(448 days)
The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of:
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The removal of lesions, excision, incision, vaporization, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;
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Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;
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Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
The Sterling Supreme 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 does not describe a study involving an AI/ML medical device, clinical performance metrics, or a comparative effectiveness study. It pertains to a 510(k) premarket notification for a medical device called the "Sterling Supreme Diode Laser."
This submission describes changes to the device's labeling and the method of delivering single-use tips (now non-sterile, requiring end-user sterilization) compared to a previously cleared predicate device. It addresses electrical safety, electromagnetic compatibility, performance bench testing, biocompatibility, and end-user sterilization verification and validation.
Therefore, I cannot extract the information required to answer your request about acceptance criteria and a study proving the device meets them, specifically regarding AI/ML performance, ground truth, expert consensus, or multi-reader multi-case studies.
The document states:
- "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."
- "The modifications consist only of changes to the device labeling and instructions for use for the end-user to be aware of the present condition of the tips and to properly prepare the tips for use. All other aspects of the device, including indications for use, are not affected by this change."
- The performance data sections focus on ensuring that the non-sterile delivery of tips and subsequent end-user sterilization do not negatively impact the device's safety or efficacy.
To answer your specific questions in the context of this document, here's what can be inferred or explicitly stated regarding the closest equivalent "acceptance criteria" and "study":
Acceptance Criteria (Implied for the Change):
The primary acceptance criterion for this 510(k) submission regarding the change from sterile to non-sterile tips is that the modification does not introduce new risks or adversely affect the safety and effectiveness of the device, and that end-user sterilization is effective.
Reported Device Performance (for the change):
The testing confirmed that:
- The device still complies with relevant electrical safety (21 CFR 1040.10, 1040.11, IEC 60601-2-22, IEC 60825-1, IEC 60601-1: 3rd Edition, IEC 60601-1-2, IEC 60601-1-6).
- No performance characteristics or specifications of the device were modified.
- No new risks or concerns regarding device performance were raised.
- Biocompatibility was not affected as no materials were modified.
- End-user sterilization of tips with an approved liquid chemical sterilant is capable of achieving a log 6 reduction in bioburden without adversely impacting performance or specifications.
- Rinsing after sterilization adequately removes residual sterilant.
Given this context, I will provide a table and address your points based on the closest applicable information in the document, acknowledging that it's not an AI/ML clinical performance study.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for the Change) | Reported Device Performance |
|---|---|
| Maintains Electrical Safety & Electromagnetic Compatibility | The Sterling Supreme Diode Laser complies with 21 CFR 1040.10 & 1040.11, IEC 60601-2-22 Edition 3, IEC 60825-1 Edition 2, IEC 60601-1: 3rd Edition, IEC 60601-1-2, and IEC 60601-1-6. |
| No adverse impact on device performance/specifications | Performance bench testing confirmed "No new risks or concerns regarding device performance" and "No performance characteristics or specifications of the device are modified" due to the non-sterile tip delivery. |
| No new biocompatibility risks due to material changes | "There are no modifications to the materials used in the device." Risk assessment showed no increased risks as long as instructions for use are followed. |
| End-user sterilization achieves required bioburden reduction & safety | "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." Also, "rinsing the tips after treatment with the sterilant adequately removes residual sterilant from the tip." |
| No change in device's fundamental safety and effectiveness or Indications for Use | The modifications "do not present any new concerns over safety and effectiveness of the device." "All other aspects of the device, including indications for use, are not affected by this change." The device is considered "substantially equivalent" to its predicate device, signifying it meets the safety and effectiveness profile for its intended use. |
2. Sample size used for the test set and the data provenance
The document does not detail specific sample sizes for electrical safety, EMC, performance bench testing, or biocompatibility, as these are typically standard engineering and material tests, not clinical studies with patient populations. The tests pertain to the device itself and the sterilization process for the tips. The data provenance is internal testing performed by the manufacturer, CAO Group, Inc. (U.S.A.). The tests are likely retrospective, as they apply to a modified product seeking clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of tests described (electrical safety, EMC, performance bench testing, biocompatibility, sterilization validation). These tests rely on established engineering standards and laboratory protocols, not human expert interpretation for "ground truth" in the way it's used for AI/ML image analysis.
4. Adjudication method for the test set
Not applicable. There is no mention of human-in-the-loop assessment or expert adjudication for the technical tests performed.
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 diode laser, not an AI/ML diagnostic system. No MRMC study was performed or is 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 AI/ML algorithm.
7. The type of ground truth used
For electrical safety and EMC, the "ground truth" is adherence to recognized international and federal standards (e.g., IEC 60601 series, 21 CFR 1040).
For performance bench testing and biocompatibility, the "ground truth" is the device's original validated performance and material safety profile, which the modifications must not adversely affect.
For end-user sterilization, the "ground truth" for efficacy is a "log 6 reduction in bioburden," which is a standard microbiological criterion for sterilization, and proof of adequate residual sterilant removal.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.