(278 days)
The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:
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- The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue.
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- Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
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- Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
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 incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
The provided document is a 510(k) summary for the Precise SHP Diode Laser. It outlines the device's characteristics, intended uses, and claims of substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or details of a study that proves the device meets those criteria in the format of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or other quantitative measures of effectiveness).
Instead, the document focuses on demonstrating substantial equivalence based on:
- Similar intended uses: Both the proposed device and predicates are for dentistry and oral soft tissue procedures, temporary pain relief, and teeth whitening.
- Similar technological characteristics: Wavelength, operating controls, laser delivery method, control systems, safety features, and performance monitoring.
- Conformity to standards: Compliance with regulatory standards like 21 CFR 1040.10, 1040.11, IEC 60601-2-22, IEC 60825-1, IEC 60601-1 (3rd Edition), IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-1-6.
- Bench testing: A general statement about bench testing indicating the device met design criteria, satisfied performance requirements of 21 CFR 1010 and 21 CFR 1040, and that outputs were within requirements and safety features functioned correctly.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the requested format (e.g., sensitivity, specificity, accuracy) because this information is not present in the provided text. The document describes a bench testing study, but not a clinical study with detailed performance metrics.
Here's an analysis of what is provided, based on your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from regulatory and design compliance) | Reported Device Performance (from Bench Testing) |
|---|---|
| Compliance with 21 CFR 1040.10 and 1040.11 (Laser Product Performance Standards) | Device met performance requirements of 21 CFR 1010 (related to general radiological health) and 21 CFR 1040 (performance standards for light-emitting products). |
| Compliance with IEC 60601-2-22 Edition 3 (Medical Electrical Equipment - Specific Requirements for Basic Safety and Essential Performance of Surgical, Therapeutic and Diagnostic Laser Equipment) | Device is designed to comply with this standard. |
| Compliance with IEC 60825-1 Edition 2 (Safety of laser products - Part 1: Equipment classification and requirements) | Device is designed to comply with this standard. |
| Compliance with IEC 60601-1: 3rd Edition (General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment) | Device is designed in compliance to this standard. |
| Compliance with IEC 60601-1-2 (Electromagnetic disturbances) | Device is designed in compliance to this standard. |
| Compliance with IEC 60601-1-4 (Programmable electrical medical systems) | Device is designed in compliance to this standard. |
| Compliance with IEC 60601-1-6 (Usability) | Device is designed in compliance to this standard. |
| Essential performance design criteria | Device met the design criteria for essential performance. |
| Device output within performance requirements | Device outputs were within performance requirements. |
| Safety features and functions operating correctly | All safety features and functions were operating correctly. |
Note: This table is an interpretation based on the provided text, which states the device "met the design criteria for essential performance, and satisfied the performance requirements indicated in 21 CFR 1010 and 21 CFR 1040. Device outputs were within performance requirements and all safety features and functions were operating correctly." Specific numerical or qualitative performance metrics beyond these general statements are not given.
2. Sample size used for the test set and the data provenance
- Sample Size: "an evaluation sample of the current device." The exact number of devices in this sample is not specified.
- Data Provenance: Not specified, but generally, bench testing for a 510(k) submission would be conducted by the manufacturer (CAO Group, Inc.) in a controlled lab environment. It is not patient or human data, so "country of origin" and "retrospective/prospective" are not applicable in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The study was bench testing, not a clinical study involving human assessment or ground truth established by experts. The "ground truth" would be the engineering specifications and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to clinical studies where different experts might disagree on an assessment. Bench testing typically involves objective measurements against predefined specifications.
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
- No. This was a bench test of a laser device, not an AI-based diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm, but a physical medical device (laser). The bench testing described essentially represents the "standalone" performance of the device against its specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the bench testing would be the engineering specifications and performance requirements defined by the manufacturer and relevant regulatory standards (e.g., maximum power output, wavelength accuracy, safety feature functionality).
8. The sample size for the training set
- Not applicable. This is not an AI device, so there is no training set in the machine learning sense. The "training" for the device would be its design and manufacturing process.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 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.