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SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

SpO2 Extension Cable consists of two parts: the SpO2 patient cable and the adapter. The SpO2 patient cable is used for connecting the monitors, and the adapter is used for connecting the SpO2 patient cable and the SpO2 sensor.

The SpO2 Extension Cable is the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.

By using the same types of construction and technological characteristics to the compatible patient monitor and SpO2 sensor, the SpO2 Extension Cable can avoid measured data corrupted.

The proposed device was modification from the legally marketed (existing) device "SpO2 Extension Cable"/K222370, manufactured by "Beijing Rongrui-Century Science & Technology Co., Ltd.", same as the sponsor of this submission.

Compared to the initial product (K222370), only the structure of the SpO2 Extension Cable has changed. Originally a non-separable complete extension cable, now an extension cable can be separated into two parts, called the SpO2 patient cable and the adapter.

The type of instrument connector (which connects one end of the monitoring device) for the SpO2 patient cable is 20pin, there are four types pairing interfaces between SpO2 patient cable and adapter, the pairing interfaces name for the SpO2 patient cable and adapter connection is DB9F-LNCS, MLNCS-MLNCS, LNOP-LNOP, RD-RD and the other end of the adapter connecting to SpO2 sensor is DB9F. Adapters are divided into two categories: with cable and without cable. Adapters for each type of interface are available with and without cables.

The provided FDA 510(k) Clearance Letter for the "SpO2 Extension Cable" is for a Class II medical device, specifically an extension cable used to connect SpO2 sensors to monitoring devices. Based on the content of the letter, the submission is about demonstrating substantial equivalence to a predicate device, not necessarily proving that an AI/ML algorithm meets specific performance criteria.

Therefore, many of the requested points, such as AI/ML specific acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI/ML, are not applicable to this type of device clearance. This clearance focuses on electrical safety, EMC, biocompatibility, and functional compatibility of a hardware component.

Here's a breakdown of the requested information based on the provided document, highlighting what is applicable and what is not:

Analysis of Acceptance Criteria and Study for SpO2 Extension Cable (K242986)

This submission (K242986) pertains to an SpO2 Extension Cable, which is a hardware component. The clearance is based on demonstrating substantial equivalence to a previously cleared predicate device (K222370), rather than establishing performance of an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study details associated with AI/ML devices are not relevant here.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of hardware device are primarily based on compliance with recognized consensus standards and functional compatibility. The "performance" here refers to meeting these engineering and safety specifications, rather than clinical accuracy metrics typically seen for diagnostic algorithms.

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

• Sample Size: Not explicitly stated in terms of a "test set" like in AI/ML validation. Compliance is shown through testing of engineering samples of the device itself and its components against the specified standards.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML algorithm. The "data" here comes from laboratory testing of the physical cable. The device manufacturer is Beijing Rongrui-Century Science & Technology Co., Ltd. in China. The testing would have been conducted in a controlled lab environment.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. Ground truth, in the sense of expert annotation for clinical data, is not established for this type of hardware device. The device's performance is verified against engineering standards and functional specifications.

4. Adjudication Method for the Test Set

• Not Applicable. As there's no "ground truth" derived from expert consensus on clinical cases, no adjudication method is relevant.

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

• Not Applicable. An MRMC study is designed to assess the impact of an AI algorithm on human reader performance. This device is an extension cable, not an AI algorithm.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This is a physical cable, not a software algorithm.

7. Type of Ground Truth Used

• Not Applicable. The "ground truth" for this device's acceptance is its adherence to recognized engineering, electrical, biocompatibility, and functional performance standards. This is established through non-clinical testing results, not clinical outcomes data or expert consensus on patient cases.

8. Sample Size for the Training Set

• Not Applicable. No training set exists as this is a hardware product, not a machine learning model.

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

• Not Applicable. No training set or associated ground truth for training.

Summary of the K242986 Submission's Core Argument:

The core of the K242986 submission is to demonstrate that the modified structure of the SpO2 Extension Cable (now separable into two parts) does not negatively impact its safety and effectiveness when compared to the predicate device (K222370), which was a non-separable cable. This is achieved by showing continued compliance with relevant performance, safety, and compatibility standards. The primary difference noted is a structural change, and the manufacturer successfully demonstrated that this change "will not affect the safety and effectiveness of the proposed device" through non-clinical testing.

