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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.

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Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast. This protective pad protects the skin, ensures that bony prominences are adequately padded to prevent undesired pressure and/or chafing from the cast and compensates for normal amounts of swelling to the affected area immediately after the injury. The polyester fibers help repel water and dry rapidly.

Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast.

The provided text is a 510(k) premarket notification letter from the FDA to Clinitex Medical Corporation regarding their Clinitex Stockinette and Clinitex Cast Padding devices.

This type of document is an approval letter for marketing medical devices based on the concept of "substantial equivalence" to devices already on the market prior to May 28, 1976. It does not contain information about:

• Acceptance criteria the device had to meet.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth was established for training sets.

The letter simply states that the FDA has reviewed the submission and found the devices to be substantially equivalent to predicates, thereby allowing them to be marketed, subject to general controls provisions of the Act.

Therefore, I cannot provide the requested information based on the given input. The requested details are typically found in clinical study reports or performance validation sections of a 510(k) submission, not in the FDA's clearance letter itself.

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Ask a specific question about this device