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The DenLaser 800 Plus is indicated for the procedures of removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue in the fields of otolaryngology (ear, nose, and throat), dentistry and oral surgery, arthroscopy, gastroenterology, dermatology, podiatry, plastic surgery, urology, gynecology, and plastic surgery.

The DenLaser 800 Plus is a device for delivering laser energy to human soft tissue for a variety of surgical procedures. 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 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 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 typical sense for AI/software devices.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not provide a table of acceptance criteria and reported device performance in the manner one would expect for a diagnostic or AI-driven device clinical study (e.g., sensitivity, specificity, AUC, etc.). Instead, the "acceptance criteria" are implied by compliance with various performance standards and demonstrated substantial equivalence to predicate devices. The "reported device performance" is described qualitatively through its technical characteristics and intended uses.

   Acceptance Criterion (Implied)	Reported Device Performance
   Substantial Equivalence to Predicate Devices (K050453, K032864, K993285)	The DenLaser 800 Plus shares similar indications for use on soft tissue (cutting, lesions, photocoagulation), design features (wavelength, operating controls, laser delivery), control systems, safety features, performance monitoring, power output, energy type, and applications to soft tissue with the predicate devices.
   Compliance with 21 CFR 1040.10 and 1040.11 (Laser Product Performance Standards)	Device complies with these standards, with permissible deviations relative to Laser Notice 50.
   Compliance with IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance)	Device complies with this standard.
   Compliance with IEC 60601-2-22 (Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)	Device complies with this standard.
   Compliance with IEC 60825-1 (Safety of laser products - Equipment classification and requirements)	Device complies with this standard.
   Compliance with 47 CFR 15 and 18 (FCC rules for radio frequency devices)	Device complies with these standards.
   Compliance with ETSI 301-489-1 (Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements)	Device complies with this standard.
   Safe and Effective for Intended Use	The device delivers laser energy at 810 ± 20nm for a maximum of 5 watts, via a proprietary optical fiber system, with a 630nm aiming beam, adjustable power, and continuous/pulsed delivery option. It is intended for removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue across several medical fields.

2. Sample size used for the test set and the data provenance:

   The document explicitly states "Clinical Performance Data" as a heading on page 2 but then provides no content under it, only moving directly to the "Conclusion" on page 3. This indicates that no clinical performance study, test set, or specific data provenance was used or reported in this 510(k) summary. The substantial equivalence argument relies on comparison to predicate devices and adherence to recognized performance standards. This type of submission generally does not require a specific clinical test set if substantial equivalence can be demonstrated through other means (e.g., technological characteristics, bench testing, and adherence to standards).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Not applicable. As no clinical test set was reported, there was no need for experts to establish ground truth.

4. Adjudication method for the test set:

   Not applicable. No clinical test set was reported.

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/diagnostic software. No MRMC study was performed or is relevant for this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   Not applicable. This is a hardware device (surgical laser), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   Not applicable. No clinical study requiring ground truth was reported. The "ground truth" for this submission are the established performance standards and the characteristics of legally marketed predicate devices.

8. The sample size for the training set:

   Not applicable. This is a hardware device, not an AI/machine learning algorithm, so there is no training set in that context.

9. How the ground truth for the training set was established:

   Not applicable. As above, no training set for an algorithm was used.

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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

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."

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