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Philips IntelliVue reusable ECG lead sets/trunk cables and Philips OR ECG trunk cables are indicated for continuous monitoring of cardiac signals for both diagnostic and monitoring purposes. These devices are limited by the indications for use of the connected monitoring and diagnostic equipment in healthcare facilities. These devices are intended to interact with patient intact skin only.

Philips Reusable ECG Lead Sets and Trunk Cables are non-invasive reusable medical devices designed to transfer ECG signals from the patient to the monitor used in the healthcare facilities, which includes intensive care unit (ICU) for both adults and neonates and the operating room (OR). The ECG cables and lead sets are used to forward an electrical cardiac signal via electrical wires from the electrode attached on patient skin to the ECG measurement hardware in the patient monitor and to support other outputs as needed. The portfolio consists of two types of trunk cables and two types of lead sets: ICU and OR, including various electrode connectors with AAMI and IEC coloring. The ECG Trunk cables and lead sets are suitable for multiple patient use. The Philips Reusable ECG Lead Sets and Trunk Cables have a service life of 18 months. The Philips Reusable ECG Lead Sets and Trunk Cables can be used with any Philips monitors including Philips monitor/defibrillator product lines and Philips monitoring or diagnostic equipment which claim compatibility to Philips Reusable ECG Lead Sets and Trunk Cables.

This document is a 510(k) premarket notification for Philips Reusable ECG Lead Sets and Trunk Cables. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study with clinical accuracy metrics. Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth are not applicable or explicitly stated in this type of submission.

However, I can extract the information that is present regarding performance testing and standards.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of specific quantitative clinical acceptance criteria and device performance metrics, this submission relies on compliance with recognized harmonized standards. The "performance" is demonstrated through successful completion of tests outlined in these standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document explicitly states: "The subject devices, like the primary predicate devices, did not require clinical trials." Therefore, there is no "test set" in the context of a clinical study for external validation of performance. Performance is primarily demonstrated through compliance with recognized standards via non-clinical bench testing. The data provenance would be from internal lab testing, not patient data.

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. No clinical test set requiring expert ground truth was used as per the statement above.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication was used.

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 an ECG cable and lead set, a hardware accessory. It is not an AI algorithm for interpreting medical images or signals, nor does it involve "human readers" or "AI assistance" in that sense.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware accessory, not an algorithm. Performance is assessed through its physical and electrical properties, not algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the sense of clinical ground truth. For non-clinical bench testing, the "ground truth" would be established by the specifications and measurement techniques defined within the harmonized standards (e.g., electrical resistance, mechanical durability measured against stated tolerances, biocompatibility testing results).

8. The sample size for the training set
Not applicable. This is a hardware accessory, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. There is no training set.

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The Ivy Biomedical RT Carbon ECG Leads are intended for use in X-ray imaging environments. They connect between ECG electrodes that are placed on the patient by a trained healthcare professional and an ECC trunk cable that connects to the ECG monitoring device. The RT Carbon ECG Leads are reusable and nonsterile. The RT Carbon ECG Leads are intended for adult, pediatric and neonatal patient populations.

The RT Carbon ECG Leads are intended to connect electrodes placed on the patient to a physiological detection module or monitor (CTM-300, CTM-400, CTM-500, 7000 Series and 3000 Series). The design includes 3 and 4 lead designs with overall lengths of 24", 30" and 36".

The provided text describes a 510(k) premarket notification for the Ivy Biomedical RT Carbon ECG Leads. This document focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than presenting novel clinical efficacy or diagnostic performance data. Therefore, many of the requested categories related to AI performance studies are not applicable.

Here's the information extracted and categorized as requested:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance in the format of specific thresholds and measured values for the RT Carbon ECG Leads. Instead, it states that the device was "thoroughly tested from design requirements through device verification and validation testing as required by 21 CFR 870.2900" and in accordance with EC53. The reported performance is summarized as:

"The performance data support the safety of the device and hardware verification and validation demonstrate that the RT Carbon ECG Leads should perform as intended in the specified use conditions and is substantially equivalent to the predicate."

This implies that the device met the acceptance criteria derived from the listed tests.

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

The document does not specify the sample size for individual tests conducted on the RT Carbon ECG Leads. The testing was described as "conducted at Ivy" (implying in-house lab testing) and does not involve human data, thus the provenance (country of origin, retrospective/prospective) is not applicable in the context of clinical data.

