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Unimed Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.

The Unimed Disposable and Reusable SpO2 Sensors are a family of oximeter sensors designed to function the same as the compatible Original Equipment Manufacturer (OEM) Pulse Oximeter Sensor.

The sensors contain two specific wavelength LEDs and a photo detector assembled into the sensor housing. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.

Four types of sensor housings are described in this submission:

• Reusable soft tip sensor comprised of an integrated silicone rubber tip.
• Reusable finger clip sensor with rigid halves and silicone pads
• Disposable non- adhesive sensor with sponge and velcro backing.
• Disposable adhesive sensors constructed of a medical tape laminate.

Each sensor has unique labeling and specifications designed for compatibility with the specific monitor (Nellcor, Nonin, BCI, Ohmeda).

The Unimed Disposable and Reusable SpO2 Sensors were evaluated through clinical testing, specifically a clinical hypoxia study, to establish their accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the clinical test results but does not provide a table with specific numerical acceptance criteria or detailed performance metrics like accuracy range (e.g., A_rms value) against arterial oxygen saturation (SaO2). It broadly states that "Clinical test results support device accuracy claims for the specified saturation range."

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

The document states that "Clinical hypoxia test results were obtained in human adult volunteers."

• Sample Size: Not explicitly stated, though it refers to "human adult volunteers" (plural), indicating more than one.
• Data Provenance: The study was "prospective" as it involved "clinical hypoxia test results obtained in human adult volunteers" under an "approved protocol with subject informed consent." The country of origin of the data is not specified.

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

This information is not provided in the document. The ground truth (SaO2) was determined by co-oximetry, which is a laboratory measurement. While experts would be involved in performing and interpreting co-oximetry, the document doesn't detail their number or qualifications as it pertains to establishing the ground truth for the test set.

4. Adjudication Method for the Test Set:

This is not applicable as the ground truth was established by co-oximetry, which is a quantitative measurement, not a subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of the device itself against a clinical standard (co-oximetry), not on how human readers improve with or without AI assistance.

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

Yes, the clinical hypoxia test evaluated the standalone performance of the Unimed Disposable and Reusable SpO2 Sensors. The study assessed the device's accuracy in continuously monitoring SpO2 and pulse rate against arterial oxygen saturation (SaO2) determined by co-oximetry. There is no mention of a human-in-the-loop component in this specific clinical test.

7. The Type of Ground Truth Used:

The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective laboratory measurement from arterial blood samples.

8. The Sample Size for the Training Set:

This information is not provided. The document describes a clinical "validation" study (test set), not a study focused on training a model.

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

This information is not provided. As mentioned above, the document describes a validation study for the device, not a training study for an algorithm.

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The Unimed Disposable ECG Lead Wires are indicated for use in the monitoring of cardiac signals for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

The unimed disposable ECG lead wire is a single patient electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.

The provided document is a 510(k) premarket notification for the "Unimed Disposable ECG Lead Wires". It describes the device, its intended use, a comparison to a predicate device, and performance data from adherence to recognized standards. However, it does not contain the specific information required to answer the prompt in detail, such as acceptance criteria in a table format, specific details of a study (sample size, data provenance, ground truth establishment, expert roles, adjudication methods), or any MRMC comparative effectiveness study results.

This document describes a device used to transmit cardiac signals, not an AI or imaging device, so many of the requested criteria (like multi-reader multi-case studies, ground truth establishment for algorithms, training sets, etc.) are not applicable to this type of medical device submission.

Based only on the provided text, here is what can be extracted:

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

The document does not provide a table of acceptance criteria with specific numerical targets and corresponding device performance results. Instead, it states that the device "meets the requirements of EC53 and IEC60601-1" and "meets the following the recognized standards." This indicates compliance with the standards are the acceptance criteria for performance, but the specific metrics and values are not detailed in this submission.

Regarding the study that proves the device meets the acceptance criteria:

The document states that "performance data" was submitted to demonstrate substantial equivalence and adherence to the listed standards. However, it does not describe a "study" in the typical clinical trial sense with the requested details. The performance data seems to refer to engineering testing and biocompatibility assessments to confirm compliance with the technical standards.

Due to the nature of this device (an ECG lead wire, essentially a cable), many of the questions are not directly applicable. I will answer the remaining questions with "Not Applicable" or "Not Provided" where the information is not present in the given text.

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

• Sample Size: Not provided. This would typically refer to the number of devices tested to meet the standards, or potentially the number of subjects if clinical performance was explicitly tested beyond standard adherence, but such detail is absent.
• Data Provenance: Not provided. The manufacturing country is China, but the origin of any test data is not specified.
• Retrospective or Prospective: Not provided.

