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JETT Medical II is a portable medical device designed for non-ablative treatment of wrinkles and rhytids. The device works on the physical principle of a sequence of DC microcurrents, which are generated by electrically or battery powered generator and that are transmited to the patient skin through indifferent conductive gel. Patient loop is formed by pairing the handpiece with one of flat applicators with the grounding electrode (cylinder or disposable). Device consists of the standard package and optional accessories.

AI/ML Overview

The provided FDA 510(k) summary for the JETT Medical II device does not contain the detailed information typically found in an AI/Software as a Medical Device (SaMD) study report. This document describes an electrosurgical device for non-ablative treatment of facial wrinkles, not an AI software.

Therefore, I cannot extract the specific information requested regarding acceptance criteria and study details for an AI-powered device, as the document focuses on the substantial equivalence of a hardware device to a predicate device based on non-clinical and a single clinical study of its performance.

Based on the provided text, here's what can be inferred about the device and its testing, though it's not an AI/SaMD study:

The device is the JETT Medical II, an electrosurgical device.

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

The document doesn't present a formal table of acceptance criteria for "device performance" in the way one would for an AI diagnostic. Instead, it describes acceptance of substantial equivalence to a predicate device (Pelleve GlideSafe Non-Ablative Wrinkle Treatment System (K102698)) based on:

Non-clinical testing: Demonstrating compliance with various standards related to electrical safety, electromagnetic compatibility, software (general medical device software, not AI-specific), biocompatibility, sterilization, risk management, and usability.
Bench testing: Specifically, "Skin temperature during treatment."
Clinical testing: A study to demonstrate safety and effectiveness for its intended use.

Acceptance Criteria Mentioned (Implicit based on testing and comparison):

Criterion Type	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance/Findings
Intended Use/Indications	Same as predicate (non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV).	Identical: JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
Principle of Operation	Similar thermal effect on tissue despite energy type difference.	Similar (justified): JETT Medical II uses DC current; Predicate uses AC current (RF). The document states: "thermal effects on tissue are identical which does not introduce new questions of safety and effectiveness." This was further supported by a "substantial equivalence test" measuring thermal effect.
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6.	Complies: "The JETT Medical II electrical safety and electromagnetic compatibility has been evaluated and found to be in compliance with..." listed IEC standards.
Software	Compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304.	Complies: "The JETT Medical II software testing was performed and found to be in compliance with..." listed FDA guidance and IEC standard. (Note: This refers to general medical device software, not specific AI/ML software.)
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 for patient-contacting components (flat applicators, cylinder electrode).	Complies: "The patient-contacting components... comply with..." listed ISO standards.
Sterilization	Compliance with ISO 17665-1 for patient-contacting components (flat applicators).	Complies: "Sterilization... has been found to be in compliance with..." ISO 17665-1. "Sterilization is performed according to validated procedure (SAL= 10-6) stated in the Instruction of use."
Risk Management	Compliance with ISO 14971.	Complies: "Risk analysis for JETT Medical II has been evaluated and found to comply with..." ISO 14971.
Usability	Compliance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices," IEC 62366-1, and IEC 60601-1-6.	Complies: "The JETT Medical II usability has been evaluated and found to comply with..." listed FDA guidance and IEC standards.
Bench Testing (Skin Temp.)	Skin temperature during treatment should not exceed 42°C. Demonstrate temperature rise with application.	Meets Criterion: "The highest temperature of 41.3 was measured at the highest intensity with a flat applicator 20 mm. The temperature never increased above 42°C." "The results showed that the temperature rise is quite well provable... The increase was in almost all cases linear."
Clinical Effectiveness	Lower bound of 95% confidence interval of the response rate (≥ 1 point improvement on FWCS from baseline at 3-month follow-up after last treatment) in the JPM II test treatment group (RRTST) is greater than 0.75.	Met Criterion (Implied by Conclusion): The conclusion states "non-clinical and clinical tests have shown that JETT Medical II is substantially equivalent in terms of safety and effectiveness." The specific response rate is not provided, only the acceptance threshold.
Clinical Safety	Demonstrated safety for intended use.	Demonstrated (Implied by Conclusion): No adverse events or safety concerns are mentioned, and the conclusion affirms safety. The bench testing on skin temperature also supports safety.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not explicitly stated as a separate "test set" in the context of an AI/ML study.
- For the clinical study: The document states "A prospective, multi-center, non-randomized, evaluator-blinded study was provided as clinical evidence... The study population consists of subjects who have wrinkles mild to moderate in severity as specified by the Fitzpatrick wrinkle classification system (FWCS) with Fitzpatrick skin scale I-IV." The number of subjects (sample size) is not provided.
Data provenance:
- Country of origin: Not specified, but it is a "multi-center" study.
- Retrospective or prospective: Prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable/provided as the "ground truth" for this device's clinical study is "improvement of ≥ 1 point on the FWCS from baseline." This is an objective measurement or clinical assessment, not AI-driven ground truth expert labeling. The study was "evaluator-blinded," implying human evaluators, but their number and specific qualifications are not specified.

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

Not applicable/provided in the context of AI ground truth. The "evaluator-blinded" nature suggests that the assessment of wrinkle improvement was done by clinical evaluators who were unaware of treatment assignment, but no specific adjudication method for their assessments is detailed.

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 a treatment device, not an AI diagnostic/imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a hardware treatment device, not an AI algorithm.

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

The "ground truth" for the clinical study was defined by the primary effectiveness endpoint: "an improvement of ≥ 1 point on the FWCS from baseline at the 3-month follow-up after the last treatment." This is a clinical assessment/outcomes data based on the Fitzpatrick Wrinkle Classification System (FWCS).

8. The sample size for the training set:

Not applicable. This is a hardware device; there is no "training set" in the AI/ML sense.

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

Not applicable. There is no "training set" for an AI model.

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K Number

K213247

Device Name

JETT PLASMA Medical II

Manufacturer

Compex, Spol. s.r.o

Date Cleared

2023-03-14

(530 days)

Product Code

QVJ

Regulation Number

878.4400

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Intended Use

JETT PLASMA Medical II is used in the removal and destruction of skin lesions and coagulation of tissue.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is an FDA 510(k) clearance letter for the "JETT PLASMA Medical II" device. It primarily discusses:

The FDA's determination of substantial equivalence to a predicate device.
Regulatory requirements the manufacturer must follow.
The indications for use of the device: "removal and destruction of skin lesions and coagulation of tissue."

It does not include:

A table of acceptance criteria or reported device performance metrics.
Details on specific studies, sample sizes, data provenance, or ground truth establishment.
Information about expert adjudication, MRMC studies, or standalone algorithm performance.

To provide the information you've requested, I would need a different type of document, such as a clinical study report, a performance validation report, or a summary of safety and effectiveness from the 510(k) submission itself (which often contains more technical details than the clearance letter).

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