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The Pioneer Elite 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 Pioneer Elite 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 text is a 510(k) summary for the Pioneer Elite Diode Laser, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, specifically noting a change in the sterilization delivery of the single-use applicator tips.

Therefore, the context of the document is not a study to prove a device meets acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, it's a regulatory submission demonstrating that a modified version of an already cleared device is still safe and effective, primarily by ensuring that the change in sterilization delivery does not negatively impact performance and that the device still meets relevant safety and performance standards.

As such, many of the requested points for describing an acceptance criteria study (e.g., sample size for test set, ground truth experts, MRMC study, training set details) are not applicable to this type of regulatory submission. The "acceptance criteria" here are compliance with recognized standards and verification/validation testing related to the specific modification.

Here's a breakdown based on the information provided:

Acceptance Criteria and Device Performance (Not a typical clinical performance study)

The acceptance criteria and device performance described in this document relate to the safety and fundamental functional compliance of the modified device, particularly concerning the change in sterilization of the single-use tips, rather than clinical efficacy metrics.

Study Details (Specific to the demonstrated change in sterilization delivery)

1. Sample size used for the test set and the data provenance: Not applicable in the traditional sense for clinical performance. The testing mentioned (End-User Sterilization) would have involved a sufficient number of samples of the single-use tips to demonstrate sterilization effectiveness and tip integrity, but specific numbers are not provided in this summary. The data provenance would be from laboratory testing conducted by or for the manufacturer.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of submission. "Ground truth" here is established via standard microbiological (bioburden reduction) and material/performance testing protocols.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Standard laboratory testing protocols would be followed, typically with independent verification.
4. 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 is not about AI or human reader performance.
5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a laser device, not an algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the sterilization effectiveness testing, the "ground truth" would be established by validated microbiological methods (e.g., direct bioburden measurement, sterility testing after sterilization, assays for residual sterilant) and physical/functional property testing of the tips.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The document describes a regulatory submission (510(k)) for a previously cleared device, the Pioneer Elite Diode Laser. The primary "study" or demonstration of compliance pertains to a specific modification: the single-use applicator tips are now delivered to the end-user in a non-sterile condition, rather than pre-sterilized.

The manufacturer conducted verification and validation testing to ensure that this change did not compromise the safety or effectiveness of the device. This testing focused on:

• Electrical Safety and Electromagnetic Compatibility: Ensuring continued compliance with relevant international and national standards (e.g., IEC 60601 series, 21 CFR 1040).
• Performance Bench Testing: Confirming that the act of changing the sterilization delivery method did not alter any original performance characteristics or specifications of the device.
• Biocompatibility: Verifying that no material changes were made and that the modified delivery method (requiring end-user sterilization) did not introduce new biocompatibility risks, provided instructions were followed.
• End-User Sterilization: Crucially, performing tests to demonstrate that:
  • Treatment of the tips with an approved liquid chemical sterilant can achieve a "log 6 reduction in bioburden" (a standard measure of sterilization efficacy).
  • This sterilization process does not adversely impact the performance or specifications of the tips.
  • Rinsing the tips after sterilization adequately removes residual sterilant.

Conclusion of the demonstration: The manufacturer concluded that these modifications and associated testing confirm that the device remains safe and effective, and substantially equivalent to the predicate device, with the change consisting only of labeling and instructions for use regarding the end-user sterilization of the tips.

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The Pioneer Elite 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 Pioneer Elite 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 ± 20mm 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 terminal 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 diode is completed by use of a foot-actuated switch.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pioneer Elite Diode Laser:

Acceptance Criteria and Device Performance for Pioneer Elite Diode Laser

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for the Pioneer Elite Diode Laser, rather than presenting a traditional clinical study with detailed acceptance criteria and performance metrics against a specific clinical outcome. Therefore, the "acceptance criteria" here are primarily conformity to standards and meeting design specifications as demonstrated through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document states "Bench testing on an evaluation sample of the current device." A specific number for the sample size is not provided.
• Data Provenance: The data is generated from bench testing performed by the manufacturer (CAO Group, Inc.). There is no information about the country of origin of this testing other than the manufacturer's address in West Jordan, UT, USA. The testing is implicitly prospective in the sense that it was conducted on the manufactured device to verify its performance prior to submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This submission relies on technical standards compliance and bench testing against engineering specifications, not expert-derived ground truth for clinical outcomes or diagnostic accuracy.

4. Adjudication Method

• Not Applicable. There is no mention of an adjudication method as the primary evaluation is technical compliance and bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. A MRMC comparative effectiveness study was not conducted or described in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with safety standards, not a clinical comparison of AI-assisted human performance.

6. Standalone Performance Study (Algorithm Only)

• Yes (implicitly, for the device's technical functions). The "Performance Data" section describes "Bench testing on an evaluation sample of the current device" where "device outputs were within performance requirements and all safety features and functions were operating correctly." This describes the standalone performance of the device's hardware and software (if any control software is involved) in meeting its design specifications. It's not an "algorithm-only" study in the modern sense of AI, but rather a verification of the entire device's functional performance.

7. Type of Ground Truth Used

• The "ground truth" for the bench testing was the design criteria and performance requirements specified by the manufacturer, and the criteria outlined in the cited federal regulations (21 CFR 1010, 21 CFR 1040) and international standards (IEC 60601 series, IEC 60825-1).

8. Sample Size for Training Set

• Not Applicable. This device is a laser surgical instrument, and its performance evaluation does not involve machine learning algorithms that require a "training set" of data.

9. How Ground Truth for Training Set Was Established

• Not Applicable. As no training set is relevant for this type of device and performance evaluation, no ground truth for a training set was established.

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