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The IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.

The IntriCon Datrix Centauri MT APETS is a device used for recording patient ECG data for as long as 30 days. Selected data are sent for review from the recorder, through a phone service to a receiving station where they are available for review by a physician or other qualified medical professional. The Centauri MT APETS is capable of 1, 2, and 3-channel recording, depending on the type of cable being used. The recorder can run for up to 30 days. Battery life depends on the mode and battery option chosen by the user. The patient's ECG signal is acquired via commercially available silver-chloride electrodes appropriate for long-term recording.

The provided 510(k) summary for the IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) does not include explicit acceptance criteria nor a detailed study proving the device meets said criteria.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Braemar, Inc. Fusion Wireless Recorder (K081444) and Datrix E-Tac EX-1000 Electrocardiographic Event Recorder (K042022)). The conclusion states: "Comparison to the predicate devices listed shows nearly identical technical data, same indications for use, same safety standards tested to, and raises no new questions of safety or efficacy."

The submission focuses on compliance with general safety and performance standards rather than specific diagnostic accuracy metrics.

Here's an breakdown of the information that can be extracted, and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical targets for performance (e.g., sensitivity, specificity, positive predictive value, negative predictive value for arrhythmia detection).
• Data demonstrating the device's ability to accurately detect and transmit various types of arrhythmias.

2. Sample Size Used for the Test Set and Data Provenance:

Missing Information:

• Sample Size for Test Set: The document does not describe any specific clinical or performance test set used to evaluate the device's diagnostic accuracy. It mentions "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system," but details of these tests, including sample size for diagnostic performance, are absent.
• Data Provenance: Without a description of a test set, there is no information on country of origin of data or whether it was retrospective or prospective.

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

Missing Information:

• As no specific test set for diagnostic performance is described, there is no mention of experts or how ground truth was established for such a set.

4. Adjudication Method for the Test Set:

Missing Information:

• No test set for diagnostic performance is described, therefore no adjudication method is mentioned.

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

Missing Information:

• No MRMC comparative effectiveness study is mentioned. The submission is focused on the device's standalone functionality and equivalence to predicates, not its impact on human reader performance.

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

• Standalone Performance: The device's intended use explicitly states it "automatically generates an event triggered by an arrhythmia detection algorithm." This implies a standalone algorithm component. However, no performance metrics (e.g., sensitivity, specificity for various arrhythmias) for this algorithm are provided in the document. The submission relies on "substantial equivalence" to predicate devices, which presumably have a similar algorithmic function.

7. Type of Ground Truth Used:

Missing Information:

• Given the lack of a detailed diagnostic performance study, the type of ground truth (e.g., expert consensus, pathology, outcomes data) used for any such evaluation is not stated.

8. Sample Size for the Training Set:

Missing Information:

• No information about a training set or its sample size is provided. This is typical for submissions focused on established technologies demonstrating substantial equivalence, where detailed de novo algorithm development data might not be required.

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

Missing Information:

• As no training set is mentioned, there is no information on how its ground truth would have been established.

Summary of Acceptance Criteria and Study Limitations:

The provided 510(k) summary is for a device seeking clearance based on "substantial equivalence" to existing predicate devices. This type of submission generally does not require a detailed clinical performance study with explicit acceptance criteria for diagnostic accuracy, nor does it typically detail the development and validation of AI algorithms with associated training and test sets in the same manner as a de novo submission or a device with novel technology.

The "Performance Testing" section primarily lists compliance with general electrical safety and EMC standards (IEC60601-1:1998, IEC 60601-1-2: 2001, AAMI EC 38-1998) and states that "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system." This indicates engineering and functional testing, not necessarily a clinical study for diagnostic performance.

Therefore, this document does not contain the detailed information requested regarding specific acceptance criteria, diagnostic performance study design, sample sizes, ground truth establishment, or expert involvement for evaluating the arrhythmia detection algorithm's accuracy. The approval is based on the claim that the device is "substantially equivalent" to already-cleared devices, implying its performance characteristics are comparable to those predicates.

Ask a specific question about this device

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).

Ask a specific question about this device

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.

Ask a specific question about this device

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.

• 20 mJ, 10 Hz, 2 sec H2O cooling: 0.08°C
• 50 mJ, 10 Hz, 2 sec H2O cooling: 1.07°C
• 100 mJ, 10 Hz, 2 sec H2O cooling: 0.84°C
• 150 mJ, 10 Hz, 2 sec H2O cooling: 1.12°C
• 200 mJ, 10 Hz, 2 sec H2O cooling: 2.3°C
  Conclusion: All observed temperature rises are significantly below the 5.5°C threshold. |
  | Pulp Vitality: No deleterious effect on pulp vitality; equivalent to control/drill methods over time. | Observed Pulp Vitality:
• H&E histological evidence over pulpal healing time: No deleterious effect for laser or control treatment.
• Pulp vitality measurements over 1.5 year follow-up: No compromise in pulp vitality.
• In 33 patients, two teeth (laser vs. drill) showed no difference in pulpal vitality pre-surgery, post-surgery, and over three months.
• In 125 randomly treated adult teeth, no significant difference in pulp vitality pre-surgery and after three months compared to drill. |
  | Surface Morphology: No changes in surface morphology except at the treatment site; equivalent to drill at treatment site. | Observed Surface Morphology:
• Animal and human studies using SEM: No changes in surface morphology except at the treatment site.
• Animal and human studies using SEM: Drill and laser show equivalent surface changes at the treatment site. |
  | Structural Morphology: Roughened dentin/enamel, no cracking, fissuring, or charring; open dentinal tubules; no remaining caries. | Observed Structural Morphology:
• Ideal etched tooth (description given): "roughened dentin or enamel surface and no evidence of cracking, fissuring or charring. The dentin demonstrates open dentinal tubules. Organic material has been vaporized leaving the inorganic components of the tooth - leaving greater tooth surface area. In addition, a cavity preparation should show no remaining evidence of caries and a crater created by removal of tooth structure below the margin of the preparation."
• Hibst and Keller: Effective removal of tooth structure with ultrastructural changes; no fissures or cracks; surface scaled and roughened without signs of thermal damage.
• Paghdiwala: No visible cracks radiated from craters. |
  | Adjacent Structures: Damage due to inadvertent lasing of adjacent structures is less than or equivalent to the drill. | Observed Adjacent Structures Effects:
• Damage due to inadvertent lasing of adjacent structures is usually less than the drill, as the laser does not cut effectively when defocused. |
  | Efficacy (Caries Removal): Effective removal of caries. | Observed Efficacy (Caries Removal):
• Investigators rate caries removal more effective than the drill.
• In a multi-site study of 125 randomized human adult teeth, 100% of Class I-V caries were completely removed. |
  | Efficacy (Cavity Preparation): Equivalent to drill. | Observed Efficacy (Cavity Preparation):
• Investigators rate cavity preparation with the laser equal to the drill.
• In a multi-site study of 125 randomized human adult teeth, 100% of cavity preparations and restorations were still adequate after 3 months. |
  | Efficacy (Etching): More effective than acid etching. | Observed Efficacy (Etching):
• Investigators rate laser etching much more effective than acid etching. |
  | Overall Equivalence: Equivalent to standard treatment. | Observed Overall Equivalence:
• Animal and human studies demonstrate that the Er: YAG laser is equivalent to standard treatment. |

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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