(56 days)
The US-101L, US-103S are indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.
US-101L, US-103S are portable type ultrasound therapy units with built in ultrasound transducer. Ultrasound head (probe) is integral with the main body. Two sizes, US-101L (L size) for 1MHz and US-103S (S size) for 3MHz are available. In the output mode, continuous output (100%) or pulsed output (50%, 40%, 20%, 10%, 5%) are used. These units are intended to treat the affected area by applying the treatment head to skin.
The provided text describes a 510(k) summary for the US-101L and US-103S ultrasound therapy units. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria as would be expected for a novel AI/software medical device.
Therefore, much of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission process.
Here's an attempt to answer the questions based on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices based on similar features and safety functions, not on specific performance metrics or acceptance criteria for a new AI/software device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The document makes no mention of a "test set" in the context of an AI/software device's performance evaluation. The non-clinical testing mentioned refers to device verification and validation, likely evaluating hardware and software functions (e.g., output accuracy, safety) rather than diagnostic or therapeutic efficacy based on patient data.
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)
This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to the type of device and submission described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are not relevant to this type of device submission.
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 information is not provided. An MRMC study is not relevant to this traditional ultrasound therapy device. This device does not involve human readers interpreting images or an AI component assisting in diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The US-101L and US-103S are physical ultrasound therapy units, not an algorithm or AI software for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. The concept of "ground truth" for a performance evaluation is not relevant to this device.
8. The sample size for the training set
This information is not provided. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided. No training set or ground truth establishment relevant to AI/ML is mentioned.
Summary based on the provided text:
The submission for the US-101L and US-103S ultrasound therapy units is a 510(k) premarket notification. The core of the submission is to demonstrate substantial equivalence to existing predicate devices (K032793- US-100 Ultrasound Therapy Unit and K024307- Dermosonic Non-Invasive Subdermal Therapy System).
The basis for this substantial equivalence is stated as the proposed devices incorporating "similar features as the predicate devices such as the main ultrasound output specification and safety functions."
Non-clinical testing was conducted, and its results are referenced in Section 15 of the submission. This testing likely focused on:
- Compliance with recognized standards (IEC 60601-1, IEC60601-1-2, IEC60601-2-5) related to electrical safety, electromagnetic compatibility, and specific requirements for medical ultrasonic equipment.
- Verification of device specifications (e.g., ultrasound frequency, output power, pulsed modes) against stated claims and comparison to predicate devices.
- Validation of safety functions.
The document does not contain information related to acceptance criteria, performance studies, sample sizes, ground truth, expert involvement, or AI/ML-specific evaluations, which are typically required for novel AI/software medical devices.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.