(181 days)
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 13 Ibs.
The provided text describes a 510(k) summary for a medical device (WLP Solo VII, a single-pressure pump for lymphedema). However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically understood in a regulatory submission for clinical performance.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated (e.g., specific thresholds for pressure accuracy, cycle time variance, etc.) | - Factory-preset for a maximum pressure less than 101 mm Hg. |
- Pressure in appliance reaches the prescribed setting 10 or more seconds before the end of the cycle. |
Explanation: The document mentions "similar pressure ranges, degrees of accuracy, cycle times," to predicate devices, and that the "Cell pressure of prototype device was measured comparing on-board gauge reading to calibrated Hg manometer." However, it does not define specific quantitative acceptance criteria for these parameters (e.g., "pressure accuracy must be within +/- 5 mmHg"). The reported performance elements are descriptive rather than criteria-meeting statements.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable as a "test set" for clinical performance is not mentioned. The non-clinical test involves measuring "Cell pressure of prototype device" but the number of devices or measurements is not specified.
- Data Provenance: Not applicable. The non-clinical tests are presumed to be conducted internally by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. The document explicitly states "clinical test data: not applicable." No ground truth was established by experts for clinical performance.
4. Adjudication Method for the Test Set:
- Not Applicable. No clinical test set or related adjudication 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 compressed limb sleeve pump; it is not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical electromechanical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable for clinical ground truth. For the non-clinical pressure measurement, the "calibrated Hg manometer" served as the reference for accuracy, acting as the ground truth for pressure readings.
8. The sample size for the training set:
- Not Applicable. This device uses electromechanical principles and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set.
Summary of Device Evaluation in the Provided Text:
The document describes a 510(k) submission where the manufacturer is claiming substantial equivalence to predicate devices. The "study that proves the device meets the acceptance criteria" in this context is primarily focused on non-clinical performance and similarity to existing devices, rather than a clinical trial demonstrating efficacy against pre-defined acceptance criteria.
The non-clinical tests included:
- Measuring cell pressure of a prototype device comparing the on-board gauge reading to a calibrated Hg manometer (no specific acceptance criteria or results beyond "measured" are provided).
- Verifying that pressure in the appliance reached the prescribed setting 10 or more seconds before the end of the cycle (again, no specific acceptance criteria or number of tests are provided).
The submission explicitly states "clinical test data: not applicable," indicating that a clinical study with a test set, ground truth established by experts, or MRMC studies was not performed or deemed necessary for this 510(k) submission based on its classification and comparison to predicate devices.
§ 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).