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510(k) Data Aggregation
(80 days)
Primary Lymphedema (for example, congenital/ milroy's disease); Secondary Lymphedema (for example, post mastectomy, chronic edema, post- traumatic edema); Venous disorders (for example, venous insufficiency, varicose veins, venous static ulcers); Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries). The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.
The Lympha Press Plus and Optimal Compression Therapy devices utilize a software controlled air compression pump, which sequentially inflates cells within a compression garment (sleeve) that is put around the area to be treated. This helps to move excessive interstitial fluid back into the venous and lymphatic systems; improve limb circulation: and thus treat the symptoms of lymphedema, a variety of venous disorders and dysfunction of the "muscle pump". The devices consist of a main control unit and compression garments. The main control unit contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and solenoid valves. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. Additional garments include the ComfySleeve 1-75 (a jacket sleeve to treat the arm and thorax) and the LymphaPod (a pant sleeve to treat the legs and abdomen).
Here's an analysis of the provided text, focusing on the acceptance criteria and the study detailing how the device meets those criteria:
Acceptance Criteria and Device Performance for Compression Therapy Device Sleeves
Based on the provided documentation, the "Compression Therapy Device sleeves: ComfySleeve 1-75; LymphaPod" device (K100521) underwent performance testing to demonstrate substantial equivalence to predicate devices and ensure safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Garment pressure comparable to set pressure | "The garment pressure was measured and found comparable to the set pressure." |
| User comfort (ComfySleeve 1-75) | "The ComfySleeve™ 1-75 garment was found suitable for the user." |
| No bruising or irritation (ComfySleeve 1-75) | "Did not cause any bruising or irritation during or after treatment." |
2. Sample Size for Test Set and Data Provenance
The provided document does not specify numerical sample sizes for the test set regarding the garment pressure measurements, user comfort, or bruising/irritation assessments.
The data provenance is retrospective as it describes testing performed on the devices to support the 510(k) submission. The document implies the testing was conducted by or for Mego Afek Ltd. in Israel, the country of origin of the applicant.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It broadly states the garment pressure was "measured" and that the ComfySleeve was "found suitable" and "did not cause any bruising or irritation," implying internal assessments rather than independent expert adjudication.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The testing appears to be based on direct measurement and observation rather than a consensus-driven expert review of subjective criteria.
5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and basic performance, not on comparing reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical compression therapy device with no mention of an AI-driven algorithm for standalone performance evaluation in the provided text. The "software controlled air compression pump" refers to the device's operational control, not an AI diagnostic or assistance tool.
7. Type of Ground Truth Used
The ground truth used was primarily direct measurement and observation for physical performance characteristics:
- Garment Pressure: Direct measurement of pressure.
- User Comfort/Bruising/Irritation: Direct observation and potentially user feedback during testing.
8. Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device requiring a training phase.
9. How Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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