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The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.

The ThermoMed Model 1.8 is a battery-operated device that delivers precisely controlled localized current field radio frequency heat to selectively destroy certain diseased tissue.

Here's an analysis of the provided text regarding the ThermoMed Model 1.8 device, focusing on acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds. The "reported device performance" are the results presented from the clinical trial, which implicitly serve as demonstration of acceptable performance for the device's intended use, particularly for basal cell carcinoma. The study concludes that the data "shows safety and effectiveness of the device."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 60 patients.
• Data Provenance: The study was a "single center study." The document does not specify the country of origin, but given the 510(k) submission to the FDA (United States), it is highly probable the study was conducted in the USA.
• Retrospective or Prospective: The phrasing "A single center study... was conducted to evaluate the safety and efficacy" indicates a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states that efficacy was determined by "histological examination 3 months after a single treatment." This implies that a pathologist or a team of pathologists established the ground truth for the presence or absence of tumor cells. However, the document does not specify the number of experts used or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not provide details about an adjudication method (such as 2+1 or 3+1 consensus) for establishing the ground truth from histological examinations. It's common practice for pathological assessments to be performed by a single pathologist, or for challenging cases to be reviewed by multiple pathologists for consensus, but this specific detail is not mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The described study evaluates the device's performance in treating basal cell carcinoma directly, not by comparing human reader performance with and without AI assistance. The ThermoMed Model 1.8 is a therapeutic device, not a diagnostic AI system for image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This question is not applicable. The ThermoMed Model 1.8 is a physical medical device (localized current field radio frequency instrument) that is applied by a healthcare professional to treat conditions. It is not an algorithm or an AI system that operates in a "standalone" or "human-in-the-loop" fashion for diagnostic interpretation.

7. The Type of Ground Truth Used

The primary ground truth for efficacy in the basal cell carcinoma study was histology (pathology), specifically "no evidence of tumor cells upon histological examination." Patient satisfaction data was self-reported by patients.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" because the study described is a clinical trial to evaluate the safety and efficacy of a therapeutic device, not to train or validate a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no mention of a training set for an AI/ML algorithm. The clinical trial described focuses on the direct physiological effect of the device on patients.

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The TTI ThermoMed™ Model 1.8 Instrument provides the therapeutic modality to treat the following benign diseases and conditions:

1. Warts
2. Molluscum Contagiosum
3. Anqioma
4. Fibroma
5. Seborrheic Keratoses
6. Acrochordon
7. Syringoma
8. Hydrocystoma
9. Clavus
10. Actinic Keratoses
11. Keloids
12. Epidermoid Cysts
13. Cystic Acne
14. Cutaneous Leishmaniasis
15. Atypical Mycobacteria
16. Dermatophytosis

The TTI ThermoMed device delivers controlled localized current field (LCF) radio frequency (RF) heat to selectively destroy certain diseased tissue. RF energy is delivered to the dermal surface via a hand held wand with an autoclaveable energy applicator. For convenience, an audial and visual signal indicates the elapsed treatment time in 30-second intervals after the selected target temperature is reached.

This document is a 510(k) summary for a Special 510(k) submission, which means it describes a modification to an already legally marketed device (the predicate device). Special 510(k)s typically do not involve new clinical studies for acceptance criteria, as the modification is usually considered to have no negative effects on safety or effectiveness. The core of this submission is a change in a temperature controller from analog to digital. Therefore, the provided information does not contain a study proving device performance against acceptance criteria in the way a new device submission would.

However, I can extract and infer information based on the typical content of a 510(k) and the provided text.

Here's an analysis based on the provided text, addressing your points where possible:

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

Based on the provided text, specific quantifiable acceptance criteria and reported device performance from a new study are not explicitly stated. This is because this is a Special 510(k) for a modification (changing an analog temperature controller to digital), and the statement mentions: "No negative effects on safety or effectiveness have been found after the risk analysis and risk mitigation process." This implies that the device is expected to maintain the performance of the predicate device, not necessarily meet new, specific numerical criteria through a separate study.

Inferred "Acceptance Criteria" (based on predicate device equivalence and risk analysis):

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

Not applicable/Not provided. Since this is a Special 510(k) for a component change, a new test set with patient data for clinical performance evaluation is not typically required or mentioned. The assessment would likely involve engineering verification and validation of the new digital controller, potentially through bench testing rather than a clinical 'test set'.

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. As there is no clinical test set for performance evaluation described, there's no mention of experts establishing ground truth for such a set.

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

Not applicable/Not provided. No clinical test set 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

Not applicable. This device is an electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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 for direct treatment, not an algorithm.

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

Not applicable/Not provided for this modification. For the original predicate device, the ground truth for its effectiveness would have been established through clinical trials or accepted medical practice demonstrating the efficacy of localized current field RF heat for the listed dermatological conditions, likely involving clinical outcomes data (e.g., clearance of lesions, symptom improvement) and potentially pathology for confirmation of diagnosis in some cases. However, for this modification, no new ground truth determination is described.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As above, no training set is relevant for this type of device modification.

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