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510(k) Data Aggregation
(267 days)
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days (up to 29 days maximum).
The Sophysa external CSF drainage catheters are intended to temporarily drain the Cerebrospinal Fluid (CSF), for less than 30 days.
There are two types of external CSF drainage catheters:
- Ventricular catheters
- Lumbar catheters
The catheter is provided sterile and with accessories to facilitate the surgical procedures and connectors. The external CSF drainage catheters need to be connected to collection systems.
The provided FDA 510(k) clearance letter and summary discuss the "External CSF Drainage" device. However, this document does not contain information related to a study proving the device meets specific performance acceptance criteria in the context of medical imaging or AI/algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical, clinical, and biological safety comparisons, along with non-clinical bench testing. It does not describe a study involving human readers, AI assistance, ground truth establishment, or specific diagnostic performance metrics (like sensitivity, specificity, AUC) that would typically be associated with performance acceptance criteria for an AI or imaging device.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance specific to diagnostic accuracy or AI performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document details bench testing performed, which validates physical and mechanical properties of the device, but not its performance in a clinical diagnostic or AI-assisted setting.
The information available regarding acceptance criteria and testing from the provided document is as follows:
Acceptance Criteria (Implicit from Bench Testing):
| Performance Standard/Characteristic | Acceptance Criteria (Implicit from Tests) | Reported Device Performance (Summary) |
|---|---|---|
| Visual Inspection | (Not explicitly stated, but implies meeting design specifications) | Performed (Summary of Non-clinical testing) |
| Dimensional Analysis | (Not explicitly stated, but implies meeting design specifications) | Performed (Summary of Non-clinical testing) |
| Radiopacity | (Not explicitly stated, but implies visible under imaging) | Performed (Summary of Non-clinical testing) |
| Pressure / Flow Characteristics | (Not explicitly stated, but implies adequate CSF drainage) | Performed (Summary of Non-clinical testing) |
| Blockage / Hemorrhagic CSF Exposure | (Not explicitly stated, but implies resistance to blockage/degradation) | Performed (Summary of Non-clinical testing) |
| Air and Water Tightness | (Not explicitly stated, but implies no leakage) | Performed (Summary of Non-clinical testing) |
| Dynamic Breaking Strength | (Not explicitly stated, but implies resistance to fracture under use) | Performed (Summary of Non-clinical testing) |
| Catheter Tensile Strength | (Not explicitly stated, but implies resistance to pulling forces) | Performed (Summary of Non-clinical testing) |
| Kink Resistance | (Not explicitly stated, but implies resistance to kinking) | Performed (Summary of Non-clinical testing) |
| Catheter Fixation | (Not explicitly stated, but implies secure attachment) | Performed (Summary of Non-clinical testing) |
| Corrosion Resistance | (Not explicitly stated, but implies material integrity) | Performed (Summary of Non-clinical testing) |
| Guidewire Tensile Strength | (Not explicitly stated) | Performed (Summary of Non-clinical testing) |
| Guidewire Bending Strength | (Not explicitly stated) | Performed (Summary of Non-clinical testing) |
| Guidewire Breakage | (Not explicitly stated) | Performed (Summary of Non-clinical testing) |
| Tuohy Needle/Hub Connection Strength | (Not explicitly stated) | Performed (Summary of Non-clinical testing) |
| Sterility | Supplied sterile | Supplied sterile (Predicate Comparison Table) |
| Biocompatibility | Biocompatible materials | Biocompatible materials established by testing and rationale for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation (brain, 4 weeks, muscle 4 weeks), Indirect Hemolysis, Neurotoxicity (Predicate Comparison Table) |
| MRI Compatibility (Ventricular) | MR Safe | MR Safe (Predicate Comparison Table) |
| MRI Compatibility (Lumbar) | MR Conditional | MR Conditional due to metallic parts in Compression Hub (Predicate Comparison Table) |
| Shelf life | 5 years | Target shelf life (Predicate Comparison Table) |
| Performance Standards | ISO 7197, ISO 20697, ISO 20698, ISO 11070 | Substantially Equivalent (Predicate Comparison Table) |
Study Details from the document (focused on Substantial Equivalence and Bench Testing):
- Sample size used for the test set and the data provenance: Not applicable for diagnostic performance metrics. Bench testing was performed on "representative samples" of the product line. No information on data provenance (e.g., country of origin, retrospective/prospective) is associated with these bench tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench tests typically involves direct measurement against engineering specifications.
- Adjudication method: Not applicable for bench testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI/algorithm-driven device for diagnosis.
- The type of ground truth used: For the bench tests, the "ground truth" would be the engineering specifications and established test methodologies (e.g., ISO standards) for physical and material properties. For biocompatibility, established ISO standards and toxicological assessments.
- The sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document from the FDA is for a physical medical device (External CSF drainage catheters) and demonstrates its safety and effectiveness through substantial equivalence to existing devices and extensive bench testing of its physical and material properties. It does not describe a study involving AI, image analysis, or human reader performance, and therefore, cannot provide the information requested for such types of studies.
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