(87 days)
The Alians Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses in adults.
The Alians Fragment Specific range consists of plates and screws designed for hand and forearm fractures, osteotomies and arthrodeses in adults.
The implants of the Alians Fragment Specific range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.
The instruments of the Alians Fragment Specific range will be provided non sterile for sterilization by health care professionals prior to use.
Single use kits (Initial FS) contain implants and instruments provided sterile by gamma sterilization.
The provided document is a 510(k) premarket notification for the "Alians Fragment Specific" range of bone fixation plates and screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through comprehensive clinical trials with pre-defined acceptance criteria and detailed study results as one might find for a novel AI/software medical device.
Therefore, the document does not contain the information required to answer most of your questions, as these questions are typically relevant to the validation of AI-driven medical devices or devices where clinical performance claims are being made based on specific outcome measures.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the document. The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing (mechanical tests) and similarity in design, materials, and intended use to predicate devices, not on setting and meeting specific clinical acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the document. The document refers to "non-clinical tests" such as comparative static bend tests, fatigue bend tests, torsional tests, insertion and removal tests, and pull-out tests. These are mechanical tests performed on the device components themselves, not on patient data or clinical datasets. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply in this context.
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)
This information is not applicable/not available. Since no clinical studies or human-involved ground truth establishment for a diagnostic/interpretive task were performed, there were no experts establishing ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not available. As no clinical test set requiring human adjudication was involved, this is not relevant.
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
This information is not applicable/not available. The device is a physical implant (bone fixation plates and screws), not an AI/software device designed to assist human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This information is not applicable/not available. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/not available in the context of clinical or diagnostic performance. For the mechanical non-clinical tests, the "ground truth" would be the established engineering standards and specifications (e.g., ASTM F382, ASTM F543) that the device must meet or be comparable to the predicate device.
8. The sample size for the training set
This information is not applicable/not available. The device is a physical implant, and there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
This information is not applicable/not available. As there is no training set, this question is not relevant.
In summary, the provided document is a 510(k) premarket notification for a physical medical device (bone fixation plates and screws) and primarily demonstrates substantial equivalence through mechanical testing and comparison to predicate devices, rather than through clinical studies requiring data sets, ground truth, or expert adjudication as would be found for AI/software devices.
§ 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.