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Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.

The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

Model: T1306, Description: Skin contact Temperature Probe, adult, reusable
Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable
Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable
Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable
Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable
Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable

The provided FDA 510(k) clearance letter describes a medical device, the Reusable and Disposable Temperature Probes, but does not include information about AI/ML performance. Therefore, I will respond to the prompt by extracting the acceptance criteria and study information pertinent to this medical device, which focuses on traditional medical device performance rather than AI/ML.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents "Accuracy" and "Measurement Range" as inherent characteristics of the device and states that bench testing was conducted to verify that design specifications were met, which implies these values are the acceptance criteria.

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

The document does not explicitly state the sample sizes used for the test sets (e.g., number of units tested, number of temperature measurements, or specific test configurations) for the bench testing or biocompatibility testing.

The document also does not provide information about the provenance of data in terms of country of origin or whether studies were retrospective or prospective. The testing described appears to be laboratory-based verification and validation.

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

This information is not applicable and not provided in the document. The device is a clinical electronic thermometer, and its performance is assessed against technical specifications and international standards, not against human expert interpretation of medical images or data. Ground truth for temperature measurement is typically established by reference standards or calibrated equipment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers), which is not relevant for the objective performance testing of a temperature probe.

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

No. An MRMC comparative effectiveness study was not conducted as this is a medical device for objective temperature measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation. The document does not mention any AI assistance.

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

No. This device is an electronic temperature probe, not an algorithm or software. Its performance is inherent to its physical and electrical properties, evaluated through bench testing against established standards.

7. Type of Ground Truth Used

The ground truth for the performance evaluations (accuracy, measurement range, electrical safety, etc.) would be established by:

• Reference Standards/Calibrated Equipment: For accuracy and measurement range, the device's readings would be compared against highly accurate and calibrated reference thermometers in controlled temperature environments.
• International Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer-specific performance (ISO 80601-2-56) serves as the ground truth for safety and performance.
• Laboratory Analysis: For biocompatibility, laboratory tests (cytotoxicity, sensitization, irritation) are conducted to assess the biological response to the device materials according to ISO 10993 standards.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a hardware medical device with no mention of machine learning or algorithms that would require a "training set."

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

This information is not applicable. As there is no training set for an AI/ML algorithm involved, no ground truth was established for a training set.

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The Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue.

The Reusable Interface Cable comprises a flexible, low-loss coaxial cable intended for high-power microwave operation and has latching connectors at each end for connection to the CROMA Electrosurgical Generator and compatible Creo Medical Instruments (Surgical Accessories). The established lifetime of the Reusable Interface Cable is for 20 uses in total.

The provided text is related to a 510(k) premarket notification for a medical device (Reusable Interface Cable 1.5 m), which is an electrosurgical accessory. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed acceptance criteria and study results for clinical efficacy or sophisticated AI performance.

Therefore, the document does not contain information relevant to:

• A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven outcome.
• Sample size used for a test set in the context of an accuracy study or provenance of data.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Description: A flexible, low-loss coaxial cable connecting a Creo Medical Instrument to a CROMA Electrosurgical Generator for delivering RF and/or Microwave energy. It specifies a lifetime of 20 uses.
• Intended Use/Indications for Use: Connection of compatible Creo Medical Instrument to the CROMA Electrosurgical Generator to deliver RF/Microwave energy for cutting, coagulation, and ablation of gastrointestinal tissue. This indication is stated to be the same as the predicate device, with reworded readability.
• Technological Comparison: The subject device is a reusable version of the predicate device. The conductor cable was modified for durability while maintaining identical electrical properties. Principles of operation, electrical properties, energy source, materials, dimensions, and cleaning methods are identical to the predicate.
• Non-Clinical Tests:
  • Electrical safety testing: Conducted in compliance with FDA-recognized versions of IEC 60601-2-2 and IEC 60601-2-6 standards.
  • Performance bench testing: Conducted to establish device durability over its established lifetime for:
    • Cleaning between uses (reprocessing)
    • Rotation load
    • Cyclic load
    • Connector connection and disconnection forces.

