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The ElastiMed's SACS PRO device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings and by so doing, aids in the stimulation of blood flow in the legs.

The SACS PRO device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device can be used in Clinics, hospital, athlete training, and home environments.

The ElastiMed SACS PRO is a lightweight, portable battery powered device, aiding in the stimulation of blood flow in the lower limb through sequential compression.

The SACS PRO device imbeds three Electro Active Polymer (EAP) straps, that sequentially stretch and contract when stimulated by an electric charge. The timely sequential upward contractions of the straps compress the limb, allowing for the repetitive squeezing and relieving actions that mimic normal muscle contractions. The device is supplied with a rechargeable battery which is incased in the fabric casing, and a microprocessor which is imbedded within the control box, located at the front of the one touch operation control box also imbeds a buzzer, LED light indicator, micro speaker, and a micro-USB port (for charging). The device can be used in Clinics, hospital, athlete training, and home environments.

The provided text is a 510(k) Premarket Notification for the SACS PRO device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving the device meets those criteria for software or algorithm performance. The "Performance Data" section addresses non-clinical validation of physical and electrical safety, software validation, and durability, but does not include a study design or results demonstrating the stated indications for use (e.g., temporary relief of minor muscle aches, temporary increase in circulation).

Therefore, I cannot extract specific information regarding acceptance criteria, test set sample sizes, expert ground truth establishment, or human reader effectiveness from this document as it is not a study report for the device's therapeutic efficacy or an AI/ML algorithm's diagnostic performance.

However, I can extract information related to the software validation process described in the document, which implicitly means the software met its specified requirements.

Here's a breakdown of what can be extracted and what cannot:

Information Present in the Document:

• Software Validation: "Software validation was conducted per FDA's Content of Premarket Submissions for Device Software Functions (June 14, 2023) and ANSI AAMI IEC 62304:2006/A1:2016 [Including Amendment 1 (2016)]."
• Device Performance Attributes (General Statement): "...have shown that the SACS PRO device has performance characteristics consistent with the predefined requirements for the devices' intended and indications for use."
• Data Provenance (Implied): The non-clinical testing was conducted for the secondary predicate device (ElastiMed SACS, K232300), which is "entirely identical in design and physical form" to the subject device (SACS PRO). The document states, "all performance data as provided for the approval of the secondary predicate device are applicable for the subject device." This suggests the data is from prior validation, likely retrospective in relation to this 510(k) submission for the SACS PRO. The country of origin of the data is not specified, but the applicant (ElastiMed Ltd.) is based in Israel.
• Sample Size for Training Set: Not applicable/not provided. This device is not described as having a machine learning component that would require a "training set" in the typical sense of AI/ML. The "software validation" refers to traditional software engineering validation, not AI model training.
• How Ground Truth for Training Set was Established: Not applicable/not provided for the same reason as above.
• Type of Ground Truth Used: Not applicable/not provided related to human physiology or clinical outcomes. The "ground truth" for the software validation would be its adherence to specified functional and safety requirements, tested against the design specifications.

Information NOT Present in the Document:

• A table of specific "acceptance criteria" and "reported device performance" for its therapeutic indications. The table provided is for "Testing" (types of tests conducted), not performance metrics for muscle ache relief or circulation increase.
• Specific "sample sizes" for a clinical or performance test set related to the device's therapeutic efficacy. The non-clinical tests mentioned (electrical safety, EMC, mechanical, functional, durability) would have their own sample sizes (e.g., number of devices tested), but these are not detailed in this summary.
• "Number of experts used to establish the ground truth" or their qualifications. This would be relevant for devices that rely on expert interpretation (e.g., imaging devices), which this is not.
• Adjudication method for a test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or human readers improved with AI assistance. This is not an AI-assisted diagnostic or therapeutic device.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., pathology, outcomes data) for clinical efficacy.

Given the nature of the device (Powered Inflatable Tube Massager) and the document provided, the "acceptance criteria" and "study" are focused on safety and functional performance as a medical device, rather than the performance of an AI/ML algorithm or a comparative clinical efficacy study.

Here's the closest one can get to answering your request based only on the provided text, focusing on the software validation aspect.

Device: SACS PRO (Powered Inflatable Tube Massager)

Study Details (as inferable from the document):

1. Sample Size used for the test set and the data provenance:
   • Test Set Sample Size: Not explicitly stated for specific tests (e.g., number of units for electrical safety, durability, mechanical).
   • Data Provenance: The data is retrospective relative to this specific 510(k) submission for the SACS PRO, as it was conducted for the "identical secondary predicate device" (ElastiMed SACS, K232300). The country of origin of the data is not specified, but the manufacturer is based in Israel.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of device and the validation described do not typically involve human experts establishing "ground truth" for performance. Ground truth for safety and performance testing would refer to engineering specifications and regulatory standards.
3. Adjudication method: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an imaging device or an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "software validation" performed is essentially a standalone (algorithm/software only) validation against its requirements and relevant standards.
6. The type of ground truth used: For software and non-clinical performance, the ground truth is defined by:
   • Compliance with specific engineering design specifications of the device.
   • Compliance with international and national standards (e.g., IEC 60601-1-2, ES60601-1, IEC 62304) and FDA guidance documents.
   • Predefined pass/fail criteria based on the device's functions, indications, and essential performance.
7. The sample size for the training set: Not applicable. This device's software is validated through traditional software engineering methods, not by training a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

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