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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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The ElastiMed's SACS device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings by stimulating blood flow in the legs. The SACS device is intended for:

• -Aid in the prevention of DVT.
• -Enhance blood circulation.
• -Diminish post-operative pain and swelling.
• -Reduce wound healing time.
• -Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, chronic lymphedema, and reduction of edema in the lower limbs.
• As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. -Reduction of edema associated with soft tissue injuries, such as burns, postoperative or postimmobilization edema or ligament sprains.

The device can be used in the home or clinical setting.

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

The SACS 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 unit. 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 the home or clinical setting.

The provided text is a 510(k) summary for the ElastiMed SACS device. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance data, sample sizes, ground truth establishment, or expert details. The "Performance Data" section only offers a high-level summary of nonclinical validation without revealing specific results or acceptance criteria.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is what can be inferred and what is missing:

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

The document does not provide a table of acceptance criteria with corresponding device performance metrics. It generally states that "nonclinical validation... verified performance attributes, pressure delivery, geometrical attributes and system durability have shown that the SACS device has performance characteristics consistent with the predefined requirements". However, it does not detail what those "predefined requirements" (acceptance criteria) are or what the specific "performance attributes" found were.

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

This information is not provided in the document. The document refers to "nonclinical validation" but does not specify sample sizes or data provenance.

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)

This information is not provided. Since the described validation is "nonclinical," it is unlikely to involve human experts establishing ground truth in the way described for medical imaging.

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

This information is not provided.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is typically for evaluating the impact of AI on human diagnostic performance, which is not applicable to a compression device like SACS based on the provided information, which focuses on physical performance characteristics.

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

The document mentions "nonclinical validation including electrical safety, EMC, software validation, environmental / shipping, life cycle (durability and shelf-life), and performance testing." This implies standalone testing of the device's physical and software performance. However, there are no specific performance metrics or acceptance criteria provided for these tests.

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

For the "nonclinical validation" mentioned, the "ground truth" would likely be based on engineering specifications, measurement standards, and physical test methods (e.g., pressure transducers for pressure delivery, calipers for geometrical attributes, endurance cyclers for durability). The document does not explicitly state the types of ground truth used but implies it relates to measurable physical and electrical properties.

8. The sample size for the training set

This information is not provided. The SACS device, as described, is a mechanical compression device with microprocessor control, not an AI/Machine Learning algorithm that typically requires a "training set" of data in the way a diagnostic software does. The "software validation" mentioned would likely pertain to functional verification and validation of the embedded software's logic and control, not to the training of a learning model.

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

Not applicable, as the device doesn't appear to use a "training set" in the context of machine learning for which ground truth would be established. The software validation would rely on established requirements and testing against those.

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