Conclusion:

This submission is for an accessory device (cable) that facilitates the use of an electrosurgical unit. The "acceptance criteria" and "study" described are primarily related to electrical safety and physical durability/reusability of the cable, ensuring it functions as intended for its specified lifespan and remains substantially equivalent to the predicate device. It does not involve complex performance metrics or clinical studies in the context of diagnostic accuracy or AI-driven decision support.

Since the provided text does not contain the requested information about diagnostic performance, AI, or specific clinical study details as implied by the questions, I cannot populate the table or answer those specific points. The information available is about engineering and regulatory compliance testing for a reusable medical cable.

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The Reusable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and reusable. It is available in adult size.

The proposed device is an accessory used in conjunction with non-invasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.

The provided text is a 510(k) summary for a Reusable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific acceptance criteria for an AI/ML medical device.

Therefore, the document does not contain the information required to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance: The document lists standards the device complies with (IEC 80601-2-30, ISO 81060-1, ISO 10993-5, ISO 10993-10), but these are general safety and performance standards for a mechanical device, not AI/ML acceptance criteria like sensitivity, specificity, or AUC. No specific performance metrics are reported against quantitative acceptance criteria.
• Sample size and data provenance for a test set: No mention of a test set, data provenance, or sample size for evaluating AI/ML algorithm performance.
• Number and qualification of experts for ground truth: Not applicable, as this is not an AI/ML device requiring expert-established ground truth.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The document states:

• "6. Non-Clinical Test Conclusion" and "6.1 Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 80601-2-30: 2018..., ISO 81060-1:2007..., ISO 10993-5: 2009..., ISO 10993-10: 2010..."
• "6.2 Human Factors / Usability Testing Usability testing is not required per the risk profile of this product."
• "7. Clinical Test Conclusion No clinical study is included in this submission."

This unambiguously indicates that the submission is for a physical medical device (a blood pressure cuff), assessed through non-clinical bench testing for compliance with manufacturing and biocompatibility standards, and not an AI/ML driven diagnostic or assistive device that would require the specified performance evaluations.

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Reusable Temperature Probes:

Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only.

Disposable Temperature Probes:

Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.

The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000.

The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.

The provided text describes the regulatory clearance of a medical device (Reusable and Disposable Temperature Probes) and its substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria through detailed performance metrics and a comparison to a defined ground truth.

Therefore, many of the requested details about acceptance criteria, specific study design elements (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details) are not present in the provided document.

However, I can extract the following information that is available:

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

The document mentions compliance with standards which inherently include performance criteria. Specifically, the "Accuracy" is listed.

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

• Sample Size for Test Set: Not specified. The document states "Non-clinical testing has been conducted to verify that the subject devices meet all design specifications." The exact number of units or measurements in these tests is not provided.
• Data Provenance: The tests are non-clinical, conducted by the manufacturer, Shenzhen SINO-K Medical Technology Co., Ltd., which is based in Shenzhen, Guangdong, China. The testing confirms compliance with international standards (IEC, ISO, ASTM).

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

• Number of Experts: Not applicable/not specified. The testing described is non-clinical performance testing against established international standards, not expert evaluation of medical images or diagnostic outputs.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. This document describes objective performance testing against engineering standards, not a diagnostic study requiring expert 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:

• MRMC Study: No. This device is a temperature probe, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Yes, in the sense that the device's inherent performance (e.g., accuracy, measurement range) was demonstrated through non-clinical testing against standards (e.g., ISO 80601-2-56) without human interpretation of results beyond reading the device's output.

7. The type of ground truth used:

• Ground Truth Type: International standards (ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2), and established biocompatibility standards (ISO 10993 series). These specify acceptable ranges and methodologies for determining performance, forming the "ground truth" for compliance.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a hardware temperature probe, not a machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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The Reusable NIBP Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in adult size.

Reusable NIBP Cuff is a reusable accessory used in conjunction with a non-invasive blood pressure measurement system. It 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.

Reusable NIBP Cuff is made of PU synthetic leather (Cuff), TPU film (bladder) and TPU (Air Hose), and the PU synthetic leather is the material used to contacting with the patient's intact skin.

The provided document is an FDA 510(k) clearance letter for a reusable NIBP (Non-Invasive Blood Pressure) cuff. It details the device's indications for use, safety and performance testing, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to a diagnostic algorithm or AI performance. The document is for a physical medical device (blood pressure cuff) and focuses on its physical characteristics, materials, and mechanical performance (e.g., durability of inflation cycles, biocompatibility) rather than a software or AI-driven diagnostic.

