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The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.

The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).

This document describes a 510(k) premarket notification for "PICC Maximal Barrier Nursing Kits" by Navilyst Medical, Inc. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The document primarily focuses on a packaging change for the kit and vendor changes for several kit accessories. It does not detail new device performance, clinical studies for efficacy, or the development of an AI/ML model. Therefore, many of your requested points regarding acceptance criteria, study details for device performance (beyond packaging integrity), expert adjudication, AI/ML impact, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems (2006)
• AAMI/ANSI/ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)
  The document states "Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit."
  (Specific test results or quantitative performance metrics for packaging integrity are not provided in this summary but are implied to meet the standards.) |
  | Equivalence to Predicate Device (Overall) | "The proposed PICC indications for use, technological characteristics, materials and operating principles are identical."
  "The performance evaluation... is the result of design verification and validation activities, and risk assessment."
  "Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit." |

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

Not applicable. This submission is for packaging and accessory vendor changes, not a new device requiring a clinical test set with patient data. The "test set" here refers to samples of the new packaging and components subjected to engineering and packaging validation tests. Specific sample sizes for these engineering tests are not provided in this summary.

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

Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring adjudication of results.

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. There is no mention of AI or machine learning in this submission.

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

Not applicable. There is no mention of AI or machine learning in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this submission, "ground truth" relates to the compliance of the new packaging and components with established engineering and regulatory standards (e.g., sterility, seal integrity, material compatibility).

8. The sample size for the training set

Not applicable. There is no mention of AI or machine learning, and therefore no training set.

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

Not applicable. There is no mention of AI or machine learning, and therefore no training set or ground truth for it.

Summary of Device and Changes:

The device, "PICC Maximal Barrier Nursing Kits," includes various PICC catheter types (BioFlo Hybrid, BioFlo, Xcela Hybrid, Xcela) packaged with procedural aides and maximal barrier precautions. The "indications for use, technological characteristics, materials and operating principles are identical" to the predicate device. The only "differences" are a packaging change (outer tray with Tyvek lid replaced with a Tyvek/Nylon Pouch) and changes in vendors for "several kit accessories." The entire submission focuses on demonstrating that these changes do not alter the substantial equivalence to the predicate device, primarily through performance testing of the new packaging configuration against recognized international standards.

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The BioFlo Midline catheter is indicated for short term access to the peripheral venous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.

The BioFlo Midline Catheter is a short term peripheral venous access device between 3 to 10 inches in length (8 to 25 cm). Midlines are usually placed in an arm vein such as the basilic, brachial or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.

This document is a 510(k) summary for the BioFlo Midline Catheter, which concerns a change in the Directions For Use (DFU) of an already cleared device. Therefore, the information typically found in acceptance criteria and detailed study reports for a device's initial clearance is not fully present or directly applicable.

Based on the provided text, the device itself (BioFlo Midline Catheter) was previously cleared, and this submission (K161866) focuses specifically on a change to its labeling (DFU). The core claim is that since only the DFU changed, and the physical device is identical to the predicate (K150407), no new performance testing was required.

Here's an attempt to answer your questions based on the available information, noting where data is implicitly accepted from the predicate or explicitly stated as not applicable for this particular submission:

1. A table of acceptance criteria and the reported device performance

For this specific 510(k) (K161866), no new acceptance criteria or reported performance data for the device itself are provided because the change is limited to the DFU. The performance of the device is considered substantially equivalent to the predicate device (K150407) based on its identical materials, design, and components.

However, the document lists the types of bench testing performed for the predicate BioFlo Midline Catheter (K150407), which would have had associated acceptance criteria at the time of its clearance.

• 4F Single Lumen/20 cm: 6 mL/sec
• 5F Single Lumen/20 cm: 6 mL/sec
• 5F Dual Lumen/20 cm: 6 mL/sec |
  | Static Burst Strength | Assumed to meet standard requirements (Detail not provided in this document) |
  | Multiple Power Injections | Assumed to meet standard requirements (Detail not provided in this document) |
  | Gravity Flow Rate | Assumed to meet standard requirements (Detail not provided in this document) |
  | Catheter Length (conforming to specified range) | "between 3 to 10 inches in length (8 to 25 cm)" |
  | Priming Volume | Assumed to meet standard requirements (Detail not provided in this document) |
  | Midline Identification | Assumed to meet standard requirements (Detail not provided in this document) |
  | Dimensional Verification (ID, OD, Length) | Assumed to meet standard requirements (Detail not provided in this document) |
  | Catheter Kink/Flex Resistance (Elongation, Stiffness, Flex Life Strength) | Assumed to meet standard requirements (Detail not provided in this document) |
  | Alcohol Compatibility | Assumed to meet standard requirements (Detail not provided in this document) |
  | Catheter Marking & Identification/Radiopacity Testing | Assumed to meet standard requirements (Detail not provided in this document) |
  | Tensile Testing (Catheter and Assembly) | Assumed to meet standard requirements (Detail not provided in this document) |
  | Compatibility Testing | Assumed to meet standard requirements (Detail not provided in this document) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For K161866, no new performance testing was conducted, hence no test set sample size is applicable.

