(62 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from Bench Testing) |
|---|---|
| No bladder leaks at 3 psi | Bladders did not leak at 3 psi |
| Bladder seal strength > 5 lbs | Bladder seal pulled apart at > 5 lbs of force |
| Velcro adhesion maintained at 2 psi | Velcro adhesion remained intact at 2 psi |
| Consistent inflation/deflation time to 40 mm Hg | Product integrity remained the same compared to the predicate device, demonstrating consistent inflation/deflation to 40 mm Hg. |
| Biocompatibility maintained | Biocompatibility not affected due to identical materials as predicate. |
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.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).