(206 days)
The Neurotube is intended for single use in patients with an injury to a perioheral news, in which the nerve gap is more than or equal to 8 mm but less than or equal to 3 cm. The time in which the nerve gap is more than of equal to o min our teen and of injury of the time of exploration of failed primary repair.
The Neurotube is a woven, flexible, polyglycolic acid tube which has been heat treated to achieve a configuration corrugated externally for wall strength. The tube is 2.3 mm in diameter and 4 cm in length.
The provided text describes a Premarket Notification [510(k)] Summary for the Neurotube™ nerve conduit, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than setting and proving acceptance criteria for an AI device.
Therefore, many of the requested categories for AI device evaluation (such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document, as it concerns a medical device, not an AI algorithm.
However, I can extract the information relevant to the clinical study conducted for the Neurotube™ and present it in a format that aligns with your request where possible, adapting categories for clarity.
Description of Acceptance Criteria and Study for Neurotube™
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Primary Goal: Demonstrate substantial equivalence to predicate devices (silicone nerve cuffs and classic nerve graft repairs). | The study indicated that a single-stage, biodegradable, polyglycolic acid conduit (Neurotube™) can be used as an alternative to a nerve graft or a biodurable nerve tube. |
| Efficacy: Provide an optimal environment for longitudinal nerve axon growth of the peripheral nerve, specifically for nerve gaps ≥ 8mm and ≤ 3 cm. | Sensory evaluations (static and moving sensory discrimination tests) at 3, 6, 9, and 12 months showed equivalent results between the Neurotube™ group and the control (classic end nerve graft repairs) group. |
| Safety: Acceptable adverse event profile. | The only adverse effects reported were delayed healing of a skin closure and skin separation with partial extrusion of the Neurotube. |
| Clinical Advantage (over predicate): Avoidance of a second surgery for removal (due to bioresorbable material). | The Neurotube is fabricated from a bioresorbable material, in contrast to nonresorbable silicone, thus precluding the need for a second surgery. (This is a design characteristic rather than a direct clinical performance metric, but it supports the "alternative" claim). |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Total subjects: 98
- Total nerve reconstructions evaluated: 102
- Control group (classic end nerve graft repairs): 56 reconstructions
- Neurotube™ group: 46 reconstructions
- Data Provenance:
- Country of Origin: United States
- Study Type: Clinical trials, conducted prospectively over a period of three and a half years.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not specify the number or qualifications of experts involved in performing or interpreting the sensory evaluations. It indicates "medical professionals" would have performed these, but specific details are not provided.
4. Adjudication method for the test set
- The document does not mention a specific adjudication method beyond the direct comparison of sensory evaluation results between the two groups.
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 was a clinical trial for a physical medical device (nerve conduit), not an AI-based diagnostic or assistive tool. Therefore, an MRMC study or assessment of human reader improvement with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This was a clinical trial for a physical medical device.
7. The type of ground truth used
- Clinical Outcomes/Functional Assessment: The "ground truth" or primary endpoints were clinical sensory evaluations (Static and moving sensory discrimination tests) at defined intervals (3, 6, 9, and 12 months) and the occurrence of adverse events. The comparison was against established surgical techniques (nerve grafts).
8. The sample size for the training set
- Not Applicable. This was a clinical trial for a physical medical device. There was no "training set" in the context of an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As there was no AI training set, this question is not relevant.
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3/22/99
PREMARKET NOTIFICATION [510(K)] SUMMARY (as required by 21CFR 807.92(a))
Submitted by: John E. Barham, Managing Member, Neuroregen L.L.C. 43 N. Bond Street, Bel Air, MD 21014 Phone 410 838-8090 Fax 410 838-8092 August 28, 1998 Date:
Trade Name: Neurotube™
Common Name: Nerve Conduit
Classification Name: Nerve Cuff (per 21 CFR Section 882.5275)
Equivalent Device: Silicone Nerve Cuffs
Description: The Neurotube is a woven, flexible, polyglycolic acid tube which has been heat treated to achieve a configuration corrugated externally for wall strength. The tube is 2.3 mm in diameter and 4 cm in length.
Intended Use: The tube provides an optimal environment for longitudinal nerve axon growth of the peripheral nerve. For single use only in patients with a peripheral nerve injury where the nerve gap is more than or equal to 8mm, but less than or equal to 3 cm.
Technological Characteristics Compared to Predicate Device: The Neurotube is fabricated from a bioresorbable material in contrast to nonresorbable silicone and thus precludes the need for a second surgery. Both the silicone and bioresorbable products are tubular in design to facilitate nerve regeneration.
Clinical Data: Clinical trials for the Neurotube were conducted in the United States over a period of three and one half years to support a determination of substantial equivalence. A total of 98 subjects were enrolled at five clinical trial sites. One hundred two nerve reconstructions were evaluated. There were 56 in the control group using classic end nerve graft repairs and 46 received the Neurotube. Subjects were given sensory evaluations at 3, 6, 9, and 12 month intervals. Static and moving sensory discrimination tests were performed. Results were equivalent between the two groups. The only adverse effects reported were delayed healing of a skin closure and skin separation with partial extrusion of the Neurotube. The study indicated that a single stage, biodegradable, polyglycolic acid conduit can be used as an alternative to a nerve graft or a biodurable nerve tube.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 199y
Mr. John E. Barham Managing Member Neuroregen, L.L.C. 43 North Bond Street Bel Air, Maryland 21014
Re: K983007 Trade Name: Neurotube™ Regulatory Class: II Product Code: JXI Dated: December 18, 1998 Received: December 22, 1998
Dear Mr. Barham:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. John E. Barham
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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510 (k) Number K983007
Device Name: Neurotube™
Indications for Use:
The Neurotube is intended for single use in patients with an injury to a perioheral news, in which the nerve gap is more than or equal to 8 mm but less than or equal to 3 cm. The time in which the nerve gap is more than of equal to o min our teen and of injury of the time of exploration of failed primary repair.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109)
(Division Sign Off) Division of General Restorative 510/k) Number
§ 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).