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Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)

The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.

Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)

The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.

The Reprocessed Compression Sleeves are the sleeve component of the pneumatic compression system intended to apply circumferential pressure to a patient's leg. This pressure will aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).

The Reprocessed Compression Sleeves are compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubing to individual bladders within the sleeve. The controller delivers and monitors the pressure within the bladders. Once predetermined time and pressure criteria are met, the pressure is released by venting air through a valve system.

The Reprocessed Compression Sleeves are for single-patient-use and are available in knee length (both Express and Comfort Sleeves) and thigh length (Express Sleeves only) configurations.

This document describes the reprocessing of Kendall SCD Express Compression Sleeves and Kendall SCD Comfort Compression Sleeves. The information provided heavily focuses on the equivalence of the reprocessed devices to previously reprocessed devices and the original equipment manufacturer (OEM) devices, rather than a study proving the device meets specific performance acceptance criteria for a new medical device.

Therefore, many of the specific questions about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of a diagnostic or AI device, for example, are not directly applicable to this submission. The "study" mentioned here is primarily bench-top verification and cleaning validation to demonstrate that the reprocessed sleeves maintain appropriate functional characteristics and are substantially equivalent.

Here's an attempt to answer the questions based on the provided text, acknowledging the limitations:

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

The document does not provide a table of discrete acceptance criteria with specific numerical thresholds for performance (e.g., sensitivity, specificity, accuracy) like one would expect for a diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating "appropriate functional characteristics" and "substantial equivalence" through the following:

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

The document mentions "Representative samples of the Reprocessed Compression Sleeves were tested." However, it does not specify the exact sample size used for the bench-top verification, simulated use, leak testing, system compatibility verification, or cleaning validation.

• Data Provenance: The document implies the testing was conducted by Covidien, a US-based company (Mansfield, MA). The data would be prospective in that the tests were carried out specifically for this 510(k) submission on samples.

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 question is not applicable to this submission. "Ground truth" in the context of expert consensus (like for AI or diagnostic devices) is not relevant here. The ground truth for this device lies in its physical functionality, safety (cleaning), and equivalence to the predicate, which would be assessed by engineers/technicians and regulatory review against established standards and internal specifications, not expert diagnostic interpretation.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation (e.g., by multiple readers) to resolve discrepancies and establish a robust ground truth. Here, the tests are objective bench-top measurements and validations.

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

This question is not applicable. The device is a reprocessed compression sleeve, not a diagnostic or AI-powered system that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is based on:

• Engineering specifications and standards: The performance metrics (e.g., pressure output, leak integrity, compatibility) are compared against pre-defined engineering requirements for the device type.
• Predicate device performance: The reprocessed device's performance is expected to be identical to the predicate device in functional characteristics.
• Cleaning validation standards: To ensure the device is safe and effectively reprocessed.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

This question is not applicable, as there is no training set for this type of device.

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