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510(k) Data Aggregation
(114 days)
Under supervision of a healthcare professional
· NeuroShield[TM] is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries. When hydrated, NeuroShield™ is easy to handle, soft, pliable, nonfriable, porous and transparent.
NeuroShield™ is provided as a sterile, non-pyrogenic rectangular sheet in the size of 40 x 30 x 0.03 mm and is intended for single use.
NeuroShield™ is perforated to support the transport of physiological liquid through the wall of the device thereby easing the attachment to nerve tissue. With a diameter of 0.2 mm the holes make up 0.8% of the surface area of NeuroShield™.
NeuroShield™ can easily be placed over the injured nerve, and can be sutured if necessary. Furthermore, the device can be trimmed or shaped to the appropriate size to fit the nerve tissue to be treated.
The Monarch Bioimplants GmbH NeuroShield device is a chitosan membrane intended for the repair of peripheral nerve injuries where no gap exists or where a gap can be closed by flexing the extremity.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" for the device's performance in a pass/fail format. Instead, it presents summaries of various tests and their results, consistently concluding that NeuroShield™ is "as safe as" and "performs as well as" or shows "substantial equivalence" to its legally marketed predicate devices (Cova™ORTHO-NERVE, Reaxon® Plus, and Nerbridge™).
However, based on the described results, we can infer the implied acceptance criteria for each test:
| Acceptance Criteria (Implied) | Reported Device Performance (NeuroShield™) |
|---|---|
| Biocompatibility: | |
| Cytotoxicity: Grade less than 2 (mild reactivity) | Only slight evidence of cell lysis or toxicity (grade 1). Met requirements. |
| Acute Systemic Toxicity: No mortality or systemic toxicity | No mortality or evidence of systemic toxicity. Met requirements. |
| Sensitization: No evidence of delayed dermal contact sensitization | No evidence of causing delayed dermal contact sensitization. Not considered a sensitizer. |
| Irritation/Intracutaneous Reactivity: Difference between test and control mean scores < 1.0 | Difference between each test extract overall mean score and corresponding control blank overall mean score was lower than 1.0 (0.0 and 0.3). Met requirements. |
| Systemic Toxicity (Implantation): No evidence of systemic toxicity | No evidence of systemic toxicity from the test article following subcutaneous implantation. |
| Implantation: Macroscopic reaction not significant; microscopic classification comparable to negative control (moderate irritant acceptable) | Macroscopic reaction not significant compared to negative control. Microscopically classified as a moderate irritant compared to negative control. |
| Pyrogenicity: Non-pyrogenic (meets USP 39 - NF 34) | Non-pyrogenic. Met requirements of USP 39 - NF 34. |
| Genotoxicity: Non-mutagenic | Non-mutagenic to S. typhimurium tester strains TA98, TA100, TA1535, and TA1537, and to E. coli WP2uvrA tester strain. |
| Hemolysis: Non-hemolytic | Mean hemolytic index of 0.0%. Non-hemolytic. |
| Performance Characteristics (Bench Tests): | |
| Dimensional and Odor: Within specified tolerances and comparable to predicate devices | Dimensional analysis completed to verify dimensions, color, and odor were within specified tolerances and comparable to predicate devices. |
| Feel Test: Soft, pliable, nonfriable, and stable for handling like predicate devices | As soft, pliable, and nonfriable as the predicate devices Cova™ORTHO-NERVE and Reaxon® Plus. |
| Pliability: As pliable as predicate devices to wrap around round surfaces | As pliable as its predicate devices Cova™ORTHO-NERVE and Reaxon® Plus to wrap around round surfaces. |
| Swelling and Water Uptake: Fully hydrated within 10 minutes, similar to predicate devices | Needs only 10 minutes in contact with aqueous solution to be fully hydrated, similarly to its predicate devices. |
| Suture Retention Strength: Sufficient strength to resist suture pull-out under anticipated loads | Sufficient strength to resist suture pull-out under loads exceeding those anticipated in the intended use environment. |
| In vivo Performance Testing: | |
| Functional recovery equivalent to predicate device | Allowed neuromuscular functional recovery equivalent to Reaxon® Plus. |
| Nerve regeneration (axons, glial cells, myelinated fibers, axon/fiber diameter, myelin thickness, g-ratio) similar to predicate device | Few axons, together with glial cells, present after two weeks. At 6 and 12 weeks, conduits colonized by regenerating fibers and Schwann cells. Morphoquantitative stereological analysis showed no statistical differences between the two experimental groups (NeuroShield and Reaxon® Plus). |
| Tissue reaction (giant cells, macrophages, polymorphonuclear cells, lymphocytes, plasma cells, neovascularization, fibrosis) similar | Similar tissue response observed for both devices. No statistical differences found for ED1-immunopositive macrophages at 6 and 12 weeks, confirming steady-state conditions. No signs of fibrosis or scar tissue formed around degrading material. |
| Degradation: Material degradation without adverse effects; fragments within regenerating tissue/surrounding connective tissue acceptable | Beginning fragmentation observed at 12 weeks. Fragments detected within regenerating tissue and surrounding connective tissue. Thickness decreased significantly, consistent with in vitro mass loss. Regenerated fibers and blood vessels occurred according to time and progress. |
2. Sample Size Used for the Test Set and Data Provenance
- Cytotoxicity: Triplicate sub-confluent monolayers of L-929 mouse fibroblast cells, with separate triplicate negative and positive controls.
