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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 muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Device Description

The sam 2.0 Long Duration Ultrasound Device consists of:

Rechargeable Power Controller and Timer
Ultrasound Generating Applicators
Applicator Adaptor Cables
Single use disposable accessories
Ultrasonic Coupling Patch
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 onetime use Ultrasonic 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 system is intended for prescription home use to apply ultrasonic energy for a long duration (4 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ZetrOZ Systems sam 2.0 Long Duration Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (ZetrOZ Ultrasonic Diathermy Device, K130978) rather than detailing specific, quantified acceptance criteria for novel performance claims. The "comparison" column in the table implicitly indicates where performance is identical or similar to the predicate. Therefore, the acceptance criteria are effectively defined by matching or being similar to the predicate device's established performance specifications.

Characteristic / Acceptance Criteria (as per predicate)	sam 2.0 Long Duration Ultrasound Device Performance (Subject)	Comparison to Predicate
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
Indications: Relief of pain, muscle spasms, joint contractures, increase in circulation	The same, with removal of "healthcare practitioner requirement" for home use	Similar (change in use environment)
Manufacturer: ZetrOZ	ZetrOZ	Identical
Console/Generator Dimensions (L x W x H cm): 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 (L x W x H cm): 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 (kg): 0.01 kg	0.01 kg	Identical
Treatment Head Weight (kg): 0.10 kg	0.10 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 (cm): 5 cm	5 cm	Identical
Acoustic Working Frequency and Accuracy (MHz): 3MHz ± 20%	3MHz ± 20%	Identical
Effective Radiating Area and Accuracy (cm2): One: 6 cm2, Two: 12 cm2 ± 20%	One: 6 cm2, Two: 12 cm2 ± 20%	Identical
Beam Nonuniformity Ratio and Accuracy: BNR:

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