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Intended Use:
The Stryker Universal Orbital Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.

Indications for Use:
The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.

The Stryker Universal Orbital Floor System includes pre-bent titanium orbital floor plates, a globe retractor and a plate holding forceps.

The pre-bent titanium plates are available in a small (L=31mm W=34mm, H=12mm) and a large size (L=35mm, W=36mm, H=16mm) along with left and right configurations. The plates can be trimmed along cutting lines and contoured to fit the specific needs of the patient.

The plates are designed based on an average anatomical model of CT-scan data taken from 300 subjects (92% Caucasian). The metadata of the 300 subjects that have been included in the generation of the average anatomical model is listed in Table 1. The selected scans were obtained from healthy subjects without any deformation of the bony orbital structures.

The globe retractor is an instrument designed to allow retraction of the orbital contents off the orbital floor and walls during implantation of the above mentioned pre-bent titanium plates.

Lastly, the plate holding forceps is an instrument designed specifically for use with above mentioned pre-bent titanium plates. They facilitate the insertion and positioning of the plate within the orbit.

This document is a 510(k) premarket notification for a medical device called the "Stryker Universal Orbital Floor System." The submission is for an expanded indication for use, allowing the device to be used in patients aged 15 and older, whereas the predicate device (K123786) was indicated for adult patients only. This document does not describe a study that proves the device meets specific acceptance criteria in the context of an algorithm or AI performance.

Instead, it focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This means showing that the device is as safe and effective as a legally marketed device and doesn't raise new questions of safety and effectiveness.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement are not applicable or cannot be extracted from this document, as it's not an AI/algorithm performance study report.

Here's a breakdown of the information that can be gleaned from the document given the context of a medical device submission, emphasizing where the requested AI/algorithm-specific details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria and reported device performance in the context of an AI/algorithm. The "acceptance criteria" here refer to demonstrating substantial equivalence for regulatory clearance, not performance metrics like accuracy, sensitivity, or specificity for an algorithm.

The core of the submission's "performance" is demonstrating that the device is safe and effective when used in patients 15 years and older, compared to its predicate that was limited to adults.

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

Not applicable for an AI/algorithm performance study. The "test set" in this context would be the scope of the substantial equivalence review.

However, the design of the device's pre-bent plates was based on an anatomical model derived from 300 CT-scan subjects.

• Data Provenance: The document doesn't explicitly state the country of origin for the 300 CT scans, nor if they were retrospective or prospective. It only states they were "selected scans... obtained from healthy subjects without any deformation of the bony orbital structures."
• Demographics of the 300 CT scans:
  • Age: Predominantly 70-79 years (72 subjects), but ranges from 10-99 years. Mean/median not provided.
  • Gender: 122 female, 178 male.
  • Ethnic Group: 276 Caucasians, 3 Middle-East, 21 unknown.

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

Not applicable for an AI/algorithm performance study. The "ground truth" here is established through regulatory requirements, comparison to a predicate, and scientific literature review. There's no mention of a ground truth established by a panel of experts for a test set in the traditional sense of an AI study.

4. Adjudication Method for the Test Set

Not applicable for an AI/algorithm performance study.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI/algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's safety and effectiveness compared to its predicate is primarily based on:

• Scientific and Clinical Literature: Specifically cited articles (References 1, 2, 3) regarding orbital floor reconstruction, orbital fractures in children, and complications in pediatric facial fractures. This literature supports the claim that the 15-21 age group is comparable to adults for this medical device application.
• Predicate Device Performance: The safety and effectiveness of the existing predicate device (Stryker Universal Orbital Floor System, K123786) serves as a benchmark and a foundation for substantial equivalence.
• Non-Clinical Testing Results from Predicate: Verification and Validation (V&V) testing (biocompatibility, cleaning, sterilization, corrosion resistance, etc.) performed for the predicate device.

8. The Sample Size for the Training Set

Not applicable for an AI/algorithm. However, the device design itself (pre-bent shape) was based on an "average anatomical model of CT-scan data taken from 300 subjects." This dataset could be seen as the "training data" for the device design.

