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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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(122 days)
PEEK Customized Cranial Implant
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 12 years of age and older.
The Stryker PEEK Customized Cranial Implant (CCI) product offerings provide customized cranial or craniofacial (craniofacial region is defined as the orbital rim, zygoma, and adjacent bone) patient specific implants based on CT data and surgeon input. This traditional 510(k) is submitted to add an additional indication for use to augment and/or restore soft tissue deformities in the cranial and craniofacial skeleton; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
This document, a 510(k) Summary for the Stryker PEEK Customized Cranial Implant Kit, outlines the device's indications for use and compares it to a predicate device. However, it explicitly states that biocompatibility testing, performance bench testing, animal testing, and clinical testing were NOT required as a basis for substantial equivalence for the new indication for use being sought in this submission (K153248).
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for a study proving the device meets acceptance criteria, cannot be provided from this document.
The document explains that substantial equivalence for the new indication (augmentation and/or restoration of soft tissue deformities, specifically PTH) was based on a literature review and case history to demonstrate that the expanded indication does not raise new questions of safety or effectiveness compared to the predicate device.
Specifically, the document states:
- "A literature review was performed to identify relevant clinical literature with applicable data to show that, when compared to the predicate device, the new Indication for use added to the subject device does not raise new questions of safety or effectiveness. The results of this review provides evidence of this fact." (Page 4)
- "To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history. A summary of the clinical literature verifies that PTH reflects a deficiency in the bulk of the temporalis muscle or overlying temporal fat pad. Surgical results with augmented implant designs have been published upon and shown to be clinically successful in addressing PTH." (Page 5)
In summary, this document does not contain a study with acceptance criteria and a test performed against them. It relies on a literature review and case history to support the expanded indications for use.
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(30 days)
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
The Stryker PEEK Customized Cranial Implant Kit is intended to replace bony voids in the cranial and the craniofacial skeleton.
The Stryker PEEK Customized Cranial Implant Kit is indicated for filling bony voids in the craniofacial skeleton in patients 12 years of age and older.
The Stryker PEEK Customized Cranial Implant (CCI) is intended to replace bony voids in the cranial and the craniofacial skeleton in patients 12 years of age and older. The PEEK CCI product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input. This special 510(k) is being submitted due to the optional removal of the Host Bone Model from the PEEK CCI Kit which creates the PEEK Customized Cranial Priority Implant product offering, and also the standard PEEK Customized Cranial Implant product offering.
This document is a 510(k) summary for the Stryker PEEK Customized Cranial Implant Kit, K152076. Based on the provided text, the device is a modified version of a previously cleared device (K121153), where the modification involves making the Host Bone Model optional.
As such, the document states that performance data, including bench testing, animal testing, and clinical testing, were NOT required as a basis for substantial equivalence because the modification does not alter the technological characteristics of the actual implant. There are no changes in material, duration or location of contact, or reprocessing methods for the implant itself.
Therefore, the document does not contain specific acceptance criteria or an explicit study proving performance against such criteria for the modified device in the typical sense of a new device clearance. Instead, it relies on the predicate device's clearance and the argument that the core functionality and safety remain unchanged.
Given this, I cannot provide the requested information in the format of acceptance criteria and reported device performance for K152076, nor details about sample sizes, ground truth establishment, or comparative effectiveness studies. The document explicitly states these were not required for this particular submission.
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