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The Stryker® External Fixation System is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, turnor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

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This document is a 510(k) summary for a medical device (Stryker® External Fixation System) and does not contain detailed information about specific acceptance criteria or an analytical study proving that the device meets those criteria.

510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a standalone study data as described in the prompt. The focus is on showing that the new device is as safe and effective as a legally marketed predicate device. Therefore, the information requested in the prompt (sample size for test/training sets, expert details, adjudication, MRMC studies, etc.) is generally not found in a 510(k) summary for this type of device.

Based on the provided text, I can extract the following relevant information:

• Device Name: Stryker® External Fixation System
• Intended Use/Indications for Use: To stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
• Predicate Devices: Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K062299).
• Regulatory Classification: Class II

To answer your specific questions, directly from the provided text:

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

   • The document does not provide a table of acceptance criteria with reported device performance metrics in the way one would for an AI/diagnostic device. The basis for clearance is substantial equivalence (SE) to predicate devices, implying similar performance for its intended use without specific quantitative metrics documented here.

2. Sample sizes used for the test set and the data provenance: Not applicable. This 510(k) summary does not describe a performance study with a test set that would have a sample size or data provenance in the context of an AI/diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is not present as the submission is for a mechanical fixation system and not an AI/diagnostic tool requiring ground truth established by experts.

4. Adjudication method for the test set: Not applicable for the reasons stated above.

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 device is an external fixation system, not an AI or diagnostic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms, not a mechanical external fixation system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an external fixation system. Its performance evaluation is typically through mechanical testing, biocompatibility, and clinical use experience of its predicates, not "ground truth" derived from expert consensus on diagnostic cases.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This device is not an AI algorithm.

In summary, the provided 510(k) pertains to a physical medical device (an external fixation system) and therefore does not contain the types of information requested, which are typically relevant for AI/diagnostic software devices. The clearance is based on substantial equivalence to existing devices, implying similar safety and effectiveness without direct performance studies against numerical acceptance criteria presented in this summary.

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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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