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The Sterling Supreme 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 tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;

2. 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;

3. 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

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.

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The Sterling Supreme 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 tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, gingivectomy, troughing, and removal of inflamed edematous tissue;

2. 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;

3. 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 dental and oral 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 the surgical site by means of an optical fiber fully ensheathed within a coated steel coil terminated in a handpiece assembly, 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 target tissues absorb the laser energy converting it to heat. Depending on the intensity or power output of the laser, the heat so generated can cause hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 650nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The device allows for selection of factoryestablished presets for common dental and oral care procedures, and allows for the operator to save desired settings for quick-reference.

Laser energy is transmitted through the fixed length of optical fiber to the distal end of the handpiece assembly. The handpiece assembly consists of a reusable, removable, sterilizable handpiece sleeve, and for surgical procedures is terminated with a single-use disposable tip. The operator uses the handpiece assembly to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a wireless foot-actuated switch.

The provided text is a 510(k) summary for the Sterling Supreme Diode Laser, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed acceptance criteria and study data typical of a clinical trial or a performance validation study for a new, non-substantially equivalent device.

The document's purpose is to establish substantial equivalence based on technological characteristics and performance specifications compared to a predicate device, not to provide a standalone clinical study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI or diagnostic device.

Therefore, many of the requested sections (sample size for test/training set, ground truth methods, expert qualifications, MRMC studies, effect size, etc.) are not applicable or not provided in this type of regulatory submission for this specific device.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "acceptance criteria" through conformance to standards and internal performance verification against labeled specifications. The predicate device's performance is used as a benchmark for "substantial equivalence" but not as formal "acceptance criteria" that the new device must meet to prove its own efficacy by objective performance metrics.

Ask a specific question about this device