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

Not applicable. This is not an AI/diagnostic device that requires expert ground truth establishment for a test set. The tests are engineering and biological evaluations.

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

Not applicable. This is not an AI/diagnostic device that requires adjudication of interpretations.

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 an ECG lead, not an AI system or diagnostic tool for interpretation.

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

Not applicable. This device is an ECG lead, not an algorithm.

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

The 'ground truth' for the performance testing is based on established engineering standards (EC53) and biocompatibility standards (ISO 10993-1). Compliance with these standards serves as the benchmark against which the device's performance is measured.

8. The sample size for the training set

Not applicable. This is a medical device (ECG lead), not an AI model that requires a training set.

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

Not applicable. This is a medical device (ECG lead), not an AI model.

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The LIFEPAK ECG cables are reusable electrode cable systems intended to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes. LIFEPAK ECG cables are intended for use in outdoor and indoor emerqency care settings.

LIFEPAK ECG Cables:

• LIFEPAK 3-wire ECG Cable -
• LIFEPAK 5-wire ECG Cable i
• -LIFEPAK 4-wire ECG cable
• LIFEPAK 3-wire extended precordial ECG Cable l
• -LIFEPAK 6-wire expandable precordial ECG cable

The LIFEPAK ECG cables are an accessory designed to be used with Physio-Control LIFEPAK 35 monitor/defibrillator. The LIFEPAK ECG cables are intended for use by Advanced Life Support (ALS) and Basic Life Support (BLS) providers to transmit signals from patient electrodes to the LIFEPAK monitor/defibrillator for monitoring purposes.

The LIFEPAK ECG Cables are reusable ECG trunk cables and lead wires that connect to the LIFEPAK 35 monitor/defibrillator for ECG monitoring. There are several types or configurations of ECG cables: 3-wire, a 4-wire cable assembly to be used with the LIFEPAK 6-wire precordial cable and/or the LIFEPAK 3-wire precordial cable to perform a 12 or 15-lead ECG Cable assembly. When the LIFEPAK 4-wire ECG cable is configured with a 6-wire expandable precordial cable, a 12-lead ECG is constructed. Likewise, when the LIFEPAK 4-wire ECG cable is configured with a 6-wire expandable precordial cable and a 3-wire extended precordial ECG cable a 15-lead ECG is constructed.

The 4- wire ECG cable is available in two lengths, 5 feet or 8 feet. Additionally, the 3-, 4-, and 5-wire ECG Cables and the 6-wire precordial ECG cable are available with color coding according to the American Heart Association (AHA) or International Electrotechnical Commission (IEC) standards.

The LIFEPAK ECG cables are a reusable electrode cable system intended to transmit signals from patient electrodes to the LIFEPAK 35 monitor/defibrillator for both diagnostic and monitoring purposes. These accessories consist of conductor wires that are shielded and insulated by a polyurethane jacket material. The lead wires are color coded according to which electrode location they are attached to on the patient.

The LIFEPAK ECG cables are not intended for use with other manufacturers' defibrillators. The LIFEPAK ECG cables are intended only for use with LIFEPAK 35 monitor/defibrillator.

The provided text describes the 510(k) premarket notification for LIFEPAK® ECG Cables. This is a device for transmitting ECG signals, not an AI/ML-based medical device. Therefore, many of the requested criteria (such as MRMC studies, AI/ML-specific ground truth, training set information, etc.) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (Multi-Link™ X2 ECG Cable and Leadwire System) primarily through performance testing of the hardware components and comparison of technical characteristics.

Here's an attempt to answer the questions based only on the provided document, acknowledging that much of it is not relevant for an AI/ML device:

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

The document lists performance tests conducted against applicable standards:

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

The document does not specify exact sample sizes for each physical test. It confirms that "Performance testing has been completed to demonstrate that the proposed LIFEPAK ECG Cables meet the safety and performance requirements established in the design specifications." These are typically laboratory-based engineering tests on device samples, not studies on patient data. The provenance for these tests is the manufacturer (Physio-Control Inc.). The tests are "non-clinical performance testing."

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

Not applicable. This is a hardware device undergoing engineering and safety performance testing, not an AI/ML algorithm requiring expert interpretation of medical images or data for ground truth.

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

Not applicable. Adjudication methods are typically for human-read or AI-generated interpretations of medical data, not for physical performance tests of a cable.

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-based device. No human clinical studies were submitted as part of this 510(k) Premarket Notification.

