Search Results

The PerioLase Nd: YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The following areas: general and cosmetic dentistry, otolary, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery, neurosurgery, gynecology, ophthalmology, and pulmonary general surgery. The following are the oropharyngeal indications for use for which the device will be marketed:

Oropharyngeal

• · Abscess incision and drainage
• · Aphthous ulcers treatment
• · Biopsies excision and incision
• · Crown lengthening
• · Hemostatic assistance
• Fibroma removal
• · Frenectomy
• · Frenotomy
• Gingival incision and excision
• · Gingivectomy
• Gingivoplasty
• · Operculectomy
• · Oral papillectomy
• · Tissue retraction for impression
• · Vestibuloplasty
• · Selective ablation of enamel (first degree) caries
• · Exposure of unerupted / partially erupted teeth
• · Implant recovery
• · Lesion (tumor) removal
• · Leukoplakia
• · Pulpotomy
• · Pulpotomy as adjunct to root canal therapy
• · Removal of filling material such as gutta-percha or resin as adjunct treatment during root canal retreatment

· Sulcular debridement (removal of diseased or in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility

· Laser-assisted new attachment procedure (cementum-mediated periodontal ligament to the root surface in the absence of long junctional epithelium)

· Periodontal regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol

The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary.

The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger.

The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure.

All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturers labels.

The document describes a 510(k) premarket notification for the PerioLase Nd:YAG Pulsed Dental Laser System. It focuses on establishing substantial equivalence to a predicate device and provides clinical data to support a new clinical outcome claim related to periodontal regeneration.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, the primary "acceptance criteria" for this 510(k) submission appear to be demonstrating substantial equivalence to a predicate device and providing histologic evidence for a new clinical outcome claim.

• Wavelength (1.064 microns / 1064 nm)
• Laser medium (Nd:YAG)
• Beam delivery system type (optical fiber)
• Laser activation method (footswitch)
• Power source (conventional AC power)
• Type of aiming beam
• Cooling system
• Intended Uses (general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery, neurosurgery, gynecology, urology, ophthalmology, and pulmonary surgery, specifically Oropharyngeal indications)
• Power, pulse duration, energy per pulse, and repetition rate (20-300mJ pulse energy, 100-650µsec pulse width, 10-100Hz repetition rate, 6W max average power)
  (Source: Section 5) |
  | Safety and Performance Standards Conformance | - Evaluated via verification and validation tests and inspections for conformance to applicable regulations and safety standards.
• Tested for electrical safety and output characteristics to meet design criteria for essential performance.
• Safety features and functions operate correctly.
• Satisfies performance requirements specified in 21 CFR 1010 and 21 CFR 1040.
• Designed to comply with applicable federal and international safety and performance standards.
  (Source: Section 6) |
  | New Clinical Outcome Claim: Periodontal Regeneration | Evidence of true periodontal regeneration (new cementum, periodontal ligament, and alveolar bone with inserting Sharpey's fibers) on previously diseased root surfaces.
• 5 out of 10 evaluated sites (50%) demonstrated regeneration coronal to the notch.
• 3 of these regenerating teeth also showed new bone, ligament, and cementum within furcations. (Source: Section 7) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Clinical Study (Test Set):
  • Patients: 8 patients
  • Teeth: 12 treated teeth were scheduled for extraction, with 10 available for microscopic evaluation after splintering of 2 teeth during histological preparation.
  • Sites: 10 sites were evaluated.
• Data Provenance: The study was a prospective human histological study. The country of origin of the data is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number of experts or their specific qualifications used to establish the ground truth (histological evaluation) for the test set. It only states that "en bloc biopsy extractions were evaluated histologically."

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

The document does not specify an adjudication method for the histological evaluation. It simply states that the biopsies "were evaluated histologically."

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a laser system, not an AI-assisted diagnostic or imaging tool involving human readers. Therefore, there is no information on human reader improvement with or without AI assistance.

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

This question is not applicable. The PerioLase Nd:YAG Pulsed Dental Laser System is a physical laser device used by a human operator (dentist/surgeon), not an algorithm or AI system. Its performance is inherent to the device's physical operation, not an "algorithm-only" performance measurement.

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

For the new clinical outcome claim (periodontal regeneration), the ground truth was pathology (histological evidence). Specifically, it involved the microscopic evaluation of en bloc biopsy extractions to identify new bone, periodontal ligament, and cementum on previously diseased root surfaces.

8. The sample size for the training set

The document does not describe the development of an algorithm or AI model, thus there is no "training set" in the context of machine learning. The study described is a clinical study for a physical device.

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

Not applicable, as there is no training set mentioned or implied for an AI/algorithm-based device.

Ask a specific question about this device