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. This is not an AI or diagnostic imaging device that requires expert interpretation for ground truth establishment. Device performance is assessed against technical standards.

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

• Not Applicable. No human adjudication is mentioned or implied for the performance testing of an ECG lead wire against technical standards.

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 an ECG lead wire, not an AI-powered diagnostic system.

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

• Not Applicable. This is not an algorithm or 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 adherence to the specifications and performance requirements outlined in the cited engineering and biocompatibility standards.

8. The sample size for the training set

• Not Applicable. This is not an AI device that requires a training set.

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

• Not Applicable. This is not an AI device that requires a training set.

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Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes.

These devices are indicated for used by qualified medical personnel only.

Unimed Skin Temperature Probe (T2252-AS, THP-AS, TMQ-AS, TSW-AS, TSM-15AS, TSL-AS, TMR-AS), and Unimed General Purpose Temperature Probe (T2252-AG, THP-AG, TMQ-AG, TSW-AG, TSM-15AG, TSL-AG, TMR-AG) are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with YSI 400 series compatible temperature measurement systems only.

Temperature probes measure temperature by a resistor that is sensitive to temperature changes.

The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.

The provided text is a 510(k) summary for a medical device (Unimed Temperature Probe) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the following information about acceptance criteria and a study to prove meeting them cannot be fully extracted as such a study with explicit acceptance criteria and corresponding performance metrics for the new device is not primarily detailed. The document primarily relies on the predicate devices' established performance and the new device having the same technology and accuracy range.

However, I can extract information related to the device's characteristics and the types of testing performed to ensure safety and effectiveness, which indirectly support its equivalency.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for the Unimed Temperature Probes themselves, nor does it provide a table of performance data against such criteria. Instead, it claims substantial equivalence based on having the "same thermistor, accuracy in 25-45℃ range" as the predicate devices. The performance data section refers to general safety and effectiveness testing to demonstrate compliance with recognized standards.

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

The document does not specify a sample size for a test set in the context of a performance study to establish specific accuracy or other performance metrics for the Unimed probes. The "performance data" section refers to general compliance testing.

• Sample Size: Not specified for performance testing.
• Data Provenance: Not specified, but the manufacturer is based in China. The document does not indicate a clinical study with patient data, so "country of origin" of data is less relevant here. It refers to "bench and laboratory testing."

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

This is not applicable. The document does not describe a study involving expert review or ground truth establishment for a test set. This type of evaluation is common for diagnostic imaging or AI devices, not typically for temperature probes where performance is assessed through physical or electrical testing.

4. Adjudication Method for the Test Set

This is not applicable. There was no expert review or ground truth adjudication process described.

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

This is not applicable. The device is a temperature probe, not an AI-assisted diagnostic tool. No MRMC study was conducted or described.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

The document describes standalone performance testing in the sense that the device's technical specifications are evaluated independently. However, it's important to clarify that this is not an "algorithm" in the context of AI, but rather the performance of the physical temperature measurement device. The "Performance data" section indicates:

• "Bench and laboratory testing to demonstrate safety and effectiveness per: IEC 60601-1, EN 12470-4, ISO 10993-5, ISO 10993-10."
• This refers to direct measurements and evaluations of the probe's conformity to electrical safety, performance (temperature measurement accuracy within a given range), and biocompatibility standards.

7. Type of Ground Truth Used

The "ground truth" for the performance claims of a temperature probe would be established by reference standard measurements (e.g., highly accurate reference thermometers/calibrators) in controlled laboratory environments. The document implies this through references to standards like EN 12470-4, which specifies performance requirements for clinical thermometers.

8. Sample Size for the Training Set

This is not applicable. The device is a physical temperature probe, not an AI or machine learning model that requires a training set.

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

This is not applicable for the same reason as above.

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The Unimed disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.

The Unimed Disposable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes.

Here's the breakdown of the acceptance criteria and the study that demonstrates the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the Unimed Disposable Blood Pressure Cuff was tested according to relevant standards to demonstrate its performance. The key acceptance criteria are derived from these standards and the comparison to the predicate device.

2. Sample Sizes and Data Provenance:

The document does not explicitly state the sample sizes used for the performance testing or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "performance testing in this submission" but does not provide details on the number of subjects or the type of study conducted.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. The performance testing appears to be based on compliance with established medical device standards and comparison to a predicate device, rather than a study requiring expert-established ground truth in the context of diagnostic interpretation.

4. Adjudication Method:

Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies involving human interpretation of data where consensus is needed to establish ground truth. This type of method is not applicable to the performance testing described for the Unimed Disposable Blood Pressure Cuff, which focuses on physical and biological properties.

