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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.

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

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.

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.

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