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The Stryker Customized Mandible Recon Plate Kit is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.
The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.

The Subject Device, CMRP Kit (CMRP) is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions and is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. The CMRP was cleared in K132519 and serves as an identical cleared Predicate Device, which shows the implant design software and design process, implant compatibility with the anatomical model, and the utilization of customized Guides which are similar to those offered for use with the Subject Device Stryker Customized Mandible Recon Plate Kit.

The Subject Device plate(s) are manufactured patient-specific plates, and the patient-specific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with the Design Proposal, an Instruction for Use (IFU), and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Guides accessory.

This 510(k) summary describes the Stryker Customized Mandible Recon Plate Kit, a device intended for surgical reconstruction of the mandible. The submission focuses on demonstrating substantial equivalence to a predicate device already on the market, particularly given a software update and compatibility with another system.

Here's an analysis of the acceptance criteria and supporting studies as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria and reported device performance in the format requested. Instead, it states that the "subject device met all pre-defined acceptance criteria as the primary predicate device," indicating that the acceptance criteria are implicitly linked to the performance of the predicate device.

The reported device performance is described generally: "the results of the tests support the substantial equivalence of the subject device to the primary predicate device." More specifically, the cadaver lab testing "showed that the subject device is performing as intended in the specified use conditions."

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

The document mentions "performance testing in the cadaver lab." However, it does not specify the sample size (i.e., number of cadavers) used for this test set nor does it explicitly state the provenance of the data (e.g., retrospective or prospective).

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver lab testing. It simply refers to "end-user test validation."

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the test set.

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

An MRMC comparative effectiveness study was not performed or mentioned in this submission. The device is a physical bone plate kit and not an AI-assisted diagnostic tool that would typically involve such a study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study in the context of an algorithm without human-in-the-loop performance is not applicable or described for this physical device. The software update mentioned is related to design and visualization, not an autonomous diagnostic algorithm.

7. Type of Ground Truth Used:

For the cadaver lab testing, the ground truth was likely established through direct observation and assessment by surgical end-users of the device's performance in physically reconstructing the mandible. This would involve evaluating how well the customized plates fit, the stability of the fixation, and ease of use in a realistic surgical environment.

8. Sample Size for the Training Set:

The concept of a "training set" in the context of machine learning is not applicable here as this is a physical medical device. While software updates are mentioned for automated bone thickness measurements and visualization, the document does not detail any machine learning models that would require a distinct training set. The software was subject to "Software Verification and Validation testing."

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

As mentioned above, the concept of a training set is not directly applicable. For the software verification and validation, the "ground truth" would be established through predefined software requirements and specifications, and the validation would verify that the software outputs (e.g., bone thickness measurements, visualization) accurately reflect the design intent and input data. These tests were performed "according to internal procedures and IEC 62304."

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The Customized Mandible Recon Plate Kit is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions. The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delaved secondary reconstruction and secondary mandibular reconstruction.

The Customized Mandible Recon Plate Kit includes customized, patient specific implants, the Customized Mandible Recon Plates. Additionally, the kit includes the Instruction for Use (IFU) and a printed version of the Design Proposal approved by the surgeon prior to plate manufacture. It may include an anatomical model, named Mandible Model. The Customized Mandible Recon Plates (CMRP) and the corresponding Mandible Model are designed and manufactured for one specific patient. The products are ordered by a surgeon on a patient-by-patient basis over an internet platform referred to as the "eRequest Lifecycle online ordering system" which was already cleared with K111065 for ordering patient specific polymer implants to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone. Based on patient specific anatomical data (CT-scan) and input from the surgeon, a virtual mandible recon plate with its specific dimensions (profile heights, length and 3D run of the plate, number and position of screw holes and bar strengthening) is created using the Customized Mandible Recon Plate Design Process (CMRP-DP) including the Plate Design Software (PDS). Screenshots of the virtual plate are then presented to the surgeon in the Design Proposal (pdf-file). After the surgeon approves the Design Proposal via the above mentioned eRequest Lifecycle online ordering system, the Customized Mandible Recon Plate, as well as the Mandible Model (if ordered by the surgeon), are manufactured according to the specifically set design requirements. Once the manufacturing process is finalized and the devices are cleaned, they are packed, labeled and shipped to the location specified during the ordering process. The CMRP implant is compatible with the Stryker Universal Mandibular System. Additionally. Stryker offers customized cutting and drill guides for use with the Customized Mandible Recon Plate.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Stryker Customized Mandible Recon Plate Kit:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary explicitly states that: "The Subject Device fulfilled all set acceptance criteria for each category in accordance with either ISO or ASTM specifications, or internally predetermined acceptance criteria if no standards were applicable."

Unfortunately, the document does not provide specific quantitative acceptance criteria values or detailed quantitative device performance results for each test. It only lists the categories of tests performed and the relevant standards. Therefore, I can only provide a table with the types of tests and the general outcome reported.

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

The document does not specify the sample sizes used for the non-clinical tests. It also does not discuss data provenance in terms of country of origin or whether the data was retrospective or prospective, as these non-clinical tests typically involve laboratory testing of manufactured devices or materials, not patient data in the conventional sense.

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

This information is not applicable to the non-clinical performance and V&V testing described. "Ground truth" in this context refers to clinical outcomes or diagnoses, which were not part of this submission's evidence for efficacy. For mechanical and biocompatibility testing, the "ground truth" is defined by the standards (ISO, ASTM) themselves or internal specifications.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers assess cases and their disagreements need to be resolved. The tests described are laboratory-based conformance tests.

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

No. The document explicitly states: "No clinical testing was performed to support this submission." Therefore, no MRMC study was conducted.

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

No. This device is a physical medical implant (a bone plate) and associated design/manufacturing process, not an algorithm or AI software for diagnosis or analysis. The "Plate Design Software (PDS)" is part of the design process, but its performance wasn't evaluated as a standalone AI diagnostic tool.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is the established acceptance limits defined by international standards (ISO, ASTM) or internal predetermined specifications. For example, a biocompatibility test result must fall within the range deemed safe by ISO 10993, and mechanical strength must exceed certain load thresholds.

8. The Sample Size for the Training Set

Not applicable. The device is a physical implant and manufacturing process. There is no concept of a "training set" as one would have for a machine learning algorithm. The design process for each plate is customized based on patient-specific CT data and surgeon input, but this is not a learning algorithm that requires a "training set" of cases to develop its core function.

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

Not applicable, as there is no "training set" for this device. The design process (CMRP-DP including PDS) relies on established engineering principles, CAD/CAM software, patient-specific imaging data (CT-scan), and surgeon input, rather than a machine learning model trained on a ground-truthed dataset.

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