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

No MRMC comparative effectiveness study is mentioned. This device is a blood pressure cuff, an accessory for non-invasive blood pressure measurement, not an AI-powered diagnostic tool requiring human reader performance analysis. Therefore, the effect size of human readers improving with or without AI assistance is not relevant or reported.

6. Standalone Performance Study:

A standalone performance study focused on the device's technical specifications and compliance with standards was conducted. The document states: "The Unimed Blood Pressure Cuff has been tested according to the following standards:" and lists ANSI/AAMI SP10 and ISO 10993 series. These tests evaluate the device's inherent performance characteristics independently.

7. Type of Ground Truth Used:

The ground truth used for this device's evaluation is based on established medical device standards and regulatory requirements. Specifically:

• ANSI/AAMI SP10: This standard sets requirements for manual, electronic, and automated sphygmomanometers, which would include accuracy and performance criteria for the cuff component.
• ISO 10993 series: These standards establish the framework for biological evaluation of medical devices to ensure biocompatibility.
• Comparison to the predicate device (JOHNSON & JOHNSON MEDICAL, INC. Soft-Cuff K974080): The predicate device serves as a benchmark for demonstrating substantial equivalence in terms of intended use, basic construction, technology, and performance.

8. Sample Size for the Training Set:

This concept is not applicable here. The Unimed Disposable Blood Pressure Cuff is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

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

As there is no "training set" for this type of device, this question is not applicable. The device's performance is assessed against established engineering and biological safety standards.

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The Unimed Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.

The provided document describes a medical device, the Unimed Blood Pressure Cuff, and its substantial equivalence to a predicate device. However, it does not contain information about an AI/ML-based device, nor details about acceptance criteria or a study proving its performance in the context of an AI/ML system.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (for an AI/ML device)
• Sample sizes, data provenance, number of experts, adjudication method (for an AI/ML device)
• MRMC comparative effectiveness study or standalone performance (for an AI/ML device)
• Type of ground truth, training set sample size, and ground truth establishment (for an AI/ML device)

The document focuses on demonstrating the bio-compatibility and physical performance characteristics of a traditional blood pressure cuff through compliance with established standards (ANSI/AAMI SP10, ISO 10993).

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The SpO2 finger sensors are indicated for use to measure the approximate, non-invasive and continuous arterial oxygen saturation and pulse rate of patients weighting more than 40kg.

Unimed's Spo2 reusable sensors are designed to function the same as the compatible Original Equipment Manufacturer (OEM) Puise Oximeter Sensor. The sensors contain two specific wavelength LEDs and a photo detector assembled into the silicon pads. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.

The provided 510(k) summary for the Unimed compatible oximeter sensors (K082546) includes information on performance testing, but it does not provide a detailed table of acceptance criteria or how the device performance specifically met those criteria in the typical format of a device's accuracy specifications. It mentions that performance testing was conducted and validated claims.

Here's a breakdown of the available information based on your requested points:

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

The submission mentions "Performance testing was conducted during clinical hypoxia studies... and was shown to validate performance claims and accuracy. Bench testing was performed to verify pulse rate accuracy." However, specific numerical acceptance criteria (e.g., A_rms values, limits for bias) and the corresponding reported device performance values are not explicitly stated in the provided document.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: The studies were conducted in an "independent lab." The text does not specify the country of origin of the data or whether the study was retrospective or prospective, though hypoxia studies are typically prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For SpO2 sensors, ground truth in clinical hypoxia studies is typically established by CO-oximetry of arterial blood samples.

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

The document does not describe any adjudication method. This is generally not applicable to the type of performance testing (clinical hypoxia study) described for oximeter sensors, where the accuracy of the device is compared against a physiological reference standard.

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, an MRMC comparative effectiveness study was not done. This type of study is not relevant for an SpO2 sensor, which is a standalone measurement device, not an AI-assisted diagnostic tool that aids human readers.
• Effect Size of Human Readers with/without AI: Not applicable, as this device does not involve AI assistance for human readers.

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

Yes, the performance testing described is for the device in a standalone capacity. The "clinical hypoxia studies" and "bench testing" evaluate the sensor's ability to measure SpO2 and pulse rate independently.

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

For the clinical hypoxia studies, the ground truth for arterial oxygen saturation would typically be established using arterial blood gas analysis with a CO-oximeter – considered the reference standard for blood oxygen saturation measurement. The document doesn't explicitly state this, but it's the standard methodology for such studies.

8. The sample size for the training set

The document does not mention a "training set" or any machine learning related development. This device is a traditional medical device (an SpO2 sensor), not an AI/ML-driven device.

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

Not applicable, as there is no mention of a training set or AI/ML components.

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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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