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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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