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The Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter.

The maximum recommended infusion rate varies by catheter. The maximum recommended infusion rate for the 3F Jet Power Injectable PICC is 1cc/sec and 5.0cc/sec for the 4F and 5F Jet Power Injectable PICC.

A family of trimmable peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger Technique).

This document is a 510(k) Pre-market Notification for the Jet Power Injectable PICC, demonstrating its substantial equivalence to a predicate device (Pro-PICC® CT). The information provided focuses on the safety and performance of the medical device itself, rather than an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies are not applicable.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study for a Medical Device (Non-AI/ML context):

The "acceptance criteria" for a medical device cleared via the 510(k) pathway are generally demonstrated through substantial equivalence to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. The "study" for this type of device typically involves a combination of bench testing, biocompatibility testing, and sterilization validation, rather than clinical efficacy studies on patient data that would be relevant for AI/ML performance.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML model's metrics (e.g., sensitivity, specificity). Instead, it lists the bench testing standards and the outcome (e.g., "Passed Per Internal Requirements", testing against specific ISO/ASTM standards).

Here's an interpretation of the requested table based on the provided "Performance Standards" (Table 6.2) and "Biocompatibility" sections:

For AI/ML Specific Questions (N/A for this document):

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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.
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): Not applicable. The "ground truth" for a medical device like this is conformance to engineering and biocompatibility standards and comparison to a predicate device.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Pro-PICC catheter with valve technology is indicated for short and long peripheral access to the central venous system for intravenous therapy and power injection media, and allow for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The Pro-PICC®07 with Valve Technology is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® Pro-PICC®CT (K091953 and K092347). The Pro-PICC®67 with Valve Technology is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each luer is a Bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size, "Valved CT Catheter" or "Do Not Power Inject", and the maximum flow rates. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.

The Pro-PICC® with Valve Technology catheter is available in additional French sizes and either a single, double, or triple lumen. The catheter has a usable length of 50cm to 60cm depending on French size with depth markings in 5cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of trav configurations with the necessary accessories to facilitate catheter insertion.

The provided text appears to be a 510(k) summary for a medical device (Medcomp® Pro-PICC® with Valve Technology), rather than a study report detailing acceptance criteria and performance data for an AI/algorithm-based device.

Therefore, many of the requested categories for AI device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and how ground truth was established for training and test sets) are not applicable or cannot be extracted from this document.

However, I can extract information related to the performance data (bench/performance data) as described in the document, which pertains to the physical device rather than an AI algorithm.

Here's the information that can be extracted, with notes on where the requested AI-specific information is not available:

Acceptance Criteria and Study for Medcomp® Pro-PICC® with Valve Technology

1. Table of Acceptance Criteria and Reported Device Performance

Notes on AI-Specific Information (Not Applicable/Available from this document):

• This document describes a physical medical device (catheter), not an AI algorithm. Therefore, there are no specific AI-driven acceptance criteria for metrics like sensitivity, specificity, AUC, or F1-score that would be relevant for an AI system.
• The "performance" referred to in the document relates to the physical and functional characteristics of the catheter (e.g., pressure injection capabilities, material properties), not algorithmic performance.

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

• Not Applicable. This document is for a physical medical device, not an AI algorithm. There is no mention of a "test set" in the context of an AI algorithm's performance evaluation. The "testing" mentioned refers to bench testing of the physical catheter.

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

• Not Applicable. This document is for a physical medical device. "Ground truth" in the context of expert consensus for image or data interpretation is not relevant here.

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

• Not Applicable. This document is for a physical medical device. Adjudication methods are relevant for expert review in AI studies, not for physical device testing.

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 a physical medical device. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant here.

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

• Not Applicable. This document is for a physical medical device. There is no "algorithm only" performance reported, as there is no AI algorithm.

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

• Not Applicable. For the bench and biocompatibility testing, the "ground truth" would be established by validated measurement techniques, chemical analyses, and adherence to relevant ISO standards, rather than expert consensus on image interpretation or pathology.

8. The sample size for the training set

• Not Applicable. This document describes a physical medical device, not an AI algorithm. There is no concept of a "training set" for this type of device submission.

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

• Not Applicable. As there is no training set for an AI algorithm, this question does not apply.

Summary of Relevant Information from the Document:

The document is a 510(k) premarket notification for a physical medical device, the Medcomp® Pro-PICC® with Valve Technology, a catheter. The core of the submission is to demonstrate substantial equivalence to existing predicate devices.

