(1432 days)
The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Enamel prior to acid etching, and Modification or Etching of Dentin prior to acid etching.
Not Found
This document is a 510(k) premarket notification for the Centauri Er:YAG Laser System, seeking FDA clearance for marketing. While it contains performance data and claims regarding the device's efficacy, it does not outline specific, pre-defined acceptance criteria for regulatory approval in the way modern AI device submissions do. Instead, the document presents study results to demonstrate substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide a table of "acceptance criteria" and "reported device performance" in the strict sense requested, because explicit, quantitative acceptance criteria for this type of medical device in 1997 are not detailed in this document. The document describes studies aiming to show the device performs safely and effectively for its intended use, comparable to existing methods.
However, I can extract the reported device performance and infer the implicit "acceptance criteria" based on the presented results and the claims made for "substantial equivalence."
Here's an analysis of the provided information, framed as closely as possible to your request:
Analysis of Centauri Er:YAG Laser System Performance and Supporting Studies
1. Table of (Inferred) Acceptance Criteria and Reported Device Performance:
| Feature/Metric | (Inferred) Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulpal Temperature Increase | ≤ 5.5 °C (to avoid irreversible damage) | - 20 mJ: 0.08°C |
- 50 mJ: 1.07°C
- 100 mJ: 0.84°C
- 150 mJ: 1.12°C
- 200 mJ: 2.3°C
- Drill in Air: 0.25°C
- Drill in H2O: 0.05°C (All well below the 5.5°C threshold) |
| Pulpal Vitality (Long-term) | No deleterious effect / no compromise in pulp vitality / no significant difference compared to control (drill) | - H&E histological evidence showed no deleterious effect for laser or control treatment. - Pulp vitality measurements over 1.5 year follow-up showed no compromise.
- No difference in pulp vitality pre-surgery, post-surgery, and over 3 months in 33 patients (laser vs. drill in same patient).
- No significant difference between laser and control over 3 months in 125 randomized teeth. |
| Caries Removal Effectiveness | Complete removal of all classes of caries | 100% of caries (all classes I-V) completely removed in 125 randomized human adult teeth. |
| Cavity Preparation & Restoration | Adequate preparation and restoration after 3 months | 100% of cavity preparations and restorations still adequate after 3 months in 125 randomized human adult teeth. |
| Surface Morphology (SEM) | No changes except at the treatment site; equivalent to drill at treatment site; no fissures/cracks, no thermal damage | - Animal and human studies demonstrated no changes in surface morphology except at the treatment site. - Equivalent surface changes to drill at treatment site.
- Ideal etched tooth presented roughened dentin/enamel, no cracking/fissuring/charring, open dentinal tubules, vaporized organic material.
- Hibst and Keller reported no fissures/cracks, scaled/roughened surface without thermal damage. |
| Adjacent Structures Damage | Less damage than drill when inadvertent lasing occurs | Damage due to inadvertent lasing of adjacent structures is "usually less than the drill," as the laser does not cut effectively when defocused. |
| Overall Efficacy (Expert Opinion) | More effective than drill for caries removal; equal to drill for cavity preparation; more effective than acid etching for etching; equivalent to standard treatment overall. | - Investigators rated caries removal more effective than the drill. - Investigators rated cavity preparation with the laser equal to the drill.
- Investigators rated laser etching much more effective than acid etching.
- Animal and human studies demonstrated equivalence to standard treatment. |
2. Sample Sizes and Data Provenance:
- Pulpal Temperature Study: Not explicitly stated as a "test set" with human or animal subjects, but rather an experimental measurement of the device's physical effect. The data provenance is not specified beyond being "a benchmark publication" and subsequent substantiation.
- Pulp Vitality Studies:
- Study 1 (H&E): Not specified.
- Study 2 (1.5 yr follow-up): Not specified.
- Study 3 (33 patients): 33 human patients ("two teeth in each of 33 patients"). Prospective. Country of origin not specified.
- Study 4 (125 teeth): 125 randomized human adult teeth. Prospective. Country of origin not specified.
- Caries Removal & Cavity Preparation Studies: 125 randomized human adult teeth for each study. Multi-site study. Prospective. Country of origin not specified.
- Surface Morphology (SEM) Studies: "Animal and human studies" - sample sizes not specified.
- Structural Morphology Studies: Refers to published literature by Hibst and Keller, and Paghdiwala. These are not explicitly device-specific studies for this submission but rather foundational science.
- Efficacy (Investigator Ratings): "Investigators" - number not specified.
3. Number of Experts and Qualifications for Ground Truth for Test Set:
The studies described do not involve a "test set" of images for diagnostic purposes requiring expert consensus in the way AI/ML device submissions typically do. Instead, they refer to clinical outcomes, histological analysis, and direct measurements.
- Pulp Vitality (H&E histological evidence): Implies a pathologist's evaluation. Qualifications not specified.
- Pulp Vitality (measurements): Objective clinical measurements.
- Caries Removal & Cavity Prep: Implies clinical assessment by dental professionals (investigators). Qualifications not specified.
- Surface Morphology (SEM): Interpretation by experts in electron microscopy. Qualifications not specified.
- Efficacy (Investigator ratings): The "investigators" are implicitly dental/medical professionals performing the procedures and making subjective assessments. Qualifications not specified.
4. Adjudication Method for the Test Set:
Not applicable in the context of this device submission. The studies involve direct clinical outcomes, measurements, or expert assessments rather than a diagnostic adjudication process. "All blinded" is mentioned for pulp vitality and surface morphology studies, indicating blinding of outcome assessors to treatment arm, which is a form of bias mitigation, but not an adjudication method for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a laser system for dental procedures, not an AI diagnostic device. There is no mention of human readers or AI assistance in the context of diagnostic interpretation. The comparisons are between the laser and a traditional drill.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical laser device, not an algorithm. Its performance is evaluated by its physical effects and clinical outcomes, not as a standalone software algorithm.
7. Type of Ground Truth Used:
- Pulpal Temperature: Direct physical measurement of temperature increase in °C.
- Pulpal Vitality:
- Histological evidence (pathology).
- Objective clinical measurements of pulp vitality.
- Caries Removal: Clinical assessment of complete removal by treating dentists/investigators.
- Cavity Preparation & Restoration: Clinical assessment of adequacy by treating dentists/investigators.
- Surface Morphology: SEM imaging and expert interpretation (morphological assessment).
- Efficacy: Subjective ratings by clinical investigators.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device requiring a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable.
Summary Interpretation:
This 510(k) submission for the Centauri Er:YAG Laser System provides data from a series of studies (some device-specific, some referencing existing literature) to demonstrate that its performance aligns with established safety thresholds (e.g., pulpal temperature increase) and clinical effectiveness when compared to the traditional dental drill for carving/ablation. The "acceptance criteria" are implied by the safe and effective performance demonstrated, particularly the lack of harm and comparable or superior efficacy to existing methods.
§ 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.