(55 days)
Dental, oral, and soft tissue surgery including: Sulcular debridement of diseased or fiberous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown lengthening Operculectomy Frenectomy Photocoagulation
The DenLaser 800 Plus is a device for delivering laser energy to surfaces within the oral cavity. 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 5 watts of energy output. The laser energy is delivered to surgical site by means of a proprietary optical fiber system, which allow for the safe transmission of laser energy to the sire 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 630mm aiming beam, adjustable power output for both the working bearn and aiming beam, and continuous delivery or pulse delivery option. The working end of the delivery fiber is contained within 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 text is a 510(k) summary for the DenLaser 800 Plus, an 810nm Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards, rather than presenting a clinical study with detailed acceptance criteria and performance data in the format requested.
Therefore, many of the requested details cannot be extracted directly from this document. The document states "See Part 7: Performance Data" for Clinical Performance Data, but Part 7 is not included in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Standards: Compliance with: |
- 21 CFR 1040.10 and 1040.11 (with permissible deviations relative to Laser Notice 50, dated July 26, 2001)
- IEC 60601-1:1998+A1
- IEC 60601-2-22:1995
- IEC 60825-1:1993+A1+A2
- 47 CFR 15 and 18
- ETSI 301-489-1 | The document states: "The DenLaser 800 Plus diode laser complies with the performance requirements of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated July 26, 2001. The device also complies with IEC 60601-1:1998+A1, IEC 60601-2-22:1995, IEC 60825-1:1993+A1+A2, 47 CFR 15 and 18, and ETSI 301-489-1."
The reported performance is an assertion of compliance with these specified standards, implying the device met the criteria outlined within those standards. Specific quantitative acceptance criteria (e.g., "power output must be within X% of Y") and the actual measured performance values are not detailed in this summary. |
| Substantial Equivalence: Similar intended uses, similar functional and performance characteristics to predicate devices. | The document concludes: "The DenLaser 800 Plus is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics." This is a qualitative statement of meeting the criteria for substantial equivalence. |
| Soft tissue surgical procedures within the oral cavity (as per "Indications for Use") | The device is intended for these uses. The provided document does not include a study demonstrating the device's efficacy or safety specifically for each of these procedures. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided 510(k) summary does not describe a clinical test set with a specific sample size. It mentions "Clinical Performance Data" but directs the reader to a section ("Part 7") that is not included. The document focuses on compliance with technical standards and substantial equivalence, which typically rely on bench testing and comparisons to existing devices rather than a dedicated clinical trial with a "test set" in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication of a test set.
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 device is a surgical laser, not an AI-assisted diagnostic or imaging tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The provided document does not describe a study involving a "ground truth" in this context. The "truth" evaluated is compliance with performance standards and similarity to predicate devices.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this device does not involve machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set."
§ 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.