Therefore, I cannot provide answers to the specific points requested (acceptance criteria table, sample size for test/training sets, expert ground truth, MRMC study, standalone performance, etc.) as they pertain to the evaluation of an AI/algorithm-based device, which is not what this document describes.

The acceptance criteria stated for this device primarily revolve around:

• Compliance with recognized standards: ISO 81060-1 (Non-Invasive Sphygmomanometers), ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Skin Sensitization).
• Biocompatibility: Demonstrated through testing for cytotoxicity, sensitization, and irritation.
• Mechanical Durability: 10,000 inflations and 3,000 hook and loop closures.
• Pressure Limits: 0-300mmHg.
• Intended Use and Patient Population Matching: For adult size, non-sterile, reusability.
• Substantial Equivalence: To a legally marketed predicate device (Orantech Inc. Reusable NIBP Cuff, K173197).

The document explicitly states: "Clinical performance is not deemed necessary." and there is no mention of an AI/ML component in this device.

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The Reusable and Disposable 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. The sensors are intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

The proposed device, Reusable and Disposable SpO2 sensors are the accessory of the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.

The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), and it is used to attach the patient's finger and measure oxygenation of blood from detecting the infrared-light and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation values and heart rate conditions.

The Reusable and Disposable SpO2 sensors consist of compatible connectors, cable, and patient sensor terminal. And the optical components of sensor are designed to a light emitting diode and a light detector. Red and Infrared lights are shone through the terminal tissues. Then parts of the emitting lights are absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. The light detector detects the light volume transmitted through the tissues on the basis of blood pulse, then the microprocessor calculates a value for the oxygen saturation by measuring the absorbance of the wave peak and the wave trough. The saturation values are determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

This document describes a 510(k) premarket notification for reusable and disposable SpO2 sensors. It details performance data, including biocompatibility, electrical safety, EMC, and clinical studies. However, the document does NOT contain information about AI/ML models or their performance, nor does it specify acceptance criteria for such models, or the details of ground truth establishment by experts for AI/ML development.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML, as the provided text pertains to a standard medical device (SpO2 sensor) without any indication of AI components.

To answer your question accurately, I would need a document that describes the performance of an AI-powered medical device.

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The Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.

The Reusable Monopolar Active Cord is used during endoscopic procedures to provide monopolar energy from an Electrosurgical Generator Unit (ESU) to an Active Endoscopic accessory. The Reusable Monopolar Active Cord consists of a male ESU end and a female device end connected via an insulated cable. The male ESU end uses a bovie style connector to connect to an ESU. The female device side connects to the active connector of an Active Endoscopic accessory.

The provided text describes the acceptance criteria and performance testing for a medical device called the "Reusable Monopolar Active Cord." However, it does not describe a study that uses a test set, ground truth established by experts, or any of the elements typically found in studies for AI/Machine Learning devices (like MRMC studies, standalone performance, training set details, etc.).

This document is a 510(k) Premarket Notification for a traditional medical device, specifically an accessory (an active cord) for electrosurgical units. The "studies" described are standard engineering verification and validation tests to ensure the device meets its design specifications and functions as intended, not clinical trials or AI performance evaluations.

Therefore, for most of the requested points, the information is not present in the provided text.

Here's an attempt to answer based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document refers to "verification activity" and "performance testing" but does not detail sample sizes for each test type. These are physical product tests, not data-based studies.
• Data Provenance: Not applicable in the context of data for an AI/ML model. The tests are performed on physical units of the device.

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 traditional device; "ground truth" in the context of AI/ML is not relevant here. The "truth" is whether the device meets engineering specifications and functions correctly.

4. Adjudication method for the test set:

• Not applicable. There is no expert adjudication process described, as it's not an AI/ML model being assessed.

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. An MRMC study is not mentioned as this is not an AI/ML device.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the AI/ML sense. The "ground truth" for the device's performance is its adherence to predefined engineering specifications, industry standards (IEC 60601-x), and functional intent.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device and does not have a "training set."

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

• Not applicable. This is not an AI/ML device and does not have a "training set."

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The Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.

The proposed device, Reusable SpO2 Sensors are accessories to patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 with Nellcor SpO2 module (K113623).

