Search Results

Therapeutic Ultrasound is indicated for:
• Pain Relief
• Reduction of muscle spasms
• Localized increase in blood flow
• Increase range of motion of contracted joints using heat and stretch techniques

Device Description

This device is a multi-frequency ultrasound therapy equipment. The mounted applicators provide both 1 and 3 MHz operation. Depending on the area of treatment, two different types of applicators, large and small, are available. They are suitable for treatment under water.
Contact control suspends the application of ultrasound energy when acoustical contact with the treatment area becomes insufficient. The user can connect two ultrasound applicators. Activation of each applicator can be controlled from the ultrasound menu.
This device is a prescription equipment. Use by any persons other than physicians is prohibited.

AI/ML Overview

This document is a 510(k) Summary for the Sonopuls 190 medical device, which is an ultrasound therapy equipment. It aims to demonstrate substantial equivalence to a predicate device (Sonomed IV/V).

Here's a breakdown of the requested information based on the provided text, focusing on the study that proves the device meets acceptance criteria:

The context of the provided document is a 510(k) submission for a non-AI-powered therapeutic ultrasound device. Therefore, many of the requested elements specifically pertaining to AI/ML device performance and testing (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or explicitly mentioned in this type of submission. The "acceptance criteria" here primarily refer to meeting regulatory standards and demonstrating substantial equivalence to a predicate device, rather than a specific performance metric for a diagnostic AI model.

However, I will extract what is available and note where the information is not present due to the nature of the device and submission.

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

The document doesn't provide specific quantitative "acceptance criteria" for the device's therapeutic performance in a table format with corresponding "reported device performance" in the way one might expect for a diagnostic AI device (e.g., sensitivity/specificity targets). Instead, it relies on demonstrating compliance with various electrical safety, performance, biocompatibility, and software standards, and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.

The closest equivalent to "performance" for this type of device relates to its physical output parameters (e.g., intensity, frequency, temperature rise, penetration depth) and compliance with safety standards. The "acceptance criteria" are implied by adherence to the listed standards and the conclusion of substantial equivalence.

Here's a table based on the "7. Technological Characteristics" and "8. Discussion of Differences", which details the device's specifications and compares them to the predicate, and serves as an indirect form of "performance" demonstration in this context. The "acceptance criteria" are implied to be "comparable to or not raising new questions of safety/effectiveness compared to the predicate device, and compliant with relevant standards."

