FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

SSL's Medical Support Stocking is a compression stocking in the 14 -17mmHg range. It is composed of Polyamide / Elastane. A cotton feel Flight sock using air jet textured spun nylon.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical support stocking (Flight Sock), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the study performed for this specific medical device.

Acceptance Criteria and Device Performance for SSL's Medical Support Stocking (Flight Sock)

The core "acceptance criteria" in this context is demonstrating substantial equivalence to legally marketed predicate devices, primarily through comparison of physical characteristics and intended use. The study performed focuses on this comparison.

| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
| :--------------------------- | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Compression Range | Equivalent compression in the 14-17 mmHg range to predicate devices. | The device is a compression stocking in the 14-17 mmHg range. Equivalent to predicate devices (Futuro's Venes Anti Embolism Stockings, K830696, and Jobst Travel Sock, K032325). |
| Composition | Equivalent materials to predicate devices. | Composed of Polyamide / Elastane (a cotton feel Flight sock using air jet textured spun nylon). Equivalent to predicate devices. |
| Intended Use | To help prevent edema and leg discomfort and help prevent deep vein thrombosis for long distance travelers. | Same as the predicate devices. |

Study Information

Sample size used for the test set and the data provenance:
- The document implies a comparative equivalency study was performed against Futuro's Venes Anti Embolism Stockings (K830696).
- The specific number of samples (e.g., individual stockings or tests) for the equivalency testing is not specified in the provided text.
- Data Provenance: Not explicitly stated, but assumed to be internal testing by SSL Americas, Inc. (retrospective for the submission).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML study generating a diagnostic output. The "ground truth" here is the established characteristics and performance of the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication of results in the AI/ML sense. The equivalency was determined through direct comparison of physical properties (compression, composition).
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:
- No. This is not an AI/ML device, so no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the equivalency testing was the established characteristics and performance of the predicate devices (Futuro's Venes Anti Embolism Stockings and Jobst Travel Sock). This would involve physical measurements of compression and analysis of material composition.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

Regulation Number and Section

§ 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.