(147 days)
The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.
The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.
The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.
The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a powered toothbrush. It concerns the "Oral-B iO Test Drive Power Brush Trial Program Kit" (K200881). The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Oral-B Test Drive Power Brush Trial Program Kit, K141018) and a reference device (Oral-B iO Rechargeable Power Toothbrush, a Class I, 510(k) exempt device).
The information provided does not relate to an AI/ML medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or the use of AI assistance for human readers. It lists performance data for a physical device, including biocompatibility, electrical safety, software verification, and cleaning/disinfection validation. Therefore, many of the requested categories related to AI/ML device performance and study design (e.g., sample size for test/training sets for AI, expert adjudication, ground truth definition for AI, effect size of AI assistance) are not applicable to this document.
However, I can extract the relevant acceptance criteria and how the device meets them based on the provided "PERFORMANCE DATA" section.
Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a physical medical device (a powered toothbrush) and not an AI/ML algorithm, the "acceptance criteria" are typically defined by compliance with recognized standards and successful completion of specific non-clinical and performance tests to demonstrate safety and effectiveness for its intended use, and ultimately substantial equivalence to a predicate device. The performance data section describes how the device meets these requirements.
Here's a table summarizing the "acceptance criteria" (or performance areas tested for compliance) and the reported device performance:
| Acceptance Criteria/Performance Area | Reported Device Performance |
|---|---|
| Biocompatibility | Tests: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-12). Consistent with ISO 10993 guidance and FDA recommendations. |
| Results: Passed all tests. Confirmed non-cytotoxic, non-sensitizing, and non-irritating, even after cleaning and disinfection. Materials are the same as those used in the predicate and reference device. | |
| Electrical Safety | Standards: UL 1431, IEC 60335-1, IEC 60335-2-52 (as outlined in ISO 20127). |
| Results: Compliant results. Confirms construction addresses risk of fire, shock, and physical injury per specified consensus standards. | |
| Electromagnetic Compatibility (EMC) | Standards: Title 47 CFR Parts 15B, 15C, and 18 of the Federal Communications Commission. |
| Results: Compliant results. Assures unintentional and intentional radiation are within federally prescribed limits across the full RF bandwidth. | |
| Software Verification & Validation | Guidance: FDA guidance documents "General Principles of Software Validation" (Jan 2002) and "Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). Consistent with "Moderate" Level of Concern. |
| Results: Verification activities demonstrate that the device performs as intended. | |
| Cleaning and Disinfection Validation | Conditions: Simulated normal use and worst-case scenario for wear. |
| Results: Demonstrated satisfactory cleaning and high-level disinfection. Repeated exposure to cleaning and disinfection procedures had no effect on physical characteristics or performance. Established a reuse life of 240 uses and subsequent cleaning and disinfection cycles. (Note: The table on page 7 shows "Reuse Life" for the subject device as "100 cycles" compared to "240 cycles" for the predicate. This seems like a discrepancy or change from the text on page 12, which states 240 uses were established. The 100 cycles value might be a specific finding or target, while 240 cycles was the tested limit without performance degradation.) | |
| Human Factors Usability Testing | Studies: Several formative studies (to develop/test instructions, software, training) and one summative study (to validate user ability to follow instructions). |
| Results: Summative study validated that users, after training, could read and understand labeling and follow instructions (with software aid) to properly clean and disinfect the reusable toothbrush handle. | |
| Substantial Equivalence | Conclusion: Based on intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K141018). |
Since this is not an AI/ML device, the following points are largely not applicable or cannot be definitively answered from the provided text:
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Sample sizes used for the test set and the data provenance:
- For biocompatibility, electrical safety, EMC, and software, "samples" are devices or components. Specific numbers of units tested are not provided in this summary, but these are typically engineering and lab tests, not clinical studies with human subjects for efficacy.
- For Cleaning and Disinfection Validation, the document mentions testing under "simulated normal use and worst-case scenario for wear" and establishing a "reuse life of 240 uses." This number (240 cycles) could be considered a "sample size" for this specific durability test.
- For Human Factors Usability testing, "several formative and a summative" studies were performed. The number of participants in these studies (i.e., "sample size") is not specified.
- Data Provenance: The manufacturer is Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio). The studies are non-clinical, not patient data (retrospective or prospective).
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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 defined for AI/ML (e.g., highly accurate disease labels) is not relevant for this type of device submission. The "ground truth" here is compliance with engineering standards and predefined performance specifications. Expert validation is implicitly part of these standardized testing processes (e.g., certified labs, qualified engineers).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is typically related to expert review of medical images or patient data for ground truth establishment in AI/ML studies.
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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 is a physical powered toothbrush, not an AI-assisted diagnostic or therapeutic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is a software component (Level of Concern - Moderate), but it's part of the device's function (e.g., user interface, power management, potentially guidance for cleaning), not a standalone diagnostic algorithm. The software verification confirms it "performs as intended."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from:
- Compliance with recognized standards: ISO 10993 (biocompatibility), UL 1431, IEC 60335 series, ISO 20127 (electrical safety), 47 CFR Parts 15B, 15C, 18 (EMC).
- Successful completion of pre-defined non-clinical tests: Cleaning/disinfection validation (e.g., microbial reduction, material integrity), Human Factors Usability (user ability to follow instructions).
- Performance against specifications: e.g., reuse life, satisfactory cleaning/disinfection.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable for the same reason as above.
§ 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.