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The C3 Wave System is indicated for use as a supplemental aid in positioning for Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy). Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P wave: atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and cronic obstructive pulmonary disease (COPD). Such patients are easily identified prior to PICC insertion. Use of additional confirmation method is necessary to confirm catheter tip location.

The C3 Wave system includes the iPad® monitor running the mobile application software, the C3 hub (a battery and power supply cord for the hub), a remote control, and an ECG clip cable (alligator clip). Procedural accessories include the ECG snap leads, ECG patient cable, ECG electrodes, remote cover, and prep pads which are provided as a convenience to the clinician.

The provided text describes the C3 Wave device and its regulatory submission, but it does not contain the detailed study information required to fully answer your request.

Specifically, the document states:

• "Design verification and validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject C3 Wave system meets predetermined performance specifications."
• "The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601-1 (3rd Edition). IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety - IEC 60601-1-2 Medical Electrical Equipment - Part 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard Electro Magnetic Compatibility - Requirements and Test"

However, it does not provide:

• A table of acceptance criteria for its core function (PICC tip location) and the reported device performance against those criteria.
• Details on the sample size for any clinical test set or its provenance.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether MRMC, standalone, or training set studies were performed, or the details of these if conducted.
• The type of ground truth used for assessing PICC tip location accuracy.

The document focuses on regulatory compliance, electrical safety standards (IEC 60601 series), and biocompatibility testing for materials that may contact the patient. These are important for device safety and general performance but do not detail the clinical performance validation for its primary "PICC tip location" function.

Therefore, I cannot fully complete the table or answer all your questions with the provided text.

Here's what can be extracted and what is missing:

Acceptance Criteria and Study Details for C3 Wave System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document mentions performance testing relating to electrical safety (IEC 60601 series) and biocompatibility (ISO 10993-1), which the device passed. However, it does not provide acceptance criteria or performance data for the primary function of "real-time catheter tip location information by using the patient's cardiac electrical activity" in terms of accuracy or precision relative to a ground truth.

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

• Test Set Sample Size: Not specified for clinical efficacy.
• Data Provenance: Not specified for clinical efficacy.

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

• Not specified.

4. Adjudication method for the test set:

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not specified. The device is for "real-time catheter tip location information" and acts as a "supplemental aid," but no details of human-in-the-loop performance studies are provided.

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

• Not specified for clinical performance. The functional descriptions imply standalone capability to detect P-wave changes, but explicit standalone clinical accuracy metrics are not provided.

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

• Not specified for clinical efficacy. The Indications for Use state, "Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy)," implying these might be used as ground truth in a clinical study, but no study details are provided.

8. The sample size for the training set:

• Not specified.

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

• Not specified.

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The Medcomp® Gen III Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the power injectable infusion port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle.

The Medcomp® Gen III Power Injectable Port includes the Dignity® Mini. Low Profile and Pro-Fuse® Low Profile and Standard are subcutaneously implantable single fluid reservoir port offered with a choice of a silicone or polyurethane cather either pre-attached by the manufacturer or attachable for application by the inserting physician. The Pro-Fuse® product line offers a round base while the Dignity® product line offers a shovel nose concaved sides and smooth contours. The Dignity® product line is offered in Midsize. which has a smaller base than the predicate, K070003. The Dignity® product line is offered in Low Profile, which is a smaller base than the Midsize therefore is smaller than predicate, K070003. The Dignity® product line is offered in Mini, it is the smallest offered profile.

Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catherer lock provides securement of the catheter to the port stem. The port is accessed by inserting needle through the skin into the self-sealing septum.

The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-coming needle at a maximum recommended infusion rate of 5 ml/s.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.

The provided text describes the Medcomp® Gen III Power Injectable Port and its 510(k) submission (K132177). This document focuses on demonstrating substantial equivalence to a predicate device (K070003) rather than a standalone study proving device performance against specific novel acceptance criteria.

The acceptance criteria are implicitly defined by the safety and performance requirements for implantable infusion ports and are primarily demonstrated through comparison to the predicate and established international standards (ISO 10555-1, ISO 10993).

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding performance results for each criterion. Instead, it lists various "Bench / Performance Data" tests performed and states that the "results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003."

Essentially, the acceptance criterion for each test is that the new device's performance is equivalent to, or meets the established safety and performance characteristics of, the predicate device and relevant ISO standards.

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

The document does not explicitly state the sample sizes (number of units or batches tested) for the "Bench / Performance Data" tests. It mentions "all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini" were tested, indicating multiple product variants were included.

The data provenance is implied to be from in vitro testing performed by the manufacturer (Medcomp®) in the US, as it's a submission to the FDA. It is prospective for the Gen III device, as these tests were conducted on the new device.

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 section is not applicable to this type of submission. This is a premarket notification for a medical device (implantable port) based on substantial equivalence and bench testing, not an algorithmic diagnostic device requiring expert interpretation of clinical images for ground truth establishment.

