(325 days)
This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening concomitantly with external fixators in pediatric or small statured patients with limb length discrepancy.
The Fassier-Duval Pediatric IM System is a telescopic rod for use in fixation of long bone fractures. The design of the nail includes a female component (which is attached to the proximal -trochanteric- cortex of the bone) and a male component (which is attached to the distal cortex of the bone). Anchorage of the components is achieved through screw-type fixation. The nail is composed of two sliding components that allow for extension of its length as the bone structures heal and normal patient growth occurs. The Fassier-Duval Pediatric IM System can be attached to bony structures without disrupting the bone growth plates.
This document describes a medical device, the Fassier-Duval Pediatric IM System, and its substantial equivalence to predicate devices, rather than a study evaluating the performance of an AI/ML powered device against specific acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth, expert adjudication, and sample sizes for training/test sets cannot be extracted from the provided text.
However, I can provide available information related to the device's performance compared to a predicate device based on the text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction in re-operation rate compared to predicate device #1 (Dubow-Bailey Intramedullary Nail) | 3-fold reduction |
| Reduction in complication rate compared to predicate device #1 (Dubow-Bailey Intramedullary Nail) | 2 to 3-fold reduction |
Explanation: The document does not state specific quantitative "acceptance criteria" but rather reports comparative clinical outcomes against a predicate device. The implied acceptance, in this context, is that the Fassier-Duval system performs better than the predicate regarding these specific clinical outcomes.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: The text states "Clinical data submitted with the current application..." which implies retrospective clinical data. The country of origin is not specified but given the contact person is in Montreal, Quebec, Canada, it's possible some data originated from Canada.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a medical device approval document, not an AI/ML performance study. Clinical data would typically be assessed by treating physicians and medical staff in an observational or interventional study setting.
4. Adjudication method for the test set
- Not applicable. This is a medical device approval document, not an AI/ML performance study. Clinical outcomes would be recorded and analyzed from patient records.
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 document is for a physical medical device (telescopic nail), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The performance claims are based on clinical outcomes data (re-operation rate and complication rate) from patients.
8. The sample size for the training set
- Not applicable. This is a medical device approval, not an AI/ML study.
9. How the ground truth for the training set was established
- Not applicable. This is a medical device approval, not an AI/ML study.
§ 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.