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Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.

Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, cramofacial; spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Stryker® Injectable Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary fragments during and is not intended to provide structural support during the healing process.

Stryker® Injectable Cement is a self-setting, calcium phosphate cement.

This 510(k) premarket notification for the Stryker® Injectable Cement does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The provided document is a 510(k) summary and the FDA's clearance letter for the Stryker® Injectable Cement. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety and effectiveness.

Here's a breakdown of why the requested information is not present in the provided text:

• Acceptance Criteria and Device Performance Table: This type of information (specific performance metrics, thresholds, and reported results) is typically found in a detailed study report that would be part of the full 510(k) submission, but not in the summary or clearance letter. The summary states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable based on that comparison, but it doesn't quantify or define specific performance criteria.
• Sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set: These items relate to the methodology and results of specific clinical or performance studies. The provided 510(k) summary of safety and effectiveness, while mentioning "Substantial Equivalency Information," does not include details of any primary studies conducted for this particular premarket notification. It references predicate devices (K060061 Stryker® Injectable Cement and K043334 Stryker® HAC Rapid Set Cement) as the basis for substantial equivalence, implying that their existing data or established safety and efficacy profiles are being leveraged.

In summary, the provided text is a regulatory clearance document, not a detailed technical report of a study designed to establish and meet specific acceptance criteria. Such studies would have been part of the broader submission that led to this clearance, but the details are not included in the publicly available summary or the FDA letter.

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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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Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Stryker® Injectable Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process.

Stryker® Injectable Cement is a self-setting calcium phosphate cement.

The provided documentation is a 510(k) summary for the Stryker® Injectable Cement, a medical device for filling bony voids. However, it does not contain the information required to answer your prompt.

Specifically, the document does not describe acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) submission summary.

The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance data from a specific study against predefined acceptance criteria. It mentions the intended use and states that the device is substantially equivalent to other Stryker Injectable Cement products and Walter Lorenz Otomimix.

Therefore, I cannot provide the requested table and details because the source document does not contain this information.

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Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Stryker® Injectable Cement is a self-setting calcium phosphate cement.

The provided text is a 510(k) summary for a medical device (Stryker® Injectable Cement) and its FDA clearance letter. It does not contain any information about acceptance criteria, device performance, or human studies for the device itself.

The document primarily focuses on:

• Device Identification: Name, common name, regulatory class, product codes.
• Submitter and Manufacturer Information.
• Date of Summary Preparation.
• Intended Use Statement.
• Substantial Equivalence Information: Listing predicate devices (K043334 BoneSource® HAC Rapid Setting Cement, K041842 Norian SRS® Fast Set Putty, and K024336 Wright Medical MIIG II).
• FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing the device to be marketed.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, study types (MRMC, standalone), or ground truth establishment based on the provided text. This type of detail is typically found in the full 510(k) submission or associated test reports, which are not included here.

Ask a specific question about this device