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

Not applicable. This is not an AI/ML-based device.

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

The "ground truth" for this device's performance is typically adherence to established engineering, electrical, and biocompatibility standards (e.g., IEC 60601, ANSI AAMI EC53, ISO 10993-1). Compliance with these standards confirms the device's technical specifications and safety profile, rather than a clinical ground truth like a pathology report.

8. The sample size for the training set

Not applicable. This is not an AI/ML-based device.

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

Not applicable. This is not an AI/ML-based device.

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The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.

The LIFEPAK Invasive Pressure Adapter Cable is a reusable, insulated, shielded, electrical cord (trunk cable) with a proximal connector (to connect with the LIFEPAK 35 device) and a main yoke that houses three distal leans with connectors (to connect with invasive pressure transducers). The LIFEPAK Invasive Pressure Adapter Cable is designed to transmit an electrical signal (data) between devices (i.e., to connect invasive pressure transducers from the patient to the LIFEPAK 35 monitor/defibrillator). The invasive pressure cable is designed to connect up to three pressure transducers to the front panel of the LIFEPAK 35 monitor/defibrillator for invasive pressure monitoring. Three channels are available for invasive pressure (IP) monitoring, with labels P1, P2, and P3. Each channel also has a user-selectable label for the line type through the LIFEPAK 35 monitor/defibrillator.

Invasive Pressure monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer (i.e., IP Probe). The invasive pressure cable passes the electrical signal from the transducers to the LIFEPAK 35 monitor/defibrillator.

The LIFEPAK Invasive Pressure Adapter Cable is available in two different models that are compatible with either ICU Medical Transpac® IV Disposable Pressure Transducers or Edwards Lifesciences TruWave® Disposable Pressure Transducers. These pressure transducers provide industry standard sensitivity and defibrillation protection of at least 360 joules.

The LIFEPAK Invasive Pressure Adapter Cable is not intended for use with other manufacturers' defibrillators and/or monitors. The LIFEPAK Invasive Pressure Adapter Cable is intended only for use with LIFEPAK 35 monitor/defibrillator.

The provided document describes a 510(k) premarket notification for the "LIFEPAK® Invasive Pressure Adapter Cable." It does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through general performance testing.

Therefore, most of the requested information cannot be extracted from this document. However, I can provide the available details:

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

This information is not provided in the document. The document states "Performance testing has been completed to demonstrate that the proposed LIFEPAK Invasive Pressure Adapter Cable meets the safety and performance requirements established in the design specifications." However, the specific acceptance criteria and the numerical results of these tests are not detailed.

2. Sample sized 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 document. The document only mentions "Biocompatibility Evaluation" and "Design Verification Testing" were completed.

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. The document does not describe a study involving expert-established ground truth.

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

Not applicable. The document does not describe a study with adjudication.

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. The device is an adapter cable, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. The device is a physical cable, not an algorithm.

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

Not applicable. The document does not describe a study that uses ground truth in this context. The "performance data" refers to engineering and biocompatibility testing.

8. The sample size for the training set:

Not applicable. The device is a physical cable, not a machine learning algorithm that requires a training set.

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

Not applicable. The device is a physical cable, not a machine learning algorithm.

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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 intended use of the RFP-100A Connector Cable (Single Use) is to connect the RFP-100A Generator to separately cleared compatible RF devices.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "RFP-100A Connector Cable (Single Use)". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does not include information about acceptance criteria, performance studies, or ground truth establishment for an AI/ML device.

The device described, a connector cable, is a passive component used to connect two other cleared medical devices (a generator and RF devices). Its function is likely to transmit electrical signals, and its acceptance criteria would focus on electrical safety, biocompatibility, mechanical integrity, and compatibility with the specified devices, rather than the kind of performance metrics (sensitivity, specificity, AUC) typically associated with AI/ML-driven diagnostic or prognostic tools.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it is not relevant to the type of device being discussed.

To provide the information you've requested, I would need a 510(k) summary or a similar document for an AI/ML-enabled medical device that performs a diagnostic, prognostic, or therapeutic function.

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SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

SpO2 Extension Cables are intended to be used to connect SpO2 sensors, placed at appropriate sites on the patient to a monitoring device for SpO2 monitoring by health care professional.

The SpO2 Extension Cable is the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after manufacturers for their respective monitors.

The SpO2 Extension Cable is comprised of Plug, Cable/Leadwires and Connector. It's intended to plug into monitoring device and connect with SpO2 sensor, for transmitting signals which generated by SpO2 sensor to monitoring device.

