(63 days)
The ACUTE Innovations® Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.
The ACUTE Innovations® Modular RibLoc System consists of plates and screws for fractures, fusions, and osteotomies. The plates are pre-contoured to minimize bending which is done intraoperatively. Instrumentation is supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium or titanium alloy.
The provided text describes a 510(k) summary for the ACUTE Innovations Modular RibLoc Fixation System. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo performance characteristics through extensive clinical studies.
Therefore, much of the information requested, such as specific acceptance criteria and detailed study designs involving human subjects, AI assistance, or pathology-based ground truth, is not typically found in a 510(k) summary for a device like a bone fixation system. Instead, the evaluation relies heavily on preclinical testing and comparison to existing devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states: "The non-clinical tests performed by the company include an analysis of strength of the ACUTE Innovations® Modular RibLoc plates. The results of the performed tests demonstrate that the ACUTE Innovations® Modular RibLoc System is substantially equivalent to legally marketed predicate devices."
This implies that the acceptance criteria are related to mechanical strength and performance and that the device's performance met those criteria by demonstrating substantial equivalence to predicate devices. However, specific numerical acceptance criteria (e.g., "withstanding X N of force for Y cycles") and corresponding reported performance values are not explicitly detailed in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the preclinical testing.
- Data Provenance: The preclinical testing was performed by "the company" (ACUTE Innovations, LLC), suggesting it was internal testing. The origin country is likely the USA, where the company is located. It would be considered prospective for the purposes of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or not provided for this type of preclinical testing. Ground truth for mechanical strength tests typically comes from engineering measurements and relevant industry standards, not expert medical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for preclinical mechanical testing.
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 is not applicable. This device is a mechanical rib fixation system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the preclinical testing mentioned, the "ground truth" would be established by engineering standards and measurements of mechanical properties (e.g., strength, fatigue life) compared against established performance benchmarks for similar predicate devices.
8. The sample size for the training set:
This is not applicable, as there is no machine learning or AI component described that would require a "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above. If there were a training set, the ground truth establishment method would depend on the specific task (e.g., expert annotation for image recognition, lab results for predictive models).
Summary of what is known based on the provided text:
- Acceptance Criteria (Implied): Substantial equivalence in mechanical strength and performance to predicate devices (MedXpert STRATOS, ACUTE Innovations® RibLoc System, ACUTE Innovations Sternal Fixation System).
- Study Proving Acceptance: "Preclinical Testing" which included "an analysis of strength of the ACUTE Innovations® Modular RibLoc plates."
- Device Performance: The tests "demonstrate that the ACUTE Innovations® Modular RibLoc System is substantially equivalent to legally marketed predicate devices."
The 510(k) pathway is designed to demonstrate that a new device is as safe and effective as (substantially equivalent to) a legally marketed predicate device, often relying on non-clinical data for devices like bone fixation systems. It does not typically require the extensive clinical trials or AI-specific validation metrics that would be associated with software as a medical device or novel therapeutic approaches.
§ 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.