The STAR 50 unit is a multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned/supplied with the unit. Vital signs parameters include ECG (Lead I / II/ III / V / AVL / AVF AVR), Plethysmograph, Respiration, Invasive Blood Pressure (IBP1 & IBP2) and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (systolic, diastolic and mean) and Temperature, EtCO2 and FiCO2 readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.

Device Description

This STAR 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry, Capnography and Invasive BP.

STAR 50 is a four channel monitor with waveform display capability for ECG (Lead 1 / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2) and Capnography (CO2). It also displays the digital values of HRPR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters except NIBP. For NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. STAR 50 has got a optional Thermal recorder for printing Tabular trends & waveforms.

AI/ML Overview

This looks like a 510(k) premarket notification for a patient monitoring system, which typically compares a new device to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance data for a standalone algorithm. Therefore, many of the requested categories for AI/algorithm-specific studies are not applicable directly from this document.

However, I can extract the relevant information from the provided text regarding the device's characteristics compared to predicate devices, which serves as the "proof" of meeting "acceptance criteria" (i.e., substantial equivalence).

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of precise numerical acceptance criteria and a detailed, quantitative performance report for the STAR 50. Instead, it asserts substantial equivalence by stating that the "no. of channels, range and accuracy of the parameters & method of sensing are similar to the predicate devices."

The "acceptance criteria" here are implicitly that the STAR 50's performance for each vital sign parameter is similar to that of the predicate devices. The "reported device performance" is the claim of this similarity.

Parameter Category	Acceptance Criteria (Implied by Predicate Device Comparison)	Reported Device Performance (Claimed for STAR 50)
General Functionality	Monitor vital signs in adult, pediatric, neonatal patients. Display ECG, Respiration, Temperature, NIBP, Pulse Oximetry, Capnography, Invasive BP.	Monitors: ECG (3/5 lead), Respiration, Temperature (2 channels), NIBP, Pulse Oximetry, Capnography, Invasive BP (2 channels). Displays values for HR/PR, SpO2, RR, NIBP (Systolic, Diastolic, Mean), Temperature, EtCO2, FiCO2.
Number of Channels	Similar to predicate devices (Eagle 3000, Model 8100, STAR K032867)	Similar to predicate devices; STAR 50 is a four-channel monitor.
Range of Parameters	Similar to predicate devices	Similar to predicate devices.
Accuracy of Parameters	Similar to predicate devices	Similar to predicate devices.
Method of Sensing	Similar to predicate devices	Similar to predicate devices.
Alarms	Audible & visual alarms similar to predicate devices	Audible & visual alarms provided; graded and color-coded.
Display	TFT color display like CSI Model 8100.	TFT color display.
Battery	Battery (2 sealed lead acid) like predicate device CSI Model 8100.	Battery (2 sealed lead acid) provided.
Trends	(Not explicitly compared in terms of equivalence, but described)	24 hours tabular and graphical trends for all parameters except NIBP (240 readings tabular trend). Last 16 alarm conditions recall.
Recorder	(Not explicitly compared in terms of equivalence, but described)	Optional Thermal recorder for printing tabular trends & waveforms.

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

Not Applicable (N/A): This document is a 510(k) summary for a hardware patient monitoring system, not an AI/algorithm device with a separate "test set" in the context of an algorithm's performance. The comparison is based on the technical characteristics and intended use aligned with predicate devices.

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

N/A: See point 2. The "ground truth" for this type of device is established through compliance with recognized standards (IEC 60601 series) and comparison to the established performance of legally marketed predicate devices.

4. Adjudication Method for the Test Set

N/A: See point 2.

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

N/A: This is not an AI-assisted diagnostic or interpretation device. It's a vital signs monitor.

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

N/A: Not an algorithm-only device.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by the performance and accepted characteristics of the legally marketed predicate devices (Eagle 3000 patient Monitoring System, Vital signs monitor Model 8100, and Patient Monitoring System - STAR K032867), coupled with compliance to international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27). The manufacturer argues "substantial equivalence" based on these factors.

8. The Sample Size for the Training Set

N/A: Not an AI/ML device that requires a training set.

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

N/A: See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized circle with the letters "L" and "T" inside. Below the logo, the text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters. Underneath the company name, it says "ELECTRICAL BUSINESS GROUP · ELECTRONIC PRODUCTS".

K051608

Mysore Works, KIADB Industrial Area, Hebbal · Hoolagall, Mysore · 570 018 · Tel : (91) - 821 · 2402468

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Ref .

JUN 2 9 2005

25th April. 2004 Page : 01 of 04

510(K) SUMMARY

(Per section 807.92 €)

CONTACT DATA
Submitter's Name	Larsen & Toubro Limited
Address	KIADB Industrial Area, Hebbal Hootagalli,Mysore – 570018, Karnataka, INDIA
Telephone	91-821-2402561	Fax	91-821-2402468
Contact Person	A.B.Deshpande	Title	Head - Quality Assurance
E-Mail address		DeshpandeAB@myw.ltindia.com
Date the summary was prepared		April 25th, 2004

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Image /page/1/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of the letters L and T inside of a circle. Below the logo, the words "LARSEN & TOUBRO LIMITED" are written in all capital letters. The text is bolded and in a sans-serif font.

