Search Results

The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.

The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use. The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.

The provided context does not offer information about the acceptance criteria or a study proving that the device meets specific acceptance criteria in the typical format of a clinical or performance study with metrics like sensitivity, specificity, or AUC.

The document is a 510(k) summary for a medical device (MyoLight Microcurrent Handpiece) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.

However, based on the non-clinical testing section, we can infer some "acceptance criteria" through compliance with recognized standards.

Here's the breakdown of the information that can be extracted, and where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and similarity to predicate devices. The "reported device performance" is essentially the device's conformance to these standards and its specifications aligning with the predicate devices.

2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set in terms of patient samples. The testing described is non-clinical (bench testing, software V&V, and compliance with electrical safety and EMC standards). Therefore, there is no information on sample size or data provenance in the context of a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set using expert-established ground truth is described.

4. Adjudication method for the test set
Not applicable, as no clinical test set with adjudication 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. The device is a microcurrent handpiece, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is not an algorithm for diagnostic or prognostic purposes. It is a physical device delivering electrical stimulation, with software controls for operation.

7. The type of ground truth used
For non-clinical testing:

• Electrical Safety, EMC, and Nerve/Muscle Stimulator Standards: Compliance is based on objective measurements against defined limits in the respective IEC standards.
• Biocompatibility: Likely based on laboratory assays and tests according to ISO 10993 standards.
• Software Validation & Verification: Based on predefined software requirements specification and test protocols.
• Bench Testing: Based on objective measurements of physical and electrical parameters against design specifications.

8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device. The "training set" concept doesn't apply.

9. How the ground truth for the training set was established
Not applicable.

Ask a specific question about this device

The intended use of the MyoLIGHT system is to perform Nuclear imaging procedures for detection and imaging of single photon radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

The MyoLIGHT system is a dedicated Gamma Camera for nuclear cardiology, highperformance dual-head nuclear medicine imaging system. It is based on the following legally marketed device: CARDIOSPECT D90 - K021823. Modifications include reduced gantry size, adapted patient table, detectors moving in an enclosed space on a fixed radius and set at 90 degrees, integrated patient table, integrated acquisition station and operator console, and built-in cardiac gating circuitry.

This document is a 510(k) summary for the GE Medical Systems F.I. Haifa MyoLIGHT device, a dedicated Gamma Camera for nuclear cardiology.

1. Acceptance Criteria and Reported Device Performance:

The document states that the MyoLIGHT device is a modification of a legally marketed predicate device, CARDIOSPECT D90 (K021823). The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device in terms of safety and effectiveness.

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

The document mentions "Bench and images data" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

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

The document does not specify an adjudication method.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable as this is not an AI-assisted device in the context of the provided document. The study focuses on demonstrating equivalence of the MyoLIGHT system to a predicate device.

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

A standalone performance evaluation (algorithm only) was not explicitly detailed as such. The "Bench and images data" likely refers to technical performance assessment of the system, not an algorithm's performance independent of human interaction for interpretation.

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

The document does not specify the type of ground truth used. The statement "Bench and images data show that the MyoLIGHT images are similar to the CARDIOSPECT D90 (K021823) images" suggests a comparison against the imaging characteristics or output of the predicate device, rather than a clinical ground truth like pathology.

8. The sample size for the training set:

There is no mention of a training set as this device is not described as involving a learning algorithm. The study focuses on comparing a modified device to a predicate.

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

Not applicable, as there is no training set mentioned.

Ask a specific question about this device