An 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. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:
(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

Device Description

The family of Grace Medical Nitinol Partial Ossicular Replacement Prostheses consists of: Nitinol Locking Incudo-Stapedial Joint Nitinol Locking Angular Piston Nitinol Locking Piston Nitinol Locking Malleus Piston Nitinol Locking PORP Footplate Shoe. The prostheses are manufactured from Nitinol (ASTM F2063-05), Unalloyed titanium (ASTM F67), Titanium alloy (ASTM F136), Hydroxylapatite (ASTM F1185), Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754), and Medical grade silicone.

AI/ML Overview

The provided text is a 510(k) summary for the Grace Medical Partial Ossicular Replacement Prostheses. This type of document is a premarket notification to the FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device.

Crucially, a 510(k) does not typically involve the kind of rigorous clinical studies, acceptance criteria, and performance metrics (like sensitivity, specificity, F1 score) that would be present for a novel device or an AI/software as a medical device (SaMD). The "study" here is primarily a comparison to predicate devices, focusing on materials, intended use, and design features to establish substantial equivalence, not a direct performance study against defined acceptance criteria in terms of clinical outcomes or diagnostic accuracy.

Therefore, many of the requested fields cannot be directly answered as they are not applicable to the nature of a medical device 510(k) for a physical implant like an ossicular replacement prosthesis.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the traditional sense for a SaMD or novel device. For a 510(k) of a physical implant like this, "acceptance criteria" are generally met by demonstrating substantial equivalence to predicate devices in:

Intended Use: Must be the same.
Technological Characteristics: Must be the same or, if different, any differences must not raise new questions of safety or effectiveness.
Materials: Must be biocompatible and safe.
Performance: Implied to be similar to predicate devices based on design and materials.

The document implicitly "accepts" the device by demonstrating these similarities. There are no quantitative performance metrics (e.g., sensitivity, accuracy, etc.) reported for "device performance" in the way one would for a diagnostic algorithm.

Parameter	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison)
Intended Use	Same as predicate devices: functional reconstruction of ossicular chain, sound wave conduction from tympanic membrane to inner ear, restoration of ossicular chain in conductive hearing loss.	Met: Explicitly stated as having "the same primary intended use as the predicate devices" and confirmed in comparison charts.
Material(s)	Biocompatible and safe; comparable to predicate devices.	Met: Materials (Nitinol, Titanium, Hydroxylapatite, Fluoroplastic, Silicone) are listed and stated as "the same materials as the predicate devices" or "Substantially Equivalent" in comparison charts.
Method of Attachment	Safe and effective; comparable to predicate devices.	Met: "Manual or Heat Crimp-Assist" described as "Same as SMart ISJ and SMart Piston. Different than but SE to Kurz Angular Prosthesis." for the Nitinol Locking Incudo-Stapedial Joint.
Lengths/Dimensions	Appropriate for intended anatomical use; comparable range to predicate devices.	Met: Listed ranges (e.g., 3.0mm to 9.0mm for Pistons, 0.5mm to 9.0mm for PORPs) are compared to predicate devices and deemed "Substantially Equivalent."
How Supplied (Sterility)	Sterile, comparable to predicate devices.	Met: "Sterile" for all device types, "Same" as predicate devices confirmed in comparison charts.
Safety and Effectiveness	No new questions of safety or effectiveness raised by differences from predicate devices.	Met (by FDA determination): Stated, "Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness." and confirmed by FDA clearance.

2. Sample Size Used for the Test Set and the Data Provenance

Not applicable. This submission is not based on a "test set" of patient data or clinical images in the way an AI/SaMD would be evaluated. Performance is established through comparison to legally marketed predicate devices, along with materials testing and design specifications, not through a prospective or retrospective study on a clinical dataset for performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. There is no "ground truth" establishment in the context of clinical expert review for this type of device submission. The FDA reviewers (Division of Ophthalmic and Ear, Nose and Throat Devices) evaluate the submission based on regulatory guidelines and comparison to established predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert adjudication process described or performed for this 510(k) 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

