(853 days)
The Conventus DRS™ is intended for use in the fixation of fractures of the distal radius.
The Conventus DRSTM is an intramedullary device intended to treat distal radius fractures. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti-6Al-4V) and Nitinol.
The provided document describes a 510(k) premarket notification for the Conventus DRS™ device, which is an intramedullary device for fixing distal radius fractures. The document is a regulatory submission and focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating the performance of an AI algorithm or diagnostic tool.
Therefore, many of the requested elements are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from the study) | Reported Device Performance |
|---|---|
| Radiographic success | 95% at 12 weeks post-operatively |
| DASH score assessment | Substantially equivalent to predicates at 12 weeks, 6 months, and 1 year post-operatively |
| Adverse events monitoring | Surgical instrument failure (4), nerve irritation and pain not requiring intervention (4), and one revision due to a fragment not properly secured |
Note: The document does not explicitly state "acceptance criteria" for radiographic success or DASH scores in quantitative terms (e.g., "X% of subjects must achieve radiographic success"). Instead, it reports the "demonstrated" performance. For adverse events, the reporting of specific numbers implies a monitoring and reporting requirement rather than a pass/fail criterion.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated as a separate "test set" from a larger training set. The clinical evaluation refers to "study subjects," implying this cohort serves as the primary evaluation set for substantial equivalence. The exact number of subjects is not provided.
- Data Provenance: Clinical evaluation was conducted "outside the United States in Tier 1 countries."
- Retrospective or Prospective: Not explicitly stated, but the mention of "collection of radiographic outcomes, functional outcomes (DASH), and adverse event information" suggests a prospective clinical trial or observation period following implantation of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "radiographic outcomes" being collected, but it does not specify how these outcomes were interpreted or if expert consensus was used to establish ground truth for the fracture classification or healing assessment.
4. Adjudication method for the test set:
- This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- An MRMC study was not conducted. This document describes a medical device (intramedullary fixator), not an AI algorithm or diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- A standalone performance assessment was not done. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the device's performance is implicitly based on clinical outcomes data, including:
- Radiographic outcomes: Assessment of fracture reduction and healing.
- Functional outcomes: Measured by the DASH (Disabilities of the Arm, Shoulder and Hand) score.
- Adverse event information: Documented complications.
8. The sample size for the training set:
- The concept of a "training set" in the context of an AI algorithm is not applicable here. This document describes a physical medical device. The "clinical evaluation" described would be the primary data for demonstrating safety and effectiveness relative to predicates.
9. How the ground truth for the training set was established:
- As mentioned above, the concept of a "training set" for an AI algorithm is not applicable. The ground truth for the clinical evaluation was established through direct clinical observation, radiographic assessment, and patient-reported outcomes.
In summary:
This 510(k) summary focuses on demonstrating the substantial equivalence of a bone fixation device to existing predicate devices. It relies on a clinical evaluation (implicitly a prospective study) to gather data on radiographic and functional outcomes, as well as adverse events. The submission does not involve AI, diagnostic image interpretation, or the associated methodologies for establishing ground truth for algorithms.
§ 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.