(174 days)
To aid in the reduction and management of peripheral edema such as lymphedema and ulceration associated with vascular insufficiency.
The Sof.Press EPC 51 System is an external pneumatic compression device that consists of a pump, an inflatable three cell sleeve, and connection tubing. Each cell of the sleeve is inflated sequentially with the highest pressure applied distally and with successively lesser pressures applied proximally.
The provided text is a Premarket Notification [510(K)] Summary for a medical device called the "Sof.Press EPC 51 System." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report with the specific information requested.
Therefore, many of the requested details cannot be extracted directly from this document. The document primarily covers regulatory information, device description, and a high-level safety summary comparing the new device to existing ones.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided text. The document includes a "Safety Summary Chart" that lists some tests (Biocompatibility, Flammability, UL Approvals, Pressure Relief Valve) and reports "pass" for the Sof.Press device. However, these are not clearly defined "acceptance criteria" with specific thresholds or metrics for performance, nor is there a detailed "reported device performance" section with quantitative results. It primarily states whether the device passed certain safety evaluations.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided text. No details about sample sizes, data provenance, or study design (retrospective/prospective) are 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):
This information is not present in the provided text. The document does not describe any studies involving experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided text. No adjudication methods are mentioned, as detailed efficacy or diagnostic studies are not described.
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:
This information is not present in the provided text. The Sof.Press EPC 51 System is a pneumatic compression device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided text. The device is a physical pneumatic compression system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present in the provided text. No specific ground truth methodology is described as the document focuses on substantial equivalence based on technological characteristics and safety.
8. The sample size for the training set:
This information is not present in the provided text. There is no mention of a "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established:
This information is not present in the provided text, as there is no training set described.
Summary of available information related to "acceptance criteria" and "study":
The document presents a "Safety Summary Chart" which can be interpreted as a limited set of safety acceptance criteria for the device itself, rather than performance criteria related to its intended use in reducing edema.
Table of "Acceptance Criteria" (Safety-focused) and Reported "Performance":
| Acceptance Criterion (Safety Aspect) | Reported Device Performance (Sof.Press EPC 51 System) |
|---|---|
| Biocompatibility: Primary skin irritation | Pass |
| Biocompatibility: Delayed contact sensitization | Pass |
| Biocompatibility: Cytotoxicity | Pass |
| Flammability | Pass |
| UL Approvals | UL 544 |
| Pressure Relief Valve | Yes (Presence of valve) |
Study/Evidence:
The "study" that proves the device meets these safety aspects is implied to be the underlying testing that resulted in the "pass" statements. However, the document does not provide details of these studies, such as methodology, sample sizes, or specific results beyond the pass/fail outcome. The entire submission is a "Premarket Notification" aiming to demonstrate substantial equivalence to predicate devices (Jobst Extremity Pump System 7500 and Huntleigh Flowpress AC300) based on similar technological characteristics and the safety data summarized in the chart. This is a regulatory filing, not a detailed clinical study report.
§ 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).