(233 days)
- To help prevent Deep Vein Thrombosis (DVT)
The Flowtron Small Calf Garment is a wraparound Calf garment comprising of a bladder and surrounding material intended to apply cyclic compression to calf to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT). The Flowtron Small Calf Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Calf Garment in a cyclic manner. Flowtron Calf Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps
This document, K172103, is a 510(k) premarket notification for a medical device called the Flowtron DVT5 Small Calf Garment, manufactured by Getinge (Suzhou) Co., Ltd. and ArjoHuntleigh.
Based on the provided text, this K172103 document is not about an AI/ML-driven medical device. Instead, it concerns a physical medical device (a compressible limb sleeve) used to prevent Deep Vein Thrombosis (DVT). The "acceptance criteria" and "study" described in the document relate to the physical and functional performance of this device and its substantial equivalence to a predicate device, not to the performance of an AI algorithm.
Therefore, many of the requested points regarding AI/ML device evaluation criteria (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training ground truth) are not applicable to this specific document as it does not describe an AI medical device.
However, I can extract and structure the relevant "acceptance criteria" and "study" information pertinent to this physical device as described in the document.
Here's the information derived from the provided text, with emphasis on what is available and a clear indication of what is not applicable due to the nature of the device:
Device Name: Flowtron DVT5 Small Calf Garment
Regulation Name: Compressible Limb Sleeve
Regulatory Class: Class II
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of quantitative acceptance criteria with numerical performance targets. Instead, it describes various performance tests conducted to demonstrate substantial equivalence to a predicate device (K925717, DVT10(S) Limb Compression Sleeves Calf Garments). The "acceptance criteria" can be inferred as "Passed" for each test, indicating that the device met the required performance for equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance testing of garments – Pressure cyclic test with Flowtron pneumatic pumps conducted successfully | Passed |
| Durability of garment fastening evaluated successfully | Passed |
| Evaluation at environmental extremes conducted successfully | Passed |
| Evaluation of shelf life conducted successfully | Passed |
| Evaluation of shipping and distribution conducted successfully | Passed |
| Evaluation of biocompatibility conducted successfully | Passed |
Note: The core "acceptance criteria" here is that the new device (DVT5) is "identical in materials, function and indications for use" to the predicate device (DVT10(S)), with the only difference being size. The testing aims to prove that this size difference does not negatively impact performance or safety, thus maintaining substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document refers to "testing to demonstrate equivalence" but does not quantify the number of units tested.
- Data Provenance: Not explicitly stated. The manufacturer is Getinge (Suzhou) Co., Ltd. in China, but the location where the testing was conducted is not specified. The studies appear to be part of the premarket notification, implying they are new studies conducted for this submission (prospective in that sense) rather than retrospective analysis of existing data.
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)
- Not Applicable. This is a physical device, and the "ground truth" for its performance is based on engineering and materials testing, not expert interpretation of diagnostic images or data. No human experts are described as establishing "ground truth" in the way an AI/ML study would require.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication process is described for the performance tests of this physical device.
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 is not an AI/ML device, and no human reader studies or MRMC studies are described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device, and therefore, no algorithm-only performance study was conducted.
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 and physical performance specifications (e.g., pressure cycles, durability, environmental stability, biocompatibility, shelf-life, shipping resilience) compared to the predicate device. These are objective measures determined through laboratory testing, not medical consensus or patient outcomes directly.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As no training set exists for this type of device, this question is irrelevant.
§ 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).