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CentroVena Central Venous Catheter (CVC)

Acute central venous catheters are indicated to provide short term access (

Vena Central Venous Catheters are power-injectable, constructed of medical grade polyurethane and designed for insertion into the central venous system. The central venous catheters are radiopaque and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with other applicable insertion kit accessories.

The CentroVena One Insertion System integrates the essential components for placing central venous catheters. It combines an introducer needle with a passive needle tip safety mechanism, syringe, guidewire, and self-dilating catheter into one unit. The device is preassembled and also has an integrated drape clip permanently attached to the guidewire designed to keep the system organized in the sterile field and prevent guidewire embolism.

The provided document is a 510(k) clearance letter for a medical device: CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System.

Important Note: The document is primarily a regulatory approval and comparison to a predicate device. It lists numerous "acceptance criteria" through reference standards and tests, but it does not provide the specific numerical results or performance metrics that demonstrate the device quantitatively meets these criteria. It also doesn't detail specific study designs for these tests beyond listing the reference standards.

Therefore, the following information will be extracted where explicitly stated or inferable from the document. Many aspects of a detailed study design (like sample sizes for performance tests, expert qualifications, adjudication methods, or specific effect sizes for human performance improvement with AI) are not typically included in a 510(k) summary for a physical medical device like a catheter and related insertion system as they are more relevant to AI/software as a medical device studies.

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

The CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System underwent various performance and safety tests to demonstrate substantial equivalence to its predicate device, the BD Acute Central Line (K190855). The acceptance criteria for the device are primarily derived from compliance with recognized industry consensus standards and FDA guidance documents. The studies involved functional performance testing, biocompatibility testing, and evaluation of the insertion system.

1. Table of Acceptance Criteria (as indicated by reference standards) and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each of the numerous tests conducted. The testing described is typical for physical medical devices and usually involves a statistically relevant number of units/components for each specific test to ensure robust results.

The data provenance is not explicitly stated beyond the fact that these are tests conducted by Becton Dickinson Inc. (BD) to support their 510(k) submission. These would generally be pre-market, prospective tests conducted in a controlled laboratory environment. The country of origin of the data is not mentioned but would presumably be where BD's testing facilities are located.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable and not provided in the document. The device is a physical catheter and insertion system, not an AI/software device that requires expert labeled ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the established scientific and engineering principles outlined in the reference standards themselves.

4. Adjudication Method

This information is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in studies where human readers are interpreting images or data and their decisions need to be reconciled to establish a ground truth, often for AI performance evaluation. This is not relevant for the type of bench and performance testing documented here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or is mentioned. This type of study is specifically designed for evaluating the performance of diagnostic devices, especially those involving human interpretation (e.g., radiology AI aids), and comparing human performance with and without AI assistance. This device is a physical medical instrument, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical instrument, not an algorithm or software requiring standalone performance testing.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is established by:

• Established Industry Consensus Standards: Such as ISO 10993, ISO 10555, ASTM F640, etc. These standards outline methodologies and acceptable performance limits for specific characteristics of medical devices.
• FDA Guidance Documents: Which also provide testing recommendations and performance expectations for device types.
• Engineering Specifications and Design Requirements: The device must meet its own design specifications, which are based on the intended use and safety considerations, often derived from the above standards.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/machine learning model that requires a training set. The tests performed are for verification and validation of the manufactured device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this type of device, no ground truth needs to be established for it.

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The SV Spectrum MRC Central Venous Catheter is indicated to provide short-term (

The SV Spectrum MRC Central Venous Catheter (CVC) is a single-use, antibiotic impregnated, antimicrobial coated, power injectable catheter that is percutaneously inserted into the vasculature using the Seldinger technique, and advanced over a wire guide until its tip is positioned above the superior vena cava-right atrium (SVC-RA) junction within the lower third of the SVC. The SV Spectrum MRC Central Venous Catheter, 7 Fr triple lumen CVC, is made from an aliphatic polyether-based polyurethane catheter shaft with a radiopaque constituent and a bonded soft distal tip. The catheter shaft is impregnated with Spectrum® (minocycline, rifampin) antimicrobial agents and coated with chlorhexidine antiseptic. The SV Spectrum MRC Central Venous Catheter is not intended for treatment of existing infections in patients; the presence of the three antimicrobial agents has been shown to reduce microbial colonization of the catheter.

