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Caremed Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric and infant patient populations.

The proposed device, Disposable SpO2 Sensors are accessories to the patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is Nihon Kohden BSM-5135A. The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. 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 heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

This document describes the performance data and acceptance criteria for the Disposable SpO2 Sensor (K191279).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."
For the expanded indication to include infants (3 kg

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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

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Rectal Temperature Probe:

The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Skin Temperature Probe:

The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Disposable temperature probes are used during patient temperature measurement. These probes consist of a plug connector on the adapter cable 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 by using an interconnect cable. These probes have a skin or rectal contact with adult patients. Both the skin and rectal probe are single use and provided non-sterile.

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 ".

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, formatted to address your specific questions.

Based on the provided document, the device in question is a "Disposable Temperature Probe" (Rectal and Skin types). This is a 510(k) submission, meaning the manufacturer is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study" are primarily focused on showing that the new device performs comparably to the predicate and meets relevant safety and performance standards for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a temperature probe, the "acceptance criteria" are intrinsically tied to the performance standards for clinical electronic thermometers and the performance of the predicate device. The document explicitly states the criteria and the results obtained for the subject device.

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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 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes.

The proposed device includes disposable blood pressure cuff and reusable blood pressure cuff, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.

The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient.

The disposable blood pressure cuff has 24 models with different population with different arm size, and the 12 models of 24 are use single tube of air hose and other 12 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The reusable blood pressure cuff is reusable device, and which is made of PU & PVC (Cuff) and PVC (Air Hose), thereinto, the PU & PVC (Cuff) is the material used to contacting with the patient.

The reusable blood pressure cuff has 16 models with different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

The provided document is a 510(k) summary for the Caremed Reusable Blood Pressure Cuff and Caremed Disposable Blood Pressure Cuff. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study for a new medical AI or advanced diagnostic device. Therefore, much of the requested information (e.g., sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) is not directly applicable or available in this type of submission for a blood pressure cuff.

However, I can extract information related to the performance data provided within the context of a 510(k) submission for this device.

1. Table of Acceptance Criteria and Reported Device Performance

For a blood pressure cuff, the "acceptance criteria" and "reported device performance" are primarily related to safety, material biocompatibility, and functional performance (e.g., pressure range, leakage, and compliance with recognized standards).

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Caremed Reusable & 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 40 kg and pediatric patients weighing 10 -50 kg at hospital facilities

Caremed Reusable & Disposable SPO2 Sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in sensor housing.

This document is a 510(k) premarket notification for the Caremed Reusable & Disposable SpO2 Sensors. It states that the device is substantially equivalent to a legally marketed predicate device. The information provided is primarily focused on demonstrating this substantial equivalence through comparisons of technical properties and adherence to standards, rather than providing a detailed clinical study report with specific acceptance criteria and detailed performance of the new device.

Here's an attempt to answer your questions based on the provided text, recognizing that some information is implicit or not fully detailed:

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

The document mentions that the subject device's SpO2 and Pulse Rate accuracy meet the requirements of ISO80601-2-61. However, it only provides the SpO2 Accuracy and Pulse Rate Accuracy of the predicate device (K100077 and K111888) as a comparison point in Table 1. It also states the subject device's accuracy has a "slight difference" from the predicate. Without the explicit values for the subject device's SpO2 and Pulse Rate accuracy and the specific ISO80601-2-61 requirements, a direct "acceptance criteria vs. reported performance" table cannot be fully constructed for the subject device.

However, based on the predicate device's performance as a proxy for expected accuracy and the statement that the subject device meets ISO80601-2-61 standards, we can infer some criteria.

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 for Test Set: Not explicitly stated. The document mentions "human adult volunteers" but does not specify the number.
• Data Provenance: Not explicitly stated for the clinical trial. The company is based in Shenzhen, China.
• Retrospective or Prospective: "Clinical hypoxia test results were obtained in human adult volunteers" typically implies a prospective study.

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 or not mentioned. For SpO2 sensor accuracy testing, the ground truth (arterial oxygen saturation, SaO2) is typically established by laboratory methods such as co-oximetry of arterial blood samples, not by expert consensus.

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

Not applicable or not mentioned. As the ground truth is established by co-oximetry, there's no need for an adjudication method involving human experts for the primary endpoints.

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 a medical device for directly measuring physiological parameters (SpO2 and pulse rate), not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, a standalone performance test was done. The document states: "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Reusable & Disposable SPO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry." This is a direct measurement of the device's accuracy against a gold standard, which is a standalone performance assessment.

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

The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry from arterial blood samples. This is considered a gold standard laboratory method.

8. The sample size for the training set

Not explicitly stated. For SpO2 sensors, "training data" often refers to data used to derive or refine the oximetry algorithm. If this refers to the data used for the algorithm, its size is not mentioned. If it refers to clinical data, the document mainly references the clinical performance study (test set).

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

Not explicitly stated. Assuming a similar methodology to the test set, the ground truth for any algorithm development or training would likely have been established using co-oximetry from arterial blood samples.

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The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.

The Caremed patient cable and lead wires including trunk cable and leadwires, are intended use for transmitting signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. The type of devices are 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 text does not describe acceptance criteria for a medical device in the typical sense of performance metrics for an AI/ML model, nor does it detail a study proving such criteria are met. Instead, it is a 510(k) Premarket Notification summary for "Caremed Patient Cable and Leadwires."

This document focuses on establishing substantial equivalence to a previously cleared predicate device, rather than defining and proving performance against specific quantitative acceptance criteria of an AI/ML system.

However, I can extract the relevant information from the document that pertains to the device's characteristics and the standards it meets, which serve as its "acceptance criteria" in the context of a 510(k) submission for a non-AI medical device.

Here's an interpretation based on the provided text, recognizing it's not about AI performance metrics:

The "acceptance criteria" for this device are its compliance with recognized industry standards and its substantial equivalence to a predicate device. The "study" proving this involves a comparison to the predicate device and demonstration of compliance with relevant safety and performance standards through testing (though detailed test results are not provided in this summary).

Here's the information formatted as requested, with explanations where the categories don't directly apply to this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. For this type of device (patient cables and leadwires), the "test set" for substantial equivalence is primarily a comparison against technical specifications and performance standards, not a clinical data set in the way an AI/ML model would be evaluated. The text indicates "Not applied" for clinical test data.
• Data Provenance: Not applicable. The "data" are technical specifications, material properties, and compliance test results (which are not detailed in this summary).

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

• Not applicable. "Ground truth" in the context of an AI/ML model evaluation does not apply to this device. The "ground truth" here is the established safety and performance requirements set by industry standards and regulatory bodies, along with the characteristics of the predicate device.

4. Adjudication method for the test set

• Not applicable. There's no "adjudication method" described as would be used for expert consensus on AI outputs. The evaluation is based on technical specifications and compliance with 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 not an AI/ML device; therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• Ground Truth: For this type of device, the "ground truth" is defined by:
  • Regulatory Standards: Specifically, ANSI/AAMI EC53, ANSI/AAMI EC13, 21 CFR Part 898, IEC 60601-1, ISO 10993-5, and ISO 10993-10.
  • Predicate Device Characteristics: The characteristics, indications for use, and performance of the Unimed Disposable ECG lead wires (K142489).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

• Not applicable. As above, no training set for an AI/ML model; the "ground truth" for compliance testing is established by recognized standards and the clear specifications of the predicate device.

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