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510(k) Data Aggregation
(29 days)
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, also referred to as MEDPOR CIs, product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input. These MEDPOR CIs are currently packaged into MEDPOR CI Kits with a patient-specific Host Bone Model (HBM) that represents the 3D patient's anatomy surrounding the defect location. This Special 510(k) is submitted specifically to include the customer option to sell new Stryker CMF MEDPOR Priority Customized Implant Kits without the Host Bone Model subcomponent.
The Stryker CMF MEDPOR Priority Customized Implant Kit is a medical device that has been cleared by the FDA. The device is intended for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard | Reported Device Performance | Study Details |
|---|---|---|---|
| Sterilization | Product Adoption Protocol | Passed | Testing performed to adopt the MEDPOR Priority CI Kit into existing Cycle 51 at Stryker Sustainability Solutions. |
| Sterilization / Biocompatibility | EO Residual Testing | Passed | Evaluated ethylene oxide (EO) residuals to ensure biocompatibility after sterilization by Stryker Sustainability Solutions. |
| Design Integrity | No change to the MEDPOR CI device itself | Confirmed no changes to the implant design. | This submission is specifically for the optional removal of the Host Bone Model subcomponent, not the implant itself. |
| Material Integrity | No change in materials of construction | Confirmed implants are still made from high-density polyethylene (HDPE). | Comparative review with predicate device (K153508). |
| Manufacturing Process Integrity | No change in manufacturing process | Confirmed manufacturing process for the implant itself remains the same. | Comparative review with predicate device (K153508). |
| Duration/Location of Contact | No change in duration or location of contact | Confirmed no changes. | Comparative review with predicate device (K153508). |
| Intended Use | Same as predicate device | Confirmed same intended use. | The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation and/or restoration 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). |
| Operating Principle | Same as predicate device | Confirmed same operating principle. | To fill bony voids, defects, and contour irregularities in non-load bearing regions of the craniofacial skeleton. |
| Mode of Fixation | Same as predicate device | Confirmed implants are fixated with Stryker Neuro, Midface, and/or Upperface self-drilling screws. | Comparative review with predicate device (K153508). |
| Safety and Effectiveness | Modifications do not raise new questions of safety or effectiveness. | Concluded that the modifications support substantial equivalence. | A risk analysis was performed. Performance bench testing, animal testing, and clinical testing were not required as a basis for substantial equivalence because the core device design and materials remained unchanged. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a separate "test set" in the traditional sense for evaluating device performance. The evaluation was primarily a comparison to a predicate device and focused on changes related to sterilization with a new facility.
- Sterilization Testing: The sample size for the "Product Adoption" and "EO Residual" testing is not explicitly stated. The text describes "tests were performed to adopt the MEDPOR Priority CI Kit into existing Cycle 51 at Stryker Sustainability Solutions." This implies samples of the MEDPOR CIs were used for these sterilization validation tests.
- Data Provenance: The new sterilization location is Stryker Sustainability Solutions, so the data would originate from that facility's testing protocols. The nature of this testing (e.g., in-house lab testing for sterility assurance) is inherently prospective for the validation of the new sterilization site.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this submission. The submission primarily addresses a change in offering (removal of a subcomponent) and validation of an additional sterilization location. It does not involve a diagnostic or interpretive device where "ground truth" would be established by experts reviewing a test set of cases. The ground truth for sterilization is established through established ISO standards and validation protocols for sterility assurance levels.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring multi-expert adjudication described for this submission. The validation focused on physical and chemical properties related to sterilization and ensuring consistency with the predicate device.
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. The device is a physical implant, not an AI-assisted diagnostic tool or an imaging system that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Stryker CMF MEDPOR Priority Customized Implant Kit is a physical implant, not an algorithm or software-based device.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Sterilization Standards: Industrial sterilization validation standards (likely ISO 11135 for Ethylene Oxide sterilization) serve as the ground truth for confirming product sterility and acceptable EO residuals.
- Predicate Device Equivalence: The established physical, chemical, and biological properties of the previously cleared predicate device (K153508) serve as the ground truth for substantial equivalence, given that the core implant design, materials, and intended use have not changed.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI/ML-based device that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8)
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