(107 days)
The PowerPICC® SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
The PowerPICC® SV catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
The subject PowerPICC® SV catheters are members of Bard Access Systems' PowerPICC® series of power injectable catheters. The PowerPICC® SV catheters are available in 3F single lumen and 4F dual lumen configurations. The catheter extension leg, luer hub and junction are printed with description markings to facilitate proper use of the device. The PowerPICC® SV catheters are provided in sterile kit configurations.
The provided text does not contain information about an AI device or a study comparing human readers with and without AI assistance. The document is a 510(k) summary for a medical device called the PowerPICC® SV Catheter, a peripherally inserted central catheter (PICC). It details the device's characteristics, intended use, indications for use, and a summary of verification and validation activities demonstrating substantial equivalence to predicate devices, but does not involve AI, image analysis, or multi-reader studies.
Therefore, I cannot fulfill most of your request regarding AI-related performance metrics and study details. However, I can extract the general acceptance criteria and the type of study conducted for the physical medical device as described.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reference/Method | Reported Device Performance |
|---|---|---|
| General Performance | - Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995 |
- ISO 10555-1:2009, Sterile, single-use intravascular catheters, Part 1. General requirements
- BS/EN/ISO 10555-3:1996/Cor 1:2002, Sterile, single-use intravascular catheters, Part 3. Central venous catheters | "The subject PowerPICC® SV catheters met all predetermined acceptance criteria derived from the above mentioned references." |
| Biocompatibility | - AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile | Implied to meet criteria, as stated "met all predetermined acceptance criteria." |
| Sterilization | - AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results - AAMI/ANSI/ISO 11135:2007, Sterilization of Healthcare Products Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Implied to meet criteria, as stated "met all predetermined acceptance criteria." |
| Design Validation | In-house protocols and design validation activities | "Design validation was conducted on the subject PowerPICC® SV configuration and yielded acceptable results." |
| Risk Management | ISO 14971:2007, Medical Devices - Risk Management for Medical Devices (Failure Modes and Effects Analysis - FMEA) | "No new types of safety or efficacy questions were identified for the subject PowerPICC® SV catheters." (This indicates acceptable risk profile within regulatory norms) |
| Flow Rate (Indications for Use) | Not a test, but stated as part of the intended use parameters. | 3 F Single Lumen: 1 mL/sec
4 F Dual Lumen: 2.5 mL/sec |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Tests were performed on sterilized, finished devices." However, it does not specify the sample size for the test set or the data provenance.
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. This is a submission for a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth for classification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a submission for a physical medical device, not an AI or diagnostic imaging device requiring adjudication.
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
No MRMC study was done, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance described is for the physical PowerPICC® SV Catheter itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a catheter, "ground truth" generally relates to adherence to physical specifications, material properties, sterility, and functional performance benchmarks (e.g., flow rates, tensile strength, biocompatibility). The document indicates performance was evaluated against "predetermined performance specifications" derived from various international standards (ISO, AAMI/ANSI) and FDA guidance documents. This can be considered the "ground truth" or benchmark against which the device's physical and functional attributes were measured.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”