(120 days)
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.
| Criteria Category | Acceptance Criteria (Predicate Device Characteristics) | Reported Device Performance (Subject Device Characteristics) |
|---|---|---|
| Intended Use | Reconstruction of orbital floor and/or medial wall; Indicated for trauma repair and reconstruction of craniofacial skeleton, including orbital floor/medial wall fractures. | Same Intended Use: reconstruction of orbital floor and/or medial wall; Same Indications for Use: reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients (predicate did not specify age). |
| Principle of Operation | Reconstruct the orbital floor and/or medial wall; plate fixation with screws inserted through dedicated screw holes; Permanent implant. | Same Principle of Operation: Reconstruct the orbital floor and/or medial wall; plate fixation with screws inserted through dedicated screw holes; Permanent implant. |
| Material | Pure Titanium | Commercially Pure Titanium (CP Ti Grade 2) |
| Design | 3D pre-bent plate based on average anatomical model; 0.4mm thickness; Based on average anatomical model of 279 Caucasian CT-scans. | 3D pre-bent plate based on average anatomical model; 0.4mm thickness; Based on average anatomical model of 300 CT-scans (92% Caucasian, i.e., 276 Caucasian subjects). |
| Mode of Modification | Cutting/trimming along dedicated lines; pliable mesh structure for bending. | Same: Cutting/trimming along dedicated lines; pliable mesh structure for bending. |
| Sizes | 2 sizes: large and small for left and right each. | Same: 2 sizes: large and small for left and right each. |
| Dimensions | Large Plate: L=35mm, W=38mm, H=18mm; Small Plate: L=31mm, W=34mm, H=10mm. | Large Plate: L=35mm, W=36mm, H=16mm; Small Plate: L=31mm W=34mm, H=12mm. (Slight dimension differences, deemed substantially equivalent due to overall design and function similarity). |
| Screw Holes | For 1.5 mm and 1.8 mm screws; 4 screw holes along rim; Two screw fixation arms with 2 screw holes each; Position of screw fixation arms at 1st and 2nd screw hole from medial. | For 1.2 mm, 1.4 mm and 1.7 mm screws; 4 screw holes along rim; Two screw fixation arms with 2 screw holes each; Position of screw fixation arms at 1st and 3rd screw hole from medial. (Differences in screw size compatibility and arm position, deemed acceptable). |
| Packaging | Non-sterile and sterile. | Non-sterile. (Difference noted, but likely a matter of processing rather than fundamental safety/effectiveness, as sterilization would occur prior to use). |
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.
§ 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.