(282 days)
The Precise SHP Diode Laser is indicated for the removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, freeectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.
The Precise SHP Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 watts of energy output. The laser energy is delivered to surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
The provided 510(k) summary for the "Precise SHP Diode Laser" does not contain information about acceptance criteria and a study proving those criteria are met in the way a diagnostic device approval would. This device is a surgical instrument (a diode laser), not a diagnostic algorithm. For such devices, the assessment criteria focus on manufacturing, safety, and performance specifications rather than diagnostic accuracy metrics.
Therefore, many of the requested points cannot be answered from the provided text, as they are not applicable to the type of device and regulatory submission presented.
Here's an analysis based on the information provided, and where information is missing for a diagnostic device context:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present acceptance criteria in a quantitative table format with corresponding performance results similar to a diagnostic device. Instead, it refers to compliance with regulatory standards and general functional performance.
| Criterion Type (as inferred for a surgical laser) | Reported Performance (or compliance statement) |
|---|---|
| Output Wavelength | 810 ± 20nm |
| Maximum Energy Output | 3 watts |
| Aiming Beam Wavelength | 630nm (switchable) |
| Delivery Method | Optical fiber system with disposable single-use tip |
| Operating Controls | Adjustable power, continuous/pulse options, foot-actuated switch |
| Safety Features | All safety features and functions operating correctly |
| Regulatory Compliance | Complies with 21 CFR 1040.10, 1040.11, Laser Notice 50, IEC 60601-2-22, IEC 60825-1, IEC 60601-1 (3rd Ed), IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6 |
| Essential Performance | Met design criteria for essential performance |
| CFR 21 1010 & 1040 Compliance | Performance requirements satisfied, device outputs within requirements |
2. Sample Size for Test Set and Data Provenance
Not applicable in the context of a diagnostic test on patient data. The "test set" here refers to the device itself.
- Sample size: "Bench testing on an evaluation sample of the current device" - implies at least one device was tested.
- Data provenance: N/A (bench testing of the physical device).
3. Number of Experts and Qualifications for Ground Truth
Not applicable. Ground truth for a diagnostic device would involve independent clinical review or pathological confirmation. For a surgical laser, experts might design the testing protocols, but they aren't establishing a "ground truth" diagnosis.
4. Adjudication Method
Not applicable for a device performance test of a surgical laser.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic imaging device where human readers interact with AI.
6. Standalone Performance Study
Yes, in a sense. The "bench testing" described is a standalone evaluation of the device's physical and functional performance without human interaction beyond operating the device.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is adherence to:
- Engineering design specifications.
- Performance requirements outlined in 21 CFR 1010 and 21 CFR 1040.
- Relevant international safety and performance standards (e.g., IEC 60601 series, IEC 60825-1).
8. Sample Size for Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable. This device is not an AI/ML algorithm.
§ 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.