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

• 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).

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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.

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:

• 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.

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