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K Number
K971639
Device Name
PLUSTRON ION TOOTHBRUSH SYSTEM
Manufacturer
SAS GROUP, INC.
Date Cleared
1997-06-24

(53 days)

Product Code
MMD
Regulation Number
872.6865
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the removal of plaque For cleaning teeth For healthier gums For fresh breath

Device Description

PlusTron Ion Toothbrush System

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device named "PlusTron Ion Toothbrush System." This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about specific acceptance criteria or study results in the manner requested.

Therefore, it is not possible to provide the requested information based solely on the provided text. The document is a regulatory approval, not a technical report detailing performance studies.

Here's a breakdown of why each requested point cannot be answered:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter. Such details would typically be in the 510(k) submission itself, which is not provided.
  2. Sample size used for the test set and the data provenance: Not available. The letter mentions "substantial equivalence" but doesn't detail performance studies or the data used for comparison.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. This level of detail about expert review or ground truth establishment is not part of an FDA clearance letter.
  4. Adjudication method for the test set: Not available.
  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 available. This device is a toothbrush system, not an AI diagnostic tool, so an MRMC study is highly unlikely and certainly not mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not available, and not applicable as this is not an algorithm-based device.
  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available.
  8. The sample size for the training set: Not available, and not applicable for this type of device.
  9. How the ground truth for the training set was established: Not available, and not applicable for this type of device.

In summary, the provided FDA 510(k) clearance letter is a regulatory document and does not contain the detailed study information or performance data requested.

§ 872.6865 Powered toothbrush.

(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.