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Perio-Mate:
Perio-Mate is intended for the following application(s):
Removal of supragival/subgingival soft deposits and soft deposits on prostheses (including implant abutments).

Perio Mate Nozzle Tip:
Perio Mate Nozzle Tip is intended for the following application(s):
Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).

The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The Air Powered Tooth Polishing System includes the Perio-Mate, which consists of a handpiece and the Perio Mate Nozzle Tip, which is connected to the end of the Perio-Mate handpiece.

Perio-Mate is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings or hoses to the treatment area. This device is a non-sterile state and intended to be cleaned and sterilized by end-users as a reusable device. This device to be used for supragingival purpose.

During subgingival treatment, Perio Mate Nozzle Tip is connected to the handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inserted in a periodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses.

The provided text is a 510(k) summary for a dental device, the "Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)". It outlines the device's indications for use, technological comparison to predicate devices, and non-clinical tests performed to support substantial equivalence.

However, the document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria in the way typically expected for performance claims related to effectiveness measured by clinical outcomes or diagnostic accuracy (e.g., sensitivity, specificity, accuracy, effect size with human readers).

The non-clinical tests mentioned are related to:

• Performance Test: Compliance with standards like ISO 20608:2018 (Dentistry - Powder jet handpieces and powders) and sterilization/reprocessing standards (ISO 17665-1, ISO 17664-1, ISO 17664-2), and FDA guidance documents related to dental handpieces and reprocessing. These tests confirm the device's functional and safety attributes, not direct clinical efficacy metrics.
• Biocompatibility Test: Compliance with ISO 10993-1:2018 and FDA guidance on biological evaluation for devices with limited contact with surface medical devices and breached or compromised surfaces. This ensures the material safety of the device.

Based on the provided text, the following points can be addressed:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: The document refers to compliance with ISO standards (e.g., ISO 20608:2018 for powder jet handpieces and powders, various ISO standards for sterilization and biocompatibility) and FDA guidance documents. Specific numerical performance acceptance criteria (e.g., specific thresholds for removal efficiency of deposits, or clinical outcomes) are not detailed in this summary.
   • Reported Device Performance: The summary states that "The tests demonstrate compliance with the requirements of the following standards and guidance." and "The test results demonstrate compliance with the requirements of the following standards and guidance". It doesn't provide specific quantitative performance metrics beyond stating compliance with these standards.

2. Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical, primarily for engineering performance, biocompatibility, and reprocessing validation against international standards, not clinical studies with patients or image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in studies involving AI or clinical diagnostic accuracy is not relevant here as the tests are non-clinical.

4. Adjudication method for the test set: Not applicable for the non-clinical tests 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: Not applicable. This device is a dental handpiece, not an AI or diagnostic imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical dental tool, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" is defined by the requirements and test methods outlined in the cited ISO standards and FDA guidance documents (e.g., for sterilization efficacy, material compatibility, or functional parameters of the handpiece).

8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices through non-clinical testing for performance against recognized standards (engineering, sterilization, biocompatibility) rather than clinical efficacy studies with specific acceptance criteria that would yield metrics like sensitivity, specificity, or reader improvement.

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