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

For the 300 CT scans used to design the device's shape:

• The "ground truth" was simply the anatomical data itself from healthy subjects.
• The selection criteria involved choosing "healthy subjects without any deformation of the bony orbital structures," implying some level of expert review (e.g., radiologist, clinician) to ensure the CT scans represented normal orbital anatomy. However, the specific process or number of experts for this selection is not detailed.

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The Stryker Universal Orbital Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.

The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.

The Stryker Universal Orbital Floor System comprises a pre-bent titanium orbital floor implant that approximates the shape and dimensions of the average normal orbital floor and medial wall (in order to facilitate the operative goal of restoring normal (pretraumatic) orbital volume as accurately as possible), a globe retractor for retraction of the orbital contents off the orbital floor and walls (in order to provide exposure of the fracture site(s)), and a plate-holding forceps (that facilitates the insertion and positioning of the plate within the orbit).

The plates are designed based on an average anatomical model of CT-scan data taken from 300 subjects (92% Caucasian). The metadata of the 300 subjects that have been included in the generation of the average anatomical model is listed in table 1. The selected scans were obtained from healthy subjects without any deformation of the bony orbital structures.

The implant is provided in pre-bent left and right and in small and large sizes. A medial wall extension is attached to the floor section of the implant in order to provide coverage for a co-extensive medial wall fracture. If not needed, this medial wall extension may be removed by cutting through the designated cutting lines on the implant. The implant is fixed to the infra-orbital rim via either the holes on the provided fixation arms or through the anterior screw holes on the plate itself.

The provided document is a 510(k) summary for the Stryker Universal Orbital Floor System, a medical device. It does not describe acceptance criteria or a study proving that the device meets acceptance criteria in the typical sense of a performance evaluation with metrics like sensitivity, specificity, accuracy, etc.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is the primary pathway for 510(k) clearance. This means the "study" is a comparison to an already legally marketed device, and the "acceptance criteria" are effectively the requirements for demonstrating this equivalence.

Here's an analysis based on your request, with the understanding that the document's content is geared towards substantial equivalence rather than performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, the "acceptance criteria" are the characteristics of the predicate device that the new device must be substantially equivalent to, and the "performance" is how the new device compares.

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

• Test Set: N/A for a performance study. Clinical testing was not performed.
• Design Basis (similar to a "development" or "validation set" for anatomical design): The implant's design is based on an "average anatomical model of CT-scan data taken from 300 subjects."
• Data Provenance: The document explicitly states "92% Caucasian" for this group of 300 subjects, implying a predominantly Caucasian population. The country of origin for these CT scans is not specified. The scans were "obtained from healthy subjects without any deformation of the bony orbital structures." This is retrospective data used for design purposes.

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

• N/A. No clinical testing or expert-adjudicated ground truth for a "test set" in the context of device performance was conducted. The device's design (not its performance against clinical outcomes) was derived from anatomical data.

4. Adjudication Method for the Test Set

• N/A. No test set requiring adjudication was performed.

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

• No MRMC comparative effectiveness study was done.
• No human readers were involved in a comparative effectiveness study of the device itself.

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

• This question is not applicable. This is a physical implant device, not an algorithm or software. Its performance is related to its mechanical properties and anatomical fit, not an "algorithm-only" evaluation.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the design of the device, the 'ground truth' was an "average anatomical model of CT-scan data" which represents a statistical average of healthy orbital structures. This is anatomical data, not clinical outcomes or expert consensus on disease.

8. Sample Size for the Training Set

• N/A in the context of machine learning. If we interpret "training set" as the data foundational to the device's design, it would be the 300 CT scans used to create the average anatomical model.

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

• The "ground truth" (the average anatomical model) for the design was established by analyzing CT-scan data from 300 subjects. These were "healthy subjects without any deformation of the bony orbital structures." The metadata included age (average 59 years), gender (122 female, 178 male), and ethnic group (276 Caucasians, 3 Middle-East, 21 unknown). The specific methodology for generating the "average anatomical model" from these scans (e.g., statistical averaging, landmark registration) is not detailed beyond stating it was an "average" model.

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