For the predicate device (K150407), which underwent the listed bench testing, the document does not specify the sample sizes used for each test or the data provenance. It only states that the tests were non-clinical bench testing conducted according to FDA guidance and international standards. This implies lab-based testing rather than 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)

This question is not applicable to an update based solely on a change to the Directions For Use (DFU), as no clinical ground truth assessment or expert review of performance data was conducted for this specific submission. The DFU change was aligned with updated Infusion Nurses Society (INS) Standards of Practice and compared to another cleared midline catheter's DFU.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this submission as no new testing was performed and no expert adjudication of performance data was required regarding the DFU change.

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 device is an intravascular catheter, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For K161866, the "ground truth" for the DFU change was the Infusion Nurses Society (INS) Standards of Practice, specifically noting changes made between the 2011 and 2016 versions, and comparison to the DFU of a similar predicate device (Bard PowerGlide Midline catheter K133856) to ensure consistent clinical interpretation and safety.

For the predicate device (K150407)'s original bench testing, the ground truth would have been established by the performance characteristics defined in the relevant international standards (e.g., EN ISO 10555-1, EN ISO 10555-3, ISO 594-2, EN ISO 10993-1) and FDA guidance documents.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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The NMI Port and NMI Port II with and without PASV Valve Technology are indicated for patients who require longterm access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. When used with a power injectable needle, the NMI Port II are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

The NMI Port and NMI Port II with and without PASV Valve Technology are a subcutaneous implantable venous access device with one reservoir and is designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing silicone septum covering the reservoir. The NMI Port and NMI Port II are available in plastic or titanium single lumen and valved or nonvalved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue; whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) to identify the port as power injectable. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories. The NMI Port II catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.

This document is a 510(k) premarket notification for a medical device, specifically, the NMI Port and NMI Port II, which are subcutaneous implantable venous access devices. The purpose of this type of submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its clinical effectiveness in AI-assisted diagnosis.

Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, expert qualifications, ground truth establishment for training sets, etc.) is not applicable to this document. This document focuses on the physical and performance characteristics of an implantable medical device.

However, I can extract the acceptance criteria and performance data related to the device's physical and functional properties based on the provided text.

1. Table of acceptance criteria and the reported device performance:

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

• Power Injection and Burst Test: 3 lots of 15 each (45 total).
• Aspiration Strength - Open Ended Test: 3 lots of 75 each (225 total).
• Aspiration Strength - Closed Ended Test: 3 lots of 75 each (225 total).
• CT Ink Durability Test: 3 lots of 75 each (225 total).
• Port body height Test: 3 lots of 75 each (225 total).
• Port Body Break Strength Test: 3 lots of 75 each (225 total).

Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective clinical data. However, given this is an engineering and material performance test for a 510(k) submission, the "data" refers to physical measurements and tests conducted on manufactured device samples, not patient data. These are likely prospective tests conducted on new production lots.

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):

This document does not describe the use of human experts to establish "ground truth" for a test set in the context of diagnostic performance. The tests are engineering and material performance assessments, likely conducted by qualified testing personnel or automated equipment, following established international standards (EN ISO 10555-1:2013, EN ISO 10555-3:2013) and FDA guidance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human interpretation or adjudication of diagnostic images or clinical outcomes.

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 document is for an implantable medical device (infusion port), not an AI/ML diagnostic software.

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

Not applicable. This document is for an implantable medical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context refers to the defined physical and functional specifications and performance standards established for the device. These are objective measurements (e.g., burst pressure, freedom from leaks, physical dimensions, breaking force) and visual inspections (e.g., no flaking/chipping of ink). The "truth" is determined by whether the device's performance meets these pre-established quantitative and qualitative acceptance criteria. It's based on engineering principles and regulatory standards.

8. The sample size for the training set:

Not applicable. There is no AI/ML model training discussed in this document.

