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510(k) Data Aggregation
(124 days)
Stryker PEEK Customized Cranial Implant Kit
The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.
The PEEK Customized Cranial Implant Kit product provides a customized cranial or craniofacial patient specific implant solution based on patient CT/CBCT data and surgeon input. This submission is to expand the Stryker PEEK CCI product portfolio to include the single stage option.
The provided text describes a 510(k) premarket notification for the Stryker PEEK Customized Cranial Implant Kit (K203055). This submission expands an existing product portfolio to include a single-stage option. The device is a custom implant for cranial and craniofacial bone and soft tissue deformities.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | No change in material, duration of contact, or reprocessing methods compared to the predicate device. |
| Sterility | No change in manufacturing processes, materials, or packaging processes compared to the predicate device. |
| Performance Bench Testing - Implant Fit | All V&V activities that were performed met their respective acceptance criteria. All end-user validation tasks were completed, passed successfully, and supports the substantial equivalence of the subject device to the predicate device. |
| Performance Bench Testing - Single Stage Surgical Procedure with/without surgical aid options (Marking guides/guided; Virtual template/Navigation system; w/out surgical aid) | All V&V activities that were performed met their respective acceptance criteria. All end-user validation tasks were completed, passed successfully, and supports the substantial equivalence of the subject device to the predicate device. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is an End-User Validation Lab as part of Performance Bench Testing. The document explicitly states: "Additionally, an end-user validation lab was conducted to evaluate the subject device and to support the basis for substantial equivalence."
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size (number of implants, tests, or end-users) used for the end-user validation lab.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It describes a "lab" setting, suggesting a controlled, prospective evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. While an "end-user validation lab" implies involvement of relevant personnel (likely surgeons or qualified medical professionals), the number and specific qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for the end-user validation lab.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a passive implant, not an AI-assisted diagnostic or therapeutic tool.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device itself is an implant, not a standalone algorithm. The "single stage surgical procedure with/without surgical aid options" described in the performance bench testing evaluates the implant's fit and the use of aids, which inherently involves human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the end-user validation lab appears to be based on successful completion of tasks and meeting pre-defined acceptance criteria for implant fit and surgical procedure performance, likely evaluated by the participating end-users and study observers. The document doesn't mention pathology or long-term outcomes data for this specific validation.
8. The sample size for the training set:
Not applicable. This device is a physical implant, not an AI or machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device. The design and manufacturing processes are validated against established standards and predicate device characteristics.
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(156 days)
Stryker PEEK Customized Cranial Implant Kit
The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.
The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input.
The Stryker PEEK Customized Cranial Implant is a medical device intended for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton for patients 3.5 years of age and older.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define quantitative acceptance criteria for this device in the same way one might for a diagnostic AI. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device and the discussion of benefits outweighing risks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Safe for implantation, no adverse biological reactions. | Not explicitly re-tested for this specific submission. Stated: "Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence. There is no change in the material, duration of contact, or reprocessing methods for the PEEK CCI." Implies performance is equivalent to predicate, which has established biocompatibility. |
| Performance Bench Testing: Mechanical integrity and fit. | Not explicitly re-tested for this specific submission. Stated: "As the Performance Bench testing of the Predicate Device are valid for the Subject Device, and because the performance bench testing of the both devices are identical, an additional performance bench testing was not required for the Subject Device as a basis for substantial equivalence." Implies performance is equivalent to predicate. |
| Clinical Safety & Effectiveness: Safe and effective for its indicated use (augmentation/restoration of cranial/craniofacial deformities in patients ≥ 3.5 years old). | "Clinical studies and findings show the potential benefits associated with the use of the device outweigh the potential risks associated with the Subject Device... the safe and effective application of alloplastic cranioplasties in patient 3.5 years of age and above." (References provided: Nguyen et al. 2018, Rocque et al. 2018, Ma et al. 2018, Sainsbury et al. 2017, Fu et al. 2016). These studies support the use of PEEK and other alloplastic implants in a similar patient population and application. |
| Risk Mitigation: Potential risks adequately addressed. | Identified potential risks (Growth related risks, Radiation related risks). Mitigation: IFU contains information regarding growth disturbance, and scan protocols include information to minimize ionizing radiation dose using low-dose and child-size CT-protocols. The overall benefit and risk ratio remains equivalent 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 an algorithm or diagnostic device. The evaluation relies on a review of existing scientific peer-reviewed publications. The sample sizes are derived from these referenced clinical studies:
- Nguyen et al. 2018: 136 cases utilizing custom CAD/CAM implants for complex craniofacial reconstruction in children. (Data provenance not specified, but likely multi-center based on similar studies).
- Rocque et al. 2018: Multicenter study at 13 institutions. (Specific sample size for PEEK implants not given, but context suggests a larger cohort of cranioplasty patients).
- Ma et al. 2018: 84 cases of cranioplasty (6 PEEK implants, 36 split calvarial grafts, 33 titanium meshes).
- Sainsbury et al. 2017: Cases involving bilateral malar reconstruction with customized PEEK implants. (Specific sample size not given, but likely a smaller case series).
- Fu et al. 2016: Pediatric patients, 73% received alloplastic implants (PEEK, PMMA, MEDPOR, titanium), 28% autologous reconstructions. (Specific sample size not given, but implied to be substantial given the percentages).
The data provenance is from published clinical literature, which often encompasses retrospective and/or prospective studies conducted in various clinical settings. Specific country of origin is not detailed for each individual study in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study evaluating a diagnostic algorithm where "ground truth" is established by experts on a test set. The clinical evidence is derived from existing peer-reviewed literature, where the outcomes of the surgical procedures serve as the "truth" regarding the device's performance in patients.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" or adjudication process described as part of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a customized cranial implant, not an AI-assisted diagnostic tool. Therefore, studies on human readers improving with or without AI assistance are not relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the effectiveness and safety of the PEEK customized cranial implant is derived from:
- Clinical Outcomes Data: Published results detailing patient outcomes following the implantation of PEEK and other alloplastic cranioplasties (e.g., successful augmentation, restoration of bony defects, complication rates, follow-up over time).
- Clinical Experience/Expert Consensus (within referenced studies): The studies reflect the collective experience and findings of clinicians and surgeons regarding the use and performance of these types of implants.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set. The design of the custom implant for a specific patient is based on that individual patient's CT data, not a general training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device in the context of an algorithm.
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