(183 days)
The entré System is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions:
- · Chronic edema
- · Lymphedema
- · Venous insufficiency
- · Wound healing
The entré model PD08-U system consists of two main components: A controller and a garment. The garment is to be wrapped around the affected extremity providing a snug yet comfortable fit. The garment will have eight (8) chambers that are filled with air by the controller to provide compression on the extremity. A harness assembly consisting of eight (8) individual tubes will connect individual chambers with the controller. The controller has an internal valve manifold with a directly connected single eight (8) port connector extension that is accessible to the user on the front panel allowing easy garment connection.
Here's a breakdown of the acceptance criteria and study information for the entré Model PD08-U, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details non-clinical performance testing. The "acceptance criteria" are implied by the statement "Pressure testing was performed to verify that the target pressures were met as stated in the device labeling" and similar wording for cycle time. The reported performance is that the device met these criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Garment Chamber Pressure | Target pressures as stated in the device labeling. | Pressure testing verified that the target pressures were met. |
| Cycle Time | Performance similar to predicate devices and as stated in device labeling. | Comparative cycle time data recorded and evaluated. Both devices (entré model PD08-U and predicate devices) performed similarly and as stated in the device labeling. |
| Electrical Safety | Compliance with IEC 60601-1:2005. | Certified to be compliant with IEC 60601-1 Ed. 3 (Medical Electrical Equipment- General require for Safety) and ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1. |
| Electromagnetic Safety | Compliance with IEC 60601-1-2:2007. | Certified to be compliant with EN 60601-1-2 (Electromagnetic Compatibility). |
| Usability | Compliance with IEC 60601-1-6. | Certified to be compliant with IEC 60601-1-6 (Usability). |
| In-Home Medical Equipment | Compliance with IEC 60601-1-11. | Certified to be compliant with IEC 60601-1-11 (In-Home Medical Equipment). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical trials or data for diagnostic performance. The testing described is non-clinical performance testing of the device's physical and electrical characteristics. Therefore, information about humans in a "test set" or data provenance (country of origin, retrospective/prospective) is not applicable to the studies reported here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is also not applicable as the studies reported are non-clinical device performance tests, not clinical evaluations requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of clinical or diagnostic performance evaluation with expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the document does not mention an MRMC comparative effectiveness study. The evaluation focused on comparing the technical characteristics of the entré Model PD08-U to predicate devices through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (compressible limb sleeve system for therapeutic compression), not a diagnostic algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance testing was the engineering specifications and design requirements for the device, as well as the performance characteristics of the legally marketed predicate devices. Compliance with international safety and performance standards (e.g., IEC 60601-1, -1-2, -1-6, -1-11) also served as a "ground truth" for safety and usability.
8. The Sample Size for the Training Set
Not applicable. The device described is a physical medical device. There is no concept of a "training set" in the way it is used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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).