Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.

Device Description

Collagen Nerve Wrap is a resorbable collagen matrix that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Collagen Nerve Wrap is designed to be an interface between the newe and the surrounding tissue. When hydrated, Collagen Nerve Wrap is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows Collagen Nerve Wrap to be spread open for easy placement over the injured nerve. The resilience of the Collagen Nerve Wrap allows the product to recover and maintain closure once the device is placed around the nerve. Collagen Nerve Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and in double peel packages.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Collagen Nerve Wrap." The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its effectiveness through a typical clinical trial with acceptance criteria and comparative studies as one might find for a novel drug or a high-risk device.

Therefore, the information you're requesting regarding acceptance criteria, specific study details (sample size for test set/training set, ground truth establishment, expert involvement, MRMC studies, standalone performance), and effect sizes of AI assistance is not typically found in a 510(k) submission for a device like this, as it's not a diagnostic AI device or a device requiring extensive clinical performance measures against predefined metrics.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, materials, and safety/biocompatibility testing.

Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not included:

1. A table of acceptance criteria and the reported device performance

This type of table is not applicable here. The submission does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) that would be typically seen for diagnostic devices or AI algorithms. Instead, the "effectiveness" is assessed by demonstrating that its characteristics meet design requirements and comparing it to predicate devices.

Acceptance Criteria (Not explicitly stated as performance metrics)	Reported Device Performance (Summary)
Safe (Biocompatibility)	Passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for biological evaluation of medical devices.
Effective (Meets design requirements for a nerve protector)	Characteristics of the Collagen Nerve Wrap meet design requirements for an effective nerve protector.
Substantially Equivalent to Predicates	Demonstrated through animal study, in vitro product characterization, in vitro and in vivo biocompatibility studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable/provided in the context of typical clinical performance testing as would be requested for an AI diagnostic device. The "test set" here would refer to the animal study and various in vitro and in vivo biocompatibility tests. No specific sample sizes for these individual tests are provided, nor are details on data provenance (e.g., country) or study design (retrospective/prospective) for these tests within this summary.
Data Provenance: Not specified for the animal study or biocompatibility tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a resorbable collagen matrix for nerve protection, not a diagnostic tool requiring expert interpretation or "ground truth" establishment in the way an imaging AI algorithm would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, no adjudication method for establishing ground truth is mentioned or relevant for this type of device submission.

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. A MRMC study is relevant for diagnostic imaging devices, especially those incorporating AI. This device is a surgically implanted collagen wrap; therefore, an MRMC study is not relevant or reported.

6. 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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly defined as "ground truth" in this context. For a device like this, "ground truth" would be inferred from the successful completion of biocompatibility tests and the in vivo animal study demonstrating appropriate physiological responses and nerve protection that are comparable to predicate devices. This isn't a diagnostic scenario where a "truth" needs to be established through expert consensus or pathology.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

9. How the ground truth for the training set was established

Not applicable. This device does not involve a "training set" or a ground truth established in the context of machine learning.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" demonstrating the Collagen Nerve Wrap's safety and effectiveness (and thus, its substantial equivalence) consisted of:

Biocompatibility Testing: The device underwent and passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. These are standard tests designed to assess the biological response to medical devices in contact with the body.
Animal Study: The submission mentions "The results of an animal study" as contributing to the conclusion of safety and substantial equivalence to its predicates. No specific details about the animal model, study design, or outcomes are provided in this summary.
In Vitro Product Characterization Studies: These studies would have evaluated the physical and chemical properties of the Collagen Nerve Wrap to ensure it meets its design specifications (e.g., hydration properties, porosity, resilience, degradation profile).
Comparison to Predicate Devices: The core of the 510(k) submission is the comparison to legally marketed predicate devices (Collagen Nerve Cuff, NeuraWrap™ Nerve Protector, FASTUBE™ Nerve Regeneration Device). The Applicant states that Collagen Nerve Wrap and its predicates have the same technological characteristics, including intended use, design, materials, material characterization, form, and sizes. This forms the basis for the claim of "substantial equivalence."

Conclusion:

The Collagen Nerve Wrap received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices through an animal study, in vitro product characterization, and in vitro and in vivo biocompatibility testing, rather than through a clinical trial with predefined performance acceptance criteria typical for diagnostic or AI-driven medical devices.

Summary

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K060952 (1/2)

510(k) Summary of Safety and Effectiveness

JUL 1 4 2006

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACDirector, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	April 5, 2006
Device Common Name:	Nerve Protector
Device Trade Name:	Collagen Nerve Wrap
Device Classification Name:Regulation Number:Device Class:Product Code:	Cuff, Nerve882.5275Class IIJXI
Predicate Device(s):	Collagen Nerve Cuff, K012814Collagen Matrix, Inc., Franklin Lakes, NJ
	NeuraWrap™ Nerve Protector, K041620Integra LifeSciences Corporation, Plainsboro, NJ
	FASTUBETM Nerve Regeneration Device, K850785Research Medical, Inc., Salt Lake City, UT

Description of the Device

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060952(k/2)

Intended Use

Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap olosure can be achieved by flexion of the extremity.

Summary/Comparison of Technical Characteristics

Collagen Nerve Wrap and its predicates have the same technological characteristics. In particular, Collagen Nerve Wrap and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.

Safety

Collagen Nerve Wrap has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical fevices.

Effectiveness

The characteristics of the Collagen Nerve Wrap meet the design requirements for an effective nerve protector.

Conclusion

The results of an animal study, in vitro product characterization studies, in vitro and in vivo biocompatibility studies, show that Collagen Nerve Wrap is safe and substantially equivalent to its predicates.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2006

Collagen Matrix, Inc. % Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K060952

Trade/Device Name: Collagen Nerve Wrap Regulation Number: 21 CFR 882.5275 Regulation Name: Nerve cuff Regulatory Class: II Product Code: JXI Dated: June 16, 2006 Received: June 19, 2006

Dear Ms. Hansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Peggy Hansen, RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Aurbene Buckup
Mark N. Malleman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060952

Indications for Use

ko60952 510(k) Number (if known): __

Device Name: __Collagen Nerve Wrap

Indications for Use:

发电子游戏 - 2017-08-19 11:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arbare Brechus SN MXM
Division Sign Off

Division of General, Restorative and Neurological Devices

510(k) Number K060952

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Regulation Number and Section

§ 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).