The sensor shall be connected with its corresponding monitor. Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and pulse rate conditions.

Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

Here's a breakdown of the acceptance criteria and study details for the Reusable SpO2 Sensor, based on the provided FDA 510(k) summary:

This device is a Reusable SpO2 Sensor, an accessory to patient monitors used for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document specifically details performance criteria and claims for SpO2 and PR accuracy compared to a legally marketed predicate device.

Note: The document emphasizes substantial equivalence to the predicate device, meaning the new device's performance is demonstrated to be equivalent to a device already cleared by the FDA. The performance data presented are in direct comparison to the predicate's stated specifications.

Study Details Proving Device Meets Acceptance Criteria:

The information provided is typical for a 510(k) submission, focusing on demonstrating substantial equivalence rather than a detailed standalone clinical study report.

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

• Test Set Sample Size: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." However, the specific number of adult volunteers (sample size) used for the clinical accuracy testing is not provided in this summary.
• Data Provenance: The data appears to be prospective clinical data gathered specifically for this submission, as indicated by "Clinical testing has been performed under an approved protocol with subject informed consent." The country of origin for the data is not explicitly stated, but the submitting company and correspondent are based in Shenzhen, China.

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

• This information is not provided in the document. For pulse oximetry clinical studies, ground truth is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual assessment or interpretation.

4. Adjudication Method for the Test Set:

• Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation of medical images or data where subjective decisions are made. For a pulse oximetry study where ground truth is established by a quantitative measurement (co-oximetry), traditional adjudication methods as described are not applicable.

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

• No, an MRMC study was not done. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, especially in diagnostic imaging. This device is a sensor, and its accuracy is assessed quantitatively against a gold standard (co-oximetry), not through human reader interpretation. Therefore, questions about an effect size of human readers improving with AI assistance are not applicable to this type of device and study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Yes, in essence. The clinical accuracy study ("Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Changke Reusable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry") assesses the performance of the device (including its internal algorithm for calculating SpO2 and PR) against a gold standard. While the device outputs data for human use, the accuracy assessment itself is effectively a standalone performance evaluation of the sensor and its processing capabilities.

7. The Type of Ground Truth Used:

• The ground truth used for the clinical accuracy testing was arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is considered the gold standard for measuring arterial oxygen saturation.

8. The Sample Size for the Training Set:

• This information is not provided in the 510(k) summary. For medical devices, particularly sensors, "training set" is often interpreted as the data used during the development and calibration of the device's algorithms. The summary focuses on the validation data (clinical studies) rather than internal R&D or algorithm training data.

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

• As the sample size and specific details of a "training set" (in an AI/ML context) are not explicitly mentioned for this device's development, the method for establishing ground truth for any such internal data is not provided. However, it is inferred that similar, highly accurate methods (like co-oximetry) would have been used during the sensor's design and calibration phases to ensure its foundational accuracy.

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The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device includes reusable blood pressure cuff. All the reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube. The reusable blood pressure cuff is reusable device, Model CK-XT-78211-XXX series are made of PU synthetic leather (Cuff) and TPU (Air Hose), and the PU synthetic leather (Cuff) is the material used to contacting with the patient's intact skin. Model CK-XT-78243-XXX series are made of Nylon (Cuff) and silica gel (Air Hose), and the Nylon (Cuff) is the material used to contacting with the patient's intact skin.

The provided text describes a 510(k) submission for a Reusable NIBP Cuff, demonstrating its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document focuses on non-clinical data and biocompatibility testing, primarily to show compliance with international standards and substantial equivalence, rather than a direct comparison against specific performance acceptance criteria for the blood pressure measurement accuracy itself (which is typically addressed by standards like ISO 81060-2).

Therefore, it is not possible to fully answer the request based on the provided text. I will extract the available information and explicitly state what is missing.

Missing Information from the Provided Document:

• A table of specific acceptance criteria for blood pressure measurement accuracy and corresponding device performance data against these criteria. The document mentions compliance with ISO 81060-1 but does not provide the specific performance results or acceptance limits for accuracy from this standard.
• The exact sample size used for any performance testing related to blood pressure measurement accuracy.
• Data provenance (country of origin, retrospective/prospective) for any detailed performance study.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone (algorithm only) performance study was done.
• The specific type of ground truth used for performance validation (e.g., direct arterial measurement, oscillometric reference).
• Sample size for the training set (no training set mentioned as this is a physical medical device, not an AI/software device).
• How ground truth for the training set was established (not applicable).

