(76 days)
The Osteo Anatomical Bone Plates are intended for internal fracture fixation of various long bones.
The Osteo Anatomical Bone Plates are used for fracture fixation on various long bones. All Osteo Anatomical Bone Plates are manufactured from stainless steel and include the following: Form Plates, Humeral Plates, Plates for Multi-Condylar Fragments ACP, Plates for Distal Femur ACP, Trochanter Hip Plates ACP, Narrow and Wide Elongation Plates.
The provided text describes a 510(k) premarket notification for "Osteo Anatomical Bone Plates." However, this submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, human reader studies, or training set information.
Therefore, most of the requested information cannot be extracted from this document, as it is generally not part of a 510(k) submission for this type of device (bone plates). 510(k) submissions for mechanical devices like bone plates typically rely on mechanical testing, material characterization, and comparison to predicate devices, rather than clinical performance studies with acceptance criteria as one might see for AI/ML-driven diagnostic devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify performance acceptance criteria in terms of clinical outcomes or metrics like sensitivity/specificity. It focuses on substantial equivalence in design and materials.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. This type of information is not relevant to a 510(k) submission for bone plates, which typically involves mechanical testing and material characterization, not patient data sets.
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)
- Cannot be provided. "Ground truth" in the context of expert review is not applicable to this device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable.
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
- Cannot be provided. This is not an AI/ML device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. "Ground truth" in this context is not applicable. For bone plates, performance is typically assessed through mechanical testing against standards and comparison to predicate devices.
8. The sample size for the training set
- Cannot be provided. Not applicable.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable.
Summary based on the provided document:
The Osteo Anatomical Bone Plates submission (K972196) is a 510(k) Premarket Notification based on substantial equivalence to predicate devices. The "study" proving the device meets criteria is primarily a comparison to legally marketed predicate devices (Waldemar Link GmbH & Co. and Synthes).
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Acceptance Criteria (Implied by Substantial Equivalence): The implicit acceptance criterion for a 510(k) is that the device is substantially equivalent in terms of intended use, design, material, and performance (e.g., mechanical properties) to a legally marketed predicate device, and that it does not raise new questions of safety and effectiveness.
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Reported Device Performance: The document states that the Osteo Anatomical Bone Plates are substantially equivalent in design and intended use to the predicate bone plates offered by Waldemar Link GmbH & Co., Synthes, and Osteo AG. All subject and predicate plates are manufactured from stainless steel, and they are intended for internal fracture fixation of various long bones. While specific mechanical performance data is not included in this summary, it would have been part of the full 510(k) submission to support the claim of substantial equivalence.
In essence, this document is a regulatory filing for a conventional medical device, not a performance study for an AI/ML-driven diagnostic device, thus many of the questions are not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.