(99 days)
Neuro-Patch (like its predicate devices) is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.
The Neuro-Patch device is a microporous fabric manufactured from a highly purified polyesterurethane (PUR), a synthetic material. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.
This submission (K960470) does not contain the level of detail necessary to complete the acceptance criteria table and information requested. This is a 510(k) summary from 1996 for a medical device (Neuro-Patch), not an AI/ML algorithm. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in terms of biocompatibility, safety, and effectiveness as a dura substitute, rather than performance metrics like sensitivity, specificity, or F1-score that would be relevant for an AI system.
However, I can extract the information provided regarding the device's assessment based on the document's content.
Device Name: Neuro-Patch
Product Code: K960470
Date of Summary: January 31, 1996
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as implied by document) | Reported Device Performance (Summary of Findings) |
|---|---|---|
| Material Composition | Highly purified polyesterurethane (PUR) | Manufactured from microporous fabric of PUR. |
| Sterility | Sterile and non-pyrogenic | Supplied sterile, non-pyrogenic. |
| Physical Properties | Adequate tear resistance and handling properties, impermeability to CSF (Characteristic of dura substitutes) | Shared technological characteristics with predicates, including adequate tear resistance, handling, and impermeability to CSF. |
| Biocompatibility | Non-sensitizing, non-toxic, non-mutagenic, weak/non-reactive immunogenic potential, well-tolerated by tissues, no adverse cellular/allergic reactions, absence of giant cells | Found not to be a sensitizing agent, non-toxic, non-mutagenic, possessing a weak or virtually non-reactive immunogenic potential. Animal studies showed extreme tissue tolerance, rapid immigration of endogenous connective tissue cells, no adverse cellular/allergic reactions, and absence of giant cells. Integrated completely into connective tissue. Clinical investigation confirmed excellent biocompatibility. |
| Safety and Effectiveness | Equivalent to predicate devices as a dura substitute | Test data from extensive in vitro/in vivo preclinical testing and human clinical findings establish equivalence to predicate devices in biocompatibility, safety, and effectiveness. |
| Manufacturing Quality | Conforms to specifications, produced under GMP | Manufactured in compliance with Good Manufacturing Practice Regulations. In-process and final product testing assures conformity to specifications. |
Additional Study Information:
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Sample size used for the test set and the data provenance:
- Preclinical Studies (Animal Studies): The document mentions "Animal studies" without specifying the number of animals or the species used.
- Clinical Studies (Human): The document refers to "A clinical investigation" and "human clinical findings," but does not specify the sample size (number of patients) or the country of origin of the data. It implies retrospective data as it's a summary of findings for a submission.
- Data Provenance: Not explicitly stated, but clinical findings are mentioned, implying human data. The geographical origin is not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable to this type of device submission. Ground truth, in the context of device performance, would be established through laboratory test results (e.g., toxicity assays), pathological examination of animal tissues, and clinical observation by treating physicians. The document does not specify the number or qualifications of experts involved in analyzing these results.
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Adjudication method for the test set:
- Not applicable or described in this document. Adjudication methods are more commonly associated with expert review of complex diagnostic data for AI/ML algorithms.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic performance of readers, usually in the context of imaging.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used:
- Preclinical: Laboratory test results (sensitization, toxicity, immunogenicity, mutagenic testing), histological/pathological examination of animal tissues following implantation.
- Clinical: Clinical observations and assessments from a human clinical investigation regarding biocompatibility and handling properties.
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The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML algorithm.
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Image /page/0/Picture/1 description: The image shows the word "AESCULAP" in a bold, sans-serif font. To the left of the word is a black square containing a white circle. Inside the white circle is a symbol resembling a staff with a snake coiled around it, topped with a crown. The "R" in "AESCULAP" has a small "®" symbol next to it, indicating that it is a registered trademark.
MAY 1 0 1996
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Neuro-Patch January 31, 1996
Aesculap®, Inc. Submitted by: 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Victoria Mackinnon (415) 876-7000 x346 Phone: FAX: (415) 589-3007
Neuro-Patch Product Name: Common Name: Dura substitute
Device Description
The Neuro-Patch device is a microporous fabric manufactured from a highly purified polyesterurethane (PUR), a synthetic material. The product is supplied sterile, non-pyrogenic and packaged as single or double pieces of varying sizes.
Intended Use
Neuro-Patch (like its predicate devices) is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.
Predicate Devices
Predicate devices are available in synthetic and organic materials (see table below).
| Device | Material Composition |
|---|---|
| Dura Film (by Codman) | Silicone rubber sheet reinforced withDacron® polyester. |
| Preclude Dura Substitute(by W.L. Gore) | expanded polytetrafluoroethlene (ePTFE) |
| Tutoplast® Dura substitute(by Biodynamics, Inc.) | Human dura composed of collagenousconnective tissue. |
| Dura-Guard™ Dural RepairPatch (by Bio-Vascular, Inc.) | Glutaraldehyde cross-linked bovinepericardium. |
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Neuro-Patch, S&E Summary, page 2.
Technological Characteristics
Neuro-Patch and its predicates have similar technological characteristics. All of these devices are available as sterile, thin flexible sheets with adequate tear resistance and handling properties, impermeability to CSF, and satisfactory biocompatibility, thus fulfilling the requirements of a dura substitute.
The technological differences between Neuro-Patch and the predicate devices do not raise new types of safety or effectiveness issues. The technological differences have been assessed by valid scientific and clinical methods. Physical, laboratory, animal and human clinical test methods have been performed and have proven the ability of Neuro-Patch to function as a dura substitute.
Performance Data
Performance data and test findings relative to the biocompatibility, pyrogenicity, toxicity, sterility and clinical safety have been performed and are provided in the this document. A summary of these findings are noted below.
- Preclinical Studies and Results
The biocompatibility of Neuro-Patch has been thoroughly evaluated and addressed in numerous preclinical studies.
Through various sensitization, toxicity, immunogenicity and mutagenic testing, Neuro-Patch was found not to be a sensitizing agent under standard test procedures. The device was also found to be non-toxic. non-mutagenic and possess a weak or virtually non-reactive immunogenic potential.
Animal studies have shown the Neuro-Patch to be extremely well tolerated by tissues. The fine-fiber microstructure is characterized by intercommunicating pores with numerous openings on the surface. This facilitates rapid immigration of endogenous connective tissue cells. No adverse cellular or allergic reactions were observed. The absence of giant cells demonstrates that Neuro-Patch is not recognized as a foreign body by the host. The implant is integrated completely into connective tissue.
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Neuro-Patch, S&E Summary, page 3.
2. Clinical Studies and Results
A clinical investigation also confirmed the excellent biocompatibility and handling properties of Neuro-Patch for human use. The implants showed rapid development of connective tissue with no immunological or adverse response
Manufacturing and Final Product Quality Testing 3.
Neuro-Patch is manufactured in compliance with Good Manufacturing Practice Regulations. In process and final product analytical, physical and microbiological testing assures that Neuro-Patch conforms to specifications prior to release.
The test data from the extensive in vitro and in vivo preclinical testing, and human clinical findings presented in the submission establish that Neuro-Patch is equivalent to predicate devices in its biocompatibility and it safety and effectiveness as a dura substitute.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).