The SV Spectrum MRC CVC has demonstrated efficacy against the following organisms:

• Staphylococcus aureus
• Staphylococcus epidermidis
• Enterococcus faecalis
• Escherichia coli
• Klebsiella pneumoniae
• Acinetobacter baumanni
• Candida albicans
• Candida glabrata

The effectiveness was evaluated using in vitro methods. The antimicrobial activity of these agents is localized to the internal and external catheter surfaces.

The working length (15, 20, or 25 cm) of the catheter is measured from distal tip to the double bar line approximately 1.5 cm distal to the manifold. The catheter shaft features centimeter length markings. The proximal portion of the SV Spectrum MRC Central Venous Catheter, like the predicate catheter, has three extension tubes with injection-molded Luer hubs connected to a manifold. The injection-molded manifold with suture wings serves as the transition point for lumens of the extension tubes into each lumen of the catheter shaft. All three lumens are power injectable; the maximum flow rate is labeled on the hub of each extension tube.

The SV Spectrum MR Central Venous Catheter is identical to the SV Spectrum MRC Central Venous Catheter except that it is not coated with chlorohexidine antiseptic.

The SV Central Venous Catheter is identical to the SV Spectrum MRC Central Venous Catheter and SV Spectrum MR Central Venous Catheter except it is not impregnated with minocycline or rifampin, nor is it coated with chlorhexidine antiseptic.

This FDA 510(k) clearance letter pertains to a central venous catheter and, as such, does not contain information about the acceptance criteria and study that proves the device meets acceptance criteria for an AI/ML-driven medical device.

The document states:

• "Software: Not applicable. The device contains no software." (Page 18)
• The performance testing for this device focuses on mechanical and shelf-life properties, biocompatibility, and antimicrobial efficacy (for certain versions), all of which are standard for physical medical devices and unrelated to AI/ML performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details specifically relevant to AI/ML device performance and testing (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, ground truth establishment) which are not present in this document as it's for a non-software, non-AI medical device.

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Mais central venous catheters are indicated to provide short-term access (

Mais Central Venous Catheter is a radio opaque catheter, which is placed mainly in the subclavian, or jugular veins down to the right auricle as a short-term channeling access to the central venous system for central administration of drugs and central infusion of fluids and transfusion of blood.

The device provides pre-operative access to infuse anesthesia drugs and quick central access in emergencies as cardiac standstill, shock, etc.

Measuring the central venous pressure can be achieved by connecting the central lumen to the measuring device tube.

Central venous (CV) catheters can be used in anesthesia, critical care, and emergency medicine.

The correct positioning of the central venous catheter is of key significance for therapeutic success.

For most applications, placement in the superior vena cava approximately 2cm before the opening into the right atrium is viewed as the optimal position for the catheter tip.

The CV Catheter is needle punctured and surgically inserted into the superior vena cava (a large vein) of a patient. It can be planted inside for one-month maximum.

Mais Catheters are made from soft polyurethane material and have double, triple or quadruple lumens, and the length is variable. The Mais catheter consists of a white radio opaque multi lumen tube which is tipped with a soft polyurethane material and has many side holes relevant to each lumen. There are markings along the effective length to indicate each centimeter. There is a connector which connects the catheter lumen(s) to a lumen of a transparent polyurethane extension tube so each catheter lumen is connected to a specific extension line. The connector is polyurethane and nearly triangular shaped. Each extension tube is marked to indicate which catheter lumen is attached to it. Distal lumen is used for the CVP monitoring. A flat clamp is put over each extension tube. The flat clamp is colored differently for a given multi lumen catheter.

This looks like a medical device submission, specifically a 510(k) summary for a "Mais Central Venous Catheter." The document describes the device, its intended use, and compares it to a legally marketed predicate device (BD Acute Central Line, K190855).

However, the provided text does not contain acceptance criteria related to device performance in a study involving human readers or AI assistance. Instead, the performance testing section (8. Performance Testing) focuses on the device's physical and biological characteristics, conforming to recognized standards like ISO 10555-1, ISO 10555-3, and ISO 10993-1. These are engineering and biocompatibility tests, not clinical performance studies with diagnostic outputs.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to human readers, AI assistance, effect size, standalone performance, ground truth, or training set specifics.

