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The Erase Pen (RF Controller) is only used with the Erase Tip (Single Use Sterile Detachable Electrode Cartridge system) for thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.

The Erase Pen (hand-held Bi-Polar Radiofrequency battery operated controller) and the Erase Tip (single use, sterile detachable electrode cartridge system) is a hand-held Electrosurgical Device to locate and ablate nerves. The depth of the electrodes, the amount of RF energy. delivered, and the duration of energy applied control the size of the ablation.

The provided 510(k) summary for the Cheng Medical Corporation Erase Pen and Erase Tip System for Nerve Ablation (K101592) does not provide explicit acceptance criteria or details of a specific study proving the device meets them.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Radionic's RFG-3C, K982489) based on shared technological characteristics and similar operating parameters. The "Device Testing Results and Conclusion" section broadly states that "All necessary testing was performed... to ensure that the [device] is substantially equivalent... and to ensure that the new device does not raise new issues regarding safety and effectiveness." This indicates that general safety and performance testing was conducted, but the specifics of what was tested, what the acceptance criteria were, and what the results were are not detailed in this summary.

Therefore, many of the requested items cannot be answered directly from the provided text.

Here is a breakdown of what can be inferred or directly stated based on the given information, and where information is missing:

1. A table of acceptance criteria and the reported device performance

• No explicit acceptance criteria are provided.
• The document presents a table comparing "Erase Pen Operating Characteristics" with the predicate device (Radionics RFG-3C), which serves as a comparison of performance parameters rather than predefined acceptance criteria. The implied "performance" is that these parameters are sufficiently similar to the predicate device for substantial equivalence.

Note: The document states "The set output level Erase Pen and adjustable output level Radionics RF generators would have an output power equivalence when the Radionics RFG-3C is at a setting of 3 to 5, depending on the tissue impedance." This implies that despite some numerical differences, the functional output can be considered equivalent under certain conditions.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The summary mentions "All necessary testing was performed," but does not specify the nature of the test set (e.g., in-vitro, ex-vivo, animal, human clinical). Therefore, details like sample size, provenance, or retrospective/prospective nature are absent.

3. 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)

• Not applicable / Not provided. Since no specific test set involving human interpretation or subjective assessment is described, there's no mention of experts or ground truth establishment in this context. The testing described appears to be engineering/performance testing of the device itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. As above, no such test design is 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

• No. This device is a radiofrequency ablation system, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a physical electrosurgical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not provided in detail. For a device like this, the "ground truth" for performance testing typically refers to objective measurements of physical parameters (e.g., power output, lesion size/temperature in a tissue phantom or animal model) and adherence to engineering specifications and safety standards. The document states "to ensure that the product... does not raise new issues regarding safety and effectiveness," implying such testing was done, but specific ground truth types are not detailed.

8. The sample size for the training set

• Not applicable / Not provided. As this is a physical medical device and not an AI/ML algorithm requiring a training set, this information is not relevant and not present in the document.

9. How the ground truth for the training set was established

• Not applicable / Not provided. See point 8.

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HurriSeal® is a desensitizer with fluoride and benzalkonium chloride to be applied prior to restorative procedures by the dental professional.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a product named "Hurriseal® Dentin Desensitizer." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this type of document (a 510(k) clearance letter) typically does not contain the detailed information required to answer your questions about acceptance criteria and a study proving those criteria were met.

A 510(k) submission generally involves demonstrating substantial equivalence rather than conducting large-scale clinical trials with acceptance criteria for device performance in the way you've described for AI/diagnostic devices. For devices like a dentin desensitizer, the evidence for substantial equivalence often relies on:

• Comparison to a predicate device: Showing similar technological characteristics, materials, and intended use.
• Bench testing: In vitro studies to confirm material properties, strength, or specific desensitizing mechanisms.
• Limited clinical data (if necessary): Small studies might be conducted if there are novel aspects, but typically not a full-blown comparative effectiveness study with AI-like metrics.

Therefore, I cannot provide the requested information based on the text provided. To answer your questions, one would need access to the full 510(k) submission document or a separate clinical study report for the Hurriseal® Dentin Desensitizer, which is not part of this letter.

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