(313 days)
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.
| Acceptance Criteria (Derived from Equivalence) | Reported Device Performance (Summary of Findings) |
|---|---|
| Mechanical Properties: | Mechanical Properties: |
| No significant difference in suture retention strength compared to predicate. | Demonstrated substantial equivalence in suture retention strength. |
| No significant difference in compression properties compared to predicate. | Demonstrated substantial equivalence in compression properties. |
| Material Properties: | Material Properties: |
| No significant difference in chemical analysis and degradation properties compared to predicate. | Demonstrated substantial equivalence in chemical analysis and degradation properties. |
| Biocompatibility: | Biocompatibility: |
| Biocompatible according to ISO 10993-1:2018 for implant device, tissue/bone contact, permanent duration (>30 days). | All tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Genotoxicity, Implantation (with histology), Hemolysis, Pyrogenicity, Subchronic systemic toxicity, Chronic systemic toxicity) showed the device is biocompatible. |
| In Vivo Performance (Nerve Repair & Functional Recovery): | In Vivo Performance (Nerve Repair & Functional Recovery): |
| Comparable healing responses (macroscopic assessment, clinical pathology, animal wellness) to predicate. | Comparable healing responses observed. |
| Comparable functional recovery (Sciatic Function Index) to predicate. | Comparable functional recovery demonstrated. |
| Comparable histological assessments (inflammation, nerve fiber density, axonal myelination) to predicate. | Comparable histological assessments observed. |
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.
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).