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The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744). The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere. On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves. The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.

The provided text describes a 510(k) premarket notification for STS Compression Sleeves, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found for an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets is not applicable in this context. The document describes a non-clinical equivalence testing rather than a clinical study or a study validating an AI/ML algorithm.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly defined with quantitative acceptance criteria and performance statistics as would be for an AI/ML device.

The determination of substantial equivalence for this device is based on non-clinical, inflation performance testing. The acceptance criterion implicitly is that the Huntleigh STS compression sleeves demonstrate similar inflation performance (pressure/time cycle) to the predicate device.

• Pressures in each chamber are similar.
• Compresses a similar area of the patient's limb.
• Made from similar materials. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified quantitatively. The text states "The sleeves are tested by fitting to a subject's limbs," implying at least one subject, but no specific number is given.
• Data Provenance: The testing appears to be internal to Huntleigh Healthcare, Inc. The country of origin of the data is not specified, but the company is based in the USA (New Jersey). The testing is prospective for the purpose of this 510(k) submission, as it was performed to support the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. There is no "ground truth" in the sense of expert medical diagnosis or labeling for this type of device. The assessment is based on physical performance comparisons to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described for this non-clinical performance test. The comparison is objective (inflation metrics) against a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device, nor a diagnostic device that would typically involve human readers. Therefore, an MRMC study is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (compression sleeves), not an algorithm or AI/ML product.

7. The Type of Ground Truth Used

Predicate Device Performance Data. The "ground truth" (or more accurately, the comparator) for determining equivalence is the established performance characteristics (inflation pressure/time cycles) of the legally marketed predicate device, the Kendall SCD Therapeutic System (K890938).

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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