To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement.

The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.

The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes).

The device is intended use in licensed practitioner's office

This device is no intended to be used at home, in hospital or out-of-hospital transport

The device is not intended use in support life and not for continuously monitoring

The system will be use by practitioner.

Device Description

The LD-Oxi System is a programmable electro medical system (PEMS) including:

2 USB plug and play Pulse oximeter device including an electronic circuit and reusable Adult SpO2 probe

2 Software installed on a computer

Description of the features

Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude (photoplethysmography).
Mathematical analysis of the pulse waveform (photoelectrical Plethysmography feature).
Mathematical analysis of the Heart Rate Variability (HRV feature).

AI/ML Overview

The provided document does not contain full details of a specific study proving the device meets acceptance criteria, specifically not in the format of a typical clinical validation study with detailed performance metrics, sample sizes, and expert ground truth establishment.

However, based on the information provided in the 510(k) Summary for the LD-Oxi System (K160956), here's what can be inferred and pieced together regarding acceptance criteria and performance, as well as the types of studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on establishing substantial equivalence to a predicate device (Electro Sensor Oxi K102442) rather than defining explicit acceptance criteria with numerical targets. For performance, it largely relies on the general equivalence to the predicate and standard compliance. The specifications table (page 4) compares the LD-Oxi with the predicate (ESO) for various parameters.

Acceptance Criteria (Implied / Predicate's Performance)	Reported Device Performance (LD-Oxi System)
Intended Use	Same as predicate (spot check/monitor SpO2% & pulse rate, analyze PP and HRV, not for diagnosis)
Material in contact with patient	Reusable SpO2 probe PTU latex free
Scientific Background	Based on red and infrared light absorption characteristics of oxygenated and deoxygenated hemoglobins
Placement of the probe	Index finger
Power Supply	5V (power supply by USB port)
Classification	Class II
Degree of protection against electric shocks	BF
Operating mode	Continuous use
IR Light Wavelength	905 ±10 nm (Predicate)
IR Light Radiant Flux	2.0mW (Predicate)
IR Light Spectral Bandwidth	50nm
IR Light Forward Voltage	1.7V
IR Light Reverse Voltage	5V
RED Light Wavelength	660nm ±2nm
RED Light Radiant Flux	1.8mW (Predicate)
RED Light Spectral Bandwidth	25nm
RED Light Forward Voltage	2.4V
RED Light Reverse Voltage	5V
Pulse Wave Resolution	1%
Pulse Wave Signal Strength	0-15
Pulse Wave Bargraph	0-15
Plethysmogram	0 - 100, auto-gained for highest resolution
Pulse Rate Measuring Range (No Alarm)	30~235 bpm
Pulse Rate Resolution	1bpm
Serial Communication Logic Levels	3.3V CMOS voltage levels
Voltage	+3.3 ± 0.17 V DC
Average Current	15mA
Module Oximeter Circuit Board	OEM from Beijing Choice Electronic Technology Co. Ltd. (MD300I K072825) (Predicate)
Circuit Board Size	128 (L) x 143 (W) x 33 (H) mm (Predicate)
Circuit Board Weight	1.2 Kg (Predicate)
Data Transmission Speed	4800 Bauds (Predicate)
Probe Connection	LEMO (Predicate)
Mathematical analysis of heart rate	At rest (Predicate)
Standards Met	60601-1 2nd Ed, 60601-1-2 2nd Ed, ISO 9919 (Predicate)

2. Sample Size for Test Set and Data Provenance

The document does not explicitly mention "test sets" or provide details on sample sizes for clinical performance evaluation. The "Performances and Effectiveness" section (page 7) lists general tests, but no specific human subject data or sample sizes for these tests are provided.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "Peer reviews for the photoelectrical plethysmography mathematical analysis" and "Peer review reference for the heart rate variability mathematical analysis." However, it does not specify the number or qualifications of these experts.

4. Adjudication Method

No adjudication method is mentioned for any "test set" or peer review process.

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

No MRMC study comparing human readers with and without AI assistance is mentioned. The device's primary function is as a monitor and analyzer, not as an AI-assisted diagnostic tool for human readers. The mathematical analyses (PP and HRV) are explicitly stated "ARE NOT intended use for diagnosis."

6. Standalone Performance Study

The document refers to the following for performance and effectiveness:

Calibration tests (simulator oximeter): This implies standalone testing of the oximeter's core functionality against known standards.
Software verification (SRS/SDS/STD/STR/ Software algorithms tests with input data from the MIT-BIH database): This indicates standalone testing of the software algorithms (including PP and HRV analysis) using a recognized physiological database. This could be considered a form of standalone performance evaluation for the algorithmic components.
Peer reviews: As mentioned above, these are qualitative assessments of the mathematical analysis.

7. Type of Ground Truth Used

For the core oximeter function (SpO2% and pulse rate), the ground truth for calibration would likely come from simulator oximeter standards.
For the software algorithms (PP and HRV), the mention of the MIT-BIH database suggests that the ground truth for these analyses would be derived from the expert-annotated physiological data contained within that database. (The MIT-BIH Arrhythmia Database, for example, is known for its expert annotations of ECG signals, which can be related to HR and HRV).