There is no mention of:

• Acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy).
• Any study involving AI or human interpretation of medical images/data.
• Sample size for test sets or training sets in the context of diagnostic performance.
• Experts establishing ground truth for diagnostic purposes.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth (e.g., pathology, outcomes data) for diagnostic tasks.

The document is about the physical and material safety and performance of an intravascular catheter, not about a diagnostic device or a device that uses AI for interpretation.

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The Cook® Spectrum® 2 MRC Central Venous Catheter is indicated to provide short-term (

The Cook® Spectrum® 2 MRC Central Venous Catheter is a single-use, antibiotic impregnated, antimicrobial coated, power injectable catheter that is percutaneously inserted into the vasculature using the Seldinger technique, and advanced over a wire guide until its tip is positioned above the superior vena cava-right atrium (SVC-RA) junction within the lower third of the SVC. The Cook® Spectrum® 2 MRC Central Venous Catheter, 7 Fr triple lumen CVC, is made from an aliphatic polyether-based polyurethane catheter shaft with a radiopaque constituent and a bonded soft distal tip. The catheter shaft is impregnated with Spectrum® (minocycline, rifampin) antimicrobial agents and coated with chlorhexidine antiseptic. The Cook® Spectrum® 2 MRC Central Venous Catheter is not intended for treatment of existing infections in patients; the presence of the three antimicrobial agents has been shown to reduce microbial colonization of the catheter. The antimicrobial activity of these agents is localized to the internal and external catheter surfaces. The working length (15, 20, or 25 cm) of the catheter is measured from distal tip to the double bar line approximately 1.5 cm distal to the manifold. The catheter shaft features centimeter length markings. The proximal portion of the Cook® Spectrum® 2 MRC Central Venous Catheter, like the predicate catheter, has three extension tubes with injection-molded Luer hubs connected to a manifold. The injectionmolded manifold with suture wings serves as the transition point for lumens of the extension tubes into each lumen of the catheter shaft. All three lumens are power injectable; the maximum flow rate is labeled on the hub of each extension tube.

The provided text is a 510(k) summary for the Cook® Spectrum® 2 MRC Central Venous Catheter. It outlines the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, nor does it contain the requested detailed information regarding test set size, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on demonstrating the substantial equivalence of a medical device (a central venous catheter) to a previously cleared predicate device. This is typically done through non-clinical performance testing (e.g., tensile strength, flow rate, biocompatibility) and a comparison of technological characteristics, rather than clinical studies with human readers or AI algorithms.

Therefore, I cannot extract the information required to answer your specific questions related to acceptance criteria and a study proving device performance as if it were an AI/ML device. The document does not contain this type of data or study design.

Here's what I can infer from the document regarding the acceptance criteria and performance, keeping in mind it's for a traditional medical device, not an AI/ML one:

Implied Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Performance Testing):

The "acceptance criteria" here are implicitly tied to demonstrating the Cook® Spectrum® 2 MRC Central Venous Catheter is as safe and effective as the predicate device. This is achieved by showing that the new device meets relevant industry standards and performs similarly to the predicate in key technical areas.

Since the requested information pertains to AI/ML device studies, and this document is for a traditional catheter, the following points cannot be addressed from the provided text:

• Sample size used for the test set and the data provenance: Not applicable in this context. The "test set" refers to physical, chemical, and biological tests on the device itself.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device involves expert annotations of data (e.g., images), which is not relevant here.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 an AI/ML device, and no human reader studies are described.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth for image interpretation or diagnosis is being established.
• The sample size for the training set: Not applicable. There is no AI/ML algorithm being trained.
• How the ground truth for the training set was established: Not applicable.

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ACENT™ Central Venous Catheter is an intravascular catheter, designed for infusion of fluid to the central venous system and/or for pressure measurements.

• for short-term (less than 30 days) infusion therapy or parenteral nutrition
• for continuous or intermittent monitoring of the central venous pressure,
• for blood sampling.

ACENT™ catheters are polyurethane, radiopaque single, double, or triple lumen catheters. The catheter is available in sizes that vary from 4 French through 8 French and lengths 8 cm through 20 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation or junction) hub, where it branches via the connector into dedicated extension tubes for infusion of fluids. Each of the extension line has a slide clamp and are labeled to provide identification of the lumen size and location. The catheter body has depth markings, measured in cm from the catheter tips. The extension line marked "distal" is used for device placement with a compatible guide wire. The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system.

