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The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central catheters (PICC). The C3 Wave provides real-time catheter tip location by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: Limiting, but not contrindicated, 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 Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a guide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

The C3 Wave system must only be operated by a skilled nurse, physician, or trained medical professional who has been qualified in placement of PICC's and trained in the proper use of this device.

This document details the substantial equivalence review for the Medcomp C3 Wave System (K180567), which is an update to a previously cleared device (K170934). The current submission focuses on expanding accessory pack offerings, specifically adding a larger drape and revising the packaging system. Therefore, the "study" described relates to the testing performed to ensure the safety and effectiveness of these modifications, rather than a clinical efficacy study of the core device functionality.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All testing was completed and is the subject of this submission" and concludes that the device raises "no new questions of safety or effectiveness compared to the predicate device." This implies that all acceptance criteria for the non-clinical testing performed on the modified accessory pack were met. Specific numerical performance metrics for each test (beyond the EO residuals) are not detailed in this summary.

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

The provided text describes non-clinical laboratory testing performed on the modified accessory pack. It does not mention a "test set" in the context of patient data or clinical performance. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or not provided for this specific submission, as it focuses on accessory modifications rather than the primary device's clinical performance.

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

This information is not applicable or not provided as the submission focuses on non-clinical testing of device accessories (drape and packaging), not on clinical performance requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or not provided for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not performed or described in this document. The C3 Wave System is an ECG-based positioning aid for PICC lines, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. This submission specifically addresses modifications to accessory packs.

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

A standalone performance study of an algorithm is not discussed or applicable to this submission. The C3 Wave System is a device that provides real-time data to a human operator (skilled nurse, physician, or trained medical professional) to aid in PICC placement. The submission pertains to modifications to non-electronic accessories.

7. The Type of Ground Truth Used

For the non-clinical testing of accessories, the "ground truth" would be established by standardized laboratory testing procedures and the specifications of relevant international and national consensus standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization, ASTM F1929 and F1140 for packaging). This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Since the submission refers to modifications of accessories and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable or not provided as there is no "training set" in the context of this submission.

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The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

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
  -Chronic obstructive pulmonary disease (COPD)
  Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

C3 Wave is designed to provide a continuous display of electrocardiograph [ECG] waveform to be used as a quide in placement of peripherally-inserted central catheters [PICC] in the lower third of the Superior Vena Cava [SVC] of a patient. The principle for operation of this system uses three ECG leads placed on the patient's chest and generates a third ECG lead by switching from RA to PICC stylet. The ECG waveform is wirelessly transmitted to a tablet which allows the operator to view and record changes to the ECG waveform as the tip of the catheter approaches the heart. As the PICC catheter approaches the atrium of the heart, the P wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P wave amplitude.

Here's an analysis of the acceptance criteria and study information for the C3 Wave System, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" as a separate table with specific numerical targets. However, the outcome of the clinical study serves as the primary performance metric for the expanded indications for use.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

Here's a breakdown of the study information as requested:

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

• Sample Size: 303 PICCs were placed. Each PICC placement likely represents a single case in the test set.
• Data Provenance: Retrospective, as indicated by the completion of "Clinical Surveys" and data collection from "two healthcare facilities." The study design involved obtaining an X-ray after the C3 Wave System was used, implying a comparison against established practice. Given it's a 510(k) submission, the data is typically from a clinical trial conducted for regulatory purposes. The specific country of origin is not mentioned, but "two healthcare facilities" implies clinical settings.

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

• Number of Experts: Not explicitly stated how many individual experts independently reviewed each X-ray for ground truth. However, the process refers to "established hospital protocol (e.g., Chest X-Ray, Fluoroscopy)," which implies that the interpretation of the chest X-rays to determine "acceptable tip location" was performed by qualified medical professionals as part of standard clinical practice. This would typically involve radiologists or trained clinicians responsible for interpreting such images.
• Qualifications of Experts: Not specifically detailed. It can be inferred that the chest X-rays were interpreted by clinicians or radiologists according to "clinical judgement and established hospital protocol."

4. Adjudication method for the test set:

• Adjudication Method: Not explicitly detailed. The study mentions that a "subsequent portable chest x-ray was to be obtained... to ascertain acceptable tip location of PICC." This implies that the chest X-ray served as the gold standard against which the C3 Wave System's positioning results were compared. There's no mention of a formal adjudicated consensus process if multiple readers were involved in interpreting the X-rays; it likely followed standard clinical practice for X-ray interpretation.

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:

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs without AI assistance.
• Nature of Study: This study evaluated the C3 Wave System as a standalone alternative to chest X-ray or fluoroscopy, not as an AI-assistance tool for human readers. The "success rate" refers to the device's ability to correctly identify tip placement compared to the X-ray, not an improvement in human reader performance.

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

• Standalone Performance: Yes, the clinical study primarily evaluated the C3 Wave System for its standalone ability to determine PICC tip location. The system provides real-time electrical activity display, and the "clinician was to complete an electronic survey document to capture specific data points within each procedure including insertion related assessments" which implies the system's output (ECG display) was used by the clinician to guide placement, and then the system's output was judged against the X-ray. The 98% success rate reflects the system's performance in guiding tip placement without requiring an X-ray for initial confirmation.

7. The type of ground truth used:

• Ground Truth: Expert Consensus (implied by clinical practice) / Imaging (Chest X-ray). The "acceptable tip location of PICC" was ascertained by a "subsequent portable chest x-ray," which is then interpreted by medical professionals according to "clinical judgement and established hospital protocol." The X-ray image and its interpretation serve as the ground truth.

8. The sample size for the training set:

• Training Set Sample Size: The document does not provide information about the sample size used for training the C3 Wave System's algorithms. As it's an ECG-based system, its "training" might involve developing and refining the algorithms that interpret ECG changes to infer catheter tip position, which could be based on prior physiological models or data, but specific data for algorithmic training is not present in this summary.

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

• Training Set Ground Truth Establishment: This information is not provided in the document. Without details on the training set, how its ground truth was established cannot be determined from this summary.

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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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