(262 days)
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.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as presented for regulatory clearance) |
|---|---|
| Intended Use: Device's intended use does not alter therapeutic use or affect safety/effectiveness relative to predicate, and is justified by literature. | Reported: Intended use (reconstruction of orbital floor/medial wall) is identical to predicate. New indication (15+ years old) is justified by literature stating 15-21 year olds are anatomically/physiologically identical to 22+ year olds regarding orbital volume. |
| Principle of Operation: Identical to predicate device. | Reported: Identical (reconstruct orbital floor/medial wall, fixation with screws, permanent implant, same CMF/orbital area of application). |
| Technological Characteristics: Identical to predicate device (design, materials, sizes, adjustment methods). | Reported: Identical (patient contacting surface, area/duration of contact, material (titanium), design (pre-bent shape based on average anatomical model), sizes/shapes, plate adjustment, non-sterile provision). |
| Benefit-Risk Evaluation: Adverse events are minimized and acceptable when weighed against benefits. | Reported: Literature review shows titanium mesh used in 15-21 year olds for 25+ years with no unique complications compared to adults (infection, migration, foreign body reaction). Complication rates not greater in this age group. |
| Non-Clinical Testing: Device passes all previously conducted performance tests (biocompatibility, cleaning, sterilization, corrosion resistance, stability, functionality, transportation, end product, design validation). | Reported: Proposed modification has no impact on performance. All prior tests passed (K123786). No new non-clinical testing performed for this 510(k). |
| Raises no new questions of safety and effectiveness. | Conclusion: Differences in Indications for Use do not raise new questions of safety and effectiveness. |
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.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.