(25 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 acidentify, and Modification or Etching of Dentin prior to acid etching.
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Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Performance Metric | Stated Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulpal Temperature Rise | Max 5.5°C rise (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 (Air): 0.25°C
- Drill (H2O): 0.05°C |
| Pulpal Healing (H&E Histology) | No deleterious effect | No deleterious effect for laser or control treatment |
| Pulp Vitality (Long-term) | No compromise in pulp vitality (1.5 year follow-up) | No compromise in pulp vitality over 1.5 year follow-up |
| Pulp Vitality (Patient-matched, pre/post) | No difference in pulpal vitality post-surgery over 3 months compared to pre-surgery/drill | No difference in pulpal vitality pre-surgery, post-surgery, and over 3 months |
| Pulp Vitality (Randomized, pre/post) | No significant difference in pulp vitality between laser and control after 3 months | No significant difference between laser and control in pulp vitality pre-surgery and after a 3 month period |
| Surface Morphology (non-treatment site) | No changes in surface morphology | No changes in surface morphology except at the treatment site |
| Surface Morphology (treatment site) | Equivalent surface changes to drill | Drill and laser show equivalent surface changes at the treatment site |
| Structural Morphology (Etched Tooth) | Roughened dentin/enamel, no cracking/fissuring/charring, open dentinal tubules, vaporized organic material (leaving inorganic components), no remaining caries, crater below margin | Effective removal of tooth structure, no fissures/cracks, scaled/roughened surface without thermal damage. At 430 mJ, hydroxyapatite vaporized, pores developed, no visible cracks. |
| Adjacent Structures Damage | Damage less than drill when defocused | Damage due to inadvertent lasing of adjacent structures usually less than the drill, as laser does not cut effectively when defocused. |
| Caries Removal Effectiveness | More effective than the drill | Investigators rate caries removal more effective than the drill |
| Cavity Preparation Effectiveness | Equal to the drill | Investigators rate cavity preparation with the laser equal to the drill |
| Laser Etching Effectiveness | Much more effective than acid etching | Investigators rate laser etching much more effective than acid etching |
| Overall Equivalence to Standard Treatment | Equivalent to standard treatment | Animal and human studies demonstrate that the Er:YAG laser is equivalent to standard treatment |
| Caries Removal Completion Rate | Not explicitly stated but 100% is implied for "completely removed" | 100% of teeth treated had all classes of caries (I-V) completely removed |
| Cavity Preparation & Restoration Adequacy | Not explicitly stated but 100% after 3 months is implied | 100% of treated teeth had adequate cavity preparation and restoration after 3 months |
| Pediatric Use Complications (Primary Teeth) | No reported complications | - Phase I (51 procedures): 12% on primary teeth, no complications. - Phase II (130 procedures): 15% on primary teeth, no complications.
- Additional data (219 procedures): 22% on primary teeth, no complications.
- Total (400 procedures): 19% on primary teeth, no complications. |
| Pediatric Use Anesthesia Request | No anesthesia requested by patient | No anesthesia requested by patient in any pediatric primary tooth procedures (Phase I). (Implied for others as well as "no reported complications") |
2. Sample Size Used for the Test Set and Data Provenance
-
Pulpal Temperature Study:
- Sample Size: Not explicitly stated, but the data is from "teeth in dogs" (Zach and Cohen) and other substantiating studies (Powell, et. Al.). The presented table shows experimental conditions, not a specific number of teeth in a test set. This appears to be a benchmark/foundational study.
- Data Provenance: Implied to be retrospective from existing literature (Zach and Cohen, Powell, et. Al.) for the benchmark, and experimental for the device's specific temperature measurements. Country of origin not specified.
-
Pulp Vitality Studies:
- Study 1 (Histological): "H&E histological evidence over pulpal healing time". Sample size not specified. Data provenance: "Animal and human studies" in surface morphology suggests this could be both, but not explicitly stated here.
- Study 2 (1.5 year follow-up): Sample size not specified.
- Study 3 (Patient-matched): 33 patients, two teeth each (total 66 teeth). Data provenance: Not specified (but likely prospective clinical study).
- Study 4 (Randomized): 125 randomized adult teeth. Data provenance: Not specified (but likely prospective clinical study).
-
Surface Morphology Studies:
- Sample Size: Not specified for animal or human studies.
