(550 days)
The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage Apthous 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 re-treatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingivaltooth mobility tooth mobility.
The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization 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, gynecology, urology, ophthalmology and pulmonary surgery. The following is the additional oral-pharngeal indication for use for which the device will be marketed: Laser assisted new attachment procedure (cementum-mediated periodontal ligament new- attachment to the root surface in the absence of long junctional epithelium.)
The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations (100-650µsec). The laser consists of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.
Here's an analysis of the provided documents to extract the requested information about acceptance criteria and the supporting study for the PerioLase Dental Laser:
Acceptance Criteria and Study Details for PerioLase Dental Laser (K030290)
The provided documents primarily focus on the regulatory submission (510(k)) for the PerioLase Dental Laser, specifically regarding its re-affirmation and an additional indication for use. While they describe the device's technical specifications and intended uses, they do not explicitly state quantitative "acceptance criteria" in the form of specific performance metrics (e.g., minimum accuracy, sensitivity, specificity values) or the overall results of a study that directly "proves" the device meets these criteria in a tabulated format as one might expect for a diagnostic or AI-driven device.
The main "acceptance" being sought and granted here is the substantial equivalence to a predicate device and the addition of a new indication for use, supported by clinical performance data. The FDA's 510(k) clearance process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving it meets pre-defined quantitative acceptance criteria in a highly detailed, algorithmic performance report.
However, based on the information provided, we can infer and construct aspects of the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit quantitative acceptance criteria for device performance (like sensitivity/specificity for a diagnostic) are not provided in the typical format. However, we can interpret the regulatory approval as meeting the following implicit criteria for its intended use and safety/efficacy:
| Acceptance Criteria (Implied by 510(k) Clearance) | Reported Device Performance/Evidence from Study |
|---|---|
| Criterion 1: Substantial Equivalence to Predicate Device | The FDA's 510(k) clearance (K030290) explicitly states that the device is "substantially equivalent... to legally marketed predicate devices." The predicate device itself is listed as "PerioLase Dental Laser," suggesting an updated version or re-submission for expanded claims. This implies the device's design, materials, and fundamental operation are equivalent to a previously cleared device. |
| Criterion 2: Safety and Effectiveness for Existing Indications | The existing indications for use (Abscess Incision and Drainage, Apthous Ulcers Treatment, Biopsies Excision and Incision, Crown lengthening, Hemostatic assistance, Fibroma Removal, Frenectomy, etc.) were already deemed safe and effective in previous clearances for the PerioLase or its predicate. The current submission reaffirms this, as the FDA states the device can "begin marketing... as described in your Section 510(k)". |
| Criterion 3: Safety and Effectiveness for New Indication: LASER-Assisted New Attachment Procedure (LANAP) | Clinical Performance Data: The 510(k) summary explicitly states: "The new clinical outcome claim [LANAP] is based on human histological and radiographic data from a controlled prospective University-based clinical study." While specific numerical performance metrics (e.g., mean attachment gain, pocket depth reduction) are not detailed in the summary, the FDA's clearance indicates that this data was sufficient to demonstrate the safety and effectiveness of the device for this new indication. The approval for this specific indication serves as the "reported device performance." |
| Criterion 4: Compliance with General Controls & Quality Systems | Implicit in any FDA clearance: The manufacturer must comply with general controls (e.g., annual registration, listing, labeling) and good manufacturing practice requirements (QS regulation). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for LANAP Indication): The summary states, "The new clinical outcome claim is based on human histological and radiographic data from a controlled prospective University-based clinical study."
- Sample Size: The exact sample size for this prospective clinical study is not provided in the given documents.
- Data Provenance: The data is described as "human histological and radiographic data" from a "controlled prospective University-based clinical study." This indicates it's human clinical data, prospective in nature, and collected at a university setting. The country of origin is not explicitly stated, but given the US-based submission, it's highly likely to be a US university or institution collaborating with one.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the documents. For a histological and radiographic study, experts (e.g., oral pathologists, periodontists, radiologists) would typically interpret the data, but the number and qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided in the documents. While a "controlled clinical study" would imply rigorous methods, the specific adjudication process (e.g., 2+1, 3+1, none) is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a MRMC comparative effectiveness study is not explicitly mentioned or implied. The study described focuses on the device's clinical outcome efficacy (histological and radiographic data) for the LANAP procedure, not a comparison of human reader performance with and without AI assistance. This device is a laser for surgical procedures, not a diagnostic imaging aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable in the context of this device. The PerioLase Dental Laser is an energy-based surgical instrument, not an AI algorithm. Its performance is measured by its clinical efficacy in a human-operated surgical context, not as a standalone algorithm.
7. The Type of Ground Truth Used
- For the new indication (LANAP), the ground truth was established by human histological and radiographic data.
- Histology: This implies microscopic examination of tissue samples, which is a gold standard for assessing tissue changes, inflammation, and new attachment formation.
- Radiography: This implies imaging (e.g., X-rays) to assess bone levels and other periodontal structures.
- Outcomes Data: The ultimate "ground truth" for a clinical outcome claim like LANAP is the demonstrated successful clinical outcome (cementum-mediated periodontal ligament new attachment to the root surface), as evidenced by these objective measures.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. As the PerioLase is a medical device (laser), not an AI/machine learning algorithm, there is no "training set" in the sense of data used to train a model. The "training" for the device would involve engineering development, bench testing, and potentially pre-clinical studies, but not a data training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided for the same reasons as point 8.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.