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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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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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