(96 days)
The sam X I Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation
The sam X1 Long Duration Ultrasound Device consists of:
- Rechargeable Power Controller and Timer
- Ultrasound Generating Applicators
- Single use disposable accessories
- Ultrasonic Coupling Patch
The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
The sam X1 Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.
The system is intended for prescription home use to apply ultrasonic energy for a long duration (1 hours) to generate deep heat within body tissues and treat selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
This document is a 510(k) Premarket Notification from ZetrOZ Systems, LLC for their sam X1 Long Duration Ultrasound Device. It seeks to demonstrate substantial equivalence to a predicate device (sam 2.0 Long Duration Ultrasound System, K191568).
The document does not describe an AI/ML-based device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details a physical medical device (an ultrasonic diathermy device) used for therapeutic purposes (deep heat generation for pain relief, muscle spasms, joint contractures, and circulation increase).
Therefore, I cannot provide the information requested in the prompt, as the prompt's questions pertain to acceptance criteria and studies for AI/ML diagnostic devices, such as those that might involve:
- A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, AUC).
- Sample sizes and data provenance for test sets (relevant to AI model validation).
- Number and qualifications of experts for ground truth establishment (critical for AI imaging diagnostics).
- Adjudication methods for test sets (common in AI imaging studies).
- MRMC comparative effectiveness studies (specifically for AI assistance to human readers).
- Standalone algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data - often used in AI validation).
- Training set sample size and ground truth establishment (fundamental to AI development).
The provided text focuses on the physical and functional equivalence of the sam X1 device to its predecessor, particularly noting a smaller battery and a maximum 1-hour treatment duration compared to the predicate's 4 hours. The testing mentioned (power output, treatment time, battery conformance, electrical safety, usability, software, cybersecurity) are standard for medical device hardware and firmware safety and performance, not for AI model validation.
In summary, as the provided document is for a non-AI medical device, the requested information regarding AI acceptance criteria and study design is not applicable and cannot be extracted from the text.
§ 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.