(83 days)
The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.
The Tanda Pearl device consists of a double biting mouth tray made of silicone for fitting both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.
Here's an analysis of the provided text regarding the Tanda Pearl device's acceptance criteria and studies:
Summary of Acceptance Criteria and Device Performance for Tanda Pearl
The provided 510(k) summary for the Tanda Pearl device does not explicitly list quantitative acceptance criteria in a dedicated section with pass/fail thresholds. Instead, it describes performance testing conducted to support substantial equivalence and confirm that the Tanda Pearl performs as intended.
Based on the information, the implicit acceptance criteria are that the device:
- Meets relevant safety and performance standards (electrical, EMC, software, integrity, biocompatibility, risk management).
- Demonstrates clinical efficacy in teeth whitening.
- Demonstrates clinical safety with no significant concerns or severe adverse events.
Here's a table summarizing the reported device performance in relation to these implicit criteria:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | Electrical safety | Confirmed as intended (IEC 60601-1: 2005) |
| Electromagnetic compatibility (EMC) | Confirmed as intended (IEC 60601-1-2: 2007) | |
| Device integrity (packaging/transport) | Confirmed as intended (ISTA 2 Series: Partial Simulation Performance Tests-Procedure 2A) | |
| Biocompatibility | Confirmed as intended (IEC 10993-1:2009) | |
| Software verification & validation | Confirmed as intended (IEC 62304: 2006) | |
| Risk analysis | Confirmed as intended (ISO 14971: 2009) | |
| Clinical Performance | Efficacy (teeth whitening) | Produced significantly greater improvement in tooth whitening than control (Vita Shade scores and Delta-E scores). Significant results maintained through 6 months. |
| Safety | No significant safety concerns; all reported events were mild in severity and resolved. |
Detailed Information about the Studies:
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A table of acceptance criteria and the reported device performance: (Provided above)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): The document states "the results of a single site IRB clinical study". While it confirms a clinical study was performed, the exact sample size for this clinical study is not provided in the given text.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the original technology developer is "Fluorinex Active Ltd.", which could be an indicator but is not definitive for the study location.
- Retrospective or Prospective: "single site IRB clinical study" indicates it was a prospective study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- The "Vita Shade scores and the Vita Shade Delta-E scores" typically rely on standardized shade guides and visual assessment, which implies trained assessors, but their number and qualifications are not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not mentioned. It's unclear how discrepancies in Vita Shade scoring, if any, were handled.
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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:
- MRMC Study: No, there is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is not an AI/imaging diagnostic device that would typically involve human readers interpreting images. The study rather compares the device to a control for tooth whitening efficacy.
- Effect Size of AI Assistance: Not applicable, as no AI assistance is mentioned or evaluated in the context of human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: The clinical study evaluated the device (Tanda Pearl) against a control, demonstrating its efficacy and safety. This can be considered a "standalone" evaluation of the device's performance, but not in the context of an "algorithm only" as typically applied to AI/software as a medical device. The device is a physical product directly used by humans.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The efficacy ground truth was established by objective measurements of tooth whitening using "Vita Shade scores and the Vita Shade Delta-E scores." These are widely accepted clinical metrics for tooth shade changes. Safety involved tracking "reported events" and their severity to resolution. This aligns with clinical outcomes data based on standardized clinical assessments.
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The sample size for the training set:
- Sample Size (Training Set): Not applicable. This device is not an AI/machine learning device that typically involves a distinct "training set" in the context of model development. The provided clinical study is a performance study to demonstrate the device's function, not to train an algorithm.
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How the ground truth for the training set was established:
- Ground Truth (Training Set): Not applicable, as there is no training set for an AI algorithm.
§ 872.6475 Heat source for bleaching teeth.
(a)
Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.(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.