The ACENT™ Central Venous Catheter is a medical device designed for infusion of fluids to the central venous system, pressure measurements, short-term infusion therapy or parenteral nutrition (less than 30 days), continuous or intermittent monitoring of central venous pressure, and blood sampling.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The provided document describes bench performance testing, biocompatibility testing, sterilization validation, and packaging & shelf life studies. It does not specify a "test set" in the context of clinical data with human subjects or a comparison to expert ground truth.

• For bench performance tests, the document states "sterilized production lot" was used, but the specific number of units tested is not provided.
• For biocompatibility tests, the document lists various tests performed, which would involve in vitro and in vivo (animal) models, but does not specify sample sizes for these tests.
• For sterilization validation and packaging/shelf life studies, standard industrial validation protocols were followed, which involve specific sample sizes per the respective standards. However, the exact sample sizes are not explicitly stated in this summary.

Data Provenance: The studies are described as bench performance, biocompatibility, sterilization, and packaging & shelf life studies, which are laboratory-based and generally not associated with country of origin in the same way as human clinical data. They are not retrospective or prospective clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable to the provided document. The studies described are technical performance tests, biocompatibility assessments, and sterilization validations, which rely on established scientific and engineering standards and validated methods, rather than expert consensus on clinical diagnoses or interpretations of images/data for a "test set" in the context of AI or advanced diagnostic devices.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no "test set" requiring adjudication by experts in the context of this device's performance data. The studies performed are based on predefined standards and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI-assisted diagnostic tools to evaluate how a device impacts human reader performance. The ACENT™ Central Venous Catheter is a hardware device for infusion and measurement, not a diagnostic tool requiring human interpretation of output.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm-only) performance study was not done. This type of study is relevant for AI or algorithmic devices. The ACENT™ Central Venous Catheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the ACENT™ Central Venous Catheter is based on adherence to international and national standards (e.g., ISO, USP, ASTM, AAMI/ANSI) for medical devices. This includes:

• Engineering specifications and standards for physical performance (e.g., strength, flow rates, connection integrity).
• Biological evaluation standards for biocompatibility (e.g., absence of cytotoxicity, irritation, systemic toxicity).
• Sterilization validation standards to ensure a specified sterility assurance level.
• Packaging integrity standards to maintain sterility and function over the shelf life.

This is distinct from clinical "expert consensus," "pathology," or "outcomes data" which would be used for diagnostic devices or clinical trials.

8. The Sample Size for the Training Set:

This information is not applicable. The ACENT™ Central Venous Catheter is a hardware medical device, not an AI or machine learning algorithm, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set for this device.

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The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
   The device is a short-term use catheter, intended for less than 30 days.
   The Cook dilator is used for dilating puncture sites or catheter tracts.
   The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

The Cook Unimpregnated Central Venous Catheter with power injection is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
7. Power injection of contrast media*
   *The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters.
   The device is a short-term use catheter, intended for less than 30 days.
   The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.
   The Cook dilator is used for dilating puncture sites or catheter tracts.
   The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

The Cook Unimpregnated Central Venous Catheter is a single use sterile intravascular catheter designed to be inserted into a patient's vascular system. The CVC is inserted into the vasculature using the Seldinger technique. The tip of the catheter is then advanced until it is above the superior vena cava-right atrium (SVC-RA) junction. The CVC configurations include a single, dual, triple, or five-lumen shaft manufactured from polyethylene, ethylene-vinyl acetate, or polyurethane tubing. The CVC is manufactured with an outside diameter between 2.5 and 10 French and has a length between 5 and 40 centimeters dependent on the configuration. Single lumen CVCs are designed with a premolded winged hub on the proximal end. Dual, triple, and five-lumen CVCs are designed with a manifold assembly, which is comprised of a winged manifold connected to extension tubes. Each extension tube has a slide clamp and is manufactured with a proximal winged hub. Certain CVC configurations are power injectable. The CVC may be packaged as a convenience kit with various other components which may include a dilator, inner catheter, wire guide, access needle, injection caps, clamps, catheter securement device, connecting tube, and other convenience accessories. The subject device inner catheter, supplied with the 9 and 10 French subject device catheters, is used to assist advancement of the main catheter over the wire guide. The inner catheter, manufactured from nylon, is designed to lock with the hub of the polyurethane catheter. The subject device dilator, used to dilate the access site during the procedure, is designed with a radiopaque extruded polyethylene shaft and a pre-molded polyethylene proximal hub. It is manufactured with an outside diameter ranging from 3.5 to 12.0 French and has a length between 6 and 11 centimeters.

