(43 days)
The Renfro Compression Socks are intended to help prevent pooling of blood in the legs by controlled pressure in the legs and help prevent deep vein thrombosis (DVT), edema and leg discomfort in individuals subjected to immobility
The Renfro Compression Socks are devices intended to help prevent pooling of blood and fluid to the extremities by applying controlled pressure. The Renfro compression socks are knitted using yarns made of nylon, polyester, cotton and spandex.
This is a 510(k) premarket notification for Renfro Compression Socks. This device is a Class II medical support stocking, and the submission establishes substantial equivalence to a predicate device rather than presenting a de novo performance study with acceptance criteria.
Therefore, the requested information elements related to standalone performance, MRMC studies, ground truth establishment, and test/training set details are not applicable in this context. The submission focuses on demonstrating that the new device has "similar physical and technical characteristics" to an already legally marketed device.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Predicate) | Reported Device Performance (Renfro Compression Socks) |
|---|---|---|
| Function | Prevent pooling of blood in legs | Prevent pooling of blood in legs |
| Principle of Operation | Application of controlled pressure | Application of controlled pressure |
| Anatomical Site | Foot/leg | Foot/leg |
| Prescription/over-the-counter use | Over-the-counter | Over-the-counter |
| Performance Testing (Specific Criteria) | Implied equivalence to predicate performance | "Comparative compression strength" |
Note: The submission states that "All necessary performance testing has been conducted for the Renfro Compression Socks to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended." However, it does not explicitly list quantitative acceptance criteria for compression strength or provide detailed results beyond stating that it was tested comparatively. The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate.
2. Sample size used for the test set and the data provenance
- Not Applicable: This submission is for a medical support stocking, not a diagnostic or AI-driven device requiring a "test set" in the conventional sense of clinical data. The performance section mentions "test units representative of finished devices" for comparative compression strength, but does not provide a specific sample size or provenance for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No clinical test set requiring expert ground truth was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set requiring adjudication was described.
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: No MRMC study was conducted as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not a standalone algorithm; it is a physical medical device (compression socks).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable: The evaluation is based on technical characteristics and comparative physical performance, not on diagnostic ground truth.
8. The sample size for the training set
- Not Applicable: There is no training set mentioned, as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable: No training set described.
§ 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.