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The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring devices, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.

The Patient Monitoring Cables are replacements for similar accessory cables manufactured or specified by Original Equipment Manufacturers (OEM) for their respective transducers, monitors, and peripheral equipment. These are non-patient-contact, insulated, electrical cables with a connector (plug or receptacle) at each end, designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect SpO2 sensor, IBP transducer to a patient monitor). They are not intended to connect to the mains (i.e., not mains power cables), do not generate any type of power and/or signal, and have no additional non-electrical conducting or processing functionality.

The provided text describes a 510(k) premarket notification for "Fogg System Patient Monitoring Cables." This document focuses on the substantial equivalence of the cables to a predicate device based on bench testing of physical and electrical properties, not on a clinical "study" involving AI or human-in-the-loop performance. Therefore, many of the questions related to AI device performance evaluation (such as MRMC studies, training set details, and expert ground truth establishment for AI) are not applicable to this submission.

Here's a breakdown of the acceptance criteria and the "study" (nonclinical test data) presented in the document:

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

The document does not present a formal table of acceptance criteria with corresponding performance results. Instead, it states that the Fogg System Patient Monitoring Cables "met all acceptance criteria from the testing and analyses". The testing and analyses performed were:

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

• Sample Size: The document mentions "worst case representative cable assemblies and cable material" were used for performance testing. It does not provide a specific number for the sample size.
• Data Provenance: The testing was "nonclinical" and performed on the physical devices/materials. The document does not specify a country of origin for the data, but given it's a US FDA submission, it's implied that the testing was conducted in a manner acceptable for US regulatory purposes. The testing is not retrospective or prospective clinical data; it's laboratory bench testing.

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

This question is not applicable. The "ground truth" for this type of device (patient monitoring cables) is established by engineering specifications, international standards (IEC 60601, AAMI/ANSI BP22), and established testing methodologies for electrical and material properties, not by human expert review of clinical cases or images.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, often involving expert readers. For physical device testing, the "ground truth" is determined by whether the device's electrical and material properties meet established engineering and safety standards. There is no human adjudication process described for this type of nonclinical 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

This question is not applicable. This submission is for patient monitoring cables, which are passive accessories, not an AI-powered diagnostic device. No MRMC study was conducted.

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

This question is not applicable. This submission is for patient monitoring cables, not a standalone AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and adherence to recognized international standards such as IEC 60601 and AAMI/ANSI BP22 for patient transducer and electrode cables. It is a technical ground truth related to electrical continuity, signal integrity, electromagnetic compatibility, and material properties, not clinical outcomes or expert consensus on clinical data.

8. The sample size for the training set

This question is not applicable. There is no AI component requiring a training set for this device.

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

This question is not applicable. As there is no AI component, no training set or its ground truth was established for this submission.

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The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Patient Monitoring Cables are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) for their respective monitors. It is a non-patient-contact, insulated, shielded, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect ECG electrodes, SpO2 sensor, IBP transducer to a patient monitor). It is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality.

This document does not contain an AI/ML device study. Instead, it is a 510(k) premarket notification for Patient Monitoring Cables. The filing asserts substantial equivalence to predicate devices (K082959 and K142489) based on the fact that the subject device's cables are "exactly the same" and "identical" to the predicate devices.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device study is not applicable to this submission.

The document primarily discusses:

• Intended Use: Patient Monitoring Cables are used with ECG, EKG, SpO2, and BP monitoring devices to connect electrodes, catheters, and/or sensors to a monitoring device for general monitoring and/or diagnostic evaluation by healthcare professionals.
• Comparison to Predicate Devices: The submission states that the subject device is "exactly the same" as the predicate devices in terms of intended use, design/appearance, cable length, material, usage (reusable and disposable), sterility, and conformance to standards (IEC 60601-1, EC53, ISO 10993-5, -10).
• Non-clinical Test Data: The device meets recognized standards for safety (IEC 60601-1), performance (ANSI AAMI EC53), and biocompatibility (ISO 10993-1, -5, -10). Biocompatibility tests for cytotoxicity, sensitization, and skin irritation were conducted on the proposed device, showing no adverse effects.
• Clinical Test Data: No clinical testing was deemed necessary because the subject and predicate devices are stated to be "exactly the same."

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Curbell patient cables are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.

Curbell Patient Monitoring Cables comprise cables and lead wires that connect from sensors and/or electrodes to a monitor for the purpose of conducting ECG diagnosis, monitoring, and SPO2 monitoring. As per 21CFR801.109, this device is a prescription device.

The provided text describes the regulatory clearance of "Curbell Patient Monitoring Cables" (K182220) and outlines the product's characteristics, intended use, and substantial equivalence to predicate devices. However, the text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, and compliance with recognized standards for biocompatibility, electrical performance, and electrical safety. It lists the standards that the device has been assessed against (e.g., ANSI/AAMI EC53:2013, IEC 60601-1:2005) and the types of tests performed (e.g., cable and lead wire noise, flex life, tensile strength, connector retention force, contact resistance, dielectric withstand voltage).

The submission is a 510(k) premarket notification, which is a regulatory pathway to demonstrate that a device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing the new device to existing ones rather than presenting novel clinical performance data or statistically robust performance studies with detailed acceptance criteria and ground truth establishment as outlined in your request.

Therefore, I cannot provide the requested information in the specified format because it is not present in the provided text.

