(448 days)
The Pioneer Elite Diode Laser is indicated for dentistry and oral soft tissue procedures of:
- 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.
- 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;
- 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.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC | Compliance with 21 CFR 1040.10 and 1040.11 (with permissible deviations relative to Laser Notice 50, dated June 24, 2007). Compliance with IEC 60601-2-22 Edition 2, IEC 60825-1 Edition 1. Compliance with IEC 60601-1: 2nd Edition, IEC 60601-1-2, and IEC 60601-1-4. | "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. The device also complies with the recognized standards of IEC 60601-2-22 Edition 2 and IEC 60825-1 Edition 1. The device is designed in compliance to the entirety of IEC 60601-1: 2nd Edition, IEC 60601-1-2, and IEC 60601-1-4." (Indicates compliance was met by design.) |
| Performance Bench Testing (after modification) | No new risks or concerns; no modification of performance characteristics or specifications due to the change in tip sterilization delivery. | "No new risks or concerns regarding device performance are raised in modifying the device to provide the single-use tips to the market in a non-sterile state. No performance characteristics or specifications of the device are modified." |
| Biocompatibility (after modification) | No modifications to materials used; the change in tip sterilization process (non-sterile delivery to end-user) does not introduce increased risks. | "There are no modifications to the materials used in the device. Risk assessment activities demonstrate that presenting the single-use tips to the end-user in a non-sterile state does not introduce any increased risks or concerns so long as provided instructions for use are followed relative to processing the tips by the end-user prior to use." |
| End-User Sterilization Effectiveness | Achieving a log 6 reduction in bioburden with approved liquid chemical sterilant; no adverse impact on tip performance/specifications; adequate removal of residual sterilant. | "Verification and validation testing indicate that treatment of the tips with an approved liquid chemical sterilant is capable of achieving a log 6 reduction in bioburden, without adversely impacting the performance or specifications of the tip. Verification tests show that rinsing the tips after treatment with the sterilant adequately removes residual sterilant from the tip." |
Study Details (Specific to the demonstrated change in sterilization delivery)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- 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.
§ 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.