(179 days)
The catheters are indicated for short term access to the peripheral venous system intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient with consideration given to adequacy of vascular anatomy and appropriateness of the catheters are suitable for use with power injectors.
The Vygon Midline Catheters are EO sterilized, single-use, polyurethane, reverse taper, short-term, peripheral venous system access catheters. They include materials containing barium sulfate for radiopacity.
The provided text is a 510(k) Summary for the Vygon Midline Catheters. It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI/Machine Learning device.
Therefore, I cannot extract information regarding:
- Sample sizes for test or training sets
- Data provenance (country of origin, retrospective/prospective)
- Number of experts or their qualifications for ground truth establishment
- Adjudication methods
- MRMC comparative effectiveness studies or effect sizes
- Standalone algorithm performance
- Type of ground truth (expert consensus, pathology, outcomes)
- How ground truth for the training set was established
The document explicitly states under "Clinical Testing": "No Clinical Testing was performed." This further confirms that the type of study you are asking about (related to AI performance, human reader improvement, and ground truth establishment) was not conducted for this medical device.
The study described is primarily bench testing and biocompatibility testing to demonstrate that the Vygon Midline Catheters are substantially equivalent to a previously cleared predicate device.
Here's the relevant information that can be extracted, pertaining to acceptance criteria and performance for this non-AI medical device:
1. A table of acceptance criteria and the reported device performance
The document lists various bench tests and biocompatibility tests along with their results. The "Acceptance Criteria" are implied by the "Result" column consistently stating "Passed" or specific equivalent findings.
Table of Acceptance Criteria (Implied) and Reported Device Performance
| Standard | Sterile Device Test / Test Name | Reported Device Performance (Result) |
|---|---|---|
| ISO 9626:2016 | Dimensional Inspections | Passed |
| ISO 10555-1:2014 | Catheter Conditioning (Saline) | Passed |
| ISO 10555-1:2014 | Leak Test | Passed |
| Internal Requirement | Priming Volume Test | Passed |
| ISO 10555-1:2014 | Gravity Flow Test | Passed |
| ISO 10555-1:2014 | Pump Flow Test | Passed |
| ISO 10555-1:2014 | Tensile Test | Passed |
| FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters Section II. D. b. (Mechanical Specifications) | Catheter Stiffness | Passed |
| ISO 10555-1:2014 | Burst Test | Passed |
| ISO 10555-1:2014 | Catheter Flexural Fatigue | Passed |
| ISO 10555-1:2014 | Power Injection Conditioning | Passed |
| Internal Requirement | Printing Font Size | Passed |
| ASTM F1842-15 | Ink Permanence | Passed |
| ISO 594-1: 1986 Via ISO 80369-7:2016 | Luer Taper Test | Passed |
| ASTM F1842-15 | Ink Integrity Test | Passed |
| Internal Requirement | Aspiration Flow Test | Passed |
| Internal Requirement | Luer Color/Orientation Test | Passed |
| Internal Requirement | Clamp Closure Maintenance | Passed |
| Internal Requirement | Clamp and ID Tag Fit Test | Passed |
| Internal Requirement | Clamp Actuation Test | Passed |
| ISO 10555-1:2014 (Aged) | Power Injection Conditioning | Passed |
| ISO 10555-1:2014 (Aged) | Burst Test | Passed |
| ISO 10993-5:2009/(R)2014 | Cytotoxicity | Non-cytotoxic |
| AAMI/ANSI/ISO 10993-10:2010/(R)2014 | Sensitization | Non-sensitizer |
| AAMI/ANSI/ISO 10993-10:2010/(R)2014 | Irritation | Non-irritant |
| ISO 10993-11:2006 | Acute Systemic Injection | Non-toxic |
| USP37 | Material Mediated Pyrogen | Non-pyrogenic |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Hemolysis (extract) | Non-hemolytic |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Hemolysis (direct) | Non-hemolytic |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Complement Activation (Predicate: PowerPICC® Catheter) | Similar when compared to predicate |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Partial Thromboplastin Time (PTT) (Predicate: PowerPICC® Catheter) | Minimal activator (same as predicate) |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Dog Thrombogenicity | Equivocal similar |
| AAMI/ANSI/ISO 10993-6:2007/(R)2014 | Implantation | Non-irritant |
| ISO 10993-18 (Nelson Labs Report does not specify year.) | Extractable/Leachable Analysis | Summarized in project #MJ16357-BIO01 |
| ISO 10993-17:2008 | Subacute/Subchronic Toxicity, Genotoxicity, Chronic Toxicity and Carcinogenicity | Evaluated in Toxicological Risk Assessment |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes (number of devices tested) for each bench or biocompatibility test, nor does it specify data provenance as this is not a study involving human data or image data as typically seen with AI devices. The testing is laboratory-based "bench testing" of the physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a physical medical device clearance, not an AI/ML device where expert ground truth is established. Performance is determined by standardized laboratory tests adhering to ISO standards and internal requirements.
4. Adjudication method
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, this type of study was not performed. The document explicitly states "No Clinical Testing was performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used
Not applicable for the reasons stated above. The "ground truth" for this device's performance is compliance with international and national standards for medical devices (e.g., ISO, ASTM, FDA guidance) and internal requirements, demonstrated through bench and biocompatibility testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).