• Study Objective: To demonstrate that the Medcomp® Pro-PICC® with Valve Technology is substantially equivalent to legally marketed predicate devices.
• Study Types:
  • Bench/Performance Testing: Conducted in accordance with applicable international standards and FDA guidance documents, and internal engineering testing methods (specifically for pressure injection, where no FDA standard exists). The document states these tests "effectively demonstrate the proposed devices are equivalent to the predicate devices."
  • Biocompatibility Testing: All materials used were tested on the complete, finished device, demonstrating they meet the requirements of ISO 10993.
• Conclusion: The device meets performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols. It has the same intended use, operation, and function as the predicates, with no differences raising new safety or effectiveness issues, thus demonstrating substantial equivalence.

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The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The CT Midlines are designed for peripheral vein catheterization and power injection of contrast media, available in 4Fx20cm single-lumen or 5Fx20cm double-lumen configurations. Fundamentally, the proposed device is physically identical to the predicate K 121094 aside from the clamp, which is now colored purple to indicate power injection.

The provided document is a 510(k) summary for the Medcomp CT Midline device, indicating that it is being submitted for substantial equivalence to existing predicate devices, K121094 (Midline) and K091953 (Pro-PICC CT). The primary focus of the submission is to demonstrate that the CT Midline, while otherwise identical to predicate K121094, is also safe and effective for power injection, an indication shared with predicate K091953.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly labeled as such but are derived from the performance data presented for the proposed CT Midline and compared against the predicate devices, particularly the Pro-PICC CT (K091953) for power injection capabilities. The document asserts that the proposed device is "substantially equivalent" to predicate devices. For mechanical performance, specifically power injection, the CT Midline is compared to the Pro-PICC CT.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a nonclinical performance test study. It specifically focused on the power injection capabilities, as this was the key performance difference between the proposed CT Midline and the primary predicate (K121094).

The document states: "The following tests were performed to establish the device's equivalence to the relevant predicate device: o Power Injection Flow Rate o Max Static Burst. These tests highlight the relevant difference between the proposed device and predicate K121094 by testing for the safety and effectiveness of the proposed device with regard to the expanded indication for use of power injection."

The reported performance data for the CT Midline in the table above demonstrates that for both 4F and 5F configurations, the proposed device achieved equal or higher flow rates and burst pressures compared to the predicate Pro-PICC CT (K091953) for power injection. This indicates that the CT Midline meets or exceeds the power injection performance of the predicate device with that indication.

For air leakage, liquid leakage, biocompatibility, and sterility, the claims of substantial equivalence are based on either being identical in materials to a cleared predicate or passing relevant ISO standards, which implies meeting the acceptance criteria set by those standards.

The remaining information requested is largely not applicable (NA) or not explicitly provided in the given excerpts, as this is a 510(k) summary for a medical device (catheter), not an AI/software device or a clinical study in the typical sense that would involve human readers, ground truth consensus, or training data for an algorithm.

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

• Sample Size: The exact sample sizes for the power injection and static burst tests are not explicitly stated as "n=X". However, for the Max Static Burst, the standard deviation and range are provided (e.g., "302±5psi," "range of burst pressures was 292-312 psi"), which implies multiple tests were performed on multiple units to generate an average and range. Without the full Section 18 (reference testing summaries and protocols), the specific number of units tested is unknown.
• Data Provenance: This is an in-vitro nonclinical performance test, conducted by the manufacturer (Medcomp). Therefore, it is a prospective test conducted on manufactured devices, likely in a laboratory setting. Country of origin of the data is the US, where Medcomp is located.

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):

• NA. This is a hardware device performance test. There are no human experts establishing ground truth for image interpretation or diagnosis. The "ground truth" is defined by the physical properties of the device and its performance under specified testing conditions as measured by instruments.

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

• NA. There is no adjudication method as this is a physical performance test, not a subjective judgment task.

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:

• NA. This is not an AI or imaging device subject to MRMC studies.

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

• NA. This is not an algorithm. Standalone performance refers to the device's functional attributes (e.g., flow rate, burst pressure) under test conditions as measured by equipment.

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

• For the nonclinical performance tests (power injection, static burst, leakage, biocompatibility), the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, verified against established ISO standards and the performance of legally marketed predicate devices.

8. The sample size for the training set:

• NA. This is a physical device, not an algorithm that requires a training set.

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

• NA. This is a physical device, not an algorithm that requires a training set and its associated ground truth establishment.

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The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.

The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions.

The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.

The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.

The provided document does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for a medical device efficacy or performance study. This document is a 510(k) summary for a hemodialysis catheter (T3 CT).

Instead of a clinical study or performance data against specific acceptance criteria, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that instead of proving the device meets certain performance metrics through a new study, the applicant argues that the new device is as safe and effective as devices already on the market because it has the same intended use, materials, anatomical location, basic design, performance, labeling, manufacturing process, and method of sterilization.

