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To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.

The Bivalve Nasal Splint, constructed of medical grade flouroplastic (i.e. Teflon®), is designed to provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splint is available in two sizes, standard and large, with two thicknesses (0.25mm and 0.50mm) for each size. The standard size is for routine use, while the large size can be be trimmed for individual applications. Both sizes feature a lengthwise slit facilitating placement and removal, and pre-formed suture holes for stabilizing the splint.

The Bivalve Nasal Splint is supplied sterile, two splints per packages per box.

The provided text describes a medical device, the Bivalve Nasal Splint, and its FDA 510(k) summary for market clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to proving the device meets acceptance criteria.

The document is a standard FDA 510(k) submission, focusing on:

• Description of the device: Bivalve Nasal Splint, made of medical grade fluoroplastic (Teflon®), available in two sizes and two thicknesses, with a lengthwise slit and suture holes.
• Indication for Use: To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
• Contraindications: None known.
• Predicate Device: Invotec International, Inc. nasal splints (Product Nos. 20-10650, 20-10655, 20-10660, and 20-10665).
• Testing (briefly mentioned): "Device is constructed using well-established medical grade flouroplastic." This is a general statement and not a description of performance testing against specific acceptance criteria.
• FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing the device to be marketed.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval document and not a clinical study report. Clinical study data, if any, would typically be in a separate report that might be referenced or summarized in a PMA (Premarket Approval) submission, but a 510(k) for a device like a nasal splint primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than novel clinical effectiveness studies against specific, quantitative performance criteria.

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