Search Results

EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity.
ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery.
GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy.
GENERAL SURGERY, DERMATOLOGY & PLASTIC SURGERY, AND PODIATRY: excision, ablation, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion.
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues.
GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue.
NEUROSURGERY: Hemostasis.
OPHTHALMOLOGY: Incision, excision and vaporization of tissue surrounding the eye and orbit; Photocoagulation of the retina.
PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue.
UROLOGY: Hemostasis, vaporization and excision of tissues.

Not Found

This document is a 510(k) clearance letter for the Aurora™ SL Diode Laser System, indicating that the device is substantially equivalent to previously marketed devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The content primarily focuses on the regulatory aspects of the device, including:

• Trade Name: Aurora™ SL Diode Laser System
• Regulatory Class: II
• Product Code: GEX
• Manufacturer: Premier Laser Systems, Inc.
• Clearance Date: November 18, 1999
• Indications for Use: A comprehensive list across various medical specialties (ENT & Oral Surgery, Arthroscopy, Gastroenterology, General Surgery, Dermatology & Plastic Surgery, Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, Urology).

Since the provided text is a 510(k) clearance letter and not a clinical study report or a summary of performance data, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, or MRMC studies. Such details are typically found in the technical documentation submitted with the 510(k) application, but they are not present in this clearance letter itself.

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EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples:

• Removal of benign lesions from the ear, nose and throat
• Excision and vaporization of vocal cord nodules and polyps
• Incision and excision of carcinoma in-situ
• Ablation and vaporization of hyperkeratosis
• Excision of carcinoma of the larynx
• Laryngeal papillomectomy
• Excision and vaporization of Herpes Simplex I and II
• Pulpotomy and pulpotomy as an adjunct to root canal therapy
• Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)

ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples:

• Meniscectomy
• Synovectomy
• Chondromalacia

GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples:

• Hemostasis of upper and lower GI bleeding
• Excision and vaporization of colorectal carcinoma
• Excision of polyps

GENERAL SURGERY, DERMATOLOGY & PLASTIC SURGERY, AND PODIATRY: excision, ablation, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion. Examples:

• Matrixectomy
• Excision of neuromas
• Excision of periungual & subungual warts
• Port wine stain removal
• Excision of plantar warts
• Excision of keloids
• Cholecystectomy
• Liver resection
• Excision of cutaneous lesions
• Hemorrhoidectomy
• Appendectomy
• Debridement of decubitus ulcer
• Hepatobiliary
• Mastectomy
• Dermabrasion
• Vaporization & hemostasis of capillary hemangioma
• Excision, vaporization & hemostasis of abdominal tumors
• Excision, vaporization & hemostasis or rectal pathology
• Pilondial cystectomy
• Herniorrhaphy
• Adhesiolysis
• Parathyroidectomy
• Laparoscopic cholecystectomy
• Thyroidectomy
• Resection of organs

GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples:

• Hemorrhoidectomy
• Excision, vaporization and hemostasis of rectal pathology
• Excision, vaporization, and hemostasis of abdominal tumors

GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue. Examples:

• Endometrial ablation
• Excision or vaporization of condylomata acuminata
• Vaporization of CIN (cervical intraepithelelial neoplasis)
• Cervical conization
• Menorrhagia

NEUROSURGERY:

• Hemostasis
• Hemostasis for myangioma

OPHTHALMOLOGY:

• Incision, excision and vaporization of tissue surrounding the eye and orbit
• Photocoagulation of the retina

PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue. Examples:

• Tracheobronchial malignancy or stricture
• Benign and malignant pulmonary obstruction

UROLOGY: Hemostasis, vaporization and excision of tissues. Examples:

• Vaporization of urethral tumors
• Release of urethral stricture
• Removal of bladder neck obstruction
• Excision and vaporization of condyloma
• Lesions of external genitalia

Aurora™ HL Diode Laser System

This document is a 510(k) premarket notification approval letter for the Aurora™ HL Diode Laser System. It does not contain any information regarding acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

The document primarily states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to legally marketed predicate devices. It then lists the indications for use of the device across various medical specialties such as ENT, Oral Surgery, Arthroscopy, Gastroenterology, General Surgery, Dermatology, Plastic Surgery, Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, and Urology.

Therefore, I cannot provide the requested information.

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Curing of all light cured bonding materials

Curing of pit and fissure sealants (unfilled resins)

Curing for all classes of composite restorations (filled resins)

Curing for endodontic composite cores

Curing composite cements for porcelain facings and inlays

Curing of light activated periodontal splint material

Curing of light activated prosthetic reline and repair material

Curing use in the fabrication of laboratory indirect light activated and provisional restorations

Teeth Whitening

BluLaze™ Blue Light Emitting Diode (LED) System

This document is an FDA 510(k) clearance letter for the BluLaze™ Blue Light Emitting Diode (LED) System. It grants marketing approval for the device but does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter from August 20, 1999, states that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a previously cleared device. However, it does not mandate a new clinical study or the establishment of new acceptance criteria for this specific device in this document.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on the performance characteristics or clinical study results that would typically be included in such a request.

