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Found 3 results
510(k) Data Aggregation
(92 days)
VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)
VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
VersaWrap Nerve Protector is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment, that starts to absorb after implantation. VersaWrap Nerve Protector is designed to be flexible and conformable for placement on or around a peripheral nerve
The provided FDA 510(k) Clearance Letter for the VersaWrap Nerve Protector outlines the determination of substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a defined table, or detailed information about a study proving the device meets said criteria in the format requested.
The letter focuses on confirming substantial equivalence based on material composition, mechanism of action, and target population, acknowledging a difference in application method (gel vs. sheet). It summarizes non-clinical tests, including an animal study and bench tests, but these summaries do not include quantitative acceptance criteria or detailed performance data.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria (What was measured / intended outcome) | Reported Device Performance (Summary from the document) |
|---|---|
| Safety | Demonstrated safe based on no procedure-related complications or device-related premature deaths in the animal study. |
| Efficacy (Providing an interface, permitting normal axonal survival and growth) | The animal study demonstrated the subject device can safely provide an interface between injured nerve and surrounding tissues, without device migration, permitting normal axonal survival and growth in a variety of clinically relevant nerve injury models, performing similar to the predicate device. |
| No Device Migration | Demonstrated in the animal study and included in bench studies. |
| Gel Integrity (Visual inspection, viscosity, cohesivity) | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Handling | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Coverage | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Dimensional and Weight Measurements | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Visual Inspection (General quality/characteristics) | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Conformability and Flexibility | Device is described as "flexible and conformable for placement on or around a peripheral nerve." (Not explicitly a performance measure, but a design feature validated in bench tests). |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the animal study, the document states "rats underwent various peripheral nerve injuries." The specific number of rats or nerves tested is not provided.
- Data Provenance: The animal study was "conducted," implying prospective data. The country of origin is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document mentions "neurological assessment, and macroscopic and histological evaluation" as methods for evaluating safety and efficacy, which typically involve expert interpretation, but the number or qualifications of these experts are not specified.
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Adjudication method for the test set:
- Not provided.
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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 nerve protector, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (nerve protector), not a software algorithm.
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The type of ground truth used:
- For the animal study:
- Neurological assessment: Clinical observation/evaluation.
- Macroscopic evaluation: Gross anatomical inspection.
- Histological evaluation: Microscopic tissue analysis (pathology).
- For the animal study:
-
The sample size for the training set:
- Not applicable / Not provided. For a medical device like this, the concept of a "training set" typically applies to machine learning models, which is not the case here. The development would involve engineering and material science, potentially with iterative testing, but not a formally defined "training set" in the computational sense.
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How the ground truth for the training set was established:
- Not applicable / Not provided. (See point 7).
Summary of Missing Information:
The provided text from the 510(k) clearance letter gives a high-level overview of the non-clinical testing performed (animal study and bench studies) to demonstrate substantial equivalence. However, it lacks the fine-grained details often found in a full study report, such as:
- Specific quantitative acceptance criteria with numerical targets.
- Precise sample sizes for both animal and bench tests.
- Detailed statistical analyses.
- Information about expert qualifications and ground truth establishment methods beyond the types of evaluations performed.
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(118 days)
VersaWrap Nerve Protector
VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue.
VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant.
VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve.
This document is an FDA 510(k) clearance letter for a medical device called "VersaWrap Nerve Protector." It states that the device is substantially equivalent to a legally marketed predicate device.
The provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.
This document is specifically for a physical medical device (a nerve cuff), and the content focuses on regulatory clearance based on substantial equivalence to an existing physical predicate device. It addresses aspects like:
- Device Name: VersaWrap Nerve Protector
- Regulation Number/Name: 21 CFR 882.5275, Nerve Cuff
- Product Code: JXI
- Indications for Use: "management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue."
- Predicate Device: VersaWrap Nerve Protector K201631
- Device Description: "thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant."
- Functional and Safety Testing: States "No additional functional or safety testing was required," implying that the substantial equivalence argument, based on the predicate device, was sufficient.
- Comparative Technological Characteristics: Highlights material (Calcium alginate and hyaluronic acid), intended use, physical structure (sheet), and precautions, showing they are identical to the predicate.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML device based on this input, as this document is not about an AI/ML device.
