(261 days)
The intended use of a compression sleeve is to aid in blood circulation in bed confined patients, to prevent deep vein thrombosis and pulmonary embolism.
The intended use of a compression sleeve is to increase venous blood flow in bed-confined patients, to prevent deep vein thrombosis and pulmonary embolism.
Compression sleeves come in 3 adjustable sizes for the leg, one size for the knee and various sizes for the foot. They are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to squeeze the blood out of the foot or leg and deflates to allow the blood to flow back into the foot or leg. On many of the machines, air pressure can be adjusted to allow for the length and thickness of the leg.
Acceptance Criteria and Device Performance Study for Reprocessed Compression Sleeves
The provided document describes the 510(k) premarket notification for Medical Instruments Technology, Inc.'s reprocessed compression sleeves, seeking substantial equivalence to the Kendall Sequential Compression Device. The study focuses on demonstrating that the reprocessed devices maintain the same functional and technological characteristics as new devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Characteristics: | |
| - Color | Reprocessed devices were substantially equivalent to new devices. |
| - Dimensions | Reprocessed devices were substantially equivalent to new devices. |
| - Damage | Reprocessed devices were substantially equivalent to new devices. |
| Performance Characteristics: | |
| - Ability to hold pressure | Reprocessed devices were substantially equivalent to the predicate device. |
| - Ability to release pressure | Reprocessed devices were substantially equivalent to the predicate device. |
| Biocompatibility: | No biocompatibility concerns exist with sequential compression devices reprocessed using MIT's procedures. |
| Technological Characteristics: | Same technological characteristics as the Kendall SCDs. Materials used in manufacture are not changed. No part affecting function is changed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the "test set" or the number of reprocessed devices subjected to detailed evaluation. It mentions "Testing by MIT has shown that the reprocessed devices are substantially equivalent..." and "MIT compared the reprocessed compression devices to the predicate device...".
The data provenance is retrospective, as the devices are reprocessed versions of existing products. The country of origin of the data is United States, as Medical Instruments Technology, Inc. is based in Saint George, UT, and the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The evaluation seems to have been conducted by MIT's internal team.
4. Adjudication Method for the Test Set
The document does not describe any explicit adjudication method (e.g., 2+1, 3+1). The comparisons were made by MIT directly, implying an internal assessment rather than a formal expert panel adjudication process for discrepancies.
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
No, an MRMC comparative effectiveness study was not performed. This submission is for reprocessed medical devices, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. The "device" in question is a physical reprocessed medical sleeve, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for performance comparison was primarily comparison to the new, predicate device. This involved:
- Direct observation and measurement for physical characteristics (color, dimensions, damage).
- Functional testing to assess pressure holding and release capabilities, likely against manufacturer specifications or observed performance of new devices.
Essentially, the "ground truth" was defined by the characteristics and performance of the original, new devices.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here, as this is not a machine learning or AI-based device. The reprocessed devices are compared against the predicate device to demonstrate functional equivalence, not to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable, the establishment of ground truth for a training set is also not relevant to this submission.
§ 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).