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ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as:

1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
2. Mechanical stabilization of middle ear and cochlear implants.
3. Attachment of middle ear implants to the ossicular bones.

ProCem™ is glass ionomer cement that is provided as two components, a glass powder and polyacrylic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ. ProCem™ is provided in a sterile capsule. The capsule includes the two separate components, a glass powder and polyacrylic acid liquid. An activator is used to release the liquid component prior to use. The capsule is then placed in a mixer, which mixes the glass powder and polyacrylic acid liquid to form a compliant cement. The applicator is used to apply the compliant cement to the appropriate location in the middle ear. The cement then hardens in place to provide a permanent bond.

Acceptance Criteria and Device Performance for ProCem™ Otologic Bone Cement

This document summarizes the acceptance criteria and supporting study for the ProCem™ Otologic Bone Cement, as derived from the provided 510(k) summary (K140644).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for ProCem™ Otologic Bone Cement are based on its substantial equivalence to predicate devices (SerenoCem, K003567 and EnvoyCem, K080032). The study conducted was primarily to demonstrate that ProCem™ meets physical and functional requirements comparable to these predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes "Design verification testing" but does not explicitly state specific sample sizes for each test (exothermic reaction, working time, snap set time, simulated preparation properties). The data provenance is not specified in terms of country of origin, but the studies were conducted by Ototronix LLC, the submitter, as part of their 510(k) application. This would be considered a prospective study conducted for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

There is no mention of experts being used to establish a "ground truth" in the context of clinical performance or diagnostic accuracy. The testing described focuses on the physical and functional properties of the bone cement itself, rather than interpretation of clinical outcomes by experts.

4. Adjudication Method for the Test Set

Not applicable. The described testing is focused on objective physical and chemical properties of the device, not on subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a bone cement, not an imaging or diagnostic AI device that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone study was done. The "Performance Bench Testing" describes in-house design verification testing, demonstrating the physical and functional properties of the ProCem™ device on its own. This testing was performed independent of human interaction in a clinical setting for performance evaluation.

7. Type of Ground Truth Used

The ground truth for the performance bench testing was based on established engineering specifications and comparison to the known performance characteristics of the predicate device (SerenoCem). This involves objective measurements of physical and chemical properties.

8. Sample Size for the Training Set

Not applicable. The ProCem™ Otologic Bone Cement is a physical medical device (bone cement), not a software algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device.

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EnvoyCem is intended for use in otologic surgery for the following applications:

• Augmentation or coupling of the middle ear ossicles.
• Attachment of the middle ear ossicles to middle ear implants.
• Mechanical stabilization of middle ear prostheses.

EnvoyCem is glass ionomer cement that is provided as two components, a glass powder and polyalkenoic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ.

This submission is for a medical device (EnvoyCem, a glass ionomer cement) and as such, the performance testing described is focused on the device's physical and biological properties rather than an AI/ML algorithm's clinical performance. Therefore, many of the requested categories for AI/ML study components (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this 510(k) summary.

Here's a breakdown of the available information based on your request, with an explanation of why certain elements are not present:

1. Table of acceptance criteria and the reported device performance

The submission mentions that "All testing indicates that EnvoyCem meets its specification requirements." However, the specific acceptance criteria (numerical thresholds for success) and the detailed reported performance values for each test are not explicitly provided in this 510(k) summary. The document broadly states that the device successfully completed various tests.

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

This information is not provided. For non-AI/ML medical devices like this cement, "test sets" typically refer to lab-based studies on the material itself, not patient data.

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 for a cement's physical and biological properties is established through standardized laboratory testing methods, not expert consensus on patient data.

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

Not applicable, as this pertained to laboratory testing of device properties, not clinical assessment requiring expert adjudication.

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 a medical device for surgical applications (cement), not an AI-assisted diagnostic tool.

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

Not applicable, as this is a medical device (cement), not an AI algorithm.