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

This is not applicable. Adjudication methods are typically used in studies involving human interpretation or performance, often for diagnostic accuracy, which is not the nature of this submission. The "ground truth" for the performance tests would be the measured physical properties of the device against engineering requirements or established 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

This is not applicable. An MRMC comparative effectiveness study is specific to diagnostic imaging devices or AI algorithms where human reader performance is a key metric. This submission is for an implantable infusion port.

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

This is not applicable as this is a physical medical device, not an algorithm or AI system. The "standalone" performance here relates to the device's physical and mechanical properties, which were tested in a "standalone" manner (i.e., the device itself was subjected to bench tests).

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

The "ground truth" for the bench tests are:

• Engineering specifications and measurements: For parameters like priming volume, burst pressure, tensile strength, etc.
• Compliance with international standards: ISO 10555-1 for performance and ISO 10993 for biocompatibility.
• Performance of the predicate device (K070003): The new device's performance is shown to be equivalent to the previously cleared predicate.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as above.

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The Peripherally Inserted Central Vein Access Catheters with valve technology are designed for Long or Short-term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.

The Vascu-PICC® with Valve Technology is available in various configurations; they are a 3F & 4F single lumen and 4F & 5F double lumen. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each huer 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 and "Valved catheter". The transition between lumen and extension is housed within a molded hub. The hub is marked with 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 catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.

This document describes a 510(k) submission for the Medcomp Vascu-PICC with Valve Technology, which is a medical device and not an AI/ML powered device. Therefore, the typical acceptance criteria and study designs relevant to AI/ML devices, such as those involving sensitivity, specificity, AUC, human readers, ground truth establishment by experts, and training/test set sample sizes, are not applicable here.

The provided document details the regulatory submission for a physical medical device (a catheter). The "acceptance criteria" in this context refer to the device meeting performance standards for physical and functional characteristics, and its "study" is the performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic accuracy.

Here's an analysis based on the provided document, addressing the closest relevant points where possible, and explicitly stating where AI/ML-specific questions are not applicable:

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

Since this is a physical medical device submission for substantial equivalence, the "acceptance criteria" are implied by the performance standards required for intravascular catheters and the demonstration of equivalence to predicate devices. The document does not provide a table of precise quantitative acceptance criteria in terms of, for example, minimum burst pressure, maximum flow rate, or specific material properties with exact thresholds. Instead, it states that performance was evaluated against "applicable international standards and FDA guidance documents" and "internal engineering testing methods."

The "reported device performance" is summarized as:

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

This information is not provided in the summary for the engineering/performance testing. As this is not an AI/ML diagnostic or prognostic device, the concept of a "test set" for diagnostic performance metrics (like sensitivity/specificity) is not directly applicable. The testing would involve physical samples of the device undergoing various mechanical and functional evaluations. The number of samples tested for each specific bench test (e.g., burst pressure, flow rate, kink resistance) is not detailed in this summary. The provenance of the "data" would be internal laboratory testing by Medcomp.

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 as this is a physical medical device. Ground truth, in the context of AI/ML, refers to a label or diagnosis established by human experts, pathology, or outcomes for comparison with AI performance. For a catheter, the "ground truth" would be established by objective, measurable physical properties and compliance with engineering specifications and regulatory standards, evaluated by engineers and quality control personnel, not by medical experts making diagnostic assessments.

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

This question is not applicable for the same reasons as #3. Adjudication methods are used in clinical studies or expert labeling processes to resolve discrepancies in human assessments, which is not relevant for the bench testing of a physical device's performance.

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

This question is not applicable. This submission is for a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks.

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

This question is not applicable. There is no "algorithm" in the sense of AI/ML in this device. Standalone performance refers to the AI's diagnostic accuracy without human involvement.

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

As discussed, the concept of "ground truth" in the AI/ML sense is not applicable. For this device, "ground truth" would refer to objective physical and chemical properties and performance characteristics measured through engineering and biocompatibility testing (e.g., the material is biocompatible per ISO 10993, the a specific flow rate is achieved under certain pressure).

8. The sample size for the training set

This question is not applicable. This is a physical device submission; there is no "training set" as understood in machine learning. The design and manufacturing processes are informed by engineering principles, historical data (including predicate device performance), and regulatory standards, not by training an algorithm on a dataset.

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

This question is not applicable for the same reasons as #8.

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The CT Power Injectable Infusion Ports are indicated for pediatric patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications. I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

The maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

The Dignity™ CT implantable infusion ports are subcutaneously implantable single fluid reservoir ports offered with a polyurethane (5F) catheter either preattached by the manufacturer or attachable for application by the inserting physician in a choice of two kit configurations. Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catheter lock provides securement of the catheter to the port stem. The port is accessed by inserting a non-coring needle through the skin into the self-sealing septum. The ports are offered in a Mini or Low Profile design with power injection capabilities.