Not applicable. This is a physical implant device, not an AI or software assistant for human "readers." Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. The "truth" for this 510(k) is whether the device is substantially equivalent to known safe and effective predicate devices, based on materials, design, and intended use as assessed by the FDA. There is no "ground truth" derived from patient-specific data or pathology results mentioned as a basis for device performance evaluation in this document.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm described.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set for an algorithm described.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Grace Medical Partial Ossicular Replacement Prostheses

GEC - 6 2006

Trade Name:	The family of Grace Medical Nitinol Partial Ossicular ReplacementProstheses consists of:Nitinol Locking Incudo-Stapedial Joint Nitinol Locking Angular Piston Nitinol Locking Piston Nitinol Locking Malleus Piston Nitinol Locking PORP Footplate Shoe
Common Name:	Partial Ossicular Replacement Prostheses
Classification Name:	Partial Ossicular Replacement Prostheses (CFR 21 §874.3450)
Official Contact:	Jeff CobbVice President of Regulatory Affairs & QualityGrace Medical, Inc.8500 Wolf Lake Drive, Suite 110Memphis, TN 38133
Telephone:	(901) 380-7000
Telefax:	(901) 380-7001
Date Prepared:	November 8, 2006

Predicate Devices

1. SMart ISJ Prosthesis manufactured by Gyrus ENT LLC and cleared via 510(k) No. K033554.
1. SMart Piston manufactured by Gyrus ENT LLC and cleared via 510(k) No. K003214.
1. Angular Prosthesis (Plester) manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K972492.
1. CliP Piston MVP manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K042503.
1. CliP Piston aWengen manufactured by Heinz Kurz GmbH Medizintechnik and cleared via 510(k) No. K021479.
1. Adjustable and Fixed-Length PORPs manufactured by Grace Medical, Inc. and cleared via 510(k) No. K061853.
1. Partial Ossicular Replacement Prosthesis manufactured by Grace Medical, Inc. and cleared via 510(k) K972815.

Intended Use - The Grace Medical Partial Ossicular Replacement Prostheses have the same primary intended use as the predicate devices.

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(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

Material(s) - The Grace Medical Partial Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:

(i) Nitinol (ASTM F2063-05)
(ii) Unalloyed titanium (ASTM F67)
(iii)Titanium alloy (ASTM F136)
(iv) Hydroxylapatite (ASTM F1185)
(v) Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754)
(vi) Medical grade silicone

Comparison Charts

NITINOL LOCKING INCUDO-STAPEDIAL JOINT

	Nitinol Locking Incudo-Stapedial Joint	SMartISJ(Gyrus)	SMartPiston(Gyrus)	AngularProsthesis(Kurz)	Similarities or Differences
Intended Use	An ossicular replacement prosthesis is a deviceintended to be implanted for the functionalreconstruction of segments of the ossicular chain andfacilitates the conduction of sound wave from thetympanic membrane to the inner ear.	Same	Same	Same	Same
Material(s)	Nitinol	Nitinol	NitinolFluoroplastic	Titanium	Substantially Equivalent
Method ofAttachment	Manual or Heat Crimp-Assist	Same	Same	Manual	Same as SMart ISJ andSMart Piston. Differentthan but SE to KurzAngular Prosthesis.
HowSupplied	Sterile	Sterile	Sterile	Sterile	Same

NITINOL LOCKING ANGULAR PISTON

	Nitinol Locking Angular Piston	SMartISJ(Gyrus)	SMart Piston(Gyrus)	AngularPiston(Kurz)	Similarities orDifferences
IntendedUse	An ossicular replacement prosthesis is a device intended to beimplanted for the functional reconstruction of segments of theossicular chain and facilitates the conduction of sound wave fromthe tympanic membrane to the inner car.	Same	Same	Same	Same
Material(s)	NitinolTitanium	Nitinol	NitinolFluoroplastic	Titanium	SubstantiallyEquivalent
Lengths	3.0mm to 9.0mm	n/a	3.0mm to6.0mm	4.25mm to4.75mm	SubstantiallyEquivalent
HowSupplied	Sterile	Sterile	Sterile	Sterile	Same

