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Unimed 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 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with GE B40i, and are supplied non-sterile.

Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

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

Acceptance Criteria and Device Performance

Study Information

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

   • Sample Size: Twelve human adult volunteers were enrolled for the clinical study. The study contains more than the minimum 200 data points.
   • Data Provenance: The study was conducted on human adult volunteers and includes sufficient darkly pigmented subjects (three dark subjects with Fitzpatrick Type 5-6). It is a prospective clinical study. The country of origin is not explicitly stated but implies testing in a controlled clinical environment, likely linked to the manufacturer's location or a designated clinical trial site.

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

   • The document implies that arterial oxygen saturation (SaO2) as determined by co-oximetry was used as the ground truth. This is a direct measurement from blood samples. Therefore, typical "experts" in the sense of human readers adjudicating images are not applicable here. The accuracy of co-oximetry itself is the standard.

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

   • Not applicable. The ground truth (SaO2 by co-oximetry) is a direct, objective measurement, not subject to human interpretation or adjudication in the same way as an imaging study.

4. 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 a sensor (hardware) for SpO2 and pulse rate measurement, not an AI-assisted diagnostic tool or an imaging system that would involve human reader interpretation. No MRMC study was conducted.

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

   • Not applicable. The device is a sensor that measures physiological parameters. Its performance is inherent to its design and function, not an algorithm's performance. The "clinical test data" section describes the validation of the sensor's accuracy in vivo.

6. The type of ground truth used:

   • Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective "gold standard" for blood oxygen measurement.

7. The sample size for the training set:

   • Not applicable. This device is a hardware sensor, not a machine learning model that requires a training set. The clinical study described is for validation/testing, not training.

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

   • Not applicable, as there is no training set for this type of device.

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The Unimed disposable blood pressure cuff (Models U1682S-C51N to U1685S-C51N) is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is non-sterile and for single-patient use. The cuff is available in neonatal sizes (4–15 cm limb circumference). The cuff is not designed, sold, or intended for use except as indicated.

The Unimed Disposable Neonatal NIBP Cuffs (Models U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N) are single-patient-use accessories for non-invasive blood pressure (NIBP) measurement. Each cuff is designed for neonatal limb circumferences ranging from 4 cm to 15 cm (Neonate 2 through Neonate 5) as follows.

• U1682S-C51N: 4 cm - 8 cm.
• U1683S-C51N: 6 cm - 11 cm.
• U1684S-C51N: 7 cm - 13 cm.
• U1685S-C51N: 8 cm - 15 cm.
  The cuffs are intended to be used with compatible blood pressure monitors employing oscillometry. They are non-sterile, and are disposed of after single-patient use to reduce cross-contamination risks.

This 510(k) clearance letter is for a Disposable Neonatal NIBP Cuff. It does not describe an AI/ML powered medical device, nor does it detail a study involving AI/ML.

Therefore, many of the requested criteria related to AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, etc.) are not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical testing and material biocompatibility.

Here's the information that can be extracted from the provided text, primarily related to the non-clinical testing performed to meet acceptance criteria for a physical medical device:

Acceptance Criteria and Device Performance for Disposable Neonatal NIBP Cuff

The acceptance criteria for this device are primarily based on established international standards for non-invasive blood pressure cuffs and biocompatibility. The performance is demonstrated through non-clinical testing, confirming adherence to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The non-clinical testing likely involved a representative sample of each cuff model (U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N).
• Data Provenance: The document states "Non-clinical tests were conducted..." but does not specify the country of origin where the testing was performed. Given the manufacturer's location (Shenzhen, China), it's plausible the testing was conducted there or at a certified lab supporting the manufacturer. The testing is described as non-clinical, implying it was laboratory-based product verification and validation, not retrospective or prospective human clinical data collection.

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

This is not applicable. This document describes the clearance of a physical medical device (NIBP cuff) via substantial equivalence, not an AI/ML algorithm. Therefore, there is no mention of "ground truth" derived from expert consensus on medical images or data. The "ground truth" for this device would be the defined specifications and performance requirements established by the relevant ISO standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trial settings, especially for AI/ML performance evaluation where multiple human readers might disagree on findings. For non-clinical device testing like this, adherence to predefined test protocols and specifications is the primary method of evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a non-AI medical device like a blood pressure cuff.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance evaluation of an algorithm was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with recognized consensus standards (ISO 81060-1, ISO 80601-2-30, and ISO 10993 series for biocompatibility). The device's performance metrics are evaluated against the specific requirements and test methods outlined in these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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Models: U403-91, U410-91 Unimed Reusable Finger Clip 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 30 kg. These devices are for prescription use only.