Here's an analysis based on the information provided, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there is no explicit table of acceptance criteria and reported device performance from a specific study presented in this 510(k) summary. The submission asserts that the device "meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." However, the details of these criteria or the test results are not included.

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

Not applicable. No new clinical or performance test set (as in a study to evaluate efficacy or performance against specific metrics) is described. The submission relies on equivalence to predicate devices and adherence to design verification standards (ISO, guidance documents, test protocols), but details of these tests are not provided.

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

Not applicable. No ground truth establishment for a test set is described as part of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring an adjudication method is described.

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

Not applicable. This is a medical device 510(k) summary for a catheter, not an AI software or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This is a medical device 510(k) summary for a catheter, not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable in the context of a new efficacy/performance study. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices, based on their prior clearance and market history.

8. Sample Size for the Training Set

Not applicable. This is a medical device 510(k) summary for a catheter. The concept of a "training set" is relevant for machine learning algorithms, which is not what this submission is about.

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

Not applicable. See point 8.

Summary of the Acceptance Criteria and "Study":

The "acceptance criteria" for the Medcomp® T3 CT catheter, as presented in this 510(k) summary, are primarily based on:

• Substantial Equivalence: The device is considered substantially equivalent to legally marketed predicate devices (K033570, K083675, K102605 as primary, and several others as secondary). This is the core "study" or justification for its market clearance. The argument is that "there are no differences that raise new issues of safety and effectiveness."
• Design Verification: The submission states that the "proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." While the specific tests and their results are not detailed, this implies that the device underwent engineering and materials testing to ensure it meets established specifications for medical catheters (e.g., strength, flow rates, material compatibility, etc.).
• Biocompatibility: The materials used meet the requirements of ISO 10993, and all materials have been cleared under past approved 510(k)s. This demonstrates the materials are biologically safe.

Conclusion:

The Medcomp® T3 CT 510(k) submission (K123292) for a hemodialysis catheter does not describe a clinical study to prove device performance against specific efficacy or performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices and adherence to established design verification standards and biocompatibility requirements. This is a common pathway for medical device clearance, especially for devices that are modifications or improvements upon existing technologies rather than entirely novel ones.

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The Medcomp® Split Cath® III is indicated for use in attaining long term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are intended for femoral vein insertion.

The Medcomp® Split Cath® III is indicated for use in attaining long term vascular access for Hemodialysis and Apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion. Translumbar insertion via inferior vena cava is indicated when all other access sites are identified as non-viable.

• 14 French, double "D" Jumen design with cuff for long-term implant.
• Variety of lumen lengths from 20cm to 55cm.
• Soft radiopaque polyurethane material
• Lumen is connected to the extension via a soft pliable hub with a suture wing
• Red and blue clamps and red and blue sleeves are provided on the extension tube to prevent air/fluid communications
• The hub contains the device name and French size, clamp I.D. Rings are printed with the priming volume.

The provided document is a 510(k) Summary for the Medcomp® Split Cath® III, a hemodialysis catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics for a novel AI device. Therefore, much of the requested information (like acceptance criteria for AI performance, sample sizes for training/test sets in an AI context, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI) is not applicable or present in this document.

The document details safety and performance tests for the physical medical device itself, not for an AI algorithm.

However, I can extract information regarding the device's functional performance and the tests conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence of a physical medical device, not an AI product, the "acceptance criteria" are implied by meeting the requirements of the standards and demonstrating performance comparable to predicate devices. The document does not explicitly list numerical acceptance criteria for each test, but it states that "Subject product testing has yielded acceptable safety and performance outcomes."

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

The document does not specify sample sizes (e.g., number of catheters tested) for the performance tests. It refers to "Subject product testing" but does not give numerical details. The data provenance is internal to Medcomp, a US-based company. The tests are prospective tests on manufactured devices, not retrospective clinical data analysis.

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

This is not applicable as the document describes physical device testing against engineering standards, not expert-based ground truth for an AI algorithm. The "ground truth" is defined by the international standards themselves.

4. Adjudication method for the test set

Not applicable, as it's not an AI study requiring adjudication of expert opinions. The tests are objective measurements against established engineering 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

Not applicable. This is a 510(k) for a physical medical device, not an AI system.

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

Not applicable. This is a 510(k) for a physical medical device designed for human use, not an AI algorithm.

7. The type of ground truth used

For the physical device performance, the "ground truth" is established by adherence to recognized international standards and engineering specifications (e.g., ISO 10555-1, ISO 10555-3, ISO 594-2, ISO 10993-1).

8. The sample size for the training set

Not applicable. There is no AI training set involved.

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

Not applicable. There is no AI training set involved.

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