The provided text describes the acceptance criteria and the results of various performance tests for the Cook Unimpregnated Central Venous Catheter. It is a submission for a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device, not an AI or algorithm-driven device. Therefore, many of the requested categories (such as sample size for test set, data provenance, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this document.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• ≥ 5 N for 2.5 and 3 Fr catheters
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Sideport Tensile (Aged) | Peak tensile load for the sideport section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Shaft-to-Hub Tensile (Aged) | Peak tensile load for the shaft-to-hub section of the catheter shall be:
• ≥ 5 N for 2.5 and 3 Fr catheters
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Shaft-to-Manifold Tensile (Aged) | Peak tensile load for the shaft-to-manifold section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Manifold-to-Extension Tube Tensile (Aged) | Peak tensile load for the manifold-to-extension tube section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Extension Tube-to-Hub Tensile (Aged) | Peak tensile load for the extension tube-to-hub section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Liquid Leakage (Aged) | No part of the catheter shall leak liquid when tested in accordance with Annex C of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Air Leakage (Aged) | No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Kink Radius (Aged) | The catheter shall not kink (flowrate reduced by 50%) at a specified kink (circumferential) length when tested in accordance with Annex B of BS EN 13868. | The acceptance criterion was met. |
  | Catheter Gravity Flow Rate (Time-Zero) | The flow rate of the test articles will be characterized when tested in accordance with Annex E of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Static Burst (Aged) | The catheter failure pressure during static burst was characterized for the test articles when tested in accordance with Annex F of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Hub Pressure (Power Injection) (Aged) | The peak hub pressure of the power injectable lumen for each specimen type for the test articles when tested in accordance with Annex G of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Inner Catheter Shaft Tensile (Time-Zero) | Peak tensile load for the shaft section of the inner catheter shall be:
• ≥ 5 N for 3 Fr catheters
• ≥ 10 N for 4 Fr catheters
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Inner Catheter Hub-to-Shaft Tensile (Time-Zero) | Peak tensile load for the hub-to-shaft section of the inner catheter shall be:
• ≥ 5 N for 3 Fr catheters
• ≥ 10 N for 4 Fr catheters
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Dilator Hub-to-Shaft Tensile (Aged) | Peak tensile load for the hub-to-shaft section of the dilator shall be:
• ≥ 5 N for 3.0 Fr dilators
• ≥ 10 N for 3.5, 4.0, 5.0, and 5.5 Fr dilators
• ≥ 15 N for dilators > 5.5 Fr
  (In accordance with BS EN ISO 11070) | The acceptance criterion was met. |
  | Dilator and Wire Guide Compatibility Analysis | Each unique dilator French size shall be compatible with the correlating wire guide. | The acceptance criteria were met (implied by "The acceptance criterion was met"). |
  | Catheter Hub Luer Compatibility Analysis | Tested in accordance with the test methods specified in ISO 594-1:1986 and ISO 594-2:1998. | The acceptance criterion was met (implied by "The acceptance criterion was met"). |
  | Packaging: Dye penetration testing | Per ASTM F1929-15. | Performed (stated "Performed to assure design and performance"). |
  | Packaging: Seal strength testing | Per ASTM F88/F88M-15. | Performed (stated "Performed to assure design and performance"). |
  | Sterilization validation testing | Per ISO 11135-1:2014. | Performed (stated "Performed to assure design and performance"). |
  | Biocompatibility Testing | Testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility were performed per ISO 10993-1 and FDA guidance. | Performed (stated "Performed to ensure the biocompatibility of the subject device set"). |

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each performance test. It mentions "each specimen type" for some tests, implying multiple samples were tested for each variation. Data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but these are laboratory-based performance tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes laboratory performance testing of a physical medical device, not a diagnostic or AI-driven system that requires expert ground truth.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, this is about the mechanical and material performance of a central venous catheter, not a diagnostic or AI system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

For the performance tests, the "ground truth" is defined by the objective physical and chemical standards and test methods specified by the referenced international standards (e.g., BS EN ISO 10555-1, BS EN 13868, ISO 594-1, ISO 594-2, ASTM F1929-15, ASTM F88/F88M-15, ISO 11135-1, ISO 10993-1). These standards outline the methods to objectively measure and verify the device's characteristics.