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

The "ground truth" for this device's performance is established through standardized laboratory testing protocols for:

• Physical properties (functional stability, hardening time, etc. – implied by "functional testing").
• Shelf life properties (implied by "accelerated shelf life testing").
• Biocompatibility (MEM Elution extract testing, Fourier transform infrared spectroscopy for chemical equivalence).
• Sterility (sterilization validation protocols).

8. The sample size for the training set

Not applicable for a medical device (cement). "Training set" is a concept specific to AI/ML algorithms.

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

Not applicable for a medical device (cement).

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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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OtoMimix™ is indicated for the following:

1. Augmentation or coupling of the middle ear ossicles.
2. Attachment of the middle ear ossicles to middle ear implants.
3. Mechanical stabilization of middle ear prostheses
4. Reconstruction of the posterior canal wall

OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens.

The OtoMimix™ device is a calcium phosphate bone replacement product intended for use in otology procedures for augmentation or coupling of middle ear ossicles, attachment of ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and reconstruction of the posterior canal wall. The provided document does not contain an explicit list of acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission relies on demonstrating substantial equivalence to previously approved predicate devices to establish its safety and effectiveness.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no explicit quantitative acceptance criteria or detailed performance study results (e.g., success rates, functional outcomes, specific measurements) provided in the summaries for OtoMimix™, a direct table comparing "acceptance criteria" against "reported device performance" cannot be fully constructed in the conventional sense for a performance study.

However, we can infer the "acceptance criteria" from the substantial equivalence comparison to predicate devices, focusing on material composition, indications for use, and critical characteristics. The "reported device performance" in this context is the assertion that OtoMimix™ shares these characteristics with the approved predicates.

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

The document does not describe a clinical "test set" in the context of a performance study for OtoMimix™. The device's safety and effectiveness are established through substantial equivalence to predicate devices. This means that instead of conducting a new large-scale clinical trial for OtoMimix™, its characteristics (materials, indications, technological features) were compared to predicates already legally marketed.

The key 'data' supporting equivalence are:

• Material composition: OtoMimix™ uses Calcium Phosphate cement, which is stated to be the "Same as Mimix Predicate."
• Ototoxicity: "Demonstrated to be non-ototoxic (Dornhoffer et al.)" for OtoMimix™, similar to the Mimix predicate. This likely refers to preclinical or clinical data associated with the material class or directly with the Mimix predicate, rather than a specific new study on OtoMimix™ itself in this submission. The origin of this Dornhoffer et al. data (country, retrospective/prospective) is not specified.

Therefore, there is no direct "test set" with a specified sample size or explicit data provenance for OtoMimix™'s performance study within this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, there was no independent "test set" requiring expert ground truth establishment for OtoMimix™'s performance study. The evaluation was primarily a comparison of device characteristics against approved predicate devices by the FDA review team.

4. Adjudication method for the test set

Not applicable. There was no "test set" for which adjudication of results would be required. The FDA's review process determines substantial equivalence based on the submitted information and comparison to predicates.

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 a surgical implant/cement, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This device is a physical product (bone replacement material), not a software algorithm.

7. The type of ground truth used

The "ground truth" for the substantial equivalence determination relies on:

• Predicate Device Approvals: The regulatory history and approved characteristics of Mimix (K990290, K003494), Oto-Cem (K011338), and Incus Stapes Prosthesis (K861369). These devices already have established safety and effectiveness.
• Material Science/Bench Testing: The assertion that OtoMimix™'s material, technological features, and ototoxicity are "Same as Mimix Predicate," implying that the data (e.g., biocompatiability, mechanical properties, ototoxicity studies like Dornhoffer et al.) associated with the Mimix predicate serve as the basis for OtoMimix™.
• Literature/Expert Consensus: The affirmation that hydroxyapatite is a commonly used material for middle ear prostheses and has an "Extensive history of middle ear use."

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model, so there is no training set.

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

Not applicable.

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