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

Not applicable. There is no AI/ML model training discussed in this document.

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Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.

Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a locking pigtail and is coated with GLYCE hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distal tip. The Exodus Array Multipurpose Drainage Catheter (when applicable) and the Exodus Believe Biliary Catheter include a polymer marker to assist with catheter placement.

The proposed Exodus Drainage Catheters will include the following accessories: a metal cannula and a plastic cannula (all product offerings) and a 0.038" trocar needle (in multipurpose offerings only).

The provided text is a 510(k) Summary for the Exodus Drainage Catheters. This document details the substantial equivalence of new drainage catheters to previously marketed predicate devices. It focuses on device description, intended use, technological characteristics, and performance data to demonstrate safety and effectiveness.

However, it does not include the type of study that would typically generate acceptance criteria and performance metrics for a diagnostic AI device. The document describes physical and chemical performance tests for a physical medical device (catheter), not a digital or AI-based diagnostic tool.

Therefore, I cannot fulfill your request for specific acceptance criteria and study details related to an AI device's performance based on the provided text. The information required (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not available in this type of FDA submission for a catheter.

Here's how I would describe the current information, acknowledging its limitations for an AI device:

Based on the provided K152069 510(k) Summary for the Exodus Drainage Catheters, the device is a physical medical device (catheter), not an AI-based diagnostic tool. Therefore, the information requested regarding acceptance criteria and study details for an AI device's performance (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not applicable or available in this document.

The document details performance testing for the physical attributes and biological compatibility of the catheter.

1. Table of Acceptance Criteria and Reported Device Performance (for a physical catheter):

The 510(k) summary lists the types of performance tests conducted for the Exodus Drainage Catheters to demonstrate substantial equivalence to a predicate device (K093392). While specific quantitative acceptance criteria and detailed reported performance values are not explicitly stated in this high-level summary, the document indicates that the results "demonstrate safety and effectiveness of the proposed device and substantial equivalence."

2. Sample size used for the test set and the data provenance: Not applicable. This summary describes physical testing of devices, not a study involving a "test set" of patient data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for patient images/data is not relevant to the physical and biological testing of a catheter.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving reader adjudication of diagnostic output.

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 document pertains to a physical medical device (catheter) and does not describe an AI system's performance or human-AI interaction.

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 to this type of device and testing. The "ground truth" for catheter performance relates to established engineering standards, material specifications, and biological safety standards (e.g., ISO 10993-1).

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

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The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media.

The Xcela PICC with PASV Valve technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media.

The Xcela Hybrid PICC with PASY Valve technology is indicated for short or long-term access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate is 6 mL/sec.

The proposed device has identical technological characteristics and performance as the predicate intravascular catheters. Both the proposed and predicate devices are, in brief, intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media. available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter; rated for maximum power injector settings up to 325 psi rated for maximum power injection flow rate up to 6 ml/second based on model; and available kitted with a range of procedural accessories for user convenience. The only difference compared to the current Xcela Power Injectable PICC, Xcela PICC with PASV Valve and Xcela Hybrid PICC with PASV Valve catheters cleared via K093366, K111906 and K150527 is a change of the catheter shaft, luer and suture wing print ink.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves device performance. It's important to note that this document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria in the way one might for a novel AI device. Therefore, some of the requested categories (especially those related to AI algorithm performance) will not be applicable or directly found in this type of document.

Summary of Acceptance Criteria and Device Performance:

The document describes the Xcela Power Injectable PICC, Xcela PICC with PASV Valve Technology, and Xcela Hybrid PICC with PASV Valve Technology. The core premise for this 510(k) submission is that the only difference compared to previously cleared predicate devices (K093366, K111906, and K150527) is a change in the catheter shaft, luer, and suture wing print ink. Therefore, the "acceptance criteria" and "device performance" largely refer to the established performance characteristics of the predicate devices, which the modified device is expected to meet due to the minor nature of the change.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a minor modification and not a de novo device, explicit numerical acceptance criteria for each test are not listed in this summary. Instead, the document states that the modified device has "identical technological characteristics and performance as the predicate intravascular catheters." The performance aspects are implied by the types of tests performed.

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The BioFlo Midline Catheter is indicated for short term access (

The BioFlo Midline Catheter is a short term (

The provided text describes a 510(k) premarket notification for the BioFlo Midline Catheter. It outlines the device's characteristics, intended use, and a comparison with predicate and reference devices, along with performance data from non-clinical bench testing. However, the document does not describe a clinical study in the format requested, nor does it provide the detailed acceptance criteria and study results for a device that relies on AI or machine learning.