8. The sample size for the training set

Not applicable, as this is not an AI or algorithm-driven device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is intended for delivery of whole blood products, drug administration and blood sampling.

The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is composed of a peripherally inserted central venous catheter, obturator, wire guide, Peel-Away® introducer, access needle, syringe, catheter securement device, thumb scalpel, drape, and tape measure. Additional set configurations may also include a dilator, gauze, Lidocaine, Monoject needles, and other convenience accessories. The catheter is available in a single (3.0, 4.0, 5.0 French) or dual lumen (7.0 French) configuration with lengths of 50 and 60 centimeters. The catheter shaft is manufactured from silicone radiopaque tubing, which is connected to a silicone winged manifold. Proximally, the winged manifold is attached to one or two silicone extension tubes with a pre-molded acetal hub. Additionally, removable polypropylene clamps are attached to each extension tube. The obturator is manufactured from stainless steel and has a hydrophilic coating. It is designed to fit in the catheter and is manufactured with a proximal Luer hub that can be locked into the proximal hub of the corresponding catheter. The wire guide is manufactured with either stainless steel or a nitinol mandril with a platinum tip. The introducer is composed of a radiopaque tetrafluoroethylene (TFE) Peel-Away® sheath and a polyethylene dilator matched for transitional fit. The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is sterilized by ethylene oxide and intended for one-time use.

The provided text describes a 510(k) premarket notification for a medical device and evaluates its substantial equivalence to predicate devices, rather than presenting a study proving a device meets acceptance criteria for an AI or imaging diagnostic tool. Therefore, much of the requested information (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or cannot be extracted from this document.

However, I can provide the acceptance criteria and performance data for the physical device based on the bench testing conducted.

1. Table of Acceptance Criteria and Reported Device Performance:

Details Not Applicable or Not Provided in the Document:

2. Sample size used for the test set and the data provenance: The document refers to "test specimens" for bench testing, but specific sample sizes for each test are not provided. The data provenance is Cook Incorporated's internal testing. This is not clinical data, but rather engineering and materials testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes physical device testing, not a diagnostic or AI-driven medical device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical device performance tests, the "ground truth" refers to established engineering standards (e.g., ISO, ASTM, BS EN) and their respective acceptance criteria.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

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The EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements.

PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients.

The pressure injectable EOCVC Oligon catheters are indicated for short term (

The Edwards Oximetry Central Venous Catheter is a non-balloon catheter that provides the means for infusion of solutions, measuring pressure, and taking blood samples through the distal lumen (terminates at the catheter tip), the proximal lumen (terminates 7 cm proximal to the tip), and the medial lumen (terminates 5 cm proximal to the tip). Edwards Oximetry Central Venous Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.

The PediaSat oximetry catheters are non-balloon catheters that provide the means for infusion of solutions, measuring pressure, and taking blood samples. These catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.

The EOCVC Oligon catheter is a non-balloon catheter that provides the means for infusion of solutions measuring pressure injecting contrast media, and taking blood samples through the distal lumen (terminates 7 cm proximate to the tip), and the medial lumen (terminates 5 cm proximal to the tip). The EOCVC Oligon catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences monitor and compatible bedside module. All catheters are manufactured with a polyurethane-based Oligon polymer (containing silver, platinum, and carbon black) which has antimicrobial properties.

Oxygen saturation is monitored by fiberoptic reflectance spectrophotometry. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood.

The PediaSat Oximetry Catheter is a 3 lumen catheter available with a diameter of 4.5 French (F) and 8 cm in length. The EOCVC Oximetry Catheters are 3 lumen catheters available with a diameter of 8.5F and in lengths of 16 and 20 cm. EOCVC and PediaSat catheters are manufactured from polyurethane.

A suture loop and a specially molded box clamp are provided with each EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheter to facilitate suturing of the catheter at the site of insertion. The suture loop and box clamp can be placed anywhere along the catheter body at the discretion of the clinician.

The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.

The EOCVC (Oligon and non-Oligon) and PediaSat Kits consist of accessories previously cleared for marketing as well as accessories that are the subject of this submission.

