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The SoftLase Pro™/OrthoLase™/HygieneLase™ is to provide the ability to perform intraoral soft tissue maxilla-facial dental. general, oral and i cosmetic surgery. The SoftLase ProTM/OrthoLase™/HygieneLase™ is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.

The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharneeal indications for use for which the device will be marketed:

-Excision and Incision Biopsies

-Hemostatic assistance

-Treatment of Apthous Ulcers

-Frenectomy

-Frenotomy

-Gingival Incision and Excision

-Gingivectomy

-Gingivoplasty

-Incising and Draining of Abscesses

-Operculectomy

-Oral Papillectomy

-Removal of Fibromas

-Soft Tissue Crown Lengthening

-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)

-Tissue retraction for Impression

-Vestibuloplasty

-Light activation of bleaching materials for teeth whitening

-Laser-assisted bleaching/whitening of teeth

Not Found

The provided text is a 510(k) summary for the SoftLase Pro/OrthoLase/HygieneLase family of products, which are surgical laser systems. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a typical diagnostic or AI device submission would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, rather than conducting new clinical trials against specific performance metrics for novel technology.

Here's a breakdown of why the requested information cannot be fully provided based on the input and what the document does say:

1. A table of acceptance criteria and the reported device performance:

   • No specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned.
   • No reported device performance metrics (e.g., specific clinical outcomes, diagnostic accuracy) are presented.
   • The document states: "Safety and performance testing" was conducted, but no details of this testing or its results are provided. The "performance" in this context refers to the device's functional characteristics (e.g., laser output values, safety features) being comparable to predicate devices, not clinical effectiveness in a statistical sense.

2. Sample size used for the test set and the data provenance:

   • Not applicable. There is no "test set" in the context of diagnostic performance evaluation or AI model validation described here. The evaluation is based on demonstrating technical equivalence and safety to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth for a test set is not established as there's no diagnostic or AI performance being measured against a gold standard.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No test set requiring adjudication is described.

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 is a surgical laser, not a diagnostic imaging device with an AI component for human reader assistance. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical surgical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior clearances and market use. The new device is deemed equivalent to these known-safe-and-effective devices.

8. The sample size for the training set:

   • Not applicable. This document describes a physical medical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. No training set is involved.

Summary of what the document does state regarding "proof" of meeting acceptance criteria (implicitly, suitability for market):

The "acceptance criteria" for this 510(k) submission are implicitly tied to the concept of substantial equivalence to predicate devices and compliance with relevant standards.

• Acceptance Criteria (Implicit): The device must be as safe and effective as legally marketed predicate devices and comply with applicable performance standards and regulations.

  • Compliance with 21 CFR 1010 & 1020 (mandated performance standards for laser products).
  • Compliance with IEC60601-1:1995+A1+A2, IEC60601-2-22:1995, and IEC60825-1:1993+A1+A2 (international electrical and laser safety standards).
  • Compliance with Quality Systems Regulations, ISO materials standards, cGMP & ISO 9000 series quality regulations.
  • Technical characteristics (e.g., laser output values) similar to predicate devices.
  • Intended use and indications for use previously cleared for predicate devices.

• Study/Evidence Proving Device Meets Criteria:

  • The "study" is a demonstration of substantial equivalence (not a traditional clinical trial comparing two intervention groups).
  • Evidence presented:
    • Comparison of intended use and indications for use with cleared predicate devices (SoftLase G2, ODYSSEY NAVIGATOR, STYLA MICROLASER/STYLAORTHO Diode Laser System).
    • Comparison of technical characteristics with predicate devices.
    • Verification that laser output values are "well within previously cleared values" of predicate devices.
    • Reference to the "proven safety and effectiveness" of predicate devices for the claimed indications.
    • Statement that "Safety and performance testing" was conducted (without providing details of the testing or results in this summary).

In essence, the "study" is a regulatory submission arguing that the new device shares fundamental characteristics and performance safety/effectiveness profiles with already approved devices, therefore requiring no new extensive clinical trials to prove efficacy or safety.

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