(176 days)
Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
The SunPolar Netex Medical Stockings which fall under the device classification of medical support stockings (21 CFR 880.5780). Both products are produced on circular knit machines and are made of nylon and spandex yarns. They provide similar compression at the ankle. This submission covers the indication that compression stockings in the 20-40mmHg range can help to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
The provided text is a 510(k) summary for the SunPolar Netex Medical Stockings, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, study methodology, or results as requested.
The document indicates that the SunPolar Netex Medical Stockings are substantially equivalent to a predicate product (Jobst Travel Sock K032325) based on materials, mode of action, and indications for use. The acceptance criteria for substantial equivalence in a 510(k) submission are not performance metrics of the device but rather a demonstration that the new device is as safe and effective as a legally marketed predicate device.
Therefore, I cannot populate the table or answer most of the questions as the provided document does not contain information about a study that would establish specific acceptance criteria and demonstrate the device's performance against them.
Here's why each specific point cannot be answered from the provided text:
- Table of acceptance criteria and reported device performance: Not available. The 510(k) process for this device relies on substantial equivalence to a predicate, not on a full performance study with acceptance criteria.
- Sample size, data provenance, retrospective/prospective: No study details are provided.
- Number of experts and qualifications for ground truth: Not applicable, as there's no study with a ground truth established by experts mentioned.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study, effect size: Not applicable. This type of study is more common for diagnostic imaging AI.
- Standalone performance study: Not mentioned.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable, as this is not a report on a machine learning model's development.
- How ground truth for training set was established: Not applicable.
§ 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.