The acceptance criteria mentioned are general performance aspects for a medical device (intravascular catheter), and the "study" referred to is a series of non-clinical bench tests. The concept of "AI performance," "human reader improvement with AI," "standalone algorithm performance," "ground truth," and "training set" are not applicable to this particular device and its regulatory submission as described.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an attempt to extract relevant information from the document, acknowledging the limitations:

1. Table of acceptance criteria and the reported device performance:

The document lists various non-clinical bench tests performed. These tests implicitly define "acceptance criteria" through their successful completion, demonstrating that the device meets relevant standards for its intended use. Exact quantitative acceptance criteria are not explicitly stated in numerical form within this summary, but the successful completion of the tests implies meeting the required thresholds.

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

• Sample size: Not specified. The document only mentions "non-clinical bench testing." For bench tests, sample sizes can vary significantly depending on the specific test and standard requirements, but these are typically physical units, not patient data sets.
• Data provenance: Not applicable in the context of clinical or image-based data. The tests are non-clinical bench tests.

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

• Not applicable. This device is a physical medical device (catheter) undergoing bench testing, not a diagnostic or AI-driven device requiring expert-established ground truth from patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This concept is relevant for clinical studies or AI evaluations involving human readers and ground truth, not for the described bench tests.

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. This is not an AI-based device, and no MRMC study was performed or mentioned.

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

• No. This is not an AI-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the context of patient data ground truth. The "ground truth" for bench testing is defined by the technical specifications and performance requirements outlined in the referenced standards (e.g., ISO 10555-1, ISO 594-2).

8. The sample size for the training set:

• Not applicable. This device does not involve an AI algorithm that requires a training set.

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

• Not applicable. This device does not involve an AI algorithm.

Summary of the Study (Bench Testing) that Proves the Device Meets Acceptance Criteria:

The study proving the BioFlo Midline Catheter meets acceptance criteria consists of a series of non-clinical bench tests. These tests were conducted in accordance with several FDA Guidance Documents and international standards, including:

• FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters"
• EN ISO 10555-1:2013 - "Intravascular Catheters - Sterile and Single-Use Catheters - Part 1: General Requirements"
• EN ISO 10555-3:2013 - "Intravascular Catheters Sterile and Single-Use Catheters Part 3: Central Venous Catheters"
• ISO 594-2:1998 - "Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings"
• EN ISO 10993-1:2009 - "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"

The specific tests performed included: Power Injection Flow Rate, Static Burst Strength, Multiple Power Injections, Gravity Flow Rate, Catheter Length, Priming Volume, Midline Identification, Dimensional Verification, Catheter Kink/Flex Resistance, Alcohol Compatibility, Catheter Marking & Identification/Radiopacity Testing, Tensile Testing, and Compatibility Testing with insertion accessories.

The submission concludes that "successful results of non-clinical bench testing" demonstrate that the proposed device is substantially equivalent to the predicate device. This implies that the device met all the required performance specifications and safety criteria as defined by the referenced standards and guidance documents.

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The Xcela Power Injectable PICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, and for power injection of contrast media. Maximum power injection flow rate:

4F Single Lumen, 45 cm - 4 mL/sec

4F Single Lumen, 55 cm - 3.5 mL/sec

5F Single Lumen, 55 cm - 5 mL/sec

5F Dual Lumen, 45 cm - 5 mL/sec

5F Dual Lumen, 55 cm - 4 mL/sec

6F Dual Lumen, 55 cm - 5 mL/sec

The Xcela Power Injectable PICC is a peripherally inserted central catheter. It is available in single and multi-lumen configurations in a wide range of sized from 4F to 6F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and rated for maximum power injection flow rate up to 5 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience. Changes from the predicate device include the addition of an oversleeve to the extension tube, a new non-valved luer design, and inclusion of maximum flow rates into the indication statement.

The provided document is a 510(k) Summary for a medical device called "Xcela Power Injectable PICC." It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data. The document does not contain information about acceptance criteria or specific studies in the context of AI/ML device performance as requested in the prompt.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/ML device. Instead, it refers to equivalence based on technological characteristics and non-clinical tests.

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

• Sample Size: Not applicable. The document describes non-clinical "performance evaluation" and "non-clinical tests" but does not specify a "test set" in the context of AI/ML validation (e.g., a dataset of images or patient cases). The tests are for the physical device.
• Data Provenance: Not applicable.

