(191 days)
The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as: Subtrochanteric Fractures, Intertrochanteric Fractures, Comminuted Fractures, Segmental Fractures, Fractures with Bone Loss, Proximal and Distal Fractures, and Nonunions
The ITST Intertrochanteric/ Subtrochanteric Fixation System is used for closed nailing of the femur. The system includes femoral intramedullary nails, lag strews, anti-rotation screws, cortical screws and nail caps. Cortical screws are used for distal locking of the nail.
The provided text describes the regulatory clearance of a medical device, the ITST® Intertrochanteric/Subtrochanteric Fixation System, specifically a line extension to add 4.5mm Cortical Screws. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way one would describe for an AI/software device.
The document focuses on demonstrating substantial equivalence to a predicate device (M/DN® Intramedullary Fixation) for regulatory purposes, not on specific performance (e.g., accuracy, sensitivity, specificity) against acceptance criteria.
Therefore, for most of your requested points, the answer derived from the provided text will be "Not applicable" or "Not specified."
Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Device Performance (Not Applicable for this Device Type and Document):
The document does not define quantitative acceptance criteria for device performance (e.g., in terms of diagnostic accuracy, image quality, algorithm output). This is because the device is a mechanical implant (cortical screws) and its "performance" is assessed through material properties, dimensional integrity, and biocompatibility, rather than an AI model's output metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
1. A table of acceptance criteria and the reported device performance:
As explained above, this section is not applicable in the context of the provided document. The "performance" assessment is described qualitatively: "The dimensional evaluation demonstrated that the subject ITST 4.5mm Cortical Screws are safe and effective and substantially equivalent to the predicate M/DN 4.2mm Cortical Screws."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for test set: Not applicable and not specified. The "test set" in this context would likely refer to samples used in non-clinical performance evaluations (e.g., mechanical testing, dimensional analysis). The document states "dimensional evaluation," but no sample size is given.
- Data provenance: Not applicable and not specified. There is no "data provenance" information as one would typically find for a clinical or imaging study.
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. Ground truth as typically understood for AI/software devices (e.g., expert consensus on clinical findings) is not relevant for this mechanical device. The "ground truth" for non-clinical testing is based on engineering specifications and validated test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically employed in clinical studies or expert review processes for complex data interpretation, which is not described here.
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 device is a surgical implant, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for the non-clinical performance evaluation mentioned (dimensional evaluation, biocompatibility, shelf life) would be based on engineering specifications, material standards, and validated laboratory test results.
8. The sample size for the training set:
Not applicable. There is no AI algorithm being trained for this device.
9. How the ground truth for the training set was established:
Not applicable. There is no AI algorithm being trained for this device.
Summary of relevant details for this specific device and document:
- Device: ITST® Intertrochanteric/Subtrochanteric Fixation System (specifically a line extension to add 4.5mm Cortical Screws).
- Purpose of Submission: To obtain FDA clearance for a line extension by demonstrating substantial equivalence to a predicate device.
- Predicate Device: M/DN® Intramedullary Fixation, manufactured by Zimmer (K142281).
- Performance Data (Non-Clinical):
- Shelf Life: Accelerated aging testing showed a shelf life of 10 years.
- Biocompatibility: Testing conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58) passed.
- Performance Evaluation: Dimensional evaluation demonstrated that the subject ITST 4.5mm Cortical Screws are safe and effective and substantially equivalent to the predicate M/DN 4.2mm Cortical Screws.
- Clinical Data: No clinical trial data was needed or submitted to show substantial equivalence for this particular line extension.
§ 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.