The subject devices, Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series), are fully compatible reusable sensors for use with Philips Itellivue MP30. These sensors are supplied non-sterile. The subject sensors (Models: U403-91 and U410-91) consist of a plug/connector (Philips D8 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Patient-contacting materials of the subject sensors include ABS, silicone, and TPU, all of which have been qualified against biocompatibility requirements in ISO 10993-5, ISO 10993-10, and ISO 10993-23.

The Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) are subject to the following acceptance criteria and the performance study described was conducted to prove the device meets these criteria. It's important to note that the provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily a full clinical trial report for novel device approval.

1. Table of Acceptance Criteria and Reported Device Performance

Note¹: The document states that according to ISO 80601-2-61:2017, both Subject Device and Predicate Device have validated accuracy over the claimed pulse range and are therefore considered substantially equivalent, despite the difference in stated accuracy metrics for pulse rate.

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

• Sample Size:
  • Clinical Study Test Set: 12 human adult volunteers.
  • Data Points: The clinical study contains "more than the minimum 200 data points."
• Data Provenance:
  • The document implies the clinical study was conducted by or on behalf of Unimed Medical Supplies Inc., which is based in China. The data provenance regarding the country of origin of the study conduct is therefore likely China or an authorized testing facility.
  • The study involved clinical hypoxia tests, which are prospective in nature, as they involve actively inducing hypoxia in volunteers to collect data on sensor performance.

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

The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth. However, for pulse oximetry accuracy studies involving induced hypoxia, the ground truth (arterial oxygen saturation, SaO2) is typically established by co-oximetry readings from arterial blood samples, which are analyzed by laboratory equipment. This process relies on the accuracy of the co-oximeter and the proper drawing and handling of blood samples by trained medical personnel. It doesn't involve subjective expert consensus in the same way an imaging study would.

4. Adjudication Method for the Test Set

Not applicable. For pulse oximetry accuracy studies using induced hypoxia and co-oximetry, the ground truth is an objective physiological measurement from a laboratory instrument (co-oximeter) from arterial blood samples. There is no human adjudication process involved in establishing this ground truth, unlike with subjective visual assessments in imaging.

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

No. The provided document details a clinical study to validate the device's standalone accuracy against established physiological measurements (co-oximetry) in human volunteers. It is not an MRMC study comparing human reader performance with and without AI assistance, as the device is a sensor for measuring physiological parameters, not an AI-powered diagnostic imaging tool.

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

Yes. The clinical hypoxia test described is a standalone performance test for the Unimed Reusable Finger Clip SpO2 Sensors. The study directly assesses the device's ability to accurately measure SpO2 against the ground truth (SaO2 from co-oximetry) without human interpretation or intervention in the measurement process itself.

7. The Type of Ground Truth Used

The ground truth used was outcomes data / physiological measurement, specifically:

• Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is considered the gold standard for measuring oxygen saturation in blood for pulse oximeter accuracy studies.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For medical device premarket notifications like this, the focus is on a verification/validation study (the "clinical study" mentioned here) rather than an AI/machine learning model where distinct training and test sets are common. The device is a sensor, not a machine learning algorithm that undergoes a training phase.

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

As this is a sensor device and not an AI/ML model, there isn't a "training set" in the typical sense for which ground truth would be established for model training. The "ground truth" (SaO2 via co-oximetry) was established for the 12-subject clinical validation study as described above.

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Unimed Reusable Finger Clip 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 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices, Unimed Reusable Finger Clip SpO2 Sensors, are fully compatible reusable sensors for use with monitors that incorporate Masimo technology. These sensors are supplied non-sterile. The subject sensors consist of a plug/connector (U403-125 and U103-125 with M8 sensor connector, and U403-254 and U103-254 with M10 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensors have identical material composition and performance characteristics to the predicate device.

Here's a breakdown of the acceptance criteria and study information for the Unimed Reusable Finger Clip SpO2 Sensors, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that the clinical study was conducted with "human adult volunteers," including "sufficient darkly pigmented subjects." However, the exact number of subjects (the sample size) is not specified.
• Data Provenance: The data is prospective as it was collected in a "clinical study... under an approved protocol with subject informed consent." The country of origin is not explicitly stated, but the submission is from "Unimed Medical Supplies Inc." located in "Shenzhen, China." It's reasonable to infer the study was conducted there or arranged by their organization.

