(46 days)
These devices are intended to be used for the fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures, as well as for temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
The Alta® CFx IM Rod System is a series of intramedullary rods in diameters of 11mm, 13mm, and 15mm with lengths of 300mm to 480mm.
This document is a 510(k) summary for a medical device called the "Alta® CFx IM Rod System." It describes the device, its intended use, and claims substantial equivalence to previously cleared devices.
However, this type of 510(k) summary (K960524) from 1995 predates the common practice of conducting and reporting detailed performance studies with acceptance criteria in the format you've requested for AI/software-as-a-medical-device (SaMD).
Medical devices like intramedullary rods primarily rely on material properties, mechanical testing (e.g., strength, fatigue), design equivalence to predicate devices, and sometimes clinical experience (though often not a formal "study" in the sense of a controlled clinical trial for 510(k) clearance).
Therefore, I cannot provide a response that directly answers your questions about acceptance criteria, detailed study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present and not typically required or reported in this format for this type of device clearance document from this era.
Here's why and what we can infer:
- Device Type: The Alta® CFx IM Rod System is an orthopedic implant (intramedullary rod). Its performance is primarily assessed through mechanical engineering principles and comparison to existing, cleared devices. It is not an AI/SaMD.
- 510(k) Process (Pre-2000s): For 510(k) clearances, the focus is on demonstrating "substantial equivalence" to a predicate device. This often involves comparing technological characteristics (materials, design, operational principles) and intended use. Detailed clinical performance studies, especially those with specified acceptance criteria and rigorous statistical analysis as seen in modern SaMD clearances, were less common or not required for many orthopedic devices, especially for 510(k)s.
- Absence of Data: The provided text does not include any information on clinical trials, standalone algorithm performance, AI assistance, expert adjudication, or ground truth establishment relevant to the questions asked.
To directly answer your numbered points based only on the provided text, the answer to most points would be "Not Applicable" or "Information Not Provided."
Let's break down why for each point:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on equivalence, not setting and meeting specific performance metrics from a study.
- Sample size used for the test set and the data provenance: Not provided. No "test set" in the context of clinical performance data is mentioned.
- Number of experts used to establish the ground truth... and qualifications: Not provided. Ground truth, in the context of diagnostic accuracy, is irrelevant here.
- Adjudication method: Not provided. Irrelevant for this type of device.
- Multi reader multi case (MRMC) comparative effectiveness study... effect size: Not provided. This is relevant for AI-assisted diagnostic tools, not orthopedic implants.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not provided. This device is a physical implant, not an algorithm.
- The type of ground truth used: Not provided. Not applicable.
- The sample size for the training set: Not provided. Not applicable.
- How the ground truth for the training set was established: Not provided. Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device from 1995. The questions you've asked are highly specific to the evaluation of AI/SaMD devices and are not addressed or typically part of a 510(k) submission for an orthopedic implant from that era.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.