(235 days)
The MEDPOR TITAN® 3D Orbital Floor Implant 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 MEDPOR TITAN® 3D Orbital Floor Implants are comprised of a pre-bent titanium mesh embedded within a MEDPOR porous polyethylene sheet. The porous side allows tissue ingrowth while a nonporous Barrier sheet on the orbit facing side does not allow tissue ingrowth. The pre-bent shape approximates the shape and dimensions of the average normal orbital floor and medial wall (in order to facilitate the operative goal of restoring normal [pre-traumatic] orbital volume as accurately as possible). The pre-bent MEDPOR titanium plates are available in a small (L=32mm W=35mm, H=13mm) and a large size (L=36mm, W=37mm, H=17mm) along with left and right configurations. The implants can be trimmed and contoured to fit the specific needs of the patient.
This document is a 510(k) premarket notification for a medical device, the Stryker MEDPOR TITAN 3D Orbital Floor Implant. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Based on the provided text, there is no study detailing acceptance criteria and reported device performance in the context of AI/ML or diagnostic accuracy. The document focuses on regulatory approval for a physical implant, not a diagnostic or prognostic algorithm.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML study is not applicable to this document.
However, I can extract the information related to the device itself and its testing:
Summary of Device Acceptance Criteria and Performance (Based on provided text)
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1; including cytotoxicity testing (DIN EN 10993-5:2009). | Cytotoxicity testing was performed using DIN EN 10993-5:2009. The tests supported the biocompatibility of the device. The device materials (titanium conforming to ASTM F67, MEDPOR porous polyethylene, nonporous barrier) are the same as predicate devices and use the same manufacturing processes. |
| Performance Bench Testing | Pre-defined acceptance criteria for: |
- Transportation testing
- End user testing
- Packaging assessment
- Bending assessment
- Trimming assessment
- Stability test (globe support)
- Sharp edge test | The Subject device met all pre-defined acceptance criteria.
In tests where it was compared to either the predicate or reference device, it was found to "not represent a new worst case." The results support substantial equivalence. |
| Principle of Operation | To reconstruct the orbital floor and/or medial wall; same mode of fixation (screws); same patient contacting surface (orbital floor and wall); same area/duration of contact; similar material and design to predicate. | The device operates on the same principle as the predicate, with the same mode of fixation, patient contacting surface, area/duration of contact. Material is similar (titanium in predicate, titanium mesh embedded in polyethylene in subject device). Design is similar (pre-bent shape based on average anatomical model), comparable sizes and shapes to predicate device. The subject device is provided sterile, similar to reference device. |
Regarding the specific questions:
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A table of acceptance criteria and the reported device performance
- See table above.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No "test set" in the context of an AI/ML diagnostic test is mentioned. The device's design was based on an average anatomical model derived from CT-scan data from 300 subjects.
- Data Provenance (for anatomical model): Not explicitly stated, but the "Ethnic Group" breakdown includes Caucasians (276), Middle-East (3), and unknown (21), suggesting a varied origin, though predominantly Caucasian data were used for the anatomical model. The manufacturer is based in Germany.
- Retrospective/Prospective: The CT-scan data for the anatomical model was likely retrospective, as it was "selected scans... obtained from healthy subjects."
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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)
- Not applicable. There is no mention of a "ground truth" established by experts for a diagnostic test. The "ground truth" for the device's design implicitly comes from clinical understanding of normal orbital anatomy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the device's design: The "ground truth" for the anatomical model was derived from CT-scan data from 300 healthy subjects without bony orbital deformations. This could be considered a form of "anatomical truth" or "normative data." Clinical outcomes are mentioned only in the context of a literature review supporting general safety, not for establishing ground truth for a test.
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The sample size for the training set
- Not applicable in the AI/ML sense. The anatomical model used for the device design was based on 300 CT scans. This could be considered analogous to a "training set" for the device's shape design.
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How the ground truth for the training set was established
- The anatomical model was established by analyzing CT-scan data from 300 subjects. These were "selected scans... obtained from healthy subjects without any deformation of the bony orbital structures." This implies that the selection process itself established the "ground truth" for what constitutes a normal orbital floor and medial wall.
§ 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.