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An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.

The Neoss Ti Reinforced Membrane a multi-layer non-resorbable dental membrane intended to be surgically placed beneath the muco-periosteum to aid in regenerative healing in 1) bone or 2) bone/periodontal ligament defects of the oral cavity. The Neoss Ti Reinforced Membrane is composed of two layers of PTFE membrane material enclosing a Titanium(Ti) mesh. The Neoss Ti Reinforced Membrane is a passive, non-load bearing material. The small pores of the PTFE membrane material, allows passage of fluid and vapor; as well as a controlled cellular ingrowth for stability and a barrier for soft tissue penetration. The Ti mesh is unalloyed surgical grade Titanium ISO 5832-2 Grade 2. The titanium mesh reinforcement is intended for space creating and shape-maintaining which minimizes movements and subsequent exposure while implanted. Neoss Ti Reinforced Membrane is provided pre-shaped in a variety of shapes and sizes detailed below. The device is supplied sterile and single use.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Neoss Ti Reinforced Membrane." It is a regulatory approval document and not a study report that details acceptance criteria and device performance in a clinical context.

Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from this document.

The document states:

• "Clinical Testing: Clinical data was not required to establish the substantial equivalence of the Neoss Ti Reinforced Membrane." This explicitly indicates that a clinical study, with its associated methodologies for acceptance criteria and performance measurement, was not performed or submitted as part of this specific FDA cleared.

The "Performance Testing" section mentions tests conducted according to ISO and ASTM standards (e.g., burst strength, bend testing, biocompatibility). However, these are engineering and material property tests to ensure the device meets specified quality and safety characteristics, not clinical performance acceptance criteria. The document lists the standards applied, but does not provide the specific acceptance criteria values or the reported performance values of the Neoss Ti Reinforced Membrane against those criteria. It only states that these tests were done "in order to confirm the strength, integrity and functionality of the device."

The document focuses on establishing "substantial equivalence" to predicate devices based on indications for use, technological characteristics, and material composition, rather than presenting a standalone study with defined acceptance criteria and performance results in a table.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance (as no clinical test set was described).
3. Number of experts or their qualifications (as no ground truth establishment for a clinical test set was described).
4. Adjudication method (as no clinical test set was described).
5. MRMC comparative effectiveness study (as no human reader study was described).
6. Standalone performance (as it refers to clinical performance, which was not assessed in a study described here).
7. Type of ground truth used (as no clinical ground truth was established).
8. Sample size for the training set (as this is not a machine learning device).
9. How ground truth for the training set was established (as this is not a machine learning device).

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