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The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of enamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues.

The PulseMaster Erbium Dental Laser System is a solid state Er.YAG laser consisting of three internally connected subassemblies: the power supply, the water cooling system, and the Er. YAG pump cavity and resonator assembly. Delivery is via a fiber optic with a sapphire contact tip. The laser delivers up to 400 mJ per pulse, with pulse repetition rates ranging from 10 to 60 Hz and an average power of up to 7.5 Watts.

The provided text is a 510(k) Summary for a medical device called the "PulseMaster Erbium Dental Laser System." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with detailed performance metrics. As such, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given text.

Here's a breakdown of what can and cannot be answered based on the provided document:

Acceptance Criteria and Device Performance

• No specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices primarily based on intended use, technical specifications, and mechanism of action, rather than a clinical trial with performance targets.

Study Information

1. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study to evaluate specific performance metrics is described in this 510(k) summary. The basis for substantial equivalence is a comparison to predicate devices, not a new clinical study with a test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment by experts is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable. This document describes a dental laser system, not an AI-assisted diagnostic or therapeutic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of What the Document Does State:

• Intended Use: The PulseMaster Erbium Dental Laser System is intended for:
  • Removal of caries and cavity preparation for primary and secondary teeth.
  • Modification and etching of enamel and dentin prior to acid etching.
  • Incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery (including gingival tissues).
• Basis for Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (K983211, K992013, K001527) because it shares:
  • The same intended use.
  • Substantially equivalent technical specifications.
  • The same mechanism of action.
  • Indication for both hard and soft tissue applications.
  • Utilizes an Er:YAG solid state laser source operating at 2.94 microns.
  • Employs fiber delivery systems with contact tips.
  • Operates within the same parameter ranges as the predicate devices.

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The American Dental Technologies, Inc. PulseMaster Dental Laser Systems are indicated for use for selective ablation of enamel (first degree) dental caries.

The American Dental Technologies PulseMaster Dental Laser Systems are Nd:YAG lasers producing laser emission at 1064 nm. The lasers consist of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.

The provided text describes the 510(k) summary for the American Dental Technologies PulseMaster Dental Laser Systems (K984486). While it discusses the device's intended use and general performance data, it does not explicitly state specific numerical acceptance criteria or detail a formal study designed to prove the device meets such criteria.

Here's an analysis based on the information provided, addressing your requested points where possible, and noting where information is absent:

Acceptance Criteria and Device Performance

The document states that the device is "substantially equivalent" to predicate devices, which is the primary mechanism for 510(k) clearance. This means the performance is deemed acceptable if it's comparable to existing, legally marketed devices for the same intended use.

Study Details for Demonstrating Acceptance Criteria

The document mentions both nonclinical (bench) and clinical performance data.

2. Sample size used for the test set and the data provenance:

• Bench Test: No sample size is provided. The provenance is "under controlled scientific conditions" but no country or retrospective/prospective status is specified.
• Clinical Study: "An extracted tooth study" for histology and a "multi-center, blinded, randomized study" for safety and effectiveness. No sample sizes for either are provided. The provenance is not explicitly stated beyond "multi-center," so country of origin is unknown, but it was a prospective study (randomized).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Bench Test: Not applicable, as it involved physical measurements.
• Extracted Tooth Study (Histology): Not specified. Likely involved a pathologist or histologist, but their number and qualifications are not mentioned.
• Clinical Study: Not specified how ground truth (e.g., initial caries diagnosis, assessment of ablation) was established or by whom.

4. Adjudication method for the test set:

• Not specified for any of the studies mentioned.

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:

• Not applicable. This device is a dental laser, not an AI-assisted diagnostic or imaging device for human readers. The clinical study compared the laser to a high-speed handpiece, which is a comparison of two treatment methods, not an AI-reader performance study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device (laser system), not an algorithm. Its performance is inherent to its physical operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Bench Test: Physical measurements of temporal pulse structures and effects on enamel caries.
• Extracted Tooth Study: Histology (likely considered a form of pathology).
• Clinical Study: Not explicitly detailed, but would involve clinical assessment of caries and treatment outcomes, likely by dentists or dental professionals.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not a machine learning model that requires a training set in that context.

9. How the ground truth for the training set was established:

• Not applicable. (See point 8).

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The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures:

• lesion (tumor) removal
• biopsies
• fibroma removal
• frenectomies and frenotomies
• gingivoplasties
• gingivectomies
• leukoplakia
• operculectomies
• oral papillectomies
• aphthous ulcers
• sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility.