The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port. The rigid top half of the port centers the silicone septum and aids in locating the implanted device under the skin.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/s and a maximum pressure setting of 300 psi.

A 22 gauge needle can be used at 2 ml/sec with a maximum pressure setting of 300 psi.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion in either a standard or micro-puncture kit.

The provided text describes a 510(k) submission for a medical device, the Dignity™ CT implantable infusion port. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the typical format of a clinical trial or performance study report with statistical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through in vitro testing. This is a common approach for 510(k) clearances when clinical studies are not deemed necessary.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner. The acceptance is based on demonstrating that the new device performs reliably and safely, and is substantially equivalent to predicate devices.

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

The text explicitly states:

• "In vitro testing was performed on the ports to assure reliable design and performance..."
• The testing was "according to the referenced standards as well as in-house protocols."
• "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices."

Therefore, there was no human "test set" or clinical data. The data provenance is from laboratory in vitro testing rather than human subjects. The sample size for these in vitro tests is not specified in the provided summary.

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

As no human "test set" or clinical study was conducted, there were no experts used to establish ground truth in the traditional sense of clinical trial adjudication. The "ground truth" for the device's performance was established through engineering and material science testing, aligned with regulatory standards and predicate device performance.

4. Adjudication Method for the Test Set

Since no human clinical test set was used, there was no adjudication method applied to clinical data. The assessment was based on compliance with in vitro test protocols and regulatory guidelines.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a physical medical implant (infusion port), not an imaging or diagnostic AI device that would involve human readers or AI assistance in interpretation.

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

This question is not applicable to the device described. The device is a physical implant, not an algorithm. Therefore, no standalone algorithm performance study was done.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance and safety largely relies on:

• Engineering specifications and performance standards: Demonstrated through in vitro testing.
• Regulatory standards: Specifically, FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990 and ISO 10993 for biocompatibility.
• Performance of legally marketed predicate devices: The new device must demonstrate substantial equivalence to these.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical implant, not a machine learning model, so there is no "training set."

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

This question is not applicable as there is no "training set" for this type of medical device.

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The Medcomp PRO-LINE® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE® CT Power Injectable CVC may not exceed 300 psi.

• Designed for central vein catherization .
• Comprised of a polyurethane material with purple pigment to indicate it for power injection.
• The lumen is connected to the extensions by a hub with a suture wing for . placement.
• Depth markings on the lumen and French size on the hub. ●
• Clamps are provided on the extension tubes to prevent air/fluid communication. ●
• A female luer connector provides the connection for intravenous administration. .
• Maximum recommended pressure limit setting 300 psi. ●
• Maximum indicated power injection flow rate 5cc/sec. .

This document describes a 510(k) submission for the PRO-LINE® CT Pressure Injectable CVC. The submission aims to demonstrate substantial equivalence to previously cleared devices. It does not contain information about an AI/ML device or a study designed to evaluate its performance against specific acceptance criteria in the context of diagnostic accuracy, which would typically involve sensitivity, specificity, or similar metrics for an AI medical device.

Therefore, the following information is not present in the provided text:

• Acceptance Criteria Table and Reported Device Performance: This document describes a medical device (a CVC) and its physical properties and intended use. There are no performance metrics specified in terms of diagnostic accuracy that would typically be associated with AI/ML device acceptance criteria (e.g., sensitivity, specificity, AUC). The performance tests mentioned are related to biocompatibility and compliance with general catheter standards, not AI performance.
• Sample Size Used for Test Set and Data Provenance: No test set is described as this is not an AI/ML device.
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as there is no diagnostic AI/ML device or ground truth establishment.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone Performance Study (Algorithm Only): Not applicable.
• Type of Ground Truth Used: Not applicable.
• Sample Size for the Training Set: Not applicable.
• How Ground Truth for the Training Set Was Established: Not applicable.

What is present in the document:

The device's performance is demonstrated through compliance with established international standards for medical devices and biocompatibility, as well as substantial equivalence to predicate devices.

Summary of Safety and Performance Tests (as described):

The document states that:

• Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met.
• Performance testing was conducted in accordance with:
  • ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General Requirements
  • ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings
• Results of these tests, in conjunction with substantial equivalence claims, effectively demonstrate that the PRO-LINE® CT Pressure Injectable CVC is substantially equivalent to the cited predicate device.

Conclusion:

This 510(k) summary is for a physical medical catheter, not an AI/ML-driven medical device. Therefore, the questions posed about acceptance criteria, study design, and ground truth establishment, which are typically relevant for AI/ML performance evaluation, are not applicable to the provided document. The "study" here refers to the performed biocompatibility and performance tests against existing medical device standards to prove substantial equivalence.

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