(41 days)
The Elvarex garments are equivalent to the preamendment Jobst-Custom garments which are used for the same indications.
Consequently, they can be used to treat the same indications, i.e. CVI, edema, lymphedema, phlebitis and vascular malformations. The contraindications for the two products are also the same, i.e. significant arterial insufficiency, cutaneous infections. dermatitis in the acute phase. wet dermatosis and conditions in which venous and lymphatic return is not desired.
While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the Elvarex garments are flat knit using yarns made of nylon, natural rubber latex, cotton and spandex and then sewn together. Both products use the specific measurements for a patient and calculate the final garment dimensions using the LaPlace formula. Compression is provided for both products by large elastic yarns that act circumferentially on the limb. The gradient compression present with both products helps to force fluid into the deep venous system and in the return of Ivmphatic fluid.
The provided text is a 510(k) summary for a medical device (Elvarex compression garments). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting scientific studies with specific acceptance criteria, performance metrics, and detailed study methodologies as would be found in a clinical trial report for a novel medical device.
Therefore, many of the requested categories of information cannot be extracted from this document, as they are not present.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The acceptance criteria seem to be based on demonstrating "substantial equivalence" to the predicate device in materials, mode of action, and indications for use, and a history of safe use.
- Reported Device Performance: The document states: "Elvarex has been on the market for several years in Europe and has an established track record. There have also been no reports of serious injury resulting from its use during the three year period assessed." This is a qualitative statement about safety, not a quantitative performance metric.
| Acceptance Criteria (inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate in materials, mode of action, indications. | Deemed substantially equivalent. |
| Established track record in Europe. | Has been on the market for several years with an established track record. |
| No reports of serious injury. | No reports of serious injury from its use during a three-year assessment period. |
| Safe and effective as predicate. | Proven to be as safe and effective as the predicate product. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The "three-year period assessed" refers to a retrospective review of safety reporting in Europe, not a formal study with a defined sample size for a test set.
- Data Provenance: European market data (retrospective safety reporting).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no "test set" in the sense of a diagnostic or performance test that required expert ground truth establishment as typically understood in medical device studies. The assessment was based on market history and safety reporting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no test set requiring expert adjudication.
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 is a compression garment, not an imaging or diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a compression garment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the claims of safety and effectiveness appears to be derived from the "established track record" of the device in Europe and the lack of "serious injury reports" over a three-year period. This can be considered a form of retrospective outcomes data or post-market surveillance data regarding safety.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. Not a machine learning or AI device.
§ 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.