The Alternating Leg Pressure® (ALP®) VasQcare™ System is a non-invasive system for reducing the incidence of deep vein thrombosis. The application of external intermittent pneumatic compression has six effects:

1. Increases blood flow velocity
2. Reduces the risk of deep vein thrombosis
3. Enhances blood circulation
4. Reduces pain and swelling
5. Reduces wound healing time
6. Aids in the treatment and healing of stasis dermatitis, venous stasis, arterial and diabetic leg ulcers, chronic vein insufficiency and reduction of edema in the lower limbs

The ALP® VasQcare™ System consists of a pump and a pair of single use calf sleeves. The pump provides intermittent cycles of compressed air, which alternately inflate the calf sleeves. The compression, when applied properly to the patient, increases blood velocity back to the heart and helps to prevent deep vein thrombosis.

The pump operates on timed cycles consisting of approximately 12 seconds of inflation where the calf sleeve compresses the limb followed by approximately 48 seconds of deflation where there is no pressure applied to the limb. Each limb compresses once per minute.

The ALP® VasQcare™ System may be used on patients at risk for developing deep vein thrombosis and in conjunction with medical therapy for high-risk patients.

Currie Medical Specialties (CMS) ALP® VasQcare™ System provides 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 toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf. The VasQcare™ pump controller predicates the inflation and deflation sequence.

This FDA 510(k) summary for the ALP® VasQcare™ System does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria in the manner requested.

The document states that "Bench testing was conducted to ensure that the new design did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices." It also mentions testing against standards like IEC 60601-1-1, 60601-1-6, and 60601-1-11 for electrical safety, EMC, mechanical integrity, and environmental/life cycle. However, it does not provide specific acceptance criteria or the reported device performance measurements for these tests.

The document explicitly states: "Per the requirements of 21 CFR 807, clinical data, non-clinical bench testing and the information provided within this 510(k) pre-market submission, Currie Medical Specialties, Inc., concludes that the ALP® VasQcare™ System performs in a manner that is substantially equivalent to the predicate devices listed above." This indicates clinical data was part of the submission, but its details are not included in this summary.

Given the information provided, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, expert involvement, or adjudication methods, as these details are not present in the provided text.

Here's what can be inferred and what cannot:

Information NOT available in the provided text:

• Specific Acceptance Criteria and Reported Device Performance: No explicit numerical acceptance criteria or performance metrics (e.g., specific pressure ranges, flow rates, failure rates) are mentioned. The document relies on a general statement of "no compromise" and "substantially equivalent."
• Sample sizes used for the test set and data provenance: No information on the number of devices or subjects tested, or where the data came from.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no ground truth establishment for a test set is described.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No mention of such a study or any associated effect sizes.
• Standalone (algorithm only) performance: Not applicable, as this is a medical device, not an AI algorithm in the typical sense.
• Type of ground truth used: Not applicable, as specific clinical or performance studies with defined ground truth are not detailed.
• Sample size for the training set: Not applicable, as this is not an AI/ML device in the context of a training set.
• How the ground truth for the training set was established: Not applicable.

What little can be extracted from the document related to "acceptance criteria" and "study":

1. Table of Acceptance Criteria and Reported Device Performance

Details of the "Study" (Bench Testing and Equivalence Rationale):

• Study Type: Non-clinical bench testing. The document states "clinical data" was part of the 510(k) submission, but details of any clinical study are not provided in this summary.
• Objective: To ensure the new design "did not compromise the performance or safety and efficacy of the device in a manner that is substantially equivalent to that of the predicate devices."
• Specific Tests Mentioned:
  • Electrical safety
  • EMC (Electromagnetic Compatibility)
  • Mechanical integrity
  • Environmental testing
  • Life cycle testing
  • Biocompatibility assessment (based on material equivalence)
• Standards Used: IEC 60601-1-1, 60601-1-6, and 60601-1-11.
• Accreditation: Tests were "confirmed by an accredited third-party."

In summary, this document is a 510(k) summary for FDA submission, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with specific acceptance criteria and performance metrics for a novel technology. The "study" described is primarily bench testing to ensure the new device performs similarly and safely to existing, legally marketed devices.

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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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