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510(k) Data Aggregation
(150 days)
The Pioneer Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of:
- 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.
- 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;
- 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
| Acceptance Criteria Category | Specific Criteria / Requirement | Reported Device Performance |
|---|---|---|
| Safety Standards | Compliance with 21 CFR 1040.10 and 1040.11 (Laser Product Performance Standards) and Laser Notice 50 | "The Pioneer Elite Diode Laser is designed to comply with the performance requirements of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated June 24, 2007." |
| Medical Electrical Equipment Safety | Compliance with IEC 60601-2-22 Edition 2 | "The device also complies with the recognized standards of IEC 60601-2-22 Edition 2" |
| Laser Safety Management | Compliance with IEC 60825-1 Edition 1.2 | "and IEC 60825-1 Edition 1.2." |
| General Medical Electrical Equipment Safety | Compliance with IEC 60601-1: 2nd Edition, IEC 60601-1-2, and IEC 60601-1-4 | "The device is designed in compliance to the entirety of IEC 60601-1: 2nd Edition, IEC 60601-1-2, and IEC 60601-1-4." |
| Design Criteria & Performance Requirements | Meet design criteria for essential performance and satisfy performance requirements in 21 CFR 1010 and 21 CFR 1040 | "Bench testing on an evaluation sample of the current device revealed that 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." |
| Substantial Equivalence | Similar intended uses, operating principles, design features, functional and performance characteristics to predicate devices. | "The Pioneer Elite Diode Laser is substantially equivalent to the listed predicate devices without raising any new issues of safety or effectiveness. This device shares similar intended uses, operating principles, design features, and similar functional and performance characteristics." (This is the overarching conclusion of the submission, based on the comparison of features and the performance data summarized above). |
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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