(19 days)
The Lelbinger titanium ossicular chain reconstruction prostheses and accessories are used for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.
Titanium ossicular chain reconstruction prostheses are available for the following indications:
Chronic otitis media
Immobility of the stapes (otosclerosis in particular)
Injury of the ossicle (trauma)
Abnormal and defective formation of the middle ear
Secondary procedure to improve hearing
Revision operation on a malpositioned prosthesis
The system consists of various implants, instrumentation, and storage containers.
| Product Designation | Product Intended Use |
|---|---|
| Stapes prosthesis | Flat band and piston prosthesis for attachment to the malleus or incus, inserted through the footplate of the stapes. |
| Total prosthesis (TORP) | Plate prosthesis with shaft and shoe as ossicle replacement between the tympanic membrane and the footplate of the stapes. |
| Neomalleus total prosthesis | Malleus prosthesis as ossicle replacement In combination with stapes prosthesis. - |
| Incus prosthesis | Incus replacement to connect malleus and head of stapes. |
| Partial prosthesis (PORP) | Malleus and incus replacement to connect tympanic membrane and head of stapes. |
This is a 510(k) summary for a medical device cleared in 1999, which predates the widespread use of AI/ML in medical devices and the associated regulatory expectations for studies proving AI performance. Therefore, the document does not contain information related to AI acceptance criteria or studies.
The document describes the Zürich Titanium Ossicular Replacement System, a device for ossicle replacement to restore middle ear function. The basis for its clearance is substantial equivalence to predicate devices already on the market, not a detailed performance study with acceptance criteria as would be required for a novel AI device today.
Therefore, I cannot provide the requested information regarding AI acceptance criteria and studies from the given input.
However, I can extract information relevant to the device's regulatory submission based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The device's acceptance was based on its substantial equivalence to predicate devices, meaning it met the requirements for intended use, materials, design, and operational principles established by already marketed devices. There are no specific quantifiable performance metrics described as acceptance criteria in this document for the device itself, beyond being "substantially equivalent."
- Reported Device Performance: The document states the device "is intended to be used for ossicle replacement to restore middle ear function when the sound transmission chain is broken." There are no reported performance metrics (e.g., success rates, hearing improvement statistics) within this 510(k) summary.
2. Sample size used for the test set and the data provenance: Not applicable. Device was cleared based on substantial equivalence, not a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device was cleared based on substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device was cleared based on substantial equivalence.
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 device is an implantable medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implantable medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI study. The "ground truth" for this device's clearance was that it was substantially equivalent in design and intended use to existing, legally marketed devices.
8. The sample size for the training set: Not applicable. This device is an implantable medical device, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This device is an implantable medical device, not an AI algorithm.
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Ka9 3583
NOV 1 0 1999
Image /page/0/Picture/2 description: The image shows the Stryker Leibinger logo. The word "stryker" is in bold, black font, with a small circle above the "e". Below "stryker" is the word "LEIBINGER" in a lighter, less bold font. The letters in "LEIBINGER" are spaced out.
4100 East Milham Avenue Kalamazoo, MI 49001 Phone (616) 323-7700 800) 253-7370
510(k) Summary
Device Name:
| Trade Name: | Zürich Titanium Ossicular Replacement System |
|---|---|
| Common Names: | Total ossicular replacement prosthesisPartial ossicular replacement prosthesis |
| Classification Names: | Total ossicular replacement prosthesis: 21 CFR874.3495, Class IIPartial ossicular replacement prosthesis: 21 CFR874. 3450, Class II |
Device Sponsor:
| Manufacturer: | Stryker CorporationStryker Leibinger GmbH and Co. KGBoetzinger Straße 41D-79111 Freiburg GermanyRegistration No.: 8010177 |
|---|---|
| Distributor: | Stryker CorporationStryker Leibinger4100 E. Milham AvenueKalamazoo, MI 49001Registration No.: 1811755 |
| Regulatory Class: | Class II |
| Date Prepared: | October 21, 1999 |
Summary of Safety and Effectiveness:
The Zürich Titanium Ossicular Replacement System is intended to be used for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction to replace missing, malformed, or immobile ossicles or in secondary procedures after tumor or trauma operations.
The system consists of various implants, instrumentation, and storage containers.
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The substantial equivlance of this device is based on the equivalence in intended use, materials, design, and operational principles to the currently marketed predicate devices such as the Micromedics S&T Total Ossicular Replacement Prosthesis and the Tubingen Titanium Prosthesis (TTP) Vario (Heinz Kurz GmbH Medizintechnik).
By: Nicole Ratty
Nicole Petty Regulatory Affairs Analyst
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 0 1999
Ms. Nicole Petty Stryker Corporation Regulatory Affairs Analyst 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K993583
Device: Zurich Titanium Ossicular Replacement System, Titan Stapes Prosthesis, Titan Incus Prosthesis. Titan TORP, and Titan Neomalleus Prosthesis Dated: October 21, 1999 Received: October 22, 1999 Classification Regulation: 77 ETA , 21 CFR 874.3495 77 ETB , 21 CFR 874.3450
Regulatory Class: II
Dear Ms. Petty:
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 requirements, as set forth in the Quality System Regulation (QS) 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 - Ms. Nicole Petty
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) 594-4613. 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,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STRYKER INSTRUMENTS NOV- 5-99 FRI 10:59 AM
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| 510(k) Number: | K993583 |
|---|---|
| Device Name: | Zürich Titanium Ossicular Replacement System |
| Indications For Use: | The Lelbinger titanium ossicular chain reconstruction prostheses and accessories are used for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations. Titanium ossicular chain reconstruction prostheses are available for the following indications: Chronic otitis mediaImmobility of the stapes (otosclerosis in particular)Injury of the ossicle (trauma)Abnormal and defective formation of the middle earSecondary procedure to improve hearingRevision operation on a malpositioned prosthesis |
| Product Designation | Product Intended Use |
|---|---|
| Stapes prosthesis | Flat band and piston prosthesis for attachment to the malleus or incus, inserted through the footplate of the stapes. |
| Total prosthesis (TORP) | Plate prosthesis with shaft and shoe as ossicle replacement between the tympanic membrane and the footplate of the stapes. |
|---|---|
| Neomalleus total prosthesis | Malleus prosthesis as ossicle replacement In combination with stapes prosthesis. - |
| Incus prosthesis | Incus replacement to connect malleus and head of stapes. |
| Partial prosthesis (PORP) | Malleus and incus replacement to connect tympanic membrane and head of stapes. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
11/9/99
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) NumberK993583
Prescriptim device
§ 874.3495 Total ossicular replacement prosthesis.
(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.