(164 days)
Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The Piccolo Composite Nailing System includes nails, interlocking screws and a set of instruments.
The Piccolo Composite Nail indicated for treatment of the tibia and femur is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 380 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 300 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end and incorporates a thread enabling connection of insertion/extraction instrumentation.
This is a submission for a medical device called the "Piccolo Composite Nailing System," which is an intramedullary nailing system for treating bone fractures. This type of submission (510(k)) focuses on demonstrating substantial equivalence to previously cleared devices, rather than comprehensive clinical performance studies like those typically seen for new drug approvals or high-risk devices. Therefore, the information provided focuses on engineering and material performance criteria rather than acceptance criteria related to diagnostic accuracy or clinical outcomes with a human-in-the-loop.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material/Design Equivalence | The Piccolo Composite Nailing System's intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to predicate devices. |
| Static 4-point Bending Test | Performed (results not detailed specifically against criteria, but implied to meet standards for substantial equivalence). |
| Static Torsion Test | Performed (results not detailed specifically against criteria, but implied to meet standards for substantial equivalence). |
| Dynamic Tests | Performed (results not detailed specifically against criteria, but implied to meet standards for substantial equivalence). |
| MR Conditional Labeling Support | Testing performed to support MR Conditional labeling. |
| Performance per ASTM F 1264 | Performance characteristics evaluated per ASTM F 1264 are comparable to those of predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or human evaluation. The tests mentioned (static bending, torsion, dynamic, MRI compatibility) are bench tests on the device itself. Therefore, sample sizes would refer to the number of nails or components tested, and the provenance would be laboratory testing rather than patient data. No patient or human subject data is mentioned for testing.
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. The "ground truth" for this device's acceptance is based on engineering standards and performance characteristics, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
This information is not applicable. There is no human adjudication process involved as the tests are for device performance against engineering standards.
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
There was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable. This device is a surgical implant, not a standalone algorithm.
7. The type of ground truth used
The ground truth used for demonstrating the device's safety and effectiveness is based on engineering standards and performance characteristic comparisons to predicate devices. Specifically, compliance with or comparability to ASTM F 1264 and the results of static and dynamic mechanical tests and MR compatibility testing.
8. The sample size for the training set
This information is not applicable. There is no training set in the context of machine learning or AI as this is a medical implant, not a diagnostic algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as above.
§ 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.