Here's an explanation of why each point of your request cannot be fulfilled based on the given document:

1. A table of acceptance criteria and the reported device performance: While the document lists standards (e.g., ANSI/AAMI EC53:2013) that the device was assessed against, it does not provide specific numerical acceptance criteria (e.g., "noise must be less than X dB") nor the actual measured performance values of the Curbell Patient Monitoring Cables. It only states that the device "have been assessed to" these standards and that engineering verification and validation protocols have been used.

2. Sample size used for the test set and the data provenance: The document mentions "Engineering Verification and Validation Protocols" and "Inspection Report" but does not specify the sample sizes used for testing nor the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable and not provided for a device like patient monitoring cables. Ground truth relevant to expert opinion is typically associated with diagnostic or prognostic devices where clinical interpretation is paramount. For cables, performance is primarily assessed against engineering and safety standards.

4. Adjudication method for the test set: This is not applicable and 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: This is not applicable. The device is patient monitoring cables, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is patient monitoring cables, not an algorithm.

7. The type of ground truth used: For a device like patient monitoring cables, the "ground truth" is defined by compliance with established engineering and safety standards (e.g., electrical safety, biocompatibility, mechanical integrity like flex life and tensile strength). The document indicates assessment against these standards (IEC 60601-1, ANSI/AAMI EC53, ISO 10993). However, it does not explicitly detail how the "ground truth" for each specific test parameter was established beyond referencing these standards.

8. The sample size for the training set: This is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: This is not applicable as the device is not an AI/ML algorithm.

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The Unimed patient cables and lead wires are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The patient cables and lead wires are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Unimed's most common cable lead wire configuration ECG cables with specific various length are the replacements for similar cables manufactured by Original Equipment Manufacturers(OEM) and other third party after market manufacturers for their respective monitors.

These cables consist of connectors on each cable end and a shielded bulk cable. The cables are used to transfer the signals from the electrodes to the patient monitor.

The Unimed cables use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC cable jacket with medical grade PVC overmolded connectors with integral relief.

The provided document is a 510(k) submission for patient monitoring cables and lead wires. It details the device's characteristics, intended use, and comparison to a predicate device, as well as the FDA's clearance letter. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert involvement, or AI involvement.

The document states that "Bench Testing demonstrates that Unimed devices perform as intended" and declares conformity to consensus standard ANSI/AAMI EC53-1995(R)2001. This implies that the acceptance criteria are likely based on the performance requirements outlined in this standard.

Based solely on the provided text, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: The document states that "Bench Testing" was performed. Given Unimed Medical Supplies Inc is based in Shenzhen, China, it's highly probable the testing was conducted there. It is a prospective test, as it's specifically for this device prior to market release.

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)

• Not applicable/Not specified. This device is a cable, and its performance is assessed against engineering standards, not through expert interpretation of data.

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

• Not applicable/Not specified. Performance is determined by measurements against engineering standards, not through adjudication of expert opinions.

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 a medical device (patient cables) and does not involve AI or human readers for diagnostic interpretation.

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

• No. This device is not an algorithm or AI.

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

• The "ground truth" for this device's performance is established by engineering and safety standards (specifically ANSI/AAMI EC53-1995(R)2001 and its amendment EC53A-1998(R)2001) for connector retention force, electrical performance, safety, and mechanical aspects.

8. The sample size for the training set

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

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

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

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Curbell patient cables are used to connect electrodes and/or sensors placed at the appro priate sites on the patient to a monitoring device for general monitoring and/or diagno stic evaluation by a healthcare professional.

Curbell Patient Monitoring Cables and Lead Wires. Curbell patient cables are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.

The provide document is a 510(k) summary for Curbell Patient Monitoring Cables. It asserts substantial equivalence to a predicate device (Merit Cables, Inc. K942321) rather than establishing novel performance criteria through a study. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance, is not directly applicable to this document.

However, based on the provided text, I can extract information related to how this device demonstrates equivalence for its intended use. The "acceptance criteria" here are effectively the performance characteristics and standards met by the predicate device, and the study is the nonclinical performance data demonstrating the Curbell device also meets these.

Here's an interpretation based on the provided document:

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

For this 510(k), the "acceptance criteria" are implied by the characteristics of the predicate device, and the "reported device performance" is the claim that the Curbell device possesses substantially equivalent characteristics.

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 detail a "test set" in the context of data for an AI/ML device. Instead, the testing pertains to nonclinical performance data of the physical device. The provenance of the data is that it was generated through testing of Curbell Patient Monitoring Cables against established standards. No specific sample sizes for these tests are mentioned beyond the implication that sufficient samples were tested to demonstrate compliance with the referenced standards. The data is likely prospective, generated specifically for this submission.

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 is for a medical device (patient monitoring cables), not an AI/ML algorithm that requires expert ground truth labeling. Therefore, this information is not applicable. The "ground truth" for compliance testing is defined by the technical specifications and requirements of the referenced standards (e.g., AAMI EC 53).

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

Not applicable for this type of medical device submission. Adjudication methods are typically relevant for human interpretation of data where consensus among experts is needed for ground truth.

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, nor does it involve human readers interpreting data enhanced by AI.

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

Not applicable. This is a physical medical device (cables and lead wires), not an algorithm.

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

The "ground truth" for the device's performance is based on the requirements and methodologies outlined in recognized national and international standards:

• 21 CFR 898
• IEC 60601-1, Subclause 56.3(c)
• ANSI/AAMI EC53:1995(R)2001

Compliance with these standards, as demonstrated through electrical, mechanical, and material testing, serves as the basis for asserting safety and effectiveness.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. There is no training set for this device.

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