(34 days)
The DM Sleeve™ is intended to be used to apply pressure to the extremities and is indicated for use in the management of: Lymphedema and other edematous conditions, phlebitis, and vascular malformations.
The DM Sleeve™ consists of a cotton and nylon fabric, which is fitted to the extremity. The DM Sleeve™ applies non-gradient pressure to move interstitial fluid into venous and lymphatic channels. The DM Sleeve™ applies pressure by means of foam protrusions.
This medical device submission for the Dr. Emily Iker's DM Sleeve™ does not contain the detailed performance study information typically found in submissions for AI/ML-driven devices or those requiring rigorous clinical validation for efficacy.
The provided information indicates a lack of specific acceptance criteria based on quantitative performance metrics and, consequently, lacks a study designed to prove the device meets such criteria in terms of clinical effectiveness. The submission focuses primarily on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, and safety.
Here's an analysis based on the provided text, addressing your points as much as possible, and highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Retain size and shape after washing (Safety) | "In all instances, the DM Sleeve™ functioned as intended and the results observed were as expected." |
| No specific performance criteria related to clinical efficacy (e.g., pressure application effectiveness, reduction in lymphedema, etc.) mentioned. | No quantitative data regarding clinical efficacy is reported. |
Missing Information: There are no reported acceptance criteria related to the device's efficacy in managing lymphedema, phlebitis, or vascular malformations. The "performance data" solely addresses safety and integrity after washing.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The "safety testing to assure that the product retained its size and shape after washing" does not mention how many sleeves were tested.
- Data Provenance: Not specified. It's presumably laboratory testing of the device itself, not human clinical data.
3. Number of Experts and Qualifications to Establish Ground Truth for the Test Set
- Number of Experts: Not applicable. The "ground truth" for maintaining size/shape after washing would be an objective measurement or visual inspection by technical staff, not clinical experts.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "safety testing" described is a simple material test, not a complex clinical assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret results, often to assess the impact of AI assistance. The DM Sleeve™ is a physical compression device and does not involve human interpretation in this manner.
- Effect size of human readers with vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not applicable. The DM Sleeve™ is a physical device, not an algorithm. Its "performance" in the 510(k) refers to its physical integrity.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "safety testing," the ground truth was the objective observation of the physical state of the sleeve (size and shape retention) after washing, against an unstated expectation of desired integrity. This is a technical/material ground truth, not a clinical one.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The DM Sleeve™ is a physical medical device. It is not an AI/ML algorithm that requires a training set. The "design" of the sleeve would be based on engineering principles and existing knowledge of compression garments, not machine learning.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
Overall Conclusion:
This 510(k) submission for the DM Sleeve™ is very light on "performance data" in the clinical sense. It primarily relies on substantial equivalence to predicate devices (D.R. Medical Controlled Pressure Garments, Jobst Elvarex Compression Garments, and Jobst Ready-To-Wear Arm Sleeves). The "Performance Data" section explicitly states: "The DM Sleeve™ underwent safety testing to assure that the product retained its size and shape after washing. In all instances, the DM Sleeve™ functioned as intended and the results observed were as expected."
This type of submission indicates that the FDA considered the device's mechanism of action (applying pressure via fabric and foam protrusions) and intended use (managing lymphedema, etc.) to be sufficiently similar to already approved devices, such that extensive new clinical efficacy studies were not required for market clearance. The "proof" is largely by analogy and a simple safety check.
§ 880.5780 Medical support stocking.
(a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.