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Pulpotomy

Pulpotomy as an adjunct to root canal therapy

This is an additional indication to the indications cleared for market NOTE: Release in 510(k) 954316.

Not Found

This a a 510k clearance document for a medical device called the Aurora Diode Laser System. This document DOES NOT contain information regarding:

• acceptance criteria and the study that proves the device meets the acceptance criteria.
• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
• 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)
• Adjudication method (e.g. 2+1, 3+1, none) for the test set
• 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
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

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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.

Not Found

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

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).

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Pulpotomy
Pulpotomy as an adjunct to root canal therapy

Pegasus Nd: YAG Laser System

This document is a 510(k) clearance letter for the Pegasus Nd:YAG Laser System. It does not contain information about acceptance criteria or a study proving device performance.

Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for the specified indications for use. It does not include performance data, the details of any studies, or how ground truth was established for such studies.

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(SULCULAR DEBRIDEMENT) - REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET. NOTE: This is an additional indication to the indications cleared for market release in 510(k) 954316.

Not Found

I am sorry, but there is no information in the provided document about the acceptance criteria and study proving the device meets them. The document is an FDA 510(k) clearance letter for the Aurora Diode Laser System, indicating it is substantially equivalent to previously marketed devices for the stated indications for use (sulcular debridement). It does not contain details about specific performance metrics, study designs, sample sizes, or expert qualifications.

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Scanning device attachment used with the Centauri™ Er:YAG Laser System for use in Dermatology for treatment of soft tissue, including incision, excision, hemostasis, ablation and vaporization of tissue.

Scanning device attachment used with the Centauri™ Er:YAG Laser System

The provided text is an FDA 510(k) clearance letter for the dERmium Scanner for the Centauri™ Er:YAG Laser System II. This document primarily focuses on the regulatory clearance for marketing the device based on substantial equivalence to a predicate device. It defines the intended use and regulatory classification.

However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot provide a detailed answer to your request in the format you specified. The information you are seeking about acceptance criteria and the study that proves the device meets them is not present in the provided text.

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1. Curing of all light cured bonding materials.
2. Curing of pit and fissure sealants (unfilled resins).
3. Curing for all classes of composite restorations (filled resins).
4. Curing for endodontic composite cores.
5. Curing composite cements for porcelain facings and inlays.
6. Curing of light activated periodontal splint material.
7. Curing of light activated prosthetic reline and repair material.
8. Curing used in the fabrication of laboratory indirect light activated restorations and provisional restorations.
9. Illumination purposes for the adjunctive use in caries detection.
10. Illumination purposes for the adjunctive use for endodontic orifice location.
11. Light activation for bleaching materials for teeth whitening.

Not Found

This is a 510(k) clearance letter for the Arago II device, a light curing unit. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on a demonstration of substantial equivalence to a previously legally marketed predicate device, not on meeting specific performance acceptance criteria via a new study. The 510(k) process typically involves showing that a new device is as safe and effective as a predicate through various comparisons, which may include performance data, but it does not necessarily require a separate, new clinical study with pre-defined acceptance criteria if substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, non-clinical tests).

Therefore, I cannot provide the requested information from the provided text.

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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.

Centauri Er:YAG Laser System

Here's an analysis of the provided text, outlining the acceptance criteria and the study data that demonstrate the device meets those criteria:

Device Name: Centauri Er:YAG Laser System

Indications For Use: Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. 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.

Contraindications: Children under the age of 18 years.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance metric with numerical thresholds. Instead, it presents various performance measures and concludes that the device is "equivalent to standard treatment" or "more effective" than drilling/acid etching for certain outcomes. Therefore, I will infer the acceptance criteria from the reported findings, primarily focusing on equivalence to established methods or a lack of deleterious effects.

2. Sample Sizes Used for the Test Set and Data Provenance

• Pulpal Temperature: The table (TABLE 1) shows measurements at various energy outputs and repetition rates for "Time with H2O Cooling". No explicit sample size for this specific test is provided beyond listing the parameters. A control "Drill in Air" and "Drill in H2O" are also mentioned, suggesting a comparison study. The study references Zach and Cohen (1965) and Powell et al. (1990) for the temperature threshold, implying the context for these measurements is based on established dental research, likely involving animal models initially.
• Pulp Vitality:
  • 33 patients (comparison of two teeth per patient: laser vs. drill).
  • 125 randomly treated adult teeth (comparison of laser vs. drill, source not explicitly stated but implies human).
  • One and a half-year follow-up for general pulp vitality measurements (sample size not specified, but context suggests human patients).
• Surface Morphology: Animal and human studies (specific sample sizes not provided).
• Efficacy:
  • 125 randomized human adult teeth for caries removal.
  • 125 randomized human adult teeth for cavity preparation and restoration adequacy.