Based on the provided text, here is the information available:

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

The document states that non-clinical tests were conducted to verify that the subject device met all design specifications and complied with specific standards, implying these standards define the acceptance criteria. However, explicit numerical acceptance criteria and the device's reported performance against them are not provided in a detailed table as requested.

The relevant standards mentioned are:

• ISO 81060-1: Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
• ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity.
• ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

For biocompatibility testing, the acceptance criteria are generally "no sensitization observed" and "Negligible (no observed primary irritation)" and passing cytotoxicity tests, which the device reportedly met. These are general statements rather than specific numerical criteria.

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

• Sample Size: Not specified for any performance testing related to NIBP accuracy. For biocompatibility, "the battery of testing" was mentioned, but specific sample sizes of biological material or animals are not detailed.
• Data Provenance: Not specified. The submission sponsor and correspondent are based in China (Shenzhen, P.R. China).

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

• This information is not provided as the device is a physical NIBP cuff, not an AI/software device usually requiring expert ground truth in this context. The performance verification likely involved physical laboratory testing and possibly clinical studies, not expert review of images or data.

4. Adjudication method for the test set

• Not applicable/Not provided. This usually pertains to studies involving expert review for AI/image analysis.

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/Not provided. This pertains to AI-assisted diagnostic devices.

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

• Not applicable/Not provided. This pertains to AI/software performance. The device is a physical medical accessory.

7. The type of ground truth used

• For NIBP cuff performance (ISO 81060-1): The standard typically describes methods for validating the accuracy of non-invasive blood pressure measurements, often against a reference method (e.g., intra-arterial pressure measurement) or a validated simulator. The exact ground truth method used in their specific tests is not detailed in this summary.
• For Biocompatibility (ISO 10993-5, -10): The ground truth is established through standardized laboratory assays for cytotoxicity, sensitization, and irritation using accepted biological models (e.g., cell cultures, animal models, or human patch tests).

8. The sample size for the training set

• Not applicable. This device is a physical NIBP cuff, not a software or AI algorithm that requires a training set.

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

• Not applicable. As above, no training set is relevant for this type of device.

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The Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for used by qualified medical personnel only.

Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.

Products are packed individually into a plastic bag in non-sterile condition. Package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".

The provided text describes the performance data for the Reusable Temperature Probe (Models: TRAG-2252, TRAS-2252, TRCG-2252 and TRCS-2252) in support of its substantial equivalence determination.

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

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

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

The document does not explicitly state the sample size used for performance testing (e.g., how many probes were tested) nor does it specify the provenance (e.g., country of origin) of the data. It indicates that "All subject devices were conducted performance testing according to ISO 80601-2-56" and references "Laboratory accuracy" and "Time response" results as well as biocompatibility testing. The nature of these tests (e.g. for electrical safety and accuracy) suggests they are conducted in a laboratory setting, not on patient data.

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

This section is not applicable as the device is a temperature probe, and the performance testing described is objective measurement against standards and physical characteristics, not expert interpretation of diagnostic images or clinical scenarios requiring ground truth establishment by experts.

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

This section is not applicable for the reasons stated above. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution.

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 section is not applicable. The device is a Reusable Temperature Probe, which is a physical measurement device, not an AI-assisted diagnostic tool.

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

This section is not applicable, as the device is a temperature probe and does not involve an algorithm for diagnostic interpretation. Its performance is inherent in its design and manufacturing.

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

For the performance metrics (accuracy, time response, safety, EMC) of the temperature probe, the "ground truth" is established by objective measurement against the specified international standards (e.g., ISO 80601-2-56 for accuracy and time response, IEC 60601-1 for electrical safety, ISO 10993 series for biocompatibility). There is no "expert consensus" or "pathology" involved in determining if a physical temperature measurement falls within a specified range.

8. The sample size for the training set

This section is not applicable. The device is a Reusable Temperature Probe, which is a hardware medical device, not an AI algorithm that requires a training set.

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

This section is not applicable, as there is no training set for this type of device.

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