The T-105 Series Vital Signs Monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is capable of monitoring:

. Pulse rate (via oximetry data)
. Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP)
. Temperature
. Blood Oxygen Saturation (SpO2 via finger oximeter)
This device is intended for use by qualified healthcare personnel trained in its use.

Device Description

The Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100 and is intended to monitor a single patient's vital signs. The device is capable of monitoring:

. Pulse rate (via oximetry data):
Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP); .
. Temperature; and
. Blood Oxygen Saturation (SpO2 via finger oximeter)

AI/ML Overview

The provided document is a 510(k) premarket notification for the Omron HBP T-105 Series Vital Signs monitor. This type of submission relies on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than presenting a full de novo study with detailed acceptance criteria and performance data as might be found in a clinical trial report for a novel AI device.

Therefore, the requested information, particularly regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (especially for AI systems), is largely not present in this document. The document focuses on demonstrating that the new device's specifications are similar to or the same as those of the predicate devices.

However, I can extract what is available and highlight what is missing based on your request.

Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" here are implicitly the specifications of the predicate devices, as the new device claims "same as predicate device" for most performance metrics. The "Reported Device Performance" is also stated in relation to these predicate device specifications.

Metric	Acceptance Criteria (Predicate)	Reported Device Performance (HBP-T105 / T-105S)
Blood Pressure
Measurement method	Oscillometric method	Same as predicate device
Patient target	Adult/Pediatric/Neonatal	Same as predicate device
Measurement range (Pressure)	0 to 300 mmHg	0 to 299 mmHg (Slight difference, but within typical ranges)
Measurement range (Pulse rate)	40 to 240 beats/min	40 to 240 beats/min
Accuracy of pressure indicator	Within ±3 mmHg or 1 % of reading	Same as predicate device
Accuracy of pulse rate	Within ±2 beats/min or ±2% of reading	Same as predicate device
Quick measurement function of Blood Pressure	No algorithm (for predicate)	Omron algorithm (HEM-757 - K001670) - This is a change
SpO2 Measurement
Measurement method	2 wave length pulse wave type	Same as predicate device
Display range	0 to 100 %	Same as predicate device
Accuracy of SpO2 (Nellcor D-25)	SpO2: 70-100% ±2%	Nellcor - Same as predicate
Accuracy of SpO2 (Nellcor N-25)	SpO2: 70-95% ±2%	Nellcor - Same as predicate
Accuracy of SpO2 (Masimo)	Not applicable to predicate as Masimo not listed for predicate	SpO2: 70-100% ±2% (for Masimo option)
Pulse rate display range (Nellcor)	20 - 250 beats/min	Same as predicate device
Pulse rate display range (Masimo)	Not applicable to predicate	25 - 240 beats/min
Accuracy of pulse rate (Masimo)	Within ±3 beats/min	Within ±3 beats/min
Temperature
Measurement method	TURBO TEMP electronic predictive thermometer	Same as predicate device
Display range (Predictive)	35.6 - 41.1℃ / 96-106°F	Same as predicate device
Display range (Monitor)	26.7 - 41.1º / 80 - 106ºF	Same as predicate device
Accuracy of TEMP	±0.1°C / ±0.2°F	Same as predicate device

Missing Information from the Document:

Sample sizes used for the test set and the data provenance: This information is not provided. A 510(k) submission for a vital signs monitor often relies on performance data collected during design verification and validation, but detailed sample sizes and population demographics are not routinely included in the public summary. Given the device is a technical modification of existing technology, the "testing" would likely involve demonstrating compliance with recognized standards (e.g., ISO 81060-1 for NIBP, ISO 80601-2-61 for Pulse Oximetry) rather than a novel clinical study for equivalence, and the results are summarized as "same as predicate."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. For device performance, the "ground truth" would be established by reference measurement devices or established clinical protocols, not by expert consensus on, for example, image interpretation.
Adjudication method for the test set: Not applicable/not provided. Adjudication is typically relevant for subjective assessments, which is not the primary mode of evaluation for a vital signs monitor.
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 vital signs monitor, not an AI-powered diagnostic imaging system. There are no "human readers" or "AI assistance" in the context of interpretation of complex medical cases.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of AI. The device's algorithms (e.g., for oscillometric NIBP, SpO2) operate intrinsically. Performance is assessed against reference standards.
The type of ground truth used: For vital signs monitors, the ground truth is typically established using independent, highly accurate reference measurement equipment/methods. For example, for NIBP, this might involve simultaneous intra-arterial pressure measurements, or non-invasive methods validated against such standards. For SpO2, it might involve co-oximetry measurements from arterial blood samples. This document does not detail the specific ground truth methods employed in its validation studies, but it is implied that standard validation procedures were followed for each parameter.
The sample size for the training set: Not applicable. This device does not employ machine learning/AI in a way that requires a distinct "training set" in the context of general-purpose vital signs monitoring. Its algorithms are based on established physiological principles.
How the ground truth for the training set was established: Not applicable, as no AI training set is described.

