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The Prophy-Mate Neo device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powders or calcium carbonate powders, air, and water onto tooth surfaces.
The Prophy-Mate neo can also be used in dental applications to prepare surface prior to bonding and to prepare for pit and fissure sealant.

The Prophy-Mate neo is an air-powered tooth polishing system. The product expels a mixture of powders (sodium bicarbonate or calcium carbonate), water, and air onto the surfaces of the tooth. The Prophy-Mate neo consists of the Powder case, Handpiece, with a 60° and 80° Nozzle attachment.

The provided text describes the 510(k) summary for the Prophy-Mate neo, an air-powered tooth polishing system. It is a submission to the FDA for market clearance, not a study report that details performance against specific acceptance criteria in a comprehensive clinical or analytical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly present in the provided document.

Here's an analysis of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for the Prophy-Mate neo's performance. For a 510(k) submission, the primary "acceptance criterion" is typically substantial equivalence to predicate devices, meaning it does not raise new issues of safety and effectiveness and performs as intended.
• Reported Device Performance: The document states: "The Prophy-Mate neo was developed and is produced under consideration of all applicable technical standards, and internal specifications. The product's conformance with applicable international and internal standards was verified in the course of bench testing."
  • This broadly indicates that the device met relevant technical and internal standards, but specific performance metrics, like efficiency of stain removal, abrasion levels, or durability, are not quantified or reported in this summary.

Without explicit performance metrics and acceptance thresholds, a table like the one requested cannot be constructed from this document.

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

• Sample Size: Not specified. The document only mentions "bench testing."
• Data Provenance: Not specified beyond "bench testing." No information on country of origin or whether it was retrospective or prospective data.

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

• Not applicable/Not specified. The assessment appears to be based on technical standards and internal specifications, not expert evaluation of clinical performance.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. There's no mention of a test set requiring adjudication in this context.

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

• No, an MRMC study was not done, or at least not reported in this summary. This type of study is typically for evaluating diagnostic imaging or AI systems where human reader performance is a key metric. This device is a dental tool, not a diagnostic system.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is a physical dental device, not an algorithm or AI system.

7. Type of Ground Truth Used

• For the purpose of this 510(k) submission, the "ground truth" implicitly refers to the adherence to "applicable technical standards, and internal specifications" and the established safety and effectiveness of the predicate devices. It is not based on expert consensus, pathology, or outcomes data in the sense typically associated with diagnostic devices.

8. Sample Size for the Training Set

• Not applicable/Not specified. There's no mention of a "training set" as this is not a machine learning or AI device.

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

• Not applicable/Not specified, as there is no training set.

In summary, the provided document is a regulatory submission focused on substantial equivalence to predicate devices for a physical medical device. It attests to compliance with technical standards through bench testing but does not detail a clinical or analytical study with specific quantifiable acceptance criteria and performance results in the way typically expected for a diagnostic or AI device.

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