The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is software-controlled and utilizes high brightness diode laser technology to provide similar performance characteristics to Nd:YAG lasers.

Here's an analysis of the provided information regarding the acceptance criteria and study for the PulseMaster® 1000 ST Dental Laser System:

This 510(k) pertains to a medical device (a dental laser system) and not an AI/ML device. Therefore, many of the requested fields (such as expert adjudication, MRMC studies, standalone algorithm performance, and training set details) are not applicable as they are specific to AI/ML device evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner as might be seen for a new AI/ML device. Instead, the performance is demonstrated by showing substantial equivalence to a predicate device through comparative testing. The criteria for acceptance are implicitly that the new device performs "the same or slightly better than" the predicate, without detrimental effects.

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

• Sample Size: Not explicitly stated (e.g., number of tissue samples, trials). The study is described as an "in vitro study."
• Data Provenance: In vitro study, comparing the device to a predicate. The specific country of origin or whether it was retrospective/prospective in a clinical sense is not applicable or provided for an in vitro comparison of physical properties.

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

• N/A. This is a hardware device assessment, not an AI/ML diagnostic or prognostic tool requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• N/A. Not an AI/ML diagnostic or prognostic tool.

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

• N/A. This is not an AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• N/A. This is a standalone hardware device, but the concept of "standalone algorithm" doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through direct physical measurement of tissue effects (width/depth of tissue removed, thermal coagulation, temperature rise) in an in vitro setting, against the performance of a known predicate device.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device that undergoes "training."

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

• N/A. This is not an AI/ML device that undergoes "training."

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Sulcular Debridement

Dental Laser System

This 510(k) summary describes a clinical study for a new indication for use of the PulseMaster laser system: sulcular debridement and bacterial reduction. The provided document focuses on the clinical study's findings regarding safety and efficacy, drawing comparisons between laser treatment and standard treatment. However, it does not explicitly state specific acceptance criteria (e.g., target accuracy, sensitivity, specificity thresholds) that the device was expected to meet. Therefore, I cannot provide a table of acceptance criteria and reported device performance with specific metrics.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

As mentioned, explicit, quantitative acceptance criteria are not stated in the provided text. The study aimed to demonstrate equivalence.

• No differences in pulp condition between laser treatment and standard treatment.
• "No new safety risks for this laser procedure. All teeth in the study were healthy out to six months." |
  | Efficacy (Short-term): Equivalence to standard treatment in improving clinical indices and microbiological measurements. | - Significant differences between treated teeth and no-treatment teeth in several indices at one month and three months.
• Laser treatment and standard treatment showed equivalent results. |
  | Efficacy (Long-term): Not explicitly stated, but "By six months all treatment differences had disappeared" suggests a return to baseline or similar long-term outcomes for both treatments. | - By six months all treatment differences had disappeared. |

2. Sample Size and Data Provenance:

• Sample Size: The document does not specify the exact number of patients or quadrants included in the study. It only states, "The patients were treated with standard treatment, laser treatment, or no-treatment on different quadrants of the mouth which were randomly assigned."
• Data Provenance: Not explicitly stated. The document describes a "clinical study," implying a prospective design, but it does not specify the country of origin.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

• The document mentions "blinded evaluators" performing pulp evaluations and tooth surface conditions for safety. It does not state the number or specific qualifications of these evaluators or if they were considered "experts" for establishing ground truth for efficacy endpoints.
• For efficacy, "clinical indices and microbiological measurements were made." It's not specified who performed these measurements or if they were considered experts for ground truth establishment.

4. Adjudication Method for the Test Set:

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It mentions "blinded evaluators" for safety assessments, implying independent assessment, but further detail is lacking.

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

• No, a MRMC comparative effectiveness study is not described. The study compares a laser treatment to a standard treatment, not human readers with and without AI assistance. The device in question is a medical device (laser system), not an AI diagnostic tool.

6. Standalone Performance:

• This is not applicable in the context of this document. The PulseMaster laser system is a treatment device, not a diagnostic algorithm, so "standalone (i.e., algorithm only without human-in-the-loop performance)" does not apply. The study assesses the performance of the treatment performed by the device, likely by a human operator.