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

• Not applicable. This is not an AI/ML device validation.

4. Adjudication method 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/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• Not applicable in the AI/ML sense. The "ground truth" for this device would be established by physical and chemical testing against defined specifications and standards, confirming material properties, dimensional accuracy, flow rates, pressure resistance, and biological safety (e.g., biocompatibility testing, not detailed here but implied by compliance with standards).

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.

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The NMI PICC II and NMI PICCIV are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft.

This document describes a 510(k) premarket notification for the NMI PICC III and NMI PICC IV devices. It focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study proving device meets acceptance criteria through performance. As such, information regarding a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement is not available in the provided text.

Specifically, the document states:

• "The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft."
• "Biocompatibility testing per ISO 10993-1 demonstrates that the new ink on the proposed device does not affect safety and/or effectiveness."
• "The NMI PICC III and NMI PICC IV are substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests..."

Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating device performance as would be found in a clinical trial or performance study report. The provided text outlines a regulatory submission demonstrating equivalence based on non-clinical testing and similar technological characteristics.

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The NMI PICC III is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI PICC III is 6 mL/sec.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The Xcela Hybrid PICC with PASV Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.

for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC). The associated accessories include: Sterile Kit: Ampule Breaker, Cannula 1 ¾" Filtered Straw, Cap, male, non-vented, Cover, Transducer, 4" x 58", CSR Wrap, Dilator/Sheath, 3-6F x 5 or 7 cm peelable, (sized to PICC), Drape, Full Body, Drape, Under arm, Drape, Fenestrated, Dressing, Tegaderm, Chloraprep 3mL clear and orange tint, Gauze 4" x 4", 4 ply, Gown, Surgical Extra Large, Guidewire, 0.18" x 45 cm, Hairnet, 24" large, Lidocaine ampule, Mask with earloops, Needle, echogenic 21G x 1.575" or 2.75" (sized to PICC), Needle, 25G x 5/8", Needle, safety 21 G x 2.75", PICC (based on family and size), Scalpel, #11, Safety, Scissors, Blunt, Sharps container, single, Skin Protectant Swab Stick, Statlock Plus Fixed Post (stabilization), Stiffening Stylet 0.014" or 0.016" x 70 cm (size to PICC), Syringe 5cc, Tape Measure, 36" Paper, Tape, Surgical 3/4" x 24", Tourniquet, 18" x 1", Towel, 14" x 25", Tuohy Borst Adapter w/side arm. Tandem Package (Pouch): Sterile OEM Devices in 'as received' packaging, Gloves, Surgeons, Pre-Filled Syringes, Saline.

The document is a 510(k) premarket notification for a medical device called the "PICC Maximal Barrier Nursing Kit" (K142616) submitted by Navilyst Medical, Incorporated. This document evaluates the substantial equivalence of the new device to a predicate device (K131038) based on packaging changes.

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

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set or the data provenance. It only states that "results of package testing" were performed.

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)

The document does not mention the use of experts to establish ground truth for the packaging test. The evaluation relies on compliance with recognized international standards for packaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe an adjudication method. The assessment of the packaging is based on adherence to AAMI/ANSI/ISO standards.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical kit (catheter, procedural aides, and barrier precautions), not an AI-assisted diagnostic or treatment device.

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

A standalone performance study was not done in the context of an algorithm. The performance evaluation relates to the physical packaging of a medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the packaging study is adherence to the specifications and performance requirements outlined in the AAMI/ANSI/ISO 11607-1 and 11607-2 standards for medical device packaging. There is no biological or diagnostic ground truth involved.

8. The sample size for the training set

The concept of a "training set" is not applicable as this is not a machine learning device. The study evaluated the physical packaging.

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

Not applicable.

Summary of the Study:

The study proving the device meets the acceptance criteria is a packaging performance evaluation. The new "PICC Maximal Barrier Nursing Kit" differs from its predicate device only in its "new outer tray lid and adhesive." The purpose of the study was to demonstrate that this new packaging maintains the sterile barrier and overall integrity of the device, similar to the predicate.

The study was conducted in accordance with the following national/international standards:

• AAMI/ANSI/ISO 11607-1: Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems (2006)
• AAMI/ANSI/ISO 11607-2: Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006)

The conclusion states that "Based on results of package testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit."

The document does not provide details on the specific number of units tested, the methodology of the tests (e.g., accelerated aging, transit testing, seal strength), or the exact numerical results. It only affirms that the testing was performed according to the cited standards and led to a conclusion of substantial equivalence for the packaging.

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