By using the same types of construction and technological characteristics to the compatible patient monitor and SpO2 sensor, the SpO2 Extension Cable can avoid measured data corrupted.

This document is an FDA 510(k) clearance letter for an SpO2 Extension Cable. It confirms that the device is substantially equivalent to a predicate device and is subject to general controls. It does not contain information about clinical studies with AI or human readers, or detailed acceptance criteria for an AI-based device.

Therefore, I cannot answer your specific questions related to acceptance criteria, study design for AI evaluation, sample sizes, expert involvement, or ground truth establishment as this information is not present in the provided text for this specific device.

The document primarily focuses on the device's classification, general controls, and non-clinical testing to demonstrate substantial equivalence to a predicate device, which is a different type of evaluation than what you typically find for AI/ML-driven medical devices.

Summary of available information (and absence of requested information):

• 1. A table of acceptance criteria and the reported device performance: Not explicitly stated as pass/fail criteria from a performance study. The "performance" is demonstrated through compliance with electrical safety, performance, and EMC standards, and biocompatibility, as well as functional compatibility.

  • Acceptance Criteria (Inferred from compliance):
    • Biocompatibility: Meet ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation).
    • Electrical Safety & Performance: Meet IEC 60601-1, ISO 80601-2-61 (Pulse Oximeter equipment), and ANSI AAMI EC53 (ECG trunk cables and patient leadwires).
    • EMC: Meet IEC 60601-1-2.
    • Compatibility: No measured data corruption during communication between SpO2 sensors and host monitors.
  • Reported Device Performance (Inferred from conclusions):
    • "The test results demonstrated that the proposed device complies with the following standards..." (listed above).
    • "SpO2 Extension Cable has also been evaluated the performance accuracy through Compatibility testing, which proves that no measured data corrupt during communication between SpO2 sensors and host monitors."

• 2. Sample sized used for the test set and the data provenance: Not applicable. This is a hardware device, not an AI model. Testing involved standards compliance and compatibility, not a data-driven test set for an algorithm.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here. Device performance is assessed against engineering standards and functional requirements.

• 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: No, this is not an AI device.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI device.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is compliance with established international and national standards for medical electrical equipment, biocompatibility, and functional compatibility.

• 8. The sample size for the training set: Not applicable. This is a hardware device.

• 9. How the ground truth for the training set was established: Not applicable.

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Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.

Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.

Disposable ECG Cable and Leadwires with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.

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

These devices use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.

The provided text describes the regulatory clearance of a medical device, the "Med-link Disposable ECG Cable and Leadwires," but it does not contain information about a study proving the device meets acceptance criteria in the way you've outlined.

The document is a 510(k) premarket notification summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical or detailed standalone studies.

Here's a breakdown of why this document doesn't fit your request and what information it does provide:

• Type of Device: The device is a Disposable ECG Cable and Leadwires, which is an accessory to ECG monitoring devices, not a diagnostic algorithm or AI system. Therefore, the concepts of "sensitivity," "specificity," "AI improvement," "training sets," "test sets," "ground truth," or "expert adjudication" as typically applied to AI/ML medical devices are not relevant here.
• Purpose of 510(k): The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Given this context, I cannot fill out your requested table and information points as they pertain to a different type of device evaluation (e.g., for an AI/ML diagnostic software).

However, I can extract the information that is relevant to the document provided:

Summary of Device Evaluation (as per the 510(k) Summary):

Acceptance Criteria and Device Performance (based on regulatory standards rather than clinical endpoints):

Here's why the other points you requested are not available in this document:

1. Sample size used for the test set and data provenance: Not applicable. This device is an accessory (cable/leadwire) and its performance is evaluated against engineering/safety standards (IEC, AAMI, ISO), not clinical data sets with "test sets" or "data provenance" in the context of an algorithm. The testing involves bench and type testing of the physical device according to standards.
2. Number of experts used to establish the ground truth... and their qualifications: Not applicable. There is no "ground truth" to establish through experts for an ECG cable's performance in the way a diagnostic algorithm requires. Compliance to standards is verified through laboratory testing.
3. Adjudication method: Not applicable. No human adjudication is mentioned or relevant for electrical and biocompatibility testing of a cable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML diagnostic device, so MRMC studies are irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, verified through bench testing.
7. The sample size for the training set: Not applicable. There is no "training set" for an ECG cable.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document details the "substantial equivalence" of an ECG cable to a predicate device by demonstrating compliance with relevant international and national standards for electrical safety, performance, and biocompatibility through non-clinical (bench and type) testing, not through a clinical study with acceptance criteria for diagnostic accuracy metrics.

