Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.

Device Description

Hydroxyapatite Cement. Powder and liquid mixed to form a paste for application. Injectable Cement. Calcium Phosphate material. Sterile.

AI/ML Overview

This document is a 510(k) summary for the Stryker® Injectable Cement, submitted to the FDA in 2006. It focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing performance against specific acceptance criteria through a dedicated study.

Therefore, the requested information elements related to the performance study, ground truth, expert involvement, and sample sizes for training/testing sets are not present in this document.

Here's an analysis of the provided text based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with quantitative thresholds. Instead, it uses a "Substantial Equivalency Information" table to compare the proposed device with predicate devices across several characteristics. The "performance" in this context refers to the device meeting these characteristics, thereby demonstrating substantial equivalence.

Characteristic	Stryker® Injectable Cement (PENDING)	K060061 Stryker Injectable Cement (Predicate)	K043334 Stryker® HAC Rapid Setting Cement (Predicate)	K042561 Walter Lorenz Otomimix (Predicate)
Intended Use:	√	(Implicitly covered by identical predicate)		√
Augmentation/coupling of middle ear ossicles	√	Identical		√
Attachment of middle ear ossicles to implants	√	Identical		√
Mechanical stabilization of middle ear prostheses	√	Identical		√
Reconstruction of posterior canal wall	√	Identical		√
Material: Calcium Phosphate	√	√	√	√
Sterility: Sterile	√	√	√	√
Operational Principle: Powder and liquid mixed to form a paste for application	√	√	√	√
Injectable Cement	√	√

Interpretation of "Acceptance Criteria" from this document: The acceptance criteria for this 510(k) revolve around demonstrating that the Stryker® Injectable Cement is substantially equivalent to already legally marketed devices. This is achieved by showing identical or highly similar:

Intended Use
Material composition (Calcium Phosphate)
Sterility
Operational Principle (powder and liquid mixed to form a paste)
Physical properties (stated as identical with K060061 predicate)
Chemical composition (stated as identical with K060061 predicate)

The "reported device performance" is that the device meets these criteria by being identical or highly similar to the predicate devices.

2. Sample size used for the test set and the data provenance:

This document does not describe a clinical performance study with a "test set" in the context of an algorithm or diagnostic device. It's a submission for a medical device (cement), and the "study" referred to is the demonstration of substantial equivalence through comparison with predicate devices.
Therefore, there is no information on a sample size or data provenance in this context.

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 a performance study described here.

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

Not applicable. There is no "test set" or adjudication method described.

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 a study involving human readers or AI.

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

Not applicable. This is not an algorithm.

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

Not applicable. The concept of "ground truth" as it applies to software or diagnostic performance is not relevant here. The ground for approval here is demonstrating equivalence to existing, approved products.

8. The sample size for the training set:

Not applicable. This is not a machine learning device.

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

Not applicable. This is not a machine learning device.

Summary of what the document does provide regarding "studies":

The "study" or justification for approval presented in this 510(k) is a demonstration of substantial equivalence to legally marketed predicate devices. The key elements of this "study" are:

Predicate Devices: K060061 Stryker® Injectable Cement (primary predicate), K043334 Stryker® HAC Rapid Set Cement, and K042516 Walter Lorenz Otomimix.
Comparison Method: A direct feature-by-feature comparison (as shown in the table) of the new device against the predicates, covering intended use, material, sterility, and operational principles.
Key Finding: The document states, "The primary predicate device, Stryker Injectable Cement (K060061), is identical in material formulation, physical properties, chemical composition and performance." This statement is the core of the "study" proving the device meets the "acceptance criteria" of substantial equivalence. The other predicates also share common characteristics.

Essentially, the "study" is a comparative review of specifications and characteristics, not a clinical trial or performance evaluation against specific quantitative metrics.

Summary

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060750

APR 1 9 2006

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:

Stryker® Injectable Cement

General Information

Proprietary Name:	Stryker® Injectable Cement
Common Name:	Hydroxyapatite Cement
Proposed Regulatory Class:	Class II
Device Classification:	NEA (21 CFR 872.3275) Cement, Ear, Nose and ThroatFMF (21 CFR 880.5860) Syringe, Piston
Submitter:	Stryker®4100 East Milham AvenueKalamazoo, MI 49001877-534-2464 x 4226
Submitter's Registration #:	8010177
Manufacturer's Registration #:	9610726
Contact Person:	Wade T. RutkoskieManager, Regulatory Affairs and Quality AssurancePhone: 877-534-2464 x 4226Fax: 269-323-4215
Summary Preparation Date:	March 6, 2006

Intended Use

Substantial Equivalency Information

Stryker® Injectable Cement is substantially equivalent to legally marketed K060061 Stryker® Injectable Cement, K043334 Stryker® HAC Rapid Set Cement, and K042516 Walter Lorenz Otomimix.

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	Stryker®InjectableCement(PENDING)	K060061StrykerInjectableCement	K043334Stryker®HACRapidSettingCement	K042561WalterLorenzOtomimix
Intended Use: Stryker® Injectable Cement isintended for use in the following: 1.Augmentation or coupling of the middle earossicles. 2. Attachment of the middle earossicles to middle ear implants. 3.Mechanical stabilization of the middle earprostheses. 4. Reconstruction of theposterior canal wall.	√			√
Material: Calcium Phosphate	√	√	√	√
Sterility: Sterile	√	√	√	√
Operational Principle: Powder and liquidmixed to form a paste for application	√	√	√	√
INJECTABLE Cement	√	√

The primary predicate device, Stryker Injectable Cement (K060061), is identical in material formulation, physical properties, chemical composition and performance. All predicate devices share the same operational principles and are provided sterile.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service . . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2006

Stryker® c/o Mr. Wade T. Rutkoskie 750 Trade Centre Way Kalamazoo, MI 49001

Re: K060750

Trade/Device Name: Stryker® Injectable Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Cement, Ear, Nose and Throat Regulatory Class: Class II Product Code: NEA Dated: March 24, 2006 Received: March 27, 2006

Dear Mr. Rutkoskie:

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 (QS) 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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Page 2 -- Mr. Wade T. Rutkoskie

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 10(t) marketed predicate device results in a classification for your device and thus, perfocts 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 (301) 827-8910. Also, please note (1) OFF C at 001), picc "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ahtain other general information on your responsibilities under the Act from the Division may onall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

MB Eychards. M

Malvina B. Eydelman, M.D. Division 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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Page 1 of 1

510(K) Number (if known): K O 6 0 75-0

Device Name: Stryker® Injectable Cement

Indications for Use:

Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle car ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.

Prescription Use (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Analshur

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

66075(

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Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.