(267 days)
The sam 2.0 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 pain, the relief of muscle spasms, the treatment of joint contractures, the local increase in circulation, and the relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy).
The sam 2.0 Long Duration Ultrasound Device consists of ultrasound: Power Controller, Cables, Applicators, Coupling Patches. The sam 2.0 Long Duration Ultrasound Device contains firmware for logging usage time. There is no control function of this firmware. The Power Controller and cables can be used to power one or two Applicators simultaneously 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 a onetime use Coupling Patches. The system is intended to apply ultrasonic energy for a long duration (4 hours) to generate deep heat within body tissues. The system is intended for prescription home use after proper instruction from a healthcare professional.
This document is a 510(k) Premarket Notification from ZetrOZ Systems, LLC for their sam 2.0 Long Duration Ultrasound Device. It seeks to demonstrate substantial equivalence to a previously cleared predicate device, K191568. The key aspect of this submission is an expansion of indications for use for an identical device design.
The document states that the substantial equivalence is supported by clinical performance testing which involved a systematic literature review and meta-analysis rather than a new clinical study. This means there is no traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one would analyze a new AI medical device's performance.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria in the way one would for a new AI or diagnostic device (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device and by providing clinical evidence from published literature supporting the expanded indications.
The 'performance' is described qualitatively as "efficacy of SAM therapy to generate deep heat within body tissues for the treatment of 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." For the expanded indications, it is stated: "the relief of pain associated with limited mobility and function related to the soft tissue injuries that have been clinically validated include knee osteoarthritis, shoulder, elbow and ankle tendinopathy, and chronic myofascial pain."
Given that this is a K-submission for an ultrasound device with expanded indications and not a novel AI/diagnostic device, the table structure won't fit perfectly with typical AI acceptance criteria. The most relevant 'performance' is the equivalency of the device's technical specifications and the clinical efficacy of ultrasound therapy as demonstrated by the literature review.
Table of Device Comparison (as presented in the document to demonstrate equivalence):
| Feature/Parameter | Subject Device: sam 2.0 Long Duration Ultrasound Device | Predicate Device: sam 2.0 Long Duration Ultrasound Device (K191568) | Comparison (Acceptance Criteria implicitly met by "Identical" or "Similar") |
|---|---|---|---|
| Classification Name | Ultrasonic Diathermy Device | Ultrasonic Diathermy Device | Identical |
| Service Type | Physical Medicine | Physical Medicine | Identical |
| Classification | 21 CFR 890.5300 | 21 CFR 890.5300 | Identical |
| Class | II | II | Identical |
| Product Code | PFW | PFW | Identical |
| Indications For Use | Extended (see document for full text) | Original (see document for full text) | Similar (expanded indications supported by clinical evidence) |
| Manufacturer | ZetrOZ | ZetrOZ | Identical |
| Console/Generator Dimensions | 6.10 cm L x 7.09 cm H x 1.88cm W | 6.10 cm L x 7.09 cm H x 1.88cm W | Identical |
| Treatment Head Dimensions | 3.81 cm L x 3.30 cm W x 1.14 cm H | 3.81 cm L x 3.30 cm W x 1.14 cm H | Identical |
| Console/Generator Weight | 0.10 kg | 0.10 kg | Identical |
| Treatment Head Weight | 0.01 kg | 0.01 kg | Identical |
| Power Supply | 120/240 VAC with 5V DC Input Power Jack and Lithium Battery Powered | 120/240 VAC with 5V DC Input Power Jack and Lithium Battery Powered | Identical |
| Leakage Current | 0.3 mA | 0.3 mA | Identical |
| Crystal Material | Lead Zirconate-Titanate | Lead Zirconate-Titanate | Identical |
| Technology of ultrasound generation | Piezoelectric | Piezoelectric | Identical |
| Treatment Mode(s) | Two discrete settings of power at same Frequency | Two discrete settings of power at same Frequency | Identical |
| Beam Type | Divergent | Divergent | Identical |
| Transducer Diameter | 5 cm | 5 cm | Identical |
| Acoustic Working Frequency and Accuracy | 3MHz ± 20% | 3MHz ± 20% | Identical |
| Effective Radiating Area | One: 6 cm² ± 20% (Two: 10 cm²) | One: 6 cm² ± 20% (Two: 10 cm²) | Identical |
| Beam Nonuniformity Ratio and Accuracy | BNR: |
§ 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.