Search Results

The VMAP PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).

The provided text is a 510(k) Summary for the VMAT PRO device, seeking substantial equivalence to a predicate device (D-Actor 200 Vibration Massage System). It focuses on demonstrating that the new device is as safe and effective as the legally marketed predicate. However, this document does not describe a study involving human readers, AI assistance, or the establishment of ground truth by multiple experts for a test set.

The closest information provided is about performance testing to establish that the VMAT PRO control unit performs as intended, and a comparison of its technological characteristics with the predicate device.

Therefore, I cannot fully address all the points in your request as the information is not present in the provided document. I will fill in what can be inferred and explicitly state where information is missing.

Here's an analysis based on the provided document:

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

The document does not explicitly state "acceptance criteria" in the format of a threshold that must be met. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing various technical specifications. The acceptance criterion is implicit: the device's performance characteristics must be sufficiently similar to the predicate device, or any differences must not impact safety or efficacy.

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

This document describes technical and performance testing of the device itself (e.g., electrical safety, EMC, acoustic characteristics), not a clinical study or a study involving a "test set" of patient data for AI evaluation. Therefore, this information is not applicable to this 510(k) summary. The testing refers to the device unit's performance, not a dataset.

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. This document does not concern an AI/clinical diagnostic device requiring expert adjudicated ground truth. The "ground truth" for the device's technical specifications is established through engineering and physical measurements according to international standards (IEC).

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

Not Applicable. As no diagnostic test set is used, no adjudication method is relevant.

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. The document explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission." Therefore, no MRMC study was performed.

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

No. This is not an AI algorithm but a physical therapeutic device. The "performance testing" described refers to the device's physical and electrical characteristics as per IEC standards, not an algorithm's output.

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

For the technical characteristics comparison, the "ground truth" is derived from:

• Engineering measurements and specifications of the VMAT PRO device itself, conducted in a laboratory setting (e.g., "measured in a laboratory, using ultrasound" for applicator displacement).
• Published specifications of the predicate device (D-Actor 200) from its own 510(k) submission or technical documentation.
• Adherence to international standards such as IEC 60601-1, IEC 60601-1-2, and IEC 63045:2020 for safety, EMC, and ultrasonic characteristics.
• Biocompatibility testing according to ISO 10993-1:2018.

For the purpose of this 510(k) submission, the "ground truth" is primarily device-centric technical specifications and compliance with recognized standards, not clinical diagnostic outcomes or human expert interpretations of patient data.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not Applicable. As there is no training set.

Ask a specific question about this device

ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.

ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. It is supplied in 250 grams and 5 Kilograms containers with a 3-year shelf life.

The provided text describes a 510(k) submission for a medical device called ULTRAEKOGEL™, an ultrasound gel. The submission claims substantial equivalence to a predicate device, AQUASONIC 100.

Here's an analysis of the acceptance criteria and the study (or lack thereof) proving device performance, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of numerical performance metrics. Instead, it claims identicality across a range of technological characteristics when compared to the predicate device, AQUASONIC 100 (510k # K802146). The underlying acceptance criterion for this 510(k) submission is that the device is substantially equivalent to the predicate.

Study to prove the device meets acceptance criteria:

The study proving the device meets the acceptance criteria is generally implied to be a comparison of technological characteristics against the predicate device. The document explicitly states: "Indeed, this device is IDENTICAL to the predicate device." This is the core of their argument for substantial equivalence.

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

The document does not describe a "test set" in the traditional sense of a clinical or performance study involving a sample of patients or physical measurements. The claim of "identical" performance is based on the assertion that the technological characteristics, including performance, are the same as the predicate device. Therefore, no specific sample size for a test set is mentioned. The data provenance would be derived from the specifications and characteristics of both the proposed device (ULTRAEKOGEL™) and the predicate device (AQUASONIC 100), likely through internal testing and material analysis to confirm the stated identicality. The country of origin of this internal data is not specified, nor is whether it was retrospective or prospective.

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

As no distinct "test set" or clinical study is described, no information is provided regarding the number of experts or their qualifications used to establish a ground truth.

4. Adjudication method for the test set

Since no test set is described, no adjudication method is mentioned.

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

This device is an ultrasound gel, not an AI-powered diagnostic system. Therefore, no MRMC comparative effectiveness study was done, and the concept of human readers improving with or without AI assistance is not applicable.

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

This device is an ultrasound gel and does not involve an algorithm. Therefore, no standalone algorithm performance study was conducted.

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

For an ultrasound gel, the "ground truth" for performance would likely revolve around its physical and chemical properties that enable effective ultrasound imaging (e.g., acoustic impedance, viscosity, stability, biocompatibility). The document implies that these properties are identical to the predicate device's established characteristics. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device in this submission.

8. The sample size for the training set

This device is an ultrasound gel and does not involve machine learning or AI. Therefore, there is no training set and no sample size is applicable or mentioned.

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

As there is no training set, this question is not applicable.

Ask a specific question about this device

BAT is intended for use in external beam Radiation Therapy (RT)/Radiosurgery (RS) to locate internal anatomy that moves relative to external or bony landmarks, so as to position that anatomy correctly for the delivery of conformal radiation.

BAT can be used for the positioning of all patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.

BAT permits its user to align the isocenter crosshairs, structure contours or calculated dose (the latter 2 imported from a treatment planning system) with perpendicular ultrasound images acquired at treatment time. The BAT system then guides couch motion to achieve the desired patient alignment with the treatment beam. Additional ultrasound images can be taken to confirm proper positioning.

The provided document K981424 does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details regarding the ground truth for training or test sets.

The document primarily focuses on the device's classification, intended use, and a summary of substantial equivalence to predicate devices, as required for a 510(k) submission in 1998. It states that "Performance standards for this type of device have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." Therefore, no specific acceptance criteria or associated studies are detailed within this summary.

Ask a specific question about this device