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Remplir is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Remplir™ is a sterile, implantable, biocompatible, resorbable, collagen membrane intended for use in the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Remplir™ is a single-ply sheet of porcine-derived, non-crosslinked collagen. It presents as a soft and pliable, white to off-white membrane with distinct smooth and rough surfaces.

The primary aim of surgical repair is to re-establish nerve continuity so that regenerating axons are guided into the distal nerve stump with minimal loss of nerve fibres at the repair site. Remplir™ is designed to protect the injured nerve. The device can be cut to the desired size and wrapped around the injured nerve in either its wet or dry form. It is wrapped around the site of nerve repair, intended to provide a favourable environment for nerve regeneration and prevent ingrowth of connective tissue.

Remplir™ is supplied as a single device in a double PETG/Tyvek blister pack in a labelled cardboard box. Remplir™ is available in 4 size variants for the convenience of clinicians (15 mm x 20 mm, 20 mm x 30 mm, 30 mm x 40 mm, 40 mm x 50 mm.). All size variants are identical in composition and function.

The Remplir Nerve Cuff is indicated for the management of peripheral nerve injuries where there has been no substantial loss of nerve tissue. The device is a sterile, implantable, biocompatible, resorbable, collagen membrane derived from porcine tissue.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the results of the performance testing which successfully met specifications, demonstrating substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The primary in-vivo performance study used a rat transected sciatic nerve model. While the exact number of rats (sample size) is not explicitly stated, the study measured data at 4, 12, and 24 weeks. The provenance of this data is a pre-clinical animal study, typically conducted in-house by the manufacturer or a contract research organization. The country of origin for the data is not specified in the document.

The other performance tests (Suturability, Tensile Strength, Biocompatibility, Sterilization, Endotoxin) are benchtop or laboratory tests, and their "sample size" would refer to the number of device units tested for each specific parameter. These details are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For the animal study ("Rat transected sciatic nerve model"), the "ground truth" would likely be established through histological examination and evaluation of nerve regeneration and tissue response. The document does not specify the number of experts or their qualifications for interpreting these results. Such expertise would typically involve veterinary pathologists or histologists with experience in nerve tissue assessment.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the interpretation of the animal study results. It implies that the "changes observed" and "reaction" were assessed and compared.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI-assisted diagnostic tools where the performance of human readers with and without AI assistance is evaluated. The Remplir Nerve Cuff is an implantable medical device, and its performance is assessed through bench testing and in-vivo animal studies, not through human reader interpretation. No effect size of human readers improving with AI vs. without AI assistance is applicable or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. Remplir is a physical medical device, not a software algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here.

7. The Type of Ground Truth Used

For the in-vivo animal study, the ground truth was histopathological observation and assessment of the nerve tissue and surrounding environment at different time points (4, 12, and 24 weeks) after implantation. This involves microscopic examination of stained tissue sections to evaluate nerve regeneration, inflammation, and integration of the device. The comparison against a "marketed predicate control material" served as the reference for determining acceptable performance.

For the benchtop tests (Suturability, Tensile Strength, Biocompatibility, Sterilization, Endotoxin), the ground truth is established by pre-defined specifications and validated testing methodologies (e.g., ISO standards, USP monographs) which are considered objective and measurable.

8. The Sample Size for the Training Set

The concept of a "training set" is generally applicable to machine learning algorithms or AI models. Since Remplir™ is a physical medical device and not an AI/ML product, there is no training set in the context of machine learning. The device development would involve design, material selection, and manufacturing process optimization, which are not typically referred to as "training" in this sense.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for this physical medical device, this question is not applicable.

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