(90 days)
Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly.
Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly.
This document is a 510(k) clearance letter from the FDA for two devices: Clinitex Stockinette (K973417) and Clinitex Cast Padding (K973420). The letter states that these devices are substantially equivalent to devices marketed prior to May 28, 1976. This means the clearance is based on a comparison to existing, legally marketed predicate devices, and not on a study proving the device meets specific acceptance criteria as you've outlined.
Therefore, I cannot provide the requested information because:
- Acceptance Criteria and Device Performance: The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy) or report device performance against such criteria. The FDA clearance is based on substantial equivalence, implying the device performs similarly to existing products, rather than meeting a specific quantifiable performance threshold.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): No study is described in this document. The 510(k) process for devices like stockinette and cast padding often relies on demonstrating similarity to predicate devices rather than extensive clinical studies with specified performance metrics.
The document indicates:
- Device Name: Clinitex® Stockinette
- Indications For Use: "Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly."
- Regulatory Class: I
- Product Code: LGF
This type of FDA clearance is for low-risk devices where substantial equivalence to a legally marketed predicate device is sufficient, and detailed performance studies with acceptance criteria are typically not required.
§ 888.5940 Cast component.
(a)
Identification. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. 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, regarding general requirements concerning records, and § 820.198, regarding complaint files.