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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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The Styla MicroLaser™/StylaOrtho™ is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The Styla MicroLaser™/StylaOrtho™ 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 oralpharingeal 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

The Styla MicroLaser™/StylaOrtho™ are the first soft-tissue laser developed as a handheld unit. It is wireless, lightweight, easy to set up, simple to use, requires less power, and cost efficient.

With the Styla MicroLaser™/StylaOrtho™ Zap Lasers introduces a miniature X-Y adjusting module for coupling a diode laser with a disposable fiber. Fiber accuracy is better than 5 um and the alignment is extremely stable. A module with a specific lens was developed by Zap Lasers in order to achieve such precision and alignment. Such a design greatly simplifies the fiber management and setup of operatory time as the fiber is attached into the tip allowing this item to be disposable and simple to be used. No fiber scoring is needed as the disposable tip is provided already scored to decrease setup tip and user's error.

The Laser and Control Box comprise the following major modules:

The laser diode assembly contains one single emitter laser diode of 2.0 watt output power (Class IV laser) lasing at 808 nm. The diode laser is directly coupled to a lens and aligned to the fiber optic inside the removable tips, using (patent pending) a 2 axis laser alignment system. It also contains a 5 m W power, 650 nm laser diode coupled to the same fiber optic. The laser's visible light is designed to aid the user to aim the tip of the delivery fiber onto the tissue.

The Styla Microlaser™/StylaOrtho™ is designed to dissipate heat during normal operation and may feel warm to the touch after prolonged use. The laser module is mounted towards the tip of the unit, which acts as a heat sink during normal operation. The temperature is monitored by a sensor that prevents overheating.

Laser power controller provides electric power to the diodes in continuous wave and pulsed mode. It supplies about 2 VDC and current up to 4A to the diodes. The controller contains a high efficiency DC to DC converter that converts the battery voltage to the precise voltage needed for laser operation. This ensures that the majority of the energy is used for light and not converted into heat.

The delivery tips with fiber built in consist of 400 micron core multi-mode optical fiber, and a precise alignment mechanism. The fiber is factory installed into the tip and requires no installation by the end user.

The foot-switch is a standard (UL-approved) commercial foot-switch that provides hands-free ON/OFF capabilities. This switch controls initiation/termination of laser power from the distal end of the delivery fiber wirelessly.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Styla MicroLaser™/StylaOrtho™ device:

This 510(k) summary is for a Class II surgical laser device, and the primary method for demonstrating safety and effectiveness is through establishing substantial equivalence to existing predicate devices, rather than conducting new, de novo clinical trials with specific acceptance criteria and performance metrics in the way one might expect for a novel AI/software device.

Therefore, many of the requested categories (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of submission. The 'study' in this context refers to the comparison against predicate devices and adherence to regulatory standards.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable. This submission relies on substantial equivalence to predicate devices, not a test set of data from human or phantom subjects.
• Data Provenance: Not applicable in the context of a "test set." The "data" primarily comes from the regulatory clearance of predicate devices and adherence to manufacturing/performance standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable. There was no test set requiring adjudication in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for demonstrating substantial equivalence for a Class II surgical laser device where technical performance and equivalence to predicates are the key elements.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This is a physical medical device (a surgical laser), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Not applicable in the typical sense of a clinical trial. The "ground truth" for this submission is implicitly derived from the established safety and effectiveness of the predicate devices as previously cleared by the FDA, and the device's adherence to relevant performance and safety standards. The assessment is about whether the new device performs effectively and safely like already-approved devices, not about its ability to diagnose or measure against a gold standard in a new context.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, this is not an AI/ML device, so there is no training set or ground truth established in that context.

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The SoftLase G2 - Surgical Diode Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The SoftLase G2 is intended for ablating, incising, excising, vaporization and coagulation intraoral soft tissues using a contact fiber optic delivery system. The system is also intended for use in teeth whitening procedures.

The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the 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
-Exposure of interrupted teeth
-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

The laser diode assembly with fiber bundle, which contains 3 single diode lasers, each of 1.6 watt output power (Class IV lasers) lasing at about 808 nm. Each diode laser is coupled directly into a 200 um core optical fiber using a special positioner. The assembly also contains a 5-mw power - 650 nm pilot laser diode, which is coupled into the three core fibers. In the second version of the device, a single 5 Watt laser diode is used. A special optical system is implemented to focus its laser diode radiation into a delivery fiber. It allows an effective use of 300 um and 200 um fibers. In both versions, a visible light of pilot laser is used for aiming the tip of the delivering fiber onto the tissue.

The laser diode power supply, with two controller PCBs supplies power to the diodes in DC or pulsed mode.

The delivery fiber cables, consist of multi-mode, single core optical fibers available in 200, 300, 400 and 600 um diameters. The standard SMA 905 fiber connector terminates one end of the delivery fiber, which is attached to the SMA union at the rear panel of the laser box. The other end of the fiber is stripped of its protective jacket and is cleaved to provide laser radiation output.

The foot-switch, is a standard (UL-approved) commercial foot-switch/pedal that provides handsfree ON/OFF capabilities. This controls initiation/termination of laser power from the distal end of the delivery fiber. Each SoftLase G2 laser system is provided with two safety goggles, one fiber stripper and one sapphire wedge scribe for fiber cleaving.

The provided document is a 510(k) premarket notification for the SoftLase G2 - Surgical Diode Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through novel clinical studies.

Therefore, the document does not contain information on:

• Acceptance criteria in the traditional sense (e.g., specific sensitivity, specificity, accuracy thresholds for a medical device's performance).
• A study that proves the device meets acceptance criteria with detailed methodologies, sample sizes, expert involvement, or statistical analysis.
• Sample sizes used for a test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices (SOFTLASE K003440, AURORA HL K992374, and TWILITE K003385) by comparing:

1. Intended Use and Indications for Use: Stating that they were previously cleared by FDA for the predicate devices.
2. Technical Characteristics: Showing similarity in device type (Diode laser), wavelength, maximum output power, operation mode, and delivery system.
3. Laser Output Values: Stating they are "well within previously cleared values" of the predicate dental laser systems.
4. Proven Safety and Effectiveness: Relying on the established safety and effectiveness of the predicate devices for the claimed indications.
5. Safety and Performance Testing: This is mentioned generally, but no specific details of this testing (e.g., what was tested, methods, results, acceptance criteria) are provided in the document. It likely refers to internal engineering and functional tests to ensure the device operates as designed and meets electrical safety standards, rather than a clinical performance study.

Table of Acceptance Criteria and Reported Device Performance (as demonstrated by substantial equivalence):

In summary, the SoftLase G2's acceptance criteria are implicitly met by demonstrating that its design, performance characteristics, and intended use are "substantially equivalent" to already legally marketed devices, as outlined in the 510(k) process. No specific new clinical study data to demonstrate novel acceptance criteria are presented in this document.

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