This submission is for clearance of proposed modifications to the accessories (suture loop, box clamp and dilator) for use with the previously cleared EOCVC Oligon (K160645), PreSep (now EOCVC), and PediaSat (K053609) Oximetry Catheter Kits. Additional accessories are listed on table below.

The provided text is a 510(k) summary for the Edwards Oximetry Central Venous Catheter (EOCVC), Edwards Oligon Oximetry Central Venous Catheter, and PediaSat Oximetry Catheters. The submission aims for clearance of proposed modifications to accessories (suture loop, box clamp, and dilator) for use with previously cleared catheters. The study described focuses on demonstrating the substantial equivalence of these modified accessories to predicate device accessories.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the functional and performance testing of the accessories. It only mentions that "Testing was conducted." The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified. These studies are typically conducted in a laboratory setting by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The testing described appears to be primarily bench testing and performance verification against engineering specifications, rather than clinical studies requiring expert ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective evaluations (e.g., image interpretation). The tests described are objective engineering and performance verification tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of a device on human reader performance, usually in diagnostic imaging. The submission focuses on the substantial equivalence of modified catheter accessories through bench and performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical catheter and its accessories, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests would primarily be engineering specifications and established performance benchmarks derived from the predicate devices and industry standards. For example, "tensile strength" would be compared against a defined maximum or minimum force, and "dimensional verifications" against specified measurements.

8. The Sample Size for the Training Set

Not applicable. The described study is not a machine learning study requiring a training set. It involves physical product testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device submission.

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Amecath Peripheral Inserted Central Venous Catheter Sets are intended for use in attaining access to the central venous system for short or long-term use for venous pressure monitoring, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is indicated for multiple injections of contrast media through a power injector. The maximum pressure linetors used with the catheter may not exceed 300 psi and the flow rate may not exceed the maximum flow rate indicated.

Not Found

This document (K152819) is a 510(k) premarket notification for a medical device called "Amecath Peripheral Inserted Central Venous Catheter Sets." It is a regulatory clearance letter and does not contain details of a study with acceptance criteria and reported device performance related to an AI/Software as a Medical Device (SaMD) product.

The content describes the device's indications for use and confirms its substantial equivalence to legally marketed predicate devices, allowing its commercialization. There is no information provided about:

• Acceptance criteria for performance metrics
• Reported device performance against such criteria
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type or establishment of ground truth

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document is for a physical medical device (catheter sets), not a software or AI product that would typically involve the detailed study characteristics you've requested.

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Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject® PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The proposed Spectrum Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-the-wire. The proposed devices are minimally tapered 4.0 Fr and 5.0 Fr single and double lumen catheters. The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

The provided text describes a 510(k) summary for the Cook Medical Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set. It outlines the device's intended use, comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For "Static Failure Pressure Testing" and "Antimicrobial Testing", the specific numerical acceptance criteria (other than >15mm for antimicrobial, which is also stated as "predetermined") are not explicitly defined in the document, but the document states the device met them.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., number of catheters tested for tensile strength or leakage).
The data provenance is retrospective, as the submission is for modifications to previously cleared devices (K081690, K072625, K132334, K132885). The testing was conducted to demonstrate substantial equivalence to these predicate devices. The country of origin of the data is not specified, but the applicant address is in Bloomington, IN, USA.

3. Number of Experts and Qualifications

The document does not mention the involvement of experts to establish ground truth for a test set. The tests describe physical and performance characteristics of the device, which are typically evaluated through laboratory testing against predefined engineering specifications.

4. Adjudication Method

Not applicable. This type of submission (510k for a medical device) typically relies on laboratory testing and engineering specifications rather than expert adjudication of a test set, which is more common in diagnostic device or AI algorithm evaluations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device is a "Peripherally Inserted Central Venous Catheter Set," a physical medical device, not a diagnostic imaging or AI-assisted system that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications and established criteria for medical device safety and effectiveness. For example:

• Tensile strength: Measured against a force (10 N).
• Leakage: Absence of liquid/air leakage.
• Pressure: Ability to withstand specified pressure (325 psi).
• Antimicrobial activity: Measured zone of inhibition (15 mm).
  These are objective, quantitative measurements against predefined standards.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal validation and verification activities, but these are not referred to as training sets.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device. The specifications and acceptable performance limits are derived from industry standards (e.g., ISO 10555-1:1995), regulatory requirements, and the performance characteristics of predicate devices.

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