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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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The Prophy-Mate device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.

This product should not be used on patients who are restricted of salt intake (hypernatremia, toxemia of pregnancy); or with critical ulcers in digestive organs, dyshepatia, cardial or lung dysfunction, damage or abnormality in a mouth, congestion, bleeding or inflammation in a mouth, contact lenses, or allergies; or who tend to have inflammation or soreness in the in the oral mucous membrane.

The Prophy-Mate device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.

The provided text is a 510(k) clearance letter from the FDA for a dental handpiece, the Prophy-Mate. It primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.

However, this document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other details requested in your prompt.

The letter is a regulatory document, not a scientific study report. It confirms that the device can be legally marketed based on its equivalence to existing products, but it does not describe the specific testing or data used to demonstrate that equivalence in the way you've asked for.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

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This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.

a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm. A variety of detachable heads, each of which is pushed into or pulled out of the motor handpiece, are available to perform required job, such as a prophy head for screw-in or snap-on prophy cups and brushes, a latch head for latch reamer or latch file, a 1/4-turn head, up-down head, 10:1 reduction speed head, etc.

The provided text is an FDA 510(k) clearance letter for a dental device, the "PROPHY-MATE Motor Handpiece." This type of document is a regulatory approval, not a scientific study report. As such, it does not contain any of the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or specific study methodologies.

The letter explicitly states that the device is deemed "substantially equivalent" to devices marketed prior to May 28, 1976. This means the FDA's decision is based on a comparison to existing, legally marketed predicate devices, rather than requiring new clinical trials or performance studies with acceptance criteria as one would find for a novel device.

Therefore, I cannot provide the requested information from the given text.

Here's a breakdown of why this information is missing:

• Acceptance Criteria and Reported Device Performance: Not included. The letter is about regulatory clearance based on substantial equivalence, not a detailed performance report.
• Sample Size and Data Provenance: Not applicable to this type of regulatory submission. The substantial equivalence pathway typically relies on existing knowledge and comparison to predicate devices, not new sample-based studies.
• Number of Experts and Qualifications: Not mentioned. Expert review in this context would be part of the FDA's internal process for assessing the 510(k) submission against the predicate device, not for establishing ground truth in a clinical study.
• Adjudication Method: Not applicable. There's no clinical trial data with adjudication described.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned and highly unlikely for a device seeking 510(k) clearance through substantial equivalence for a basic dental handpiece.
• Standalone (algorithm only) Performance: Not applicable, as this is a mechanical dental handpiece, not an AI or algorithm-driven device.
• Type of Ground Truth Used: Not applicable. There's no clinical study described that would require a ground truth.
• Sample Size for Training Set: Not applicable, as there's no machine learning model or algorithm being trained.
• How Ground Truth for Training Set was Established: Not applicable.

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