Summary of Study that Proves the Device Meets Acceptance Criteria

The document states that the Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100. The primary method for proving the device meets acceptance criteria in a 510(k) submission like this is demonstrating substantial equivalence to a previously cleared predicate device.

The "study" in this context is not a standalone clinical trial in the sense of a drug or novel AI device, but rather a series of verification and validation (V&V) tests to confirm that the modified device performs according to its specifications and is at least as safe and effective as the predicate.

The provided table itself serves as the core of this proof, by showing that:

Many key specifications (measurement method, patient target, accuracy of pressure indicator, accuracy of pulse rate for NIBP, SpO2 measurement method and accuracy for Nellcor, temperature measurement method and accuracy) are "same as predicate device."
Where changes exist (e.g., power source, display, operating/storage conditions, dimensions, weight, BP module, SpO2 module, addition of Masimo sensors, use of an Omron algorithm for quick BP measurement), these changes are either presented as minor design updates (e.g., battery type, display technology) or by referencing other legally marketed predicate devices for the specific component/feature (e.g., Omron HEM907 for Air Control Valve/Applicable Cuff, Omron HEM-757 for Quick BP algorithm, Nellcor N-595 and Masimo RAD-5 with their respective sensors for SpO2).

The conclusion of the FDA (as shown in pages 4-6) is that the device is "substantially equivalent" to the predicate devices, which signifies that the manufacturer successfully demonstrated that the changes do not raise new questions of safety or effectiveness and that the performance meets acceptable standards, usually through bench testing, engineering analysis, and potentially limited clinical testing if deemed necessary for specific changes (though not detailed here).

Summary

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Omron

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 4 12-Jun-07

Omron Healthcare, Inc.1200 Lakeside Dr.Bannockburn, IL 60015	Tel - 847-247-5609Fax - 847-680-6269
Official Contact:	Ranndy Kellogg - VP Marketing & Product Development
Proprietary or Trade Name:	HBP T-105 Series Vital Signs monitor
Common/Usual Name:	Monitor, Physiological, Patient (without arrhythmia detection oralarms)
Classification Name/Code:	MWI - Monitor, Physiological, Patient (without arrhythmiadetection or alarms)
Device:	Models HBP T-105 and T-105S
Predicate Devices:	Colin - Press-Mate PM-2100 - K022537Omron - HEM 907 - K001848Omron - HEM 757 - K001670Nellcor - N595 – K012891Nellcor - Oximax - K052186Masimo - RAD 5 - K033296Masimo - LNCS – K041815

Device Description:

The Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100 and is intended to monitor a single patient's vital signs. The device is capable of monitoring:

. Pulse rate (via oximetry data):
Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP); .
. Temperature; and
. Blood Oxygen Saturation (SpO2 via finger oximeter)

Indications for Use:

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 4 12-Jun-07

Pulse rate (via oximetry data) ◆
Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP) .
. Temperature
. Blood Oxygen Saturation (SpO2 via finger oximeter)

This device is intended for use by qualified healthcare personnel trained in its use.

Patient Population: Adult, pediatric, neonate

Hospital, acute care settings, outpatient surgery, healthcare practitioner Environment of Use: facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition.

