(27 days)
The EBI® XFIX® DFS® System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The System consists of external fixation components and implantable bone screws. The EBI XFIX DFS System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of an Angulating Screw Clamp to the System.
This looks like a 510(k) premarket notification for a medical device. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance. Based on the provided text, there is no acceptance criteria or detailed study proving device performance in the way you've described.
Here's why and what the document does include, addressing your points:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document explicitly states that the submission is "only for the addition of an Angulating Screw Clamp to the System" and that "The intended use and fundamental scientific technology have not changed from the previously cleared submission." It relies on substantial equivalence to a predicate device (EBI® XFIX® DFS® System K953406) rather than new performance testing against specific acceptance criteria.
- The comparison focuses on:
- Same materials (aluminum, stainless steel, titanium alloy).
- Same indications for use (leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to external fixation).
- Similar design principle for bone screw clamps.
- Provided non-sterile.
- The conclusion is: "There are no significant differences between the modified EBI XFIX DFS System and the currently marketed EBI XFIX DFS System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. No new clinical or performance test set data is presented for the modified device. The submission relies on the existing clearance of the predicate device.
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)
- Not Applicable. No new ground truth establishment is described as there's no new performance study data presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No new test set and adjudication method is described.
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 a hardware modification for an external fixation device, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. As above, this is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. No new ground truth is described. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable. There is no mention of a training set as this is not a learning algorithm or AI device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no corresponding ground truth establishment described.
In summary: This 510(k) submission seeks clearance for a modification to an existing device (the addition of an Angulating Screw Clamp). The primary "study" proving it meets "acceptance criteria" is the demonstration of substantial equivalence to a previously cleared predicate device. This is achieved by comparing the materials, intended use, function, and manufacturing process of the modified device to the predicate, and asserting that there are no significant differences. New extensive performance studies, as one might find for novel devices or AI systems, are not typically required or presented for such substantial equivalence claims.
§ 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.