreed with Biolitec's assessment that the provided performance data sufficiently demonstrated substantial equivalence to the legally marketed predicate devices.
§ 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.