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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.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical testing was not necessary to support substantial equivalence of the sam CS device." This implies that no specific "test set" of patient data was used for a clinical performance study of the sam CS device itself. The data provenance of the predecessor device (sam X1) is not provided in this document.

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)

Not applicable, as no clinical testing with a specific test set was conducted for the sam CS device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing with a specific test set was conducted for the sam CS device.

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

Not applicable. This device is an ultrasound diathermy device, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an "algorithm only" performance, often relevant for AI/software devices. While the device does have firmware, it is for control functions like timing and battery level, not for diagnostic or therapeutic algorithms that would require standalone performance evaluation in the context of an "algorithm." The device's primary function is physical energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical testing with a specific test set was conducted for the sam CS device. The "ground truth" for the device's technical specifications is established through engineering and physical measurements against recognized standards (e.g., IEC standards).

8. The sample size for the training set

Not applicable, as no machine learning / AI model was trained for the device's primary function.

9. How the ground truth for the training set was established

Not applicable, as no machine learning / AI model was trained for the device's primary function.

In summary:

This 510(k) submission for the "sam CS Long Duration Ultrasound Device" focuses on demonstrating substantial equivalence to an already cleared predicate device ("sam X1 Long Duration Ultrasound Device"). The argument is that since the sam CS device has identical technical specifications and a similar intended use (a subset of the predicate's indications), it poses no new questions of safety or effectiveness. Therefore, clinical performance data and detailed studies on acceptance criteria, test sets, or ground truth were deemed "not necessary" for this particular submission. The "acceptance criteria" here are implicitly that the device's technical characteristics and performance match those of the predicate device.

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