(28 days)
Piccolo Composite Humeral, Proximal Humerus, Tibial and Femoral Nails: Indications 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 nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. Piccolo Composite Ankle Arthrodesis Nails: Indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular discase; Revision ankle arthrodesis; Neuroarthropathy; Rheumatoid arthritis; Osteoarthritis; Pseudoarthrosis; Post-traumatic arthrosis; Previously infected arthrosis; Charcot foot; Severe endstage degencrative arthritis; Severe defects after tumor resection; Pantalar arthrodesis
The Piccolo Composite Nailing Systems include nails, interlocking screws and instrumentation sets. The nails are made, in general, of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with tantalum markers, to provide for their visualization under fluoroscopy. The nails provide for holes at the proximal and distal sections, designed for the insertion of the titanium-alloy-made screws.
The provided text is a 510(k) summary for the CarboFix Orthopedics Ltd. Piccolo Composite® Nailing Systems. This type of submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel device that requires extensive clinical studies to establish safety and effectiveness from scratch. As such, the information you're requesting regarding acceptance criteria and performance studies (often seen in PMA submissions or for novel high-risk devices) is not typically found in a 510(k) summary.
A 510(k) typically relies on:
- Comparison to predicate devices: Showing that the new device has the same intended use, similar technological characteristics, and comparable performance to a legally marketed device.
- Bench testing: Mechanical and material testing to confirm that the device meets established engineering standards and performs as intended under simulated conditions.
- Material characterization: Ensuring the materials used are biocompatible and meet specifications.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way one might see in a clinical trial report. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance is assessed by comparison to these predicates and through general evaluation, not quantified against specific clinical performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The submission refers to "evaluation of expected performance characteristics" based on comparison to predicate devices, which implies bench testing and material comparisons rather than clinical trials with patient data.
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 establishment for a test set (as in a diagnostic AI study) is not part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication for a test set is not part of this 510(k) submission.
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 is not a diagnostic AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This 510(k) does not present a study requiring clinical ground truth for validation. The "ground truth" for demonstrating substantial equivalence is adherence to engineering standards and functional similarity to predicates.
8. The sample size for the training set
Not applicable. This refers to an AI training set, which is not relevant for this device.
9. How the ground truth for the training set was established
Not applicable. This refers to an AI training set, which is not relevant for this device.
Summary Table (based on available information):
| Information Category | Details from K132774 |
|---|---|
| Acceptance Criteria | Based on "substantial equivalence" to predicate devices. This implies meeting the same safety and performance profiles through: |
- Intended Use: Same as predicates.
- Design: Compared to predicates.
- Materials: Compared to predicates (Carbon Fiber Reinforced PEEK with tantalum markers).
- Technological Characteristics: Compared to predicates.
- Principles of Operation: Same as predicates. |
| Reported Device Performance | "Evaluation of expected performance characteristics and MR Conditional labeling parameters for the Piccolo Composite Nailing Systems was based on comparison to predicate devices." Conclusion: "All the above demonstrate that the device is safe and effective for its intended use." (This points to bench testing and comparison, not clinical performance metrics). |
| Sample Size (Test Set) | Not applicable for clinical testing, likely refers to samples for bench/material testing (details not provided in summary). |
| Data Provenance (Test Set) | Not applicable for clinical testing. |
| Number of Experts (Ground Truth) | Not applicable. |
| Qualifications of Experts | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | No. Not an AI-assisted diagnostic device. |
| Standalone Performance Study (Algorithm Only)| No. Not an AI algorithm. |
| Type of Ground Truth Used | Not applicable. Evaluation primarily based on engineering and material standards, and comparison to predicates. |
| Sample Size (Training Set) | Not applicable. |
| Ground Truth Establishment (Training Set) | Not applicable. |
In essence, a 510(k) submission like this focuses on demonstrating substantial equivalence to existing devices, relying on a dossier of engineering, materials, and functional comparisons, rather than de novo clinical studies with specific performance metrics and acceptance criteria as outlined in your request.
§ 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.