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Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.

Integral-Process Medical Patient Cable and Leadwire Systems are electrical cables interfacing and connecting transducers/sensors/electrodes placed on patients, to monitoring/recording/diagnostic devices/equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use. This cabling facilitates the conduction of signals between the patient and the monitoring/recording/diagnostic device. Integral-Process manufactures all type of interfacing transducer and patient cables, as replacement cables and/or as sub-contractor of main brands. These Medical Patient Cable and Leadwire systems are divided into 3 categories: 1) Electrocardiograph (EKG/ECG) cables, 2) SpO2 cables, and 3) IBPT cables.

The provided text describes a 510(k) premarket notification for "Integral-Process Medical Patient and Leadwire Systems." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study to prove acceptance criteria for a novel device performance.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, how ground truth for training was established) are not applicable in this context, as they pertain to performance studies typically conducted for new or significantly modified devices, especially those involving AI/ML.

This submission is about establishing that a cable and leadwire system performs comparably to already approved cables.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Integral-Process Medical Patient Cable and Leadwire Systems) is a Class II medical device (Product Code: DSA, Regulation Number: 21 CFR 870.2900 - Cable, Transducer and Electrode, Patient, (Including Connector)).

For such devices seeking 510(k) clearance, acceptance criteria are generally met by demonstrating conformance to recognized consensus standards and by showing substantial equivalence to legally marketed predicate devices. The "performance" in this context refers to the device's ability to facilitate signal conduction and meet safety/electrical requirements, rather than a diagnostic or clinical performance metric.

Explanation of "Study that Proves the Device Meets the Acceptance Criteria":

The document explicitly states: "Other effectiveness and safety compliance (electrical safety and biocompatibility of skin-contact components) to required standards and requirements are demonstrated in the market authorization file." This indicates that the "study" for these acceptance criteria involved testing against the listed consensus standards. While the specific test results are not detailed in this summary, the claim is that they exist in the full submission. The main "proof" of meeting acceptance criteria for a 510(k) is demonstrating that the device is "as safe, as effective for their intended use and perform as well as or better than the legally marketed devices." This is achieved through a comparison to predicate devices and showing conformance to recognized standards.

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

• Test Set Sample Size: The document mentions that while there are around 1260 part numbers for cables, "a limited quantity of samples to have a good representation of the total range" was selected for comparison. This "sampling" approach is used to represent the different categories of connectors (monitor side, intermediate, yoke side leadwires, patient side leadwires). The specific number of each type of cable tested is not explicitly stated, but several examples are given in the comparison table (e.g., 72512-US, 70626NGJ3-US, 90797IP).
• Data Provenance: Not applicable for device performance testing here. The studies mentioned are primarily standard compliance tests on manufactured devices, not clinical data from patients. The manufacturer (INTEGRAL PROCESS SAS) is based in France.

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

• Not applicable. This submission involves physical device testing against engineering and safety standards and a comparison against the technical characteristics of predicate devices. It does not involve human interpretation of medical images or data requiring expert "ground truth."

4. Adjudication Method for the Test Set:

• Not applicable. As there is no expert interpretation or human element involved in establishing "ground truth" for this type of device, an adjudication method is irrelevant.

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 a passive cable and leadwire system, not an AI or imaging device that would involve human readers or diagnostic interpretation.

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

• Not applicable. This device is a cable system and does not contain an algorithm.

7. The Type of Ground Truth Used:

• For the purpose of establishing substantial equivalence and meeting safety/performance criteria, the "ground truth" is derived from:
  • Consensus Standards: The requirements and methodologies defined in national and international standards (e.g., AAMI, IEC, ISO).
  • Predicate Device Characteristics: The established design features, materials, and performance specifications of legally marketed predicate devices.
  • Engineering Test Results: Measurements and observations from physical and electrical tests conducted on the Integral-Process cables themselves, demonstrating their conformity to established specifications.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. As above, no training set for an algorithm is involved.

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ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates.

By design and manufacturing process, the IP-SET® ECG electrodes are of multidisciplinary use, and the unit choice is performed by the Physician, in function of the desired application.

Set of disposable, single-use, pre-gelled ECG electrodes are regrouped on a flat cable sole or by pair (dual electrodes) and located to ease their positioning on the patient. Electrode number and positioning design vary according to the monitoring/diagnostics application.

Pre-gelled (hydro-gel) electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 90 mm in diameter or oblong / rectangular shape.

Lead wires are regrouped in a flat cable and are made of copper (radio-opaque) or carbon fiber (radio-translucent).

Sets are supplied non-sterile. Each set / harness is packaged in one OPP/PE laminated pouch (sealed foil); 10 to 50 pouches are supplied per box; Shipping cartons contain 12 boxes.

The provided document, K101685, is a 510(k) summary for Integral-Process's ECG Electrode "IP-SET®". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on specific performance acceptance criteria. As such, it does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding specific acceptance criteria and detailed study results from a clinical trial or performance study.

The document primarily relies on comparisons to legally marketed predicate devices and compliance with relevant standards. Here's what can be inferred from the provided text regarding device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" (e.g., in terms of sensitivity, specificity, accuracy, or electrical performance thresholds) and reported device performance (e.g., percentages, mean improvements) from a dedicated study are provided. The device performance is generally stated as being "at least as well as other disposable ECG electrodes" based on comparison to predicate devices and compliance with standards.

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

Not applicable. The document does not describe a performance study with a test set. Substantial equivalence is demonstrated through technological comparisons and compliance with relevant standards.

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

Not applicable. There is no mention of a test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is described.

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

No MRMC study was conducted or reported. This device is an ECG electrode, not an AI or image-based diagnostic tool that would typically undergo an MRMC study to compare human reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This device is a physical medical device (ECG electrode), not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

Not applicable. There is no mention of a primary ground truth established through expert consensus, pathology, or outcomes data. The "ground truth" for demonstrating substantial equivalence for this type of device relies on established performance characteristics of the predicate devices and compliance with recognized standards.

8. Sample Size for the Training Set:

Not applicable. This document pertains to the 510(k) clearance of a physical medical device (ECG electrode), not an AI or machine learning model that would require a training set.

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

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

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