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The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:

1. The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, troughing, and removal of inflamed edematous tissue.

2. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;

3. 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.

This submission (K181601) is for a labeling change to the previously cleared Precise SHP Diode Laser (K123443). The key change is that the disposable applicator tips will now be delivered non-sterile, and the end-user will be responsible for sterilization. Therefore, the "device performance" in terms of clinical efficacy of the laser itself is not re-evaluated or specifically measured against acceptance criteria in this document. The focus of the "study" described here is to demonstrate that the new labeling and the end-user sterilization process do not negatively impact safety or effectiveness.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

Since this is a labeling change and not a re-evaluation of the laser's primary performance, the "acceptance criteria" are related to the safety and efficacy of the sterilization process for the tips and the laser's continued compliance with safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample size for the "verification and validation testing" performed on the tips for sterilization efficacy or performance. It simply states "Verification and validation testing indicate..."
• Data Provenance: Not specified. The document outlines a submission to the US FDA by a US-based company (CAO Group, Inc., West Jordan, Utah, U.S.A.). However, the location/country where the testing was performed is not mentioned, nor is it explicitly stated if the data is retrospective or prospective, though it would logically be prospective testing conducted specifically for this submission.

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

Not applicable. This submission concerns a labeling change and the effect of end-user sterilization on a device component. It does not involve establishing ground truth based on expert clinical or radiological reviews. The "ground truth" here is objective laboratory testing against established sterilization standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is used in studies involving human interpretation or decision-making (e.g., image reading). The testing performed here (sterilization efficacy) is objective laboratory testing.

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 document does not describe an MRMC study or any AI component.

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

Not applicable. This document does not describe any algorithm or AI performance.

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

The "ground truth" for the sterilization efficacy testing would be objective laboratory standards for sterilization, specifically achieving a Log 6 reduction in bioburden, as measured by standard microbiological assays. For tip performance, it would be instrumental measurements against predefined performance specifications.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning study.

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

Not applicable. There is no "training set."

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The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of:

• 1. 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.
• 2. 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;
• 3. 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

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.

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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.

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.

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