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NITINOL LOCKING PISTON

	Nitinol Locking Piston	SMartISJ(Gyrus)	SMart Piston(Gyrus)	AngularPiston(Kurz)	Similarities orDifferences
IntendedUse	An ossicular replacement prosthesis is a device intended tobe implanted for the functional reconstruction of segmentsof the ossicular chain and facilitates the conduction ofsound wave from the tympanic membrane to the inner ear.	Same	Same	Same	Same
Material(s)	NitinolTitaniumFluoroplastic	Nitinol	NitinolFluoroplastic	Titanium	SubstantiallyEquivalent
Lengths	3.0mm to 9.0mm	n/a	3.0mm to 6.0mm	4.25mm to4.75mm	SubstantiallyEquivalent
HowSupplied	Sterile	Sterile	Sterile	Sterile	Same

NITINOI. LOCKING MALLEUS PISTON

	Nitinol Locking Malleus Piston	CliP PistonMVP(Kurz)	CliP PistonaWengen(Kurz)	Similarities orDifferences
IntendedUse	An ossicular replacement prosthesis is a device intended to be implanted forthe functional reconstruction of segments of the ossicular chain and facilitatesthe conduction of sound wave from the tympanic membrane to the inner ear.	Same	Same	Same
Material(s)	NitinolTitaniumFluoroplastic	Titanium	Titanium	SubstantiallyEquivalent
Lengths	3.0mm - 9.0mm	5.00mm -6.25mm	4.0mm -5.5mm	SubstantiallyEquivalent
HowSupplied	Sterile	Sterile	Sterile	Same

Nitinol Locking PORP

	Nitinol Locking PORP	SMartISJ(Gyrus)	SMart Piston(Gyrus)	Grace Adjustable andFixed-length PORPs	Similarities orDifferences
IntendedUse	An ossicular replacement prosthesis isa device intended to be implanted forthe functional reconstruction ofsegments of the ossicular chain andfacilitates the conduction of soundwave from the tympanic membrane tothe inner ear.	Same	Same	Same	Same
ShaftMaterial(s)	NitinolTitaniumSilicone (sleeve on adjustable models)	Nitinol	NitinolFluoroplastic	TitaniumSilicone (sleeve on adjustablemodels)	SubstantiallyEquivalent
HeadMaterial(s)	TitaniumHydroxylapatite	Nohead	No head	TitaniumHydroxylapatite	Same
Lengths	Fixed Sizes: 0.5mm to 9.0mmAdjustable model - Trimmedintraoperatively to length	n/a	3.0mm to 6.0mm	Fixed Sizes: 0.5mm to 9.0mmAdjustable model - Trimmedintraoperatively to length	SubstantiallyEquivalent
HowSupplied	Sterile	Sterile	Sterile	Sterile	Same

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FOOTPLATE SHOE

	Footplate Shoe	Grace HA Footplate ShoeK972815	Similarities orDifferences
Intended Use	An ossicular replacement prosthesis is a device intended tobe implanted for the functional reconstruction of segmentsof the ossicular chain and facilitates the conduction of soundwave from the tympanic membrane to the inner ear.	Same	Same
Material(s)	NitinolTitaniumHydroxylapatite	Hydroxylpaptite	SubstantiallyEquivalent
AccommodatesShafts withDiameters:	0.3mm to 1.07mm	1.07mm	SubstantiallyEquivalent
How Supplied	Sterile	Sterile	Same

Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Grace Medical, Inc. c/o Jeff Cobb Regulatory Affairs & Quality 8300 Wolf Lake Drive Suite 110 Memphis, TN

DEC = 6 2006

Re: K063374

Trade/Device Name: Partial Ossicular Replacement Prostheses, Nitinol Incudo-Stapedial Joint, Nitinol Angular Piston, Nitinol Piston, Nitinol Malleus Piston, Nitinol PORP and Footplate Shoc Regulation Number: 21 CFR 874.3450 Regulation Name: Partial ossicular replacement prosthesis Regulatory Class: Class II Product Code: ETB Dated: November 8, 2006 Received: November 8, 2006

Dear Mr. Cobb:

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 complies 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 premated nevice 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/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychler S.M.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: ¥063374

Device Name: Partial Ossicular Replacement Prostheses including: Nitinol Incudo-Stapedial Joint, Nitinol Angular Piston, Nitinol Piston, Nitinol Malleus Piston, Nitinol PORP, and Footplate Shoe

Indications for Use:

(a) Chronic middle ear disease,
(b) Otosclerosis.
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

(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)

Karus boha

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510(k) Number K063374

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.