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CMRP:
The Customized Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation.

SMRP:
The Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone araft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation.

The subject devices include the Stryker Customized Mandible Recon Plate (CMRP) and Stryker Surgeon iD Mandible Recon Plate (SMRP). Both CMRP and SMRP are intended to be used for rigid internal fixation of primary, secondary mandibular reconstructions, and fixation of mandibular fractures; and have an indication for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation. Subject devices have similar intended use and technical characteristics as the primary predicate device (K193136) and the reference device (K190696), and the additional language in indications for use statement is supported by the reference device (K014263).

The subject devices' plate(s) are designed and manufactured for one patient and/or surgeon specifically, and the customized patient-specific and surgeon-specific design of the plate(s) allows certain features to be configured to meet the individual needs of each patient and surgeon. The subject devices' plate has additional design configuration options (such as branches and flanges, and updated plate bar widths of 5.75-7.5mm) when compared to the primary predicate device. The subject devices' plate(s) are provided with the Design Proposal document, an Instruction for Use (IFU), and an optional Anatomical Model. Additionally, the subject device is compatible with a separately provided Surgical Guides accessory.

The provided text describes a medical device submission (K222650) for the Stryker Customized Mandible Recon Plate and Stryker Surgeon iD Mandible Recon Plate. It focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets clinical acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it pertains to clinical performance which was explicitly stated as not required.

However, the document does mention "performance testing" related to mechanical strength and "End User Validation" that met pre-defined acceptance criteria.

Here's the information that can be extracted, and where details are missing:

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)

• Test Set Sample Size: Not specified for mechanical strength testing (e.g., number of plates tested). Not specified for end-user validation.
• Data Provenance: Not specified.

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)

• Number of Experts: For End User Validation, it refers to "skilled users" and "surgeons," but the specific number is not provided.
• Qualifications of Experts: It specifies "skilled users" and "surgeons" for the end-user validation, but further details on their specific qualifications or experience are not provided.

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

• Not applicable to the mechanical bench testing or the described end-user validation.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (bone plate), not an AI/software device.

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

• Not applicable. This is not an algorithm/AI device.

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

• Mechanical Strength Testing: The "ground truth" or reference for evaluating mechanical strength was established by "the corresponding worst case design" and the tests performed "according to the standards ASTM F382 and ASTM STP 731."
• End User Validation: The "ground truth" was whether the "user needs / design inputs were met." This was assessed by surgeons in a simulated use scenario.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model that requires a training set.

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

• Not applicable. This device is not an AI/machine learning model.

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The Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.

The Stryker Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.

The Subject Device, the Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.

The Surgeon iD Mandible Recon Plate is a surgeon-specific plate which is designed based on an average mandible model. The plate is designed per surgeon's preference within the following design envelope. The Surgeon iD Mandible Recon Plate is offered in hemi and full shapes and three different sizes (Small, Medium, and Large). The plate can be designed with a profile height of 2.0 mm or 2.8 mm, with a number of screw holes between 4 and 50, and bar widths between 5.5 mm and 6.5 mm. The plate is made of commercially pure titanium.

The provided text describes the Stryker Surgeon iD Mandible Recon Plate and its acceptance criteria, but it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study showing device performance against specific, quantifiable acceptance criteria in the manner typically expected for AI/software devices. The acceptance criteria in this document relate more to the validation process rather than direct performance metrics against a clinical standard.

Here's an attempt to extract and interpret the requested information based on the provided text. It's important to note that many sections of your request are not directly applicable or explicitly stated in this type of 510(k) summary for a physical medical device. This summary focuses on materials, design, and comparison to a predicate, not AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" are related to the successful completion of verification and validation (V&V) activities and the functional demonstration that the device performs as intended and is compatible with its packaging.

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

This information is not provided in the document. The text mentions "Verification and Validation activities" and "performance testing" but does not specify sample sizes for these tests or the provenance of any data beyond indicating that existing predicate device data was referenced for some aspects. Given this is a physical implantable device, the "test set" would likely refer to the number of plates or components tested, not a dataset in the AI sense.

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

This information is not applicable as presented. The concept of "ground truth" established by experts, particularly for an AI/software device, is not discussed in this 510(k) summary for a bone plate. Ground truth for a physical device like this is typically established through engineering specifications, material testing standards, and ultimately, clinical outcomes (though clinical trials were not required here).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation (e.g., radiology reads) to resolve discrepancies among experts. This 510(k) summary describes bench testing and equivalence to a predicate device, not expert adjudication of a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices comparing human reader performance with and without AI assistance. This document is for a physical medical device (a bone plate), not an AI diagnostic tool. Clinical testing was explicitly stated as "not required as a basis for substantial equivalence."

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

No, a standalone algorithm performance study was not done. This device is a physical bone plate, not an algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for the performance bench testing would be defined by engineering specifications, material science standards, and the expected mechanical behavior of such a plate. For aspects like biocompatibility and sterilization, the ground truth is established by regulatory standards and established test methods that were either performed or referenced from the predicate device. Clinical outcomes data was not a basis for this submission.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical bone plate, not an AI model that requires a training set. The design of the plate is based on an "average mandible model" and "surgeon's preference," which are design inputs, not a 'training set' in the machine learning sense.

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

This information is not applicable and not provided. As the device is not an AI algorithm, there is no "training set" or corresponding ground truth to be established in that context.

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