Characteristic / Acceptance Metric	Subject Device Performance (Sonopuls 190)	Predicate Device (Sonomed IV/V) Performance	Discussion/Substantial Equivalence Commentary (Implicit "Acceptance")
Indications for Use	Pain Relief, Reduction of muscle spasms, Localized increase in blood flow, Increase range of motion of contracted joints using heat and stretch techniques	Same as Subject Device	Similar. Formally accepted for substantial equivalence.
Product Code & Regulation	IMI, 890.5300	IMI, 890.5300	Identical. Formally accepted for substantial equivalence.
Crystal Material	PZT-8 (lead zirconate titanate) piezoceramic material	PZT	Similar. Accepted.
Technology of ultrasound generation	piezoelectric	piezoelectric	Identical. Accepted.
Power source	100 - 240 VAC +/- 10%	100 - 240 VAC	Similar. Accepted.
Output Mode	Continuous, Pulsed	Continuous, Pulsed	Identical. Accepted.
Intensity	0 - 3.0 W/cm²	0.1 - 2.0 W/cm² (cont), 0.1 - 3.0 W/cm² (pulsed)	Similar. Accepted.
Frequency	1 MHz, 3 MHz	1 MHz +/-5%, 3 MHz +/-5%	Similar. Accepted.
Acoustic Working Frequency and Accuracy (MHz)	5 cm², 0.8 cm² and 1 MHz: 0.98 MHz ± 5%; 3 MHz: 3.1 MHz ± 5%	1 MHz ± 5%, 3.3 MHz ± 5%	Similar. Accepted.
Effective Radiating Area (ERA) and Accuracy	5 cm² applicator: 5 cm² ± 20%; 0.8 cm² applicator: 0.8 cm² ± 20%	3.2cm² +/- 10%	Different. The ERA for the subject device's 5cm² applicator is larger and less accurate than the predicate's. However, it's deemed acceptable because it's identical to a cleared reference device (Omniversa) which uses the same parameters, thus raising no new safety questions.
Beam Nonuniformity Ratio (BNR) and Accuracy	6:1 maximum	2.8:1 maximum	Different. Subject device has a higher BNR. Accepted because BNR values in other cleared devices range between 2 and 6:1, and reliance on the thermal tissue testing using the reference device. No new safety/performance questions.
Maximum Value of the Output Power (Rated Output Power) and Accuracy (W)	5 cm² applicator: 10 W ± 20%; 0.8 cm² applicator: 2 W ± 20%	6.4 W ± 20%	Different. Subject device has higher maximum output power. Accepted because the reference device (Omniversa) was used safely in thermal tissue testing to support the submission, implying safety at these power levels.
Peak Temperature Rise vs. Time and Tissue Depth	1.0MHz, 2.0W: 4.8°C for 10 min, depth 2.5cm; 3.0MHz, 2.0W: 5.8°C for 3 min, depth 0.8cm	1MHz, 6.4W: 18°C for 20 min, depth 3cm; 3.3MHz, 6.4W: 19°C for 20 min, depth 1cm	Different. Subject device has less temperature rise over shorter time/shallower depth. Accepted as lower/slower temperature rise is "safer for the patient."
Maximum Patient Contact Surface Temperature of Treatment Head	5 cm² applicator: <43 deg C; 0.8 cm² applicator: <34 deg C	1MHz: 32 °C; 3.3MHz: 36 °C (continuous use 6.4W)	Different. Subject device has higher contact temperature. Accepted because the reference device was used safely in thermal tissue testing to support the submission.
Penetration Depth	1MHz: 2.5cm; 3.0MHz: 0.8cm	1MHz: 5cm; 3.3MHz: 2cm	Different. Subject device has less penetration depth. Accepted as "less penetration is safer for the user." Device performance was established via thermal tissue test study using the reference device.
Timer Range (Treatment Time)	0 - 10 minutes	0 - 20 minutes	Different. Subject device has a shorter maximum treatment time. Accepted as less exposure to energy is safer, and performance was established in thermal tissue test study using the reference device.
Compliance to Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5, IEC 62304, ISO 10993-1	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5	Similar. Subject device shows compliance with additional (more contemporary) standards, further supporting safety and performance. Satisfactory results were reported for all listed tests.

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 is for a physical medical device (ultrasound therapy equipment), not an AI/ML diagnostic device. Therefore, there isn't a "test set" in the sense of a dataset of medical images or patient data. The "testing" refers to bench testing, electrical safety testing, biocompatibility testing, and software assessment.

Sample size for test set: Not applicable in the context of a dataset for an AI model. For physical product testing, it would typically relate to the number of devices tested, which isn't specified but typically follows established engineering test protocols (e.g., testing multiple units to confirm reproducibility). The text mentions "final, finished devices" were tested.
Data provenance (country of origin, retrospective/prospective): Not applicable for this type of device testing. Testing was done on the physical device itself.

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. "Ground truth" in this context is established by engineering measurements, compliance with international standards, and verification against known physical parameters. There are no human experts classifying data for ground truth in the way there would be for a diagnostic AI model.

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

Not applicable. This is not a study involving human reader adjudication of data.

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 is a physical therapy device, not an AI-assisted diagnostic tool. No MRMC study was performed or required.

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

Not applicable. This is a physical therapy device, not an AI algorithm. Its "standalone performance" refers to its ability to meet its specifications and safety standards as tested in the lab, which was done as indicated under "9. Summary of Testing."

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

The "ground truth" for this device's performance is established through:

Compliance with international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5, IEC 62304, ISO 10993-1. These standards define acceptable safety limits, performance parameters, and testing methodologies for medical electrical equipment and specifically ultrasonic physiotherapy equipment.
Bench testing/Laboratory measurements: Demonstrated electrical safety, electromagnetic compatibility, and ultrasonic physiotherapy equipment requirements.
Biocompatibility testing: According to ISO 10993-1.
Software assessment: In accordance with FDA software validation guidelines (IEC 62304).
Thermal tissue testing: For parameters related to temperature rise and penetration depth, using a "reference device" with identical (or similar and proven safe) parameters to support the submission where direct predicate data was not available (e.g., for maximum output power, contact temperature, penetration depth, timer range). This implicitly serves as the "outcomes data" for thermal effects, demonstrating that the device operates safely within thermal limits.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

Ask a Question

Ask a specific question about this device

Page 1 of 1