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The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).

The Stryker CMF MEDPOR Customized Implant (CI) product offerings provide customized craniofacial patient specific implants designed at the request of a surgeon. The customized craniofacial implants are molded from porous high density polyethylene (HDPE) and the MEDPOR material provides a porous structure which allows for tissue ingrowth. The MEDPOR CI is manufactured to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.

This document is a 510(k) premarket notification for a medical device called the "Stryker CMF MEDPOR Customized Implant." The purpose of this notification is to demonstrate that the device is substantially equivalent to a previously cleared predicate device.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, primarily through comparison of technological characteristics and indications for use, rather than presenting de novo performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because this information is not present in the provided document. The document explicitly states:

• "Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence." (Page 5)
• "Performance Bench testing was not required as a basis for substantial equivalence." (Page 5)
• "Animal testing was not required as a basis for substantial equivalence." (Page 5)
• "Clinical Testing: To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history." (Page 6) - This indicates a literature review, not a new clinical study with acceptance criteria.

The document is a declaration of substantial equivalence, which often relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device without requiring new performance data against specific acceptance criteria, especially if the changes are minor or relate to a new indication for a similar device.

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The Stryker CMF MEDPOR® Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

The Stryker CMF MEDPOR® Customized Implant is sold as a kit of two identical implants plus one host bone model. The Stryker CMF MEDPOR Customized Implants are molded from porous high density polyethylene (HDPE) to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request. The porous structure of the MEDPOR material allows for tissue ingrowth. The implant is fixed into place using compatible Stryker fixation systems. The implants and host bone model are provided sterile for single use only.

This document describes a 510(k) premarket notification for the Stryker CMF MEDPOR® Customized Implant. The submission focuses on adding two additional surgeon design options to an already cleared predicate device (K121315). As such, the information provided primarily addresses the differences and similarities to the predicate device rather than a comprehensive, standalone performance study for the original device.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative numerical format typically found in performance studies for new algorithms or devices with new functionalities. Instead, the "acceptance" for this 510(k) hinges on demonstrating substantial equivalence to the predicate device.

The performance data supplied is for the modifications to the device and demonstrates that the modifications do not negatively impact the device's equivalence to the predicate.

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

This document does not describe a "test set" in the context of typical AI algorithm validation (e.g., a dataset of images with ground truth). The performance data cited are primarily bench tests and software/material assessments against the predicate device.

• Screw Pullout Testing: The specific sample size for this test is not mentioned.
• End User Validation Testing: The number of end-users or cases involved is not specified.
• Data Provenance: Not applicable in the context of this 510(k) where clinical dataset provenance is not the focus. The documentation comes from Stryker Leibinger (Germany and USA).

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

Not applicable. This 510(k) is not for an AI algorithm that requires expert-established ground truth on a test set. The validation revolves around maintaining safety and effectiveness equivalent to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication of ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a customized implant, not an AI diagnostic algorithm, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical customized implant, not an AI algorithm, and therefore does not have a "standalone" or "human-in-the-loop" performance in the sense of AI. While software is used in its design process, the 510(k) states that the addition of design options does not change the manufacturing process or internal control systems, implying that the existing software validation (from the predicate K121315) is sufficient, and no new standalone software performance study was required.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI algorithms (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device (K121315). The aim of the submission is to demonstrate that the proposed modifications do not alter this established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This 510(k) is not for an AI algorithm developed using a training set.

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

Not applicable. This 510(k) is not for an AI algorithm.

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The Stryker CMF MEDPOR Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

The Stryker CMF MEDPOR Customized Implant is sold as a kit of two identical implants plus one host bone model. The customized craniofacial implant is molded from porous high density polyethylenc (HDPE) to the specific dimensions indicated by the surgeon via submission of CT scans. The porous HDPE Implant is fixed into place using compatible Stryker screws.

The provided text details a 510(k) submission for the Stryker CMF MEDPOR Customized Implant. This is a traditional 510(k) for a medical device (implant), not an AI/ML software. Therefore, the typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, F1-score, etc.) and studies with ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various non-clinical performance data.

Here's a breakdown of the requested information based on the provided text, adapted to the context of a medical implant:

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

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 applicable to this type of submission. The performance data is based on bench testing of the physical implant, manufacturing process validation, and biocompatibility testing, not on clinical patient data in the way an AI/ML study would utilize it. No "test set" in the context of patient data is mentioned.

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)

This is not applicable. Ground truth for an AI/ML model is established by experts reviewing data. For a medical implant, "ground truth" relates to material properties, strength, sterility, and biocompatibility, which are verified through laboratory tests and engineering validations, not expert consensus on medical images or clinical outcomes.

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

Not applicable. Adjudication methods are typically used in clinical studies or expert review processes, which are not described here.

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. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in conjunction with AI. This submission is for a physical implant.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device is derived from:

• Standards Compliance: Demonstrating adherence to established ISO and ASTM standards for biocompatibility, sterilization, packaging, and pyrogenicity.
• Bench Test Results: Objective measurements of the implant's physical and mechanical properties.
• Validation of Manufacturing Processes: Ensuring that the Virtual Implant Design Process (VIDP) consistently produces implants to specifications.
• Predicate Device Data: Leveraging the safety and effectiveness data of previously cleared, substantially equivalent devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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