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The Stryker Facial iD System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use:

• Orbital reconstructive/ trauma surgery

The Stryker Facial iD System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orbital reconstructive and/or trauma surgery. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented, and not intended for cranial use.

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

Here's a breakdown of the acceptance criteria and study information for the Stryker Facial iD System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of "acceptance criteria" with quantitative targets for each test, followed by the measured "device performance." Instead, it describes various performance tests and states that the "acceptance criteria were met" or that the device "met all pre-defined acceptance criteria."

I'll synthesize the information into a table format based on the tests performed and the outcomes mentioned:

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

• Mechanical Bench Testing: The document states that "All tests have been performed with the corresponding worst-case design considering the entire design envelope and all design features." It does not specify a numerical sample size (e.g., number of implants tested).
  • Data Provenance: Not explicitly stated, but it's in vitro bench testing.
• Biocompatibility Testing: Not specified.
  • Data Provenance: Not explicitly stated, but it's in vitro laboratory testing.
• Cleaning & Sterilization: Not specified.
  • Data Provenance: Not explicitly stated, but it's in vitro laboratory testing.
• End-User Testing: Not specified.
  • Data Provenance: Not explicitly stated, but it implies internal testing or simulation scenarios.

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

This information is not provided in the document. The studies described are primarily laboratory and bench testing, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are technical performance tests (mechanical, biocompatibility, sterilization) and not clinical studies requiring human interpretation and adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The document states "Clinical testing was not required as a basis for substantial equivalence." The studies focused on technical performance and comparison to predicate and reference devices.

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

This concept is not directly applicable to the Stryker Facial iD System as described. The "system" involves the design and manufacturing of patient-specific implants. While there's likely software involved in generating the designs from CT scans (similar to the predicate KLS Martin IPS software), the document focuses on the implant's performance rather than the standalone performance of a diagnostic algorithm or AI for interpretation. The device itself is an implant, not an AI software intended for standalone diagnostic use.

7. The Type of Ground Truth Used

• Mechanical Bench Testing: The ground truth is established by the performance characteristics of the Reference Device (K221855), against which the Subject Device's mechanical stability was compared for "substantial equivalence."
• Biocompatibility Testing: The ground truth is established by the international standards (ISO 10993-1, DIN EN ISO 10993-5, DIN EN ISO 10993-12) for biocompatibility.
• Cleaning & Sterilization: The ground truth is established by international standards (DIN EN ISO 17665-1, ISO 17665-2, ISO 14937) for sterilization and sterility assurance levels.
• End-User Testing: The ground truth is the "intended performance" under specified use conditions.

8. The Sample Size for the Training Set

This information is not applicable. The Stryker Facial iD System is a patient-specific implant system, not an AI model that requires a "training set" in the context of machine learning. The design of each implant is based on individual patient CT data.

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

This information is not applicable for the reasons stated above (not an AI model with a training set). The patient-specific designs are generated from individual patient CT scans based on established engineering principles and medical design specifications, informed by the capabilities proven by the predicate and reference devices.

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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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Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler) and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.

The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following major components: distractor frame, which incorporates connection screws for the plates, a removable activation rod, plates, and an activation key. The plates and frame initially stabilize and then gradually distract the osteotomy. The removable activation rod, covered with a protective sheath, is connected to the frame and provides the point of attachment for the activation key used to initiate the distraction of the osteotomy.

The provided text is a 510(k) summary for a medical device called "The Leibinger Advance Internal Midface Distraction System." This document is for a bone distraction system, which means it is a physical device used in surgery, not a diagnostic AI/ML algorithm.

Therefore, many of the requested fields related to AI/ML software performance (like sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of device and are not present in the provided text.

The information that can be extracted relevant to the "acceptance criteria" for a physical device typically comes from performance testing (e.g., mechanical, biocompatibility) demonstrating its safety and effectiveness, usually against established standards or predicate devices. However, this 510(k) summary provides a high-level overview and does not detail specific acceptance criteria or the studies that prove they are met in a quantitative manner (e.g., stress tests to a specific load, cycle tests to a specific number of cycles).

Here's a breakdown of what can be inferred or stated as "not applicable" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific quantitative performance acceptance criteria and results. A full 510(k) submission would contain detailed test reports.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• N/A. This is a physical medical device. Performance is typically evaluated through bench testing (mechanical, material, sterility, biocompatibility) rather than a "test set" of data like an AI/ML algorithm.

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):

• N/A. Ground truth establishment is relevant to diagnostic or AI/ML devices. For a physical device, performance is evaluated against engineering specifications, regulatory standards, and clinical outcomes (which are not detailed in this summary).

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

• N/A. See point 3.

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:

• N/A. This is not an AI-assisted diagnostic device.

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

• N/A. This is not a standalone algorithm.

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

• N/A. See point 3. The "truth" for this device's performance would be its ability to physically distract bones safely and effectively, demonstrated through mechanical tests and potentially clinical data (though not detailed here).

8. The sample size for the training set:

• N/A. This is not an AI/ML device that requires a training set.

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

• N/A. See point 8.

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The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Not Found

This document primarily concerns the 510(k) summary and FDA clearance letter for the Stryker® Twist Drills. It focuses on establishing substantial equivalence to predicate devices and detailing the intended use and regulatory classification.

Based on the provided text, there is no information available regarding acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven device. The Stryker® Twist Drills are a physical medical device (drills), not an AI or software-based system that would typically have the acceptance criteria and study details you've outlined.

Therefore, I cannot provide the requested information for the following points as they are not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on regulatory clearance for a physical medical tool, asserting its substantial equivalence to existing drills based on design and intended use, rather than demonstrating algorithm performance.

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