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -

Mysore Works, KIADB Industrial Area, Hebbal · Hootagalii, Mysore · 570 018 · Tel · (91) · 821 · 2402468

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સિદ્ધા

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DEVICE
Trade name	STAR 50
Common name	Patient Monitoring System
Classification name	Vital Signs Monitor

PREDICATE DEVICE IDENTIFICATION
CFR21 Section	870.2300	Product code (optional)	MWI
Classification panel		Cardiovascular
Device Class		Class II
Legally marketed Comparison Device / K#		Eagle 3000 patient Monitoring System (Marquette Electronic) / K952474 Vital signs monitor Model 8100 (CSI) / K001020 Patient Monitoring System - STAR, (Larsen & Toubro Limited), K# K032867

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Image /page/2/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "L" and "T" enclosed in a circle. Below the logo, the words "LARSEN & TOUBRO LIMITED" are printed in bold, uppercase letters.

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS

Mysore Works, KIADB Industrial Area, Hebbal · Hosore · 570 018 · Tel · (91) - 821 · 2402551 · Fax : (91) - 821 · 2402468

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DEVICE DESCRIPTION

This STAR 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry, Capnography and Invasive BP.

INTENDED USE OF THE DEVICE

The STAR 50 multiparameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned ! supplied with the unit. Vital signs parameters include ECG (Lead I / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2) and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings.

The user. responsible to interpret the monitored data made available, will be a professional health care provider. The device , which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.

Website - www.mtcog.com

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Image /page/3/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "L" and "T" enclosed in a circle. Below the logo, the text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.

-- ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS --

Hootagalli, Mysore · 570 018 · Tel · (91) · 821 · 2402561 · Fax : (91) · 821 · 2402468 Mysore Works, KIADB Industnal Area, Hebbal

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25" April, 2004 Page : 04 of 04

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Device : Larsen & Toubro limited make STAR 50 Patient Monitoring System.

Predicate device :

Eagle 3000 patient Monitoring System (Marquette Electronic), K+ K952474 Vital signs monitor Model 8100 (CSI), K# K001020 Patient Monitoring System - STAR, (Larsen & Toubro Limited), K.# K032867

The parameters available with these predicate devices are available with the Larsen & Toubro Limited make STAR 50 patient monitoring system (ECG-3/5 lead, Respiration, Temperature - 2 channels, NIBP, Pulse oximetry, Capnography and Invasive BP- 2 channels). The no. of channels, range and accuracy of the parameters & method of sensing are similar to the predicate devices. In STAR 50 monitor audible & visual alamis are provided similar to those in the Predicate devices.

STAR 50 has got TFT color display like CSI Model 8100. Weight is also comparable with that of Marquette Eagle 3000. Battery (2 scaled lead acid) is provided in STAR 50 monitor like that of the predicate device CSI Model 8100.

Comparison of all the parameters of STAR 50 to that of the predicate devices is given in the "Substantial Equivalence Equipment comparison" document.

Compliance to standards :

The following international standards are referred. IEC 60601-1 Medical Electrical safety IEC 60601-1-2 EMC compliance IEC 60601-2-27 ECG safety

Conclusion :

Based on the Technological characteristics of STAR50 and its comparison with those of a predicate device CSI Model 8100 and Marquettee Eagle 3000 monitors, Larsen & Toubro Limited believes that their device is substantially equivalent to these Monitors and doesn't pose any additional risk on safety & effectiveness of the device.

(N Ravindran)
Head - Design & Development

Regd. Off : L & T House, Ballard Estate P. O. Box 278. Mumbar 400 001 · Phone : 261 6181 : 82 · 262 0223 Website : www.inteba.com

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2005

Larsen & Toubro Ltd. c/o Mr. Ned Devine Intertek Testing Services NA, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K051608

Trade Name: STAR 50 Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor without Arrhythmia Detection and Alarms Regulatory Class: Class II (two) Product Code: MWI Dated: June 16, 2005 Received: June 17, 2005

Dear Mr. Devine:

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 for associo in 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 I ou may a 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 may or dayse to daen and 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. Ned Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I DT b issum that your device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally i coclar suttates and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 807), adoling (21 OF RT & 007), govern 820); and if applicable, the electronic form in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation comic of provision (crice as described in your Section 510(k) I mis letter will unow you to ough finding of substantial equivalence of your device to a legally premaired 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 If you desire specific acres at (240) 276-0295 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 may be obtained from the Other general mionination sturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bluminauer for

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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Indications for Use

510(k) Number (if known): K05 1608

Device Name: STAR 50

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumena

Division Slan-Off Division of Cardiovascular Devices 510(k) Number

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).