Data Provenance: The document references investigations from various researchers (e.g., Zach and Cohen, Powell, Hibst and Keller, Paghdiwala, Arcoria, Kumazaki). This suggests a compilation of findings from multiple studies, both animal and human. The "multi-site study" for efficacy suggests data from different clinical locations. The general impression is that this is a retrospective summary of existing research and possibly some newly compiled data to support the 510(k) submission. No specific country of origin is mentioned for the sample data beyond the general context of medical device regulatory submissions in the USA.

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

The document directly mentions "Investigators" rating efficacy for caries removal, cavity preparation, and laser etching. It also mentions "blinded" assessments for Pulp Vitality and Surface Morphology.

• Pulpal Temperature: The ground truth for the acceptable temperature rise (5.5°C) is established by publications from Zach and Cohen (1965) and Powell et al. (1990). These would be established dental researchers or pathologists.
• Pulp Vitality: "H&E histological evidence" implies assessment by pathologists. "Pulp vitality measurements" would likely be performed and interpreted by dental professionals. The term "blinded" suggests that the assessors were unaware of whether the treatment was laser or control. The number of experts is not specified.
• Surface Morphology: "SEM demonstrated" implies interpretation by experts trained in electron microscopy, likely with dental or material science backgrounds. The term "blinded" is used. The number of experts is not specified.
• Structural Morphology: This section relies on findings reported by Hibst and Keller (dental researchers) and Paghdiwala (who specifically researched the Er:YAG laser in hard dental tissues). Their qualifications would be in dentistry, laser physics, and material science as applied to dentistry.
• Efficacy: "Investigators rate..." suggests multiple dental professionals or clinicians were involved in evaluating the outcomes of caries removal, cavity preparation, and etching effectiveness. Their specific qualifications (e.g., years of experience as a dentist or oral surgeon) are not detailed, nor is their exact number. Given the context of a 510(k), these "investigators" would typically be qualified dentists or oral surgeons.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). For the "blinded" evaluations (Pulp Vitality, Surface Morphology), it implies individual expert assessments, but doesn't describe a formal consensus or tie-breaking process. For the "Investigators rate..." efficacy statements, it suggests a collective judgment rather than individual adjudication results for each case. The "multi-site study" implies that data might have been collected and analyzed collectively rather than through a strict adjudication panel for each individual finding reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a formal MRMC comparative effectiveness study in the way this term is typically used for AI-assisted image interpretation studies. However, it does present data that can be considered a comparative effectiveness assessment:

• Comparison to Drill: Multiple sections compare the laser's performance to the conventional drill for pulpal temperature, pulp vitality, surface morphology, and efficacy in caries removal (laser more effective), cavity preparation (laser equal), and adjacent tissue damage (laser usually less).
• Comparison to Acid Etching: The laser is rated "much more effective" than acid etching.
• "Investigators rate..." and "Animal and human studies demonstrate..." suggest a collective assessment over multiple cases by multiple readers (investigators/experts) comparing the laser to standard methods.

Effect Size: The document provides qualitative rather than quantitative effect sizes for "human readers improve with AI vs without AI assistance." Instead, it focuses on the device's standalone performance or direct comparison to current standards:

• Caries removal: laser "more effective" than drill.
• Cavity preparation: laser "equal" to drill.
• Laser etching: "much more effective" than acid etching.
• Adjacent structures: damage "usually less" than drill when defocused.

There is no mention of human-in-the-loop performance augmentation by the device. The device is a direct treatment tool, not an AI diagnostic aid for human readers.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Yes, the studies described are essentially standalone performance studies of the Centauri Er:YAG Laser System as a treatment device. The device performs the action (caries removal, cavity preparation, etching, etc.) directly. The "efficacy" and "safety" evaluations are assessments of the laser's direct effects, not its assistance to a human operator in a diagnostic or interpretive task. The quantitative measurements (e.g., pulpal temperature rise) and qualitative observations (e.g., histological evidence, SEM changes) are direct outputs of the laser's application.

7. Type of Ground Truth Used

The ground truth used is a combination of:

• Expert Consensus/Clinical Judgment: For efficacy ratings (caries removal, cavity preparation, etching), "Investigators rate..." suggests expert consensus or clinical judgment.
• Histopathology: "H&E histological evidence" for pulpal healing.
• Physiological Measurements: "Pulp vitality measurements" (likely using cold/electric pulp tests or similar clinical methods). "Temperature in °C" for pulpal temperature rise.
• Imaging/Microscopy: "SEM demonstrated" for surface morphology.
• Established Scientific Literature: The 5.5°C pulpal temperature threshold is derived from benchmark publications (Zach and Cohen, Powell et al.). Structural morphology descriptions also rely on existing research findings.
• Outcome Data: "100% of Class I-V caries were completely removed" and "100% of cavity preparation and restoration was still adequate after 3 months" are direct outcome measures.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI system. This 510(k) submission is for a physical medical device (laser system) and describes its performance validation, not the development and training of an AI algorithm. Therefore, this question is not applicable to the provided document. The studies referenced are for validating the device's safety and efficacy, not for training a model.

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

As there is no "training set" described for an algorithm, this question is not applicable. The information provided relates to the validation of a physical laser device.

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