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

The document mentions that "arterial oxygen saturation (SaO2) as determined by co-oximetry" was used to establish the ground truth. This is a direct physiological measurement and does not involve human expert interpretation for ground truth establishment. Therefore, information about the number or qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth was established by co-oximetry, which is an objective measurement, not a subjective interpretation requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an oximeter sensor, which directly measures physiological parameters (SpO2 and pulse rate). Its performance is evaluated against a gold standard method (co-oximetry), not by comparing human reader performance with and without AI assistance.

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

Yes, the clinical study performed appears to be a standalone (algorithm only) performance evaluation. The device, an SpO2 sensor, directly provides measurements. The study evaluated the accuracy of these measurements against a reference method (co-oximetry) without integrating a human in the loop for interpreting the device's output.

7. Type of Ground Truth Used

The ground truth used was outcomes data (physiological measurements), specifically "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is considered a clinical gold standard for measuring blood oxygen levels.

8. Sample Size for the Training Set

Not applicable. The document describes a medical device (SpO2 sensor), not an AI/machine learning algorithm that requires a training set. The device operates based on physical principles (two-wavelength relative optical absorption) and is validated through clinical performance against a reference standard.

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

Not applicable. As the device is not an AI/machine learning algorithm, there is no training set and therefore no ground truth established for a training set.

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The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatic (≥10Kg) patients during both no motion and for patients who are well or poorly perfused.

Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.

The Pulse Oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR) and perfusion index (PI) by measuring the absorption of red and infrared light passing through perfused tissue. It indicated for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.

The provided text describes the Unimed Medical Supplies Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) and its acceptance criteria as well as the study that proves it meets those criteria.

Acceptance Criteria and Device Performance

The device's performance is compared against the ISO 80601-2-61 standard for pulse oximeters. The acceptance criteria and reported device performance are presented in the table below:

Table 1: Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria is Met

The document states that the subject devices (Unimed Pulse Oximeters) are identical to the predicate device (Nariq Bio-Medical Pulse Oximeter, K211632). Therefore, the studies conducted for the predicate device are used to demonstrate the substantial equivalence and compliance of the subject device.

Here's the breakdown of the study details based on the provided text:

• 1. Sample sized used for the test set and the data provenance:

  • The document does not explicitly state the sample size for the test set of the predicate device.
  • The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin specified in detail for the clinical data. It generally refers to clinical testing that aligns with ISO 80601-2-61:2017.

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

  • This information is not provided in the document. The general reference is to compliance with ISO standards, which implies the ground truth methodology as defined in those standards for pulse oximetry accuracy.

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

  • This information is not provided in the document. The text indicates that the predicate devices have undergone clinical testing that meets relevant consensus standards (ISO 80601-2-61:2017), which would dictate the clinical study design and ground truth establishment methods for SpO2 accuracy.

• 4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • This is not applicable to this device. The device is a pulse oximeter for measuring SpO2 and pulse rate, not an AI-assisted diagnostic tool for human readers.

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

  • The performance metrics provided (SpO2 and PR accuracy) are inherent to the device's measurement algorithms and sensors. Therefore, the bench and clinical testing of the predicate device assesses the standalone performance of the oximetry technology. No human-in-the-loop component is mentioned for these accuracy measurements.

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

  • For SpO2 accuracy claims, the ground truth would typically be established through controlled desaturation studies against a co-oximeter (which provides gold standard arterial blood gas measurements). This is implied by the adherence to ISO 80601-2-61, which outlines these requirements.

• 7. The sample size for the training set:

  • This information is not applicable as the device is not described as an AI/ML product developed with a training set in the conventional sense. Its performance is based on established optical measurement principles.

• 8. How the ground truth for the training set was established:

  • This information is not applicable for the same reason as above.

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The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery in Emergency Medicine/Transport or Respiratory care.

The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an auto-zero adjustment systemand gain control. The operation of the CO2 Mainstream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to theenergy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the module's memory. The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate the calculation for the concentrations of carbon dioxide, which improves the design accuracy. The module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent(%), or kilopascals (kPa). In addition, a CO2 waveform (Capnogram) may be displayed, which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time interval between detected breaths.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Unimed CO2 Mainstream Module:

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

The provided document describes acceptance criteria in the context of "EtCO2 Accuracy" and "Respiration Rate Accuracy." It also states that the device complies with ISO 80601-2-55. The table below combines the reported performance with these accuracy criteria.

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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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