(71 days)
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility.
Shape to Fit Compression Socks and their substantial equivalents, mentioned above, are compression socks knitted by circular knit machines with nylon and spandex. They all include knee-high which are sized based on ankle and calf circumference fit. Shape to Fit Compression Socks provide controlled, uniform graduated compression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 15 mmHg to 20 mmHg / 20 mmHg to 30 mmHg (based on average ankle size) then gradually decreases up to the proximal end.
This document describes a 510(k) submission for Shape to Fit Compression Socks. While it addresses the safety and effectiveness of the device by establishing substantial equivalence to predicate devices, it does not contain information about a study based on acceptance criteria for device performance in the way a clinical or algorithm performance study would.
The context is a regulatory submission for a medical device (compression socks), not an AI algorithm or a diagnostic tool that would typically have quantitative performance metrics like sensitivity, specificity, or AUC against a ground truth. Therefore, many of the requested items (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of submission as the demonstration of safety and effectiveness relies on different principles.
Here's an analysis of the provided information based on your request, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to existing, legally marketed predicate devices. This means the new device must be as safe and effective as the predicates, based on similar intended use, technological characteristics, and performance.
- Reported Device Performance: The document states:
- "Shape to Fit Compression Socks provide controlled, uniform graduated compression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 15 mmHg to 20 mmHg / 20 mmHg to 30 mmHg (based on average ankle size) then gradually decreases up to the proximal end."
- "The Shape to Fit products being submitted are substantially equivalent to the predicate product in material content, function and indication and as such can be considered as safe and effective as the referenced, predicate products. This statement is to assure that Shape to Fit Compression Socks is safe and effective when worn for their intended purpose and fit properly according to the guidelines."
- "See Section on Performance Testing -for nonclinical testing that demonstrates that the device is safe, effective, and performs in comparison to predicate devices." (Note: The actual "Section on Performance Testing" details are not provided in the excerpt, only its mention).
Table:
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Help prevent edema, leg discomfort, and DVT in immobilized individuals (for OTC use and circulatory wellness, preventing swelling, alleviating varicose veins). | Matches the predicate devices (K062873, K091141, K032325), as stated: "This submission covers the indication that Shape to Fit Compression Socks... help encourage circulatory wellness and prevent, ankles and feet, and alleviate swelling in legs and help prevent deep varicose veins." and "substantially equivalent to the predicate product in material content, function and indication." |
| Technological Characteristics: | "Shape to Fit Compression Socks and their substantial equivalents... are compression socks knitted by circular knit machines with nylon and spandex. They all include knee-high which are sized based on ankle and calf circumference fit. Shape to Fit Compression Socks provide controlled, uniform graduated compression... starting with more compression circumferentially at the ankle at approximately 15 mmHg to 20 mmHg / 20 mmHg to 30 mmHg (based on average ankle size) then gradually decreases up to the proximal end." This matches the description of predicate devices. "material content, function and indication" are stated to be substantially equivalent. |
| Performance: Safety and Effectiveness | Stated as "safe and effective as the referenced, predicate products" based on substantial equivalence to predicates. The document refers to "nonclinical testing" (details not provided in the excerpt) that "demonstrates that the device is safe, effective, and performs in comparison to predicate devices." |
| Risk Assessment: No new questions of safety or effectiveness. | Implied by substantial equivalence claim. No new risks are identified in the provided text. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a 510(k) submission based on substantial equivalence, not a clinical trial or a performance study with a test set of data points in the traditional sense for an AI algorithm. "Nonclinical testing" is mentioned, but no details about its methodology, sample size, or data provenance are provided in this excerpt.
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. Ground truth in the context of expert review for data labeling is not relevant for this type of device and submission. The "ground truth" here is established regulatory precedents of existing devices and their proven safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication process for data labeling is 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. This is not an AI-assisted diagnostic device, and therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (compression socks), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a 510(k) submission for a device like compression socks, the "ground truth" for demonstrating safety and effectiveness is largely based on:
- Regulatory Precedent / Predicate Device Performance: The established safety and effectiveness of legally marketed predicate devices (Supolar Netex Stockings, Therafirm anti-embolism stockings, Knit-Rite Inc. K091141, and Jobst Institute Inc. K032325).
- Nonclinical Testing (Physical Performance Data): The document mentions "nonclinical testing" that demonstrates the device performs in comparison to predicate devices, likely involving measurements of compression levels, material durability, sizing, etc., to ensure it meets established standards (though details are not provided in this excerpt).
- Material Equivalence and Functional Equivalence: The comparison of material content (nylon and spandex), knitting method (circular knit machines), and functional characteristics (graduated compression profile, sizing by ankle/calf circumference).
8. The sample size for the training set
- Not Applicable. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this 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.