- Acute Systemic Toxicity: One group of five mice for the test article extract, and a separate group of five mice for the control blank (extraction vehicle).
- Sensitization: Ten test guinea pigs per extract (for 0.9% sodium chloride and sesame oil extracts), and five control blank guinea pigs per vehicle.
- Irritation/Intracutaneous Reactivity: Three rabbits, with five separate injection sites on the right side of the back of each rabbit for the test article extract, and five injection sites for the control blank on the left side.
- Systemic Toxicity (Implantation): Twelve male and 12 female rats, randomly assigned to either the test or negative control group (6 rats of each sex per group).
- Implantation: Unspecified number of rabbits.
- Pyrogenicity: 3 rabbits.
- Genotoxicity: Triplicate plates for each of the five tester strains (Salmonella typhimurium TA98, TA1535, TA1537; Escherichia coli WP2uvrA) at a single test dose, plus control blank and positive controls.
- Hemolysis: Triplicate tubes for the test article extract, plus control blanks, negative control, and positive controls.
- Bench Tests (Dimensional, Feel, Pliability, Swelling, Suture Retention): The sample sizes are not explicitly stated for these physical tests. They involve direct measurements of NeuroShield™ samples and comparisons to predicate devices.
- In vivo Performance Testing: 17 adult female Wistar rats, weighing approximately 200 g. The animals were divided into 6 experimental groups:
- 2 weeks: Reaxon® Plus (n=3), Neuroshield (n=4)
- 6 weeks: Reaxon® Plus (n=3), Neuroshield (n=3)
- 12 weeks: Reaxon® Plus (n=4), Neuroshield (n=4)
Data Provenance:
The studies appear to be primarily pre-clinical studies conducted in a laboratory setting (in vitro and in vivo animal models). The provenance for animal studies is specifically stated as "guinea pigs," "mice," "rabbits," and "Wistar rats." Human blood was used for the hemolysis test. The document does not specify the country of origin for these studies, but Monarch Bioimplants GmbH is located in Switzerland. The studies are prospective as they were designed specifically to test the NeuroShield device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not detail the number or qualifications of experts establishing ground truth for the test sets. For the animal studies, the "ground truth" is established by the observed biological responses and histological analysis in comparison to a predicate device. This implies expertise in veterinary medicine, pathology, and neurobiology for interpretation. For the in vitro tests, the ground truth is based on standardized laboratory protocols and measurements.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth, as is common in clinical imaging studies. The evaluations for biocompatibility tests follow established ISO and USP standards where results are typically objective measurements or qualitative observations that are then interpreted against predefined criteria. For the in vivo animal study, "Morphoquantitative stereological analysis" and "Immunohistochemical and electron microscopical analyses" were carried out, suggesting quantitative and qualitative assessments by researchers, but not a multi-reader adjudication process in the clinical sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a bioimplant (nerve cuff), not an AI-assisted diagnostic or imaging device for human interpretation. Therefore, the concept of "human readers improving with AI assistance" does not apply to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. NeuroShield™ is a physical medical device, not a software algorithm. Its performance is evaluated through biological and mechanical testing, not as a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth for the tests conducted includes:
- Standardized Laboratory Measurements and Observations: For most in vitro biocompatibility tests (cytotoxicity, acute systemic toxicity, sensitization, irritation, pyrogenicity, genotoxicity, hemolysis) and bench tests (dimensional, feel, pliability, swelling, suture retention strength). These are objective measurements and qualitative assessments against established biological and mechanical benchmarks.
- Histopathology and Morphological Analysis: For the implantation study and the in vivo performance testing. This involves microscopic examination of tissue samples to assess local tissue response, nerve regeneration (number of myelinated fibers, axon and fiber diameter, myelin thickness, g-ratio), presence of various cell types (macrophages, giant cells), and the extent and nature of device degradation.
- Behavioral Analysis (Functional Outcomes): For the in vivo performance testing, the "grasping test" was used to evaluate functional recovery, providing an objective behavioral measure.
- Comparison to Predicate Devices: A significant aspect of establishing "ground truth" and demonstrating performance for regulatory purposes is the comparison of NeuroShield™'s results to those of legally marketed predicate devices, asserting substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. NeuroShield™ is a physical medical device, not a machine learning model. There is no "training set" in the context of this biological and mechanical device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
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