MILLS INCUS HA SLEEVE by EXMOOR PLASTICS LTD.

The provided text is a 510(k) submission for a medical device called the "Mills Sleeve Prosthesis," which is a middle ear prosthesis. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with detailed acceptance criteria and performance metrics for a new AI/software device.

Therefore, many of the requested categories for describing an AI-driven study's acceptance criteria and performance cannot be extracted or are not applicable from the provided text. The document is from 1998, predating widespread AI in medical devices and the typical reporting standards for AI performance studies.

Here's an analysis based on the information provided, highlighting what is missing or not applicable:

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

Not Applicable in the traditional sense for an AI device. The document does not present quantitative acceptance criteria or device performance metrics in the way an AI diagnostic tool would. Instead, it relies on the safety and effectiveness of the material (hydroxylapatite) and the design, as well as the manufacturer's attestation and the FDA's substantial equivalence determination.

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

Not applicable. This document describes a physical medical device (a prosthesis), not a software or AI device that relies on a "test set" of data for performance evaluation. There's no mention of a test set, data provenance, or study design for performance. The "summary of safety & effectiveness" is a general statement based on prior experience with similar prostheses and materials.

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. No test set or ground truth establishment process is described. The "expertise" mentioned is that of R. P. Mills, MS, MPhil, FRCS, a Consultant ENT Surgeon, who affirms the device's safety and effectiveness based on his "many years' experience" and general knowledge of middle ear prostheses and materials. This is an expert opinion or attestation, not a ground truth establishment process for a performance study.

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

Not applicable. No test set or adjudication process is mentioned.

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 is a physical medical device, not an AI system designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

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

Not applicable. There is no "ground truth" established for a performance study in the context of an AI device. The safety and effectiveness are inferred from the known properties of the materials and the design based on existing knowledge and practice.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI device.

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

Not applicable. No training set is mentioned.

Summary of what can be extracted or inferred from the provided text regarding device acceptance and study (though not in the AI/software context):

Device: Mills Sleeve Prosthesis
Intended Use: "Any gap in the ossicular chain caused by erosion of the incus."
Basis for Acceptance:
- Prior Experience: "Based on previous experience of middle ear prostheses, there is no reason to believe that the proposed prosthesis... will have any detrimental effect."
- Material Safety: "The available data indicate that hydroxylapatite does not alter with time in any way that might have an adverse effect on the patient or on the efficiency of the reconstruction."
- Fail-safe mechanism (implied): "Should the reconstruction fail, it is likely that the prosthesis would be extruded from the ear without causing any harm."
- Expert Attestation: A Consultant ENT Surgeon (R. P. Mills, MS, MPhil, FRCS) attests that the device "will be completely safe and effective in use."
- FDA Substantial Equivalence: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness concerns as a device already on the market. This is the primary "acceptance criterion" for this type of submission.

Therefore, the "study" proving the device met "acceptance criteria" here is primarily the argument for substantial equivalence presented in the 510(k) submission, supported by expert opinion and general knowledge about the device's materials and design, rather than a clinical trial or performance study typical for an AI device.

Summary

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K974365

SUMMARY OF SAFETY & EFFECTIVENESS

JAN 2 2 1998

Based on previous experience of middle ear prostheses, there is no reason to believe that the proposed prosthesis, or the material from which it is constructed, will have any detrimental effect on the condition of the patient. The available data indicate that hydroxylapatite does not alter with time in any way that might have an adverse effect on the patient or on the efficiency of the reconstruction. Should the reconstruction fail, it is likely that the prosthesis would be extruded from the ear without causing any harm. The prosthesis will not be harmful to the user or any third party.

I therefore affirm, as an otologist of many years' experience, that this device will be completely safe and effective in use.

R. P. Mills, MS. MPhil, FRCS Consultant ENT Surgeon

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Margaret Blackmore Regulatory Affairs Exmoor Plastics Lisieux Way Taunton, TA1 2LB, U.K. Re:

K974365 Mills Sleeve Prosthesis Dated: November 10, 1997 Received: November 19, 1997 Regulatory class: II 21 CFR 874.3450/Procode: 77 ETB JAN 2 2 1998

Dear Ms. Blackmore:

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 includes) 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; Drag; and Cosmetic Act (Act). "Tou may, therefore, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Radiation Control provisions, or other Federal laws or regulations.

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 question 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,

hồ tiêu Yri

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Listing Number: A895750 t a first o a other of the start of the s

510(k) Number (if known):	K97 4365
Device Name:	MILLS SLEEVE PROSTHESIS

Indications for Use:

Any gap in the ossicular chain caused by erosion of the incus.

(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 CFR 801.109)

(

Over-The-Counter Use

(Optional Format 1-2-96)

David L. Jessop

(Division Sign-Off) Division of Reproductive, Abdominal, ENT) and Radiological Device 510(k) Number

Regulation Number and Section

§ 874.3450 Partial ossicular replacement prosthesis.

(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.