(200 days)
used to prevent deep vein thrombosis (DVT) in patients deemed to be at risk by their physicians.
The AC550 Flowtron®Excel pump, coupled with the Flowtron DVT compression garments, is an external pneumatic compression system used to prevent deep vein thrombosis (DVT) in patients deemed to be at risk by their physicians.
This document is a 510(k) summary for the Flowtron®Excel AC550, which is a pneumatic compression system. It aims to demonstrate substantial equivalence to a predicate device (Flowtron®DVT AC500).
Based on the provided text, there is no study described that proves the device meets acceptance criteria related to its clinical effectiveness in preventing DVT.
Here's why and what can be extracted from the provided text:
The 510(k) summary focuses on demonstrating that the new AC550 pump is substantially equivalent to the predicate AC500 pump. The argument for this equivalence relies on:
- Same intended use, claims, clinical applications, patient population, and method of operation.
- Use with currently marketed, unchanged Flowtron DVT compression garments.
- Functional components (compressor, timing motor, valve) remaining the same.
- An updated fault monitoring system (microprocessor-controlled pressure transducer vs. pressure switch input) that provides additional information (actual pump output pressures).
- The alarm mechanism not controlling pump function but providing feedback.
The document explicitly states: "The Flowtron®Excel raises no new safety or effectiveness concerns." This statement, coupled with the detailed comparison to the predicate device, indicates that the regulatory submission is not based on a new clinical study demonstrating DVT prevention efficacy for the AC550 itself. Instead, it leverages the established safety and effectiveness of the existing technology and predicate device.
Therefore, it is not possible to complete the requested table and sections regarding clinical acceptance criteria and a study proving their fulfillment. The information provided does not pertain to such a study.
Here's how we can address each point based on the absence of such information in the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable. The document does not describe clinical acceptance criteria (e.g., a specific reduction in DVT incidence) or present a study showing the AC550's performance against such criteria. The "acceptance criteria" discussed are implicitly related to demonstrating substantial equivalence for regulatory clearance, not clinical efficacy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set or data provenance for a clinical efficacy study is mentioned.
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. No clinical ground truth establishment process or experts are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication method is mentioned.
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 medical pump, not an AI-assisted diagnostic tool for human readers. No MRMC study is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This pertains to an algorithm's performance. The device is a physical pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth is discussed for a clinical efficacy study. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate device and the new device's substantial equivalence to it in terms of function and safety.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" in the context of developing this medical device's DVT prevention capabilities. The device's design is based on established pneumatic compression principles and iteration from a predicate device.
9. How the ground truth for the training set was established
- Not applicable. As no training set is mentioned, its ground truth establishment is also not applicable.
§ 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).