- Data Provenance: "Animal and human studies" (likely retrospective or previously published experimental for establishing general findings, then performed with the device).
-
Structural Morphology Studies:
- Sample Size: Not specified for Hibst and Keller or Paghdiwala. Laser dosimetries ranged from 50-350 mJ (Hibst and Keller) and 430 mJ (Paghdiwala).
- Data Provenance: Reported by "Hibst and Keller" and "Paghdiwala," suggesting these are from published literature used as reference points, or studies performed by them.
-
Caries Removal / Cavity Prep / Equivalence Studies:
- Study 1,2,3 (Investigator Ratings): Sample size of investigators not specified.
- Study 4 (Overall Equivalence): Sample size not specified. Data provenance: "Animal and human studies."
- Study 5 (Caries Removal Rate): 125 randomized human adult teeth. Data provenance: "Multi-site study," implies prospective clinical data.
- Study 6 (Cavity Prep & Restoration Adequacy): 125 randomized human adult teeth. Data provenance: "Multi-site study," implies a prospective clinical data.
-
Pediatric Use Studies (Phase I, II, Additional Patient Data):
- Phase I: 51 laser procedures (6 on primary teeth).
- Phase II: 130 laser procedures (18 on primary teeth).
- Additional Patient Data: 219 laser procedures (48 on primary teeth).
- Total: 400 laser procedures (68 on primary teeth).
- Data Provenance: Clinical data described as "Phase I," "Phase II," and "additional patient data," suggesting prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Pulp Vitality (Histological): Not specified.
- Pulp Vitality (Clinical): "Pulp vitality measurements" (Studies 3 & 4). The method of establishing ground truth (e.g., specific tests like electric pulp testing, thermal tests) is implied by "measurements," but the number and qualifications of experts interpreting these are not specified.
- Surface Morphology: "Animal and human studies using SEM". Ground truth likely established by expert interpretation of SEM images. Number and qualifications of experts not specified.
- Structural Morphology: "Hibst and Keller reported," "Paghdiwala showed." These are likely based on expert interpretation of micrographs. Number and qualifications not specified for these external references.
- Caries Removal / Cavity Prep / Etching Ratings: "Investigators rate." Number and qualifications of these "investigators" are not specified.
- Caries Removal Completion (125 teeth study): "completely removed in 100%". The method for determining "completely removed" (e.g., visual inspection, excavation to hard dentin, radiographs, pathological examination) and the number/qualifications of experts making this determination are not specified.
- Cavity Preparation & Restoration Adequacy (125 teeth study): "still adequate after 3 months in 100%". The criteria for "adequate" and the number/qualifications of experts making this determination are not specified.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "all blinded" statements for Pulp Vitality and Surface Morphology suggest efforts to reduce bias, but not a specific consensus or adjudication process. For investigator ratings, it's unclear if there was a consensus process or if individual investigator opinions were aggregated.
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
There is no mention of an AI component in this device. Therefore, no MRMC study involving AI assistance for human readers was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a physical laser system, not an algorithm. Therefore, no standalone algorithm performance study was reported.
7. The Type of Ground Truth Used
- Pulpal Temperature: Objective thermal measurements (°C rise) compared against a physiological benchmark (irreversible damage threshold).
- Pulp Vitality:
- H&E histological evidence (pathology).
- Pulp vitality measurements (clinical tests, likely electric, thermal, or visual assessment of health status).
- Surface Morphology: SEM (Scanning Electron Microscopy) observations and interpretations.
- Structural Morphology: Detailed visual/microscopic observations (etched surface characteristics, cracks, charring, open tubules) and reported findings from scientific literature (Hibst, Keller, Paghdiwala).
- Caries Removal / Cavity Prep / Etching Efficacy: "Investigators rate" (expert opinion/clinical judgment).
- Caries Removal Completion / Cavity Prep & Restoration Adequacy (125 teeth study): Clinical assessment of presence/absence of caries and adequacy of preparation/restoration. The specific methodology for these assessments and the experts performing them are not detailed beyond "completely removed" and "adequate."
- Pediatric Complications: Clinical observation/reporting of complications by healthcare professionals.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a physical medical device, not an AI/machine learning model. The various studies and experiments described serve as validation/testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable (see 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.