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(90 days)
VersaWrap Nerve Protector
VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant. VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve
The provided text describes non-clinical tests and an animal study for the VersaWrap Nerve Protector. Here's a breakdown of the requested information based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Purpose | Acceptance Criteria Summary | Reported Device Performance |
|---|---|---|---|
| Non-Clinical Tests | Dimensional & Visual Inspection | Direct measurement of mass, lengths, width, thickness with micrometers, calipers, pH meter or balance; and visual inspection. | Dimensional analysis was completed to verify the dimensions and visual characteristics and met specifications. |
| Pliability/Tissue Conformance and Adherence | The device is placed on a simulated model and graded for visual conformance and adherence. | Visual inspection was conducted and met specifications. | |
| Swelling | Direct measurement of the device (with micrometers, calipers) when exposed to fluid. | Dimensional analysis was completed and met specifications. | |
| Strength/Puncture | Direct measurement of the device strength/puncture when measured with a probe. | Testing was completed and met specifications. | |
| Pouch Seal Integrity/Sterile Barrier | The integrity of the pouch was verified with a visual inspection, peel tester, and burst tester. | Testing was completed and met specifications. | |
| Sterilization | The e-beam sterilization process was validated to achieve a sterility assurance level (SAL) of 10-6 per ISO 11137. | Testing was completed and met specifications. | |
| Bacterial Endotoxin Validation | The bacterial endotoxin validation testing was conducted per USP Bacterial Endotoxins and Ph.Eur. Chpt 2.6.14. | Testing was completed and met specification. | |
| Cytotoxicity | The device was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test, following ISO 10993-5 guidelines. | The test extract showed no evidence of causing cell lysis or toxicity. | |
| Sensitization | The device was evaluated for the potential to cause delayed dermal contact sensitization in a guinea pig maximization test, based on ISO 10993-10. | The test article showed no evidence of causing delayed contact sensitization. | |
| Irritation | The device was evaluated for the potential to cause irritation following intracutaneous injection, based on ISO 10993-10. | There was no evidence of significant irritation from the extracts injected intracutaneously. | |
| Acute Systemic Toxicity | The device was evaluated for acute systemic toxicity, based on ISO 10993-11. | The sesame oil test article extracts and the sodium chloride test article extracts injected met the passing requirements of the test. | |
| Pyrogenicity | The device was evaluated for material mediated pyrogenicity in the rabbit. | The total rise of temperatures during the observation period was within acceptable limits (implied by "Testing was completed and met specifications" below). | |
| Genotoxicity | The device was evaluated for mutagenic potential, mutagenic changes, and to produce cytogenetic damage. | Extract did not cause cytogenetic damage/micronuclei formation. Extracts were well within the limits defined for a negative response and the test article is considered non-mutagenic. | |
| Subchronic Toxicity | The device was surgically implanted in the subcutaneous tissue of the rat to evaluate potential systemic toxicity and local tissue response at the implantation sites. | No evidence of systemic toxicity following subcutaneous implantation. Microscopically, the test article was classified as a non-irritant. | |
| Muscle Implantation | The study assessed local tissue effects and absorption profile following implantation in muscle tissue in at multiple timepoints. | At long term timepoints the device was considered to be a non-irritant and a slight irritant at earlier weeks following implantation when compared to the control. Microscopic evaluation demonstrated the device is bioresorbing as expected. | |
| Neurotoxicity Assessment | A risk analysis was conducted to determine any neurotoxicity risk to the patient. | An analysis was conducted to determine any neurotoxicity risk to the patient (implied satisfactory outcome given overall conclusion). | |
| Animal Study | Performance/Safety | Comparable safety and performance to predicate device, no significant events, no apparent difference in character or severity of reactivity to test or predicate implant, no microscopic changes in the nerve at any interval for either test or Integra implants, similar microscopic appearance of nerve and surrounding tissue for control and VersaWrap. | VersaWrap animals and the predicate control animals demonstrated equivalent safety and equivalent performance results; there were no significant events reported in any group. Histopathological evaluations showed no apparent difference in the character or severity of the reactivity, and no microscopic changes in the nerve. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document states the "sample size was selected to be large enough to show consistent results and to be able to compare the test, control, and untreated groups" for the animal study. However, a specific numerical sample size is not explicitly provided for the animal study (e.g., "N=X rats"). For non-clinical tests, sample sizes are implied by "testing was completed" but not detailed (e.g., number of pouches for seal integrity, number of samples for cytotoxic evaluation).
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The animal study appears to be prospective as it involved conducting the study on "multiple injury types for subject device, predicate control device, and untreated groups" with data collected at "an early period, a mid-term period; and a late period." The non-clinical tests are also inherently prospective as they are performed on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not provide information on the number of experts or their qualifications used to establish ground truth for the animal study or any other test. It mentions "Histopathological evaluations were performed," which implies expert analysis, but details are lacking.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not specify any adjudication method for the test set, whether for the animal study or non-clinical tests.
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
- No, an MRMC comparative effectiveness study was not done. This device is a physical nerve protector and not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm-only performance study was not done. This device is a physical medical implant, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the animal study, the ground truth appears to be based on pathology/histopathology ("Histopathological evaluations were performed to assess local and systemic tissue effects...There were no microscopic changes in the nerve...") and physiological/observational outcomes data ("motor and sensory neurological assessments were conducted...no significant events reported").
- For non-clinical tests, the "ground truth" is typically defined by pre-defined specifications and validated test methods (e.g., ISO standards for biocompatibility, direct measurements for dimensional analysis).
8. The sample size for the training set
- This device is not an AI/ML model, so there is no concept of a "training set" as described in the context of AI.
9. How the ground truth for the training set was established
- As there is no training set for an AI/ML model, this question is not applicable.
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