(56 days)
The Lympha Press Plus device is intended for treatment of lymphatic disorders, venous disorders, post- mastectomy lymph-edema and dysfunction of the "Muscle Pump".
The Lympha Press Plus Device is a programmable sequential compression therapy device with compression garments for the treatment of lymphatic and venous disorders. The Lympha Press Plus device consists of a main console and compression garments. The main console contains an air compressor that is regulated by a mechanical air pressure regulator. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments containing up to 12 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.
Acceptance Criteria and Device Performance Study for the Lympha Press Plus Device
This document describes the acceptance criteria and the study that proves the Lympha Press Plus device meets these criteria, based on the provided FDA 510(k) summary.
Evaluation Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria, statistical analysis, and performance metrics as typically found in a clinical trial report for novel devices. Therefore, the information below is derived from the context of substantial equivalence and assumes that the "acceptance criteria" for a 510(k) submission are met by showing similar technological characteristics and intended use to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit for 510(k)) | Reported Device Performance (as per 510(k) justification) |
|---|---|---|
| Intended Use | Device is intended for specific medical conditions. | "Treatment of Lymphatic Disorders, Venous Disorders, Postmastectomy Lymphedema and Dysfunction of the 'Muscle Pump'." |
| Technological Characteristics | Mechanism of action, overall design, materials, mode of operation, and performance characteristics are similar to predicate devices. | "The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Lympha Press Plus device are substantially equivalent to the predicate devices cited above." |
| Safety and Effectiveness | Device is as safe and effective as the predicate devices for its intended use. | Demonstrated by substantial equivalence to legally marketed predicate devices (Lympha Press, Jobst Extremity Pump, Sequential Circulator). The FDA's issuance of a substantial equivalence determination signifies this. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe a specific clinical test set, corresponding sample size, or data provenance (e.g., country of origin, retrospective/prospective). 510(k) submissions for substantial equivalence often rely on comparative analysis of technical specifications, existing clinical data for predicate devices, and sometimes bench testing, rather than a new clinical trial with a "test set" in the context of AI/diagnostic algorithm validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no specific test set or clinical study described in detail, there is no information about experts used to establish ground truth. Substantial equivalence for this type of device typically relies on regulatory review of technical specifications and comparison to predicate devices, not expert consensus on a diagnostic outcome.
4. Adjudication Method for the Test Set
Given the lack of a defined test set for a clinical study, no adjudication method is described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric. The Lympha Press Plus is a therapeutic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The Lympha Press Plus is a mechanical therapeutic device, not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" implicitly refers to the established safety and effectiveness of the legally marketed predicate devices (Lympha Press, Jobst Extremity Pump, and Sequential Circulator). The Lympha Press Plus device claims substantial equivalence to these devices, meaning its
"ground truth" for regulatory approval is based on its similarity to products already proven safe and effective through their own regulatory pathways (which could have included clinical trials, post-market surveillance, or pre-amendment status).
8. The Sample Size for the Training Set
The Lympha Press Plus device is a mechanical therapeutic device, not an AI/machine learning model. Therefore, the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a "training set" does not apply to this device.
§ 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).