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Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

The Rebuilder Nerve Guidance Conduit is designed to be a permeable and bioresorbable poly(lactide-co-caprolactone) based tube. It is designed to serve as an interface between the nerve and the surrounding tissue, providing a protective environment for peripheral nerve repair after injury. The Rebuilder Nerve Guidance Conduit offers guidance and protection for axonal growth across a nerve gap. The Rebuilder Nerve Guidance Conduit is provided sterile, non-pyrogenic, for single use only, in various sizes (with product inner diameter ranging from 1.5mm to 10 mm). The Rebuilder Nerve Guidance Conduit is provided in double peel package.

This document describes the premarket notification for the "Rebuilder Nerve Guidance Conduit" (K230794). It is a medical device intended for the reconstruction of peripheral nerve discontinuities.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Neurolac Nerve Guide (K112267). The study aimed to show that the Rebuilder Nerve Guidance Conduit performs similarly to the predicate across various characteristics.

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

• Mechanical and Chemical Testing: The document does not specify the exact sample sizes for these tests. It generally states that "Non-Clinical Tests were conducted and performed on the subject device and predicate device."
• Biocompatibility Testing: The sample sizes for individual biocompatibility tests (e.g., cytotoxicity assays) are not provided in this summary.
• In Vivo Animal Testing:
  • Sample Size: Not explicitly stated as a number of animals, but refers to "a rat nerve sciatic nerve transection model." This implies a group of rats for the test article and a group for the comparator control.
  • Data Provenance: Prospective animal study conducted in a laboratory setting (rat model). Country of origin is not specified.

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

This type of information is generally not applicable to a device like a nerve guidance conduit, as the "ground truth" is established through objective performance measures (mechanical, chemical, biological, and functional outcomes) rather than expert interpretation of images or clinical reports. Therefore, no experts were used for establishing ground truth in the traditional sense of diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable, as ground truth was established through objective measurements and not subjective expert evaluation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical implant, not an AI software intended to assist human readers in diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for evaluating the device's performance was established using a combination of:

• Objective Laboratory Measurements: Suture retention strength, compression properties, chemical analysis, degradation properties, and various in vitro biocompatibility assays.
• Pathology/Histology: Histological assessments of implantation sites for inflammation, nerve fiber density, and axonal myelination in the animal study.
• Outcomes Data (Animal Functional Outcomes): Sciatic Function Index using walking tracks in the rat model.
• Macroscopic Assessments: Observation of nerve implant sites for tissue adhesions in the animal study.
• Clinical Pathology (Animal): Hematology and serum chemistry in the animal study.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a physical device.

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The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

SpinMedix Absorbable Fibrous Membrane provides a non-constricting protective layer between the injured tissue and surrounding tissues and may be secured in place using standard fixation techniques. It is designed for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. SpinMedix is composed of poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol), and is provided in a variety of sizes, ranging from 25mm * 25mm to 200mm * 300mm. It is a single use, sterilized, porous, polymeric membrane in double peel packages.

It appears you've provided a 510(k) submission document for a medical device called "SpinMedix Absorbable Fibrous Membrane." This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, not typically a study proving the device meets acceptance criteria for an AI/CADe system.

The information provided describes:

• Device Name: SpinMedix Absorbable Fibrous Membrane
• Intended Use: Management and protection of tendon injuries where there has been no substantial loss of tendon tissue.
• Composition: Poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol).
• Testing: Mechanical performance, biocompatibility (ISO 10993-1), and an in vivo animal study (calcaneal tendon incision model and inguinal hernia model).

Crucially, this document does NOT describe an AI/CADe system or a study that would require acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC). The "acceptance criteria" and "study" you are asking for, with details like sample size for test/training sets, expert ground truth establishment, MRMC studies, etc., are specific to the validation of diagnostic AI algorithms, not for a physical medical implant like an absorbable fibrous membrane.

Therefore, I cannot extract the requested information from this document because it is not relevant to the type of device and study you are asking about.

To reiterate, the provided document does NOT contain information about:

• A table of acceptance criteria and reported device performance for an AI algorithm.
• Sample sizes for test sets for an AI algorithm or data provenance.
• Number of experts or their qualifications for establishing AI ground truth.
• Adjudication methods for AI ground truth.
• MRMC studies for human readers with/without AI assistance.
• Standalone AI performance.
• Type of ground truth (expert consensus, pathology, outcomes) for AI diagnostics.
• Sample size for a training set for an AI algorithm.
• How ground truth for a training set for an AI algorithm was established.

This document focuses on showing the physical implant is substantially equivalent to existing implants based on design, materials, performance (mechanical), and biological safety (biocompatibility, animal integration/resorption).

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