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9Line patient leadwires are intended to be used to connect electrodes placed at appropriate sites on the patient to an ECG or EKG monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. The device is intended for single-patient use.

9Line is comprised of multiple patient leadwires that connect electrodes affixed to the patient's body either to an external trunk cable or directly into an electrocardiogram (ECG) monitor. Each leadwire connects to a separate patient electrode. Leadwires and electrode placement are color-coded in accordance with Association for the Advancement of Medical Instrumentation (AAMI) recommendations. The device transmits ECG signals from the patient for both diagnostic and monitoring purposes.

This document is a 510(k) Premarket Notification for a medical device called "9Line," which consists of patient leadwires for ECG/EKG monitoring. The purpose of this notification is to establish that the 9Line device is substantially equivalent to a previously cleared predicate device (APK Technology Co.'s ECG Disposable Lead Wires, K170536).

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

Since this is a substantial equivalence submission for a Class II device (patient transducer and electrode cable), the "acceptance criteria" are primarily established by demonstrating equivalence to a predicate device and adherence to recognized electrical, mechanical, and biocompatibility standards. Performance is reported in terms of compliance with these standards.

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

For this type of device (patient leadwires), the "test set" does not refer to a clinical study with a patient population in the way an AI/ML algorithm might. Instead, the testing is non-clinical and focuses on material properties, electrical, and mechanical performance. The "sample size" would refer to the number of leadwire units tested for each specific non-clinical test (biocompatibility, electrical safety, mechanical safety).

• Sample Size for Non-Clinical Testing: The document does not explicitly state the exact number of units tested for each non-clinical test (biocompatibility, electrical safety, mechanical safety). These numbers are typically found in detailed test reports referenced by the submission, but not usually in the summary document provided here.
• Data Provenance: The tests were conducted to FDA-recognized standards (ISO 10993-5:2009, ISO 10993-10:2010, IEC 60601-1:2005, ANSI/AAMI EC 53:2013). This implies that the testing was performed in a controlled laboratory environment, likely by accredited testing facilities specializing in medical device testing. The results are therefore prospective in nature, generated specifically for this submission. The country of origin of the data is not specified, but adhering to international standards suggests widely recognized testing practices.

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 in the typical sense for this device. The "ground truth" for patient leadwires is their compliance with established engineering and safety standards, rather than expert interpretation of medical images or clinical outcomes. The "experts" involved are the engineers and scientists who developed and executed the non-clinical tests, and the regulatory reviewers at the FDA who assess the compliance of the device with these standards and guidelines. Their qualifications would be expertise in biocompatibility, electrical engineering, mechanical engineering, and medical device regulation.

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

This concept of adjudication (e.g., 2+1 reader scheme) is typically used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnosis or evaluation, often in the context of imaging or pathology. For non-clinical testing of a device like leadwires, there is no such adjudication method. The outcomes are objective measurements against predefined thresholds specified by the recognized standards. If there is a dispute in test results, it would typically be resolved through repeat testing or verification by a different accredited lab, not through expert adjudication in the medical sense.

**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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where the performance of human clinicians is assessed with and without AI assistance to measure the AI's incremental benefit. The 9Line device is a passive component (ECG leadwires) and does not involve AI or human interpretation in its function.

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

No, a standalone (algorithm only) performance study was not done. As explained above, the 9Line device is not an algorithm or an AI system. It is a physical medical device.

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

The "ground truth" for the 9Line device is based on objective engineering and scientific standards:

• Biocompatibility: Established by in-vitro and in-vivo tests according to ISO 10993 standards, demonstrating the material's safety for contact with the body.
• Electrical Safety: Established by measurements against thresholds defined in IEC 60601-1, ensuring the device does not pose electrical hazards.
• Mechanical Safety: Established by physical tests against specifications in ANSI/AAMI EC 53, ensuring mechanical integrity and performance.

These are not forms of expert consensus, pathology, or outcomes data in a clinical sense, but rather compliance with universally recognized standards for medical device safety and performance.

8. The sample size for the training set:

Not applicable. The 9Line device is a physical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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