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The Precise SHP Diode Laser is indicated for the removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, freeectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.

The Precise SHP 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 provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

The provided 510(k) summary for the "Precise SHP Diode Laser" does not contain information about acceptance criteria and a study proving those criteria are met in the way a diagnostic device approval would. This device is a surgical instrument (a diode laser), not a diagnostic algorithm. For such devices, the assessment criteria focus on manufacturing, safety, and performance specifications rather than diagnostic accuracy metrics.

Therefore, many of the requested points cannot be answered from the provided text, as they are not applicable to the type of device and regulatory submission presented.

Here's an analysis based on the information provided, and where information is missing for a diagnostic device context:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in a quantitative table format with corresponding performance results similar to a diagnostic device. Instead, it refers to compliance with regulatory standards and general functional performance.

2. Sample Size for Test Set and Data Provenance

Not applicable in the context of a diagnostic test on patient data. The "test set" here refers to the device itself.

• Sample size: "Bench testing on an evaluation sample of the current device" - implies at least one device was tested.
• Data provenance: N/A (bench testing of the physical device).

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Ground truth for a diagnostic device would involve independent clinical review or pathological confirmation. For a surgical laser, experts might design the testing protocols, but they aren't establishing a "ground truth" diagnosis.

4. Adjudication Method

Not applicable for a device performance test of a surgical laser.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic imaging device where human readers interact with AI.

6. Standalone Performance Study

Yes, in a sense. The "bench testing" described is a standalone evaluation of the device's physical and functional performance without human interaction beyond operating the device.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is adherence to:

• Engineering design specifications.
• Performance requirements outlined in 21 CFR 1010 and 21 CFR 1040.
• Relevant international safety and performance standards (e.g., IEC 60601 series, IEC 60825-1).

8. Sample Size for Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

Not applicable. This device is not an AI/ML algorithm.

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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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