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• Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants
• For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
• For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
  Calculi and tartar cannot be removed with Clinpro Prophy Powder.

Clinpro TM Prophy Powder is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning. As the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289), Clinpro Prophy Powder is a glycine based air polishing powder to be used with air polishing devices in the professional tooth cleaning.

The provided text is a 510(k) summary for a dental device (Clinpro Prophy Powder) and does not describe acceptance criteria for a study or a study proving that a device meets such criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, performance characteristics, and biocompatibility. It does not contain a typical "acceptance criteria" table or details of a clinical study designed to quantitatively prove the device meets specific performance thresholds with a defined "test set" or "training set" as would be expected for a diagnostic or AI-based device.

Here's an breakdown of why the requested information cannot be extracted from the provided text, and what information is available:

Information NOT available in the document:

• A table of acceptance criteria and the reported device performance: The document compares characteristics to predicate devices but does not list specific numerical acceptance criteria (e.g., Sensitivity > X%, Specificity > Y%) or quantifiable performance metrics like a standalone study would.
• Sample size used for the test set and the data provenance: There is no mention of a specific test set, its size, or its origin.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about expert adjudication for a test set.
• Adjudication method for the test set: Not applicable as no specific test set or expert review process is described.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a dental powder, not an AI diagnostic device. MRMC studies are not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this device type.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While it mentions "in vitro and in vivo studies" and "clinical literature review," it doesn't specify a rigorous ground truth establishment process for a performance study.
• The sample size for the training set: Not applicable for this type of submission.
• How the ground truth for the training set was established: Not applicable.

What the document does provide, in relation to device evaluation:

The evaluation conducted for this 510(k) submission primarily relies on:

• Comparison to predicate devices: The manufacturer argues "substantial equivalence" based on similar materials, indications for use, and a literature review of glycine-based air-polishing powders.
• Biocompatibility testing: This was carried out against "FDA & internationally recognized guidelines."
• In vitro and in vivo investigations: The document states that "Results of in vitro and in vivo investigations using Clinpro Prophy Powder and glycine based air-polishing powder (i.a.) published in numerous literature show that Clinpro Prophy Powder is substantially equivalent to the predicate device with regard to the performance of the product." However, it does not provide details of specific studies, their methodologies, sample sizes, or numerical results.
• Clinical literature review: The document states, "The overall conclusion, based also on the clinical literature review, is that Clinpro Prophy Powder is suitable and safe for its intended use."

Topics of "studies evaluated to substantiate performance and safety":

• Removal of subgingival bacterial load in supportive periodontal therapy
• Root debridement
• Use on contaminated implant material
• Professional oral hygiene treatment of patients with orthodontic appliances (effects on plaque index (PI) and gingival bleeding)
• Gingival tissue effects
• Abrasiveness of air-polishing

In conclusion, this document describes a 510(k) submission for a dental prophy powder asserting substantial equivalence to existing devices, supported by general statements about in vitro/in vivo studies and a clinical literature review, rather than a detailed report of a specific device performance study with predefined acceptance criteria.

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Clinpro™ Prophy Powder is intended for use in dental polishing units. The air polishing unit produces a stream of water, air and Clinpro Prophy Powder to clean and polish tooth surfaces.
Cleaning, polishing and restoring the natural esthetics of tooth enamel

Clinpro Prophy Powder is classified as a class II medical device because it is a device intended for use during dental cleaning and periodontal therapy to remove deposits and stains from teeth (Ultrasonic Scaler, 21 C.F.R. § 872.4850). Clinpro Prophy Powder is intended for use in dental polishing units. The air polishing unit produces a stream of water, air and Clinpro Prophy Powder to clean and polish tooth surfaces.

The provided text describes a 510(k) summary for a dental cleaning powder, Clinpro™ Prophy Powder, and its substantial equivalence determination by the FDA. However, it does not contain the information required to populate the requested table and answer the questions related to acceptance criteria, device performance, and study details for an AI/software device.

The document discusses:

• Device Name: Clinpro™ Prophy Powder
• Classification: Class II medical device, Ultrasonic Scaler (21 C.F.R. § 872.4850), later identified as Airbrush (21 CFR 872.6080)
• Intended Use: Cleaning, polishing, and restoring the natural aesthetics of tooth enamel; specifically for use in dental polishing units to produce a stream of water, air, and powder to clean and polish tooth surfaces.
• Predicate Device: New Prophy Powder by Dentsply (K014188)
• Conclusion: The submitter believes the device is substantially equivalent to the predicate device and that performance and biocompatibility data provide evidence that safety and effectiveness requirements are met.

There is no mention of:

• Acceptance criteria in terms of metrics (e.g., sensitivity, specificity, accuracy).
• Reported device performance values for such metrics.
• Any clinical study, test set, training set, or ground truth details.
• AI/software components, human readers, or comparative effectiveness studies.

Therefore, I cannot fulfill the request as the provided text is for a physical dental cleaning powder undergoing a 510(k) submission, not an AI/software device evaluation.

Ask a specific question about this device