The Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) are recommended for the use in pediatric patients for whom external compression the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.

Currie Medical Specialties (CMS) ALP® pediatric compression sleeves are compression devices, which when attached to the ALP® 501 Pump System, provide intermittent pneumatic pressure to a patient's leg for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse, which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The inflation and deflation sequence is predicated by the ALP® 501 Pump System controller.

The provided document describes a 510(k) premarket notification for the "Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)." This is a medical device, and the submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through a traditional clinical study with acceptance criteria often seen in AI/ML performance evaluations. Therefore, many of the requested categories (like MRMC study, effect size, number of experts, adjudication method, sample size for training set) are not applicable in this context.

Instead, the submission focuses on bench testing to ensure that design changes (specifically smaller sizing for pediatric use) do not negatively impact the device's fundamental performance, safety, and efficacy compared to the predicate device.

Here's an attempt to structure the information based on the provided document, acknowledging the limitations given the nature of the submission:

Acceptance Criteria and Study for Currie Medical ALP Pediatric Calf Compression Sleeves

The submission for the Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device (K955853 – Healthcare Service & Supply Pump ALP 501 System). The "acceptance criteria" and "study" are therefore focused on demonstrating that the new device, primarily due to smaller sizing for pediatric use, maintains the performance and safety characteristics of the predicate device through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

This table is constructed from the bench testing details provided. The acceptance criteria are implicitly that the performance of the pediatric sleeves should not be compromised compared to the predicate device, or meet specific thresholds to ensure functionality.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes (number of sleeves or bladders tested) for each bench test. The provenance is internal bench testing conducted by Currie Medical Specialties, Inc. (non-clinical, in-house testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was bench testing against engineering specifications and predicate device performance, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. This was bench testing against engineering specifications, not a clinical study requiring adjudication.

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 a compression sleeve, not an AI/ML-driven diagnostic or assistive device. No MRMC study was performed.

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 sleeve), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this submission is based on engineering specifications and the established performance characteristics of the legally marketed predicate device (K955853). The goal was to show that the new pediatric device performs equivalently to the predicate in key functional aspects.

8. The sample size for the training set

Not applicable. This refers to a medical device's engineering and performance evaluation, not an AI/ML model's training.

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

Not applicable. See point 8.

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The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system.

The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.

Currie Medical Specialties (CMS) ALP reprocessed compression sleeves are compression devices, which when attached to the ALP 501 Pump System, provide intermittent, sequentially gradient pressure to a patients leg/foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf, thigh or foot. The inflation and deflation sequence is predicated by the ALP 501 Pump System controller.

This document is a 510(k) summary for the Currie Medical Reprocessed ALP® Calf, Thigh and Foot Compression Sleeves. It describes the device's technical characteristics, intended use, and the "Summary of Comparison Tests (Non-Clinical Tests)" conducted to demonstrate substantial equivalence to predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the specified performance characteristics that were tested.

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

• Sample Size: The document does not explicitly state the sample size (number of devices) used for each bench test. It refers to "bladders," "bladder seal," and "bladders" for the respective tests, implying multiple units were tested, but no specific number is given.
• Data Provenance: The document describes "Bench testing was conducted." This implies the tests were performed in a laboratory or controlled setting. There is no information regarding country of origin for the data or if it was retrospective/prospective, as it's not clinical data.

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

Not applicable. This document describes non-clinical bench testing for device reprocessing validation, not a study involving human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This document describes non-clinical bench testing. Adjudication methods are typically associated with human review or clinical study endpoints.

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 document describes non-clinical bench testing of a reprocessed medical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This document pertains to a physical medical device (compression sleeves), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this study is the performance of the predicate device. The reprocessed device's performance was compared against the known performance characteristics of the original, new device to demonstrate substantial equivalence. The tests also established "ground truth" for specific mechanical properties (no leaks at 3 psi, seals intact at > 5 lbs force, velcro intact at 2 psi).

8. The Sample Size for the Training Set

Not applicable. This document describes validation testing for a reprocessed medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model in this context.

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