7. Type of Ground Truth Used:

• For Safety: Clinical observation by "blinded evaluators" regarding pulp evaluations and tooth surface conditions.
• For Efficacy:
  • Clinical indices: These would be standardized clinical measurements (e.g., probing depth, bleeding on probing, clinical attachment levels) typically collected by trained dental professionals.
  • Microbiological measurements: Laboratory tests to quantify or identify specific bacteria.

8. Sample Size for the Training Set:

• The document does not describe a "training set" as this is a clinical trial, not an AI model development. The entire patient cohort where the treatments were applied serves as the study population.

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

• Not applicable as there is no "training set" in the context of this traditional clinical trial for a medical device. The "ground truth" for evaluating the treatment effectiveness was established through the clinical and microbiological measurements taken across the study's duration.

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The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for coagulation of other intraoral soft tissue.

Dental Laser System

This 510(k) summary for the PulseMaster Dental Laser System describes a new indication for use: treatment of aphthous ulcers. The provided text is a summary of the clinical evidence to support this new indication, focusing on substantial equivalence to existing uses.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed performance from the first study (21 patients):

• Immediate relief of pain: 63%
• Faster healing: 50%
• No recurrence within 6 months: 50%
• Less severe recurrences (for remainder): 75%
• Authors' conclusion: "the pulsed Nd: YAG laser treatment was effective in the control and relief of most aphthous lesions."

Detailed performance from the second study (3 case studies):

• Immediate relief of painful symptoms.
• Authors' conclusion: "laser treatment compared favorably with other treatments due to no side effects or contraindications, and immediate palliation of the lesions." |
  | Substantial Equivalence: To existing intraoral soft tissue use. | "The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for coagulation of other intraoral soft tissue." (Summary asserts this based on study results). "The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for ablation and coagulation of other intraoral soft tissues." (Conclusion of the summary) |

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

• Test Set Sample Size:
  • First study: 21 patients (8 with recurrent aphthous ulcers, 14 with herpes labialis lesions - it's unclear if all 21 had aphthous ulcers or if the 14 herpes patients were also treated for aphthous ulcers if present. The reported results focus on "those with aphthous ulcers.")
  • Second study: 3 case studies (patients with recurrent aphthous ulcers).
• Data Provenance: Not explicitly stated (e.g., country of origin). Both studies are described as "Independent studies." No mention of retrospective or prospective; however, the description of follow-up periods and daily calendars suggests they were prospective studies.

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

• The text refers to "the investigator's evaluation at follow-ups" in the first study. It does not specify the number of investigators/experts or their qualifications (e.g., "radiologist with 10 years of experience").
• For the second study, "The authors' conclusion" is mentioned, implying expert evaluation, but again, no specific details on number or qualifications.

4. Adjudication Method for the Test Set

• The text explicitly mentions: "Results were based on both the investigator's evaluation at follow-ups and the patient's self evaluation." This indicates a dual assessment, but no formal adjudication method (like 2+1 or 3+1 consensus) between different investigators or in cases of disagreement between investigator and patient is described.

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

• No, an MRMC comparative effectiveness study was not done.
• The device is a direct treatment laser, not an AI diagnostic or assistance tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Yes, in spirit. The studies evaluate the laser device's direct performance as a standalone treatment without explicit human-in-the-loop diagnostic assistance within the evaluation itself. The human is operating the device, but the device's efficacy is being measured. The laser itself is not an "algorithm" in the typical sense of AI, but its effect is observed directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Combined Expert Evaluation and Patient Reported Outcomes (PROs):
  • First study: "investigator's evaluation at follow-ups" (expert clinical assessment) and "patient's self evaluation" (patient-reported outcomes for pain relief, healing speed, recurrence).
  • Second study: Based on "patients reported no discomfort," "immediate relief of the painful symptoms," and "The authors' conclusion" (expert clinical opinion).
• No mention of objective measures like pathology or specific outcomes data beyond clinical assessment and patient reporting.

8. The sample size for the training set

• Not applicable / Not explicitly mentioned. The provided text describes clinical studies evaluating the laser's performance. The laser itself is a physical device, not an AI/machine learning algorithm that requires a "training set" in the context of device development. The closest analogy would be prior clinical experience, but not a formally defined training set as per AI standards.

9. How the ground truth for the training set was established

• Not applicable. As above, there is no "training set" in the context of an AI algorithm, so no ground truth for a training set was established here. The existing literature and prior uses of the PulseMaster for other intraoral soft tissue coagulation might be considered analogous to establishing a baseline understanding, but not a formal ground truth for data for an AI training set.

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