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The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.

The sam CS 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 CS 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 provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for a medical device (sam CS Long Duration Ultrasound Device). It aims to demonstrate substantial equivalence to a predicate device (sam X1 Long Duration Ultrasound Device, K211513) to gain market clearance from the FDA.

Here's what can be extracted based on your request, highlighting the absence of specific details about acceptance criteria and a detailed study:

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

The document provides a "Substantial Equivalence Summary" (Table 1 on pages 5-6) which compares the subject device (sam CS) to the predicate device (sam X1) across various technical specifications. This table effectively serves as a comparison of performance characteristics, where "Identical" implies the sam CS meets the same reported performance as the sam X1. However, it does not explicitly state pre-defined acceptance criteria (e.g., "Device must achieve X% accuracy," or "Temperature rise must be between Y and Z degrees"). Instead, the acceptance is based on demonstrating equivalence to the predicate device.

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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 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):

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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:

1. A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, AUC).
2. Sample sizes and data provenance for test sets (relevant to AI model validation).
3. Number and qualifications of experts for ground truth establishment (critical for AI imaging diagnostics).
4. Adjudication methods for test sets (common in AI imaging studies).
5. MRMC comparative effectiveness studies (specifically for AI assistance to human readers).
6. Standalone algorithm performance.
7. Types of ground truth (e.g., pathology, outcomes data - often used in AI validation).
8. 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.

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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.

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.

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.

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