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 K-Helix Partial Ossicular Replacement Prostheses consists of:

K-Helix Piston
K-Helix PORP
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)

AI/ML Overview

This 510(k) summary describes a medical device, not an AI/ML powered device. As such, the typical acceptance criteria and study designs applicable to AI/ML devices (e.g., performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies) are not relevant here.

The K-Helix Partial Ossicular Replacement Prostheses (K-Helix Piston and K-Helix PORP) gained clearance through a substantial equivalence pathway, meaning the manufacturer demonstrated that the new device is as safe and effective as a legally marketed predicate device.

Here's the information derived from the provided text, framed within the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "reported device performance" are based on demonstrating substantial equivalence to predicate devices, rather than statistical performance metrics as seen with AI.

Feature / Criteria	K-Helix PORP Performance (Grace Medical, Inc.)	K-Helix Piston Performance (Grace Medical, Inc.)
Intended Use	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. Indicated for conductive hearing loss due to chronic middle ear disease, otosclerosis, congenital fixation of stapes, secondary surgical intervention, and trauma.	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. Indicated for conductive hearing loss due to chronic middle ear disease, otosclerosis, congenital fixation of stapes, secondary surgical intervention, and trauma.
Material(s)	Nitinol (ASTM F2063-05) and/or Unalloyed titanium (ASTM F67), Titanium alloy (ASTM F136)	Nitinol (ASTM F2063-05) and/or Unalloyed titanium (ASTM F67), Titanium alloy (ASTM F136)
Method of Attachment	Manual or Heat Crimp-Assist	Manual or Heat Crimp-Assist
Lengths	3.0mm to 18.0mm	3.0mm to 18.0mm
How Supplied	Sterile	Sterile
Acceptance Criteria Basis	Demonstrated to have the same primary intended use and similar materials/design features as legally marketed predicate devices (SMart ISJ Prosthesis, SMart Piston, Angular Prosthesis (Plester), CliP Piston MVP). The differences do not affect safety or effectiveness.	Demonstrated to have the same primary intended use and similar materials/design features as legally marketed predicate devices (SMart ISJ Prosthesis, SMart Piston, Angular Prosthesis (Plester), CliP Piston MVP). The differences do not affect safety or effectiveness.

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

This submission does not discuss a "test set" or clinical data in the way an AI/ML device would. The equivalence is based on design, materials, intended use, and manufacturing processes compared to existing predicate devices. There is no mention of a clinical study with a specific sample size for demonstrating performance.

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. Ground truth, in the AI/ML sense, is not established for this type of device submission. The FDA's review relies on comparing the device's technical specifications and intended use against predicate devices.

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

Not applicable.

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 not an AI-assisted device.

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

Not applicable. This is a physical medical implant.

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

Not applicable in the AI/ML context. The "ground truth" for this submission is established by the safety and effectiveness profile of the predicate devices and the demonstration that the new device shares fundamental scientific technology and intended use.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm requiring a training set.

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

Not applicable. There is no AI/ML algorithm requiring a training set.

Summary

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K080070

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS APR 1 7 2008 K-Helix Partial Ossicular Replacement Prostheses

The family of K-Helix Partial Ossicular Replacement Prostheses Trade Name: consists of:

· K-Helix Piston
K-Helix PORP

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:	January 8, 2008

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.

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

(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.

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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)

Comparison Charts .

K-HELIX PORP

	K-Helix PORP(Grace Medical, Inc.)	SMart ISJ(Gyrus)	SMart Piston(Gyrus)	AngularProsthesis(Kurz)
Intended Use	An ossicular replacement prosthesis is a device intended to beimplanted for the functional reconstruction of segments of the ossicularchain and facilitates the conduction of sound wave from the tympanicmembrane to the inner ear.	Same	Same	Same
Material(s)	Nitinol and/or Titanium	Nitinol	NitinolFluoroplastic	Titanium
Method ofAttachment	Manual or Heat Crimp-Assist	Manual or HeatCrimp-Assist	Manual orHeat Crimp-Assist	Manual
Lengths	3.0mm to 18.0mm	n/a	3.0mm to6.0mm	4.25mm to4.75mm
HowSupplied	Sterile	Sterile	Sterile	Sterile

K-HELIX PISTON

	K-Helix PISTON(Grace Medical, Inc.)	SMartISJ(Gyrus)	SMart Piston(Gyrus)	AngularPiston(Kurz)
IntendedUse	An ossicular replacement prosthesis is a device intended to be implanted for thefunctional reconstruction of segments of the ossicular chain and facilitates theconduction of sound wave from the tympanic membrane to the inner ear.	Same	Same	Same
Material(s)	Nitinol and/orTitanium	Nitinol	NitinolFluoroplastic	Titanium
Lengths	3.0mm to 18.0mm	n/a	3.0mm to6.0mm	4.25mm to4.75mm
HowSupplied	Sterile	Sterile	Sterile	Sterile

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/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2008

Grace Medical c/o Jeff Cobb VP Regulatory Affairs and Quality Assurance 8500 Wolf Lake Drive Suite 110 Memphis, TN 38133

Re: K080070

Trade/Device Name: K-Helix Piston and PORP Regulation Number: 21 CFR 874.3450 Regulation Name: Partial Ossicular Replacement Prosthesis Regulatory Class: Class II Product Code: ETB Dated: March 19, 2008 Received: March 21, 2008

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Marling B. Eggleton, M.D.

Malvina B. Eydelman, M. 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:

Device Name: K-Helix Partial Ossicular Replacement Prostheses

The family of K-Helix Partial Ossicular Replacement Prostheses consists of:

K-Helix Piston t
K-Helix PORP

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)

Karent Sohler

lon of Oohthalmic Ear,

K0 80070
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.