Contraindications: None

Specification	PredicatePM2100 - K022537	New ModelsHBP-T105 T-105S
Power source	Battery (Tin acid) or AC	Battery(Lead-acid) or AC adapter
Power range	AC : 100-120V,220-240V,50/60HzBattery6V 5Ah	AC : 100-115V,220-240V,50/60HzBattery12V 3.2Ah
Display	Monocolor LCD and LED	LED
Operating conditions	0 to 50 ℃, 30 to 85 %RH	0 to 40 °C, 30 to 85 %RH
Storage conditions	-20 to 70 °C, 30 to 85 %RH	-20 to 60 ℃, 10 to 95 %RH
Dimensions (mm)	240 (W) × 250 (D) × 238 (H) mm	239 (W) × 239 (D) × 150 (H) mm
Weight (without batteries)	7.5 lbs	7.7 lbs
BP module	M2600	M3600
Measurement method	Oscillometric method	same as predicate device
Patient target	Adult/Pediatric/Neonatal	same as predicate device
Measurement range	Pressure: 0 to 300 mmHgPulse rate: 40 to 240 beats/min.	Pressure: 0 to 299 mmHgPulse rate: 40 to 240 beats/min.
Pressure sensor	Semiconductor pressure sensor	same as predicate device
Air Control Valve	Electromagnetic solenoid	Omron HEM907 - K001848
Applicable cuff	Regular sized cuff	Omron HEM907 - K001848
Specification	PredicatePM2100 - K022537	New ModelsHBP-T-105 / T-105S
Accuracy of pressure indicator	Within ±3 mmHg or 1 % of reading	same as predicate device
Accuracy of pulse rate	Within ±2 beats/min or ±2% of reading	same as predicate device
Inflation method	DC Rolling diaphragm pump	same as predicate device
Deflation method	Dynamic linear deflation	same as predicate device
Quick measurement function ofBlood Pressure	No algorithm	Omron algorithmHEM-757 - K001670
SpO2 Measurement method	2 wave length pulse wave type	same as predicate device
SpO2 display range	0 to 100 %	same as predicate device
SpO2 module	Nellcor NELL-3(MP-506)	Nellcor NELL-1N-595 - K012891same technology as NELL-1.Masimo MS-11RAD-5 - K033296same technology as MS-11.User can select which one
Accuracy of SpO2	D-25 disposable sensorSpO2:70-100% ±2%other ranges unspecifiedN-25 disposable sensorSpO2:70-95% ±2%other rangesunspecified	Nellcor - Same as predicateOXIMAX Sensors - K052186Add option of - MasimoSpO2:70-100% ±2%LNCS sensors - K041815
Pulse rate display range	20 - 250 beats/min	Nellcor -same as predicate deviceMasimo -25 - 240 beats/min
Accuracy of pulse rate	Within ±3 beats/min	Nellcor - same as predicate deviceMasimo - Within ±3 beats/min
TemperatureMeasurement method	TURBO TEMP electronicpredictive thermometer	same as predicate device
TEMP display range	Predictive mode: 35.6 - 41.1℃ / 96-106°FMonitor mode: 26.7 - 41.1º / 80 - 106ºF	same as predicate device
Accuracy of TEMP	±0.1°C / ±0.2°F	same as predicate device
Scale	Selectable from °C to °F	same as predicate device
Shock protection	Type BF(Defibrillator protected)	same as predicate device

Summary of substantial equivalence

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Non-Confidential Summary of Safety and Effectiveness Page 3 of 4

12-Jun-07

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K071645
Omron p4/4

Non-Confidential Summary of Safety and Effectiveness Page 4 of 4 12-Jun-07

Differences Between Other Legally Marketed Predicate Devices

The Model HBP T-105 Series is viewed as substantially equivalent to the following predicate device - Colin Press-Mate PM-2100 - K022537.

The difference between the Model T-105 and T-105S is that the T-105S model does not have the ability to set the time interval of the BP measurement. The T-105S model BP is done on an as needed / manual activation basis. All other features, specifications, etc. are otherwise identical.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2007

Omron Healthcare, Inc. c/o Mr. Paul Dryden, ProMedic, Inc. 3460 Pointe Creek Court # 102 Bonita Springs, FL 34134-2015

Re: K071645

HBP-105 and T-105S Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: June 12, 2007 Received: June 15, 2007

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Paul Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ashley B. Brown

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Omron

Page 1 of 1

Device Name: HBP T-105 and T-105S

Indications for Use:

. Pulse rate (via oximetry data)
. Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP)
. Temperature
. Blood Oxygen Saturation (SpO2 via finger oximeter)

This device is intended for use by qualified healthcare personnel trained in its use.

Prescription Use XX (Part 21 CFR 801 Subpart D) Or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antilu Bvanu An BDZ

510(k) Number K071645

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).