8. Sample Size for Training Set

The document does not specify a separate "training set" or its sample size. The description of the device and its validation focuses on direct measurement, software verification against existing databases, and established principles of oximetry and physiological analysis, rather than a machine learning model that requires a distinct training phase.

9. How Ground Truth for Training Set was Established

Since a "training set" as commonly understood in machine learning is not explicitly detailed, the method for establishing its ground truth is also not described. If the device uses algorithms developed using physiological databases like MIT-BIH, then the ground truth for those underlying algorithms would have been established by the experts who curated and annotated those databases.

In summary:

The LD-Oxi System's acceptance criteria and proven performance rely heavily on demonstrating substantial equivalence to a predicate device (ESO) and compliance with relevant medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-61). Performance claims are supported by calibration tests using simulators and software verification using data from established databases like MIT-BIH, implying a form of standalone algorithmic testing. Detailed clinical trial data with specific sample sizes, expert qualifications, or adjudication methods for new data collection are not provided in this 510(k) summary, as the nature of the modifications and the intended use (monitoring and analysis, not diagnosis from AI) did not necessitate such extensive studies for this particular submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2016

LD Technology LLC Albert Maarek Quality Manager 100 N. Biscayne Blvd. Suite 500 Miami. Florida 33132

Re: K160956

Trade/Device Name: LD-Oxi System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA Dated: June 3, 2016 Received: June 6, 2016

Dear Albert Maarek:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mude Jellman
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 K160956

Device Name

LD-Oxi- system

Indications for Use (Describe)

LD-Oxi system is intended for use:

To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.

To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement.

the bad quality signal transmission.

The device is intended use in licensed practitioner's office

This device is no intended to be used at home, in hospital or out-of-hospital transport

The device is not intended use in support life and not for continuously monitoring

The system will be use by practitioner.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for LD Technology. The logo consists of a green plant-like design inside of a circle on the left, and the text "LD Technology" on the right. The text is in a light gray color and is slightly italicized.

L.D Technology LLC.

Special 510(k) Premarket Notification Number: Preparation date: March 2, 2016

510(k) Summary LD-Oxi System

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92

Submitter's Identification: Manufacturer: L.D TECHNOLOGY Owner of LD Technology: MAAREK Albert Address: L.D Technology 100 N.Biscayne Blvd, Suite 502 Miami, FL, 33132, USA Tel: 305-379-9900 Email: albert.ldteck@gmail.com
Device Name / Classification LD-Oxi System components: 21 CFR 870.2300 21 CFR 870.2700 Product Codes: MWI and DQA. Classification: Class II Classification Panel: Cardiovascular /Anesthesiology

3. Predicate legally marketed device

Electro Sensor Oxi (ESO) K102442 Applicant: LD Technology LLC Product codes: MWI and DQA

4. Device Description

The LD-Oxi System is a programmable electro medical system (PEMS) including:

2 USB plug and play Pulse oximeter device including an electronic circuit and reusable Adult SpO2 probe

2 Software installed on a computer

Description of the features

网 Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude

(photoplethysmography).
ನ Mathematical analysis of the pulse waveform (photoelectrical Plethysmography feature).
Mathematical analysis of the Heart Rate Variability (HRV feature).

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Software specifications

The system carries out the following operations:

Image /page/4/Figure/2 description: The image is a block diagram showing the flow of information in a system. The system starts with "HARDWARE" at the bottom, followed by "PROTOCOL COMMUNICATION". The "PROTOCOL COMMUNICATION" block feeds into "SpO2 %" and "Pulse wave", which then feed into "Photoelectrical plethysmography analysis". The "Photoelectrical plethysmography analysis" block feeds into "Heart rate", which then feeds into "Heart rate variability analysis". All of these blocks feed into "BACK UP" at the top.

5. Intended use and indications for use

LD-Oxi system is intended for use:

To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.

To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement.

To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis.

The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.

The device is intended for use in licensed practitioner's office

This device is not intended to be used at home, in hospital or out-of-hospital transport

The device is not intended use in support life and not for continuously monitoring

The system will be used by practitioner.

6. Device specifications and comparison with predicate device

Specifications	ESO	LD-Oxi
SIMILARITIES
Intended use	To spot check or monitor Oxygen saturation ofarterial hemoglobin (SpO2%) and pulse rate.To analyze the pulse waveform (PhotoelectricalPlethysmography or PP) provided by theoximeter. It only provides mathematicalanalyses of the input of the SpO2 measurement.To analyze the basic rhythms of the NN or RRintervals in heart rate, both in the time domainand in the frequency domain (short time 5	To spot check or monitor Oxygen saturation ofarterial hemoglobin (SpO2%) and pulse rate.To analyze the pulse waveform (PhotoelectricalPlethysmography or PP) provided by theoximeter. It only provides mathematicalanalyses of the input of the SpO2 measurement.To analyze the basic rhythms of the NN or RRintervals in heart rate, both in the time domainand in the frequency domain (short time 5
	minutes). It only provides mathematical analysis	minutes). It only provides mathematical analysis
	of the input of the heart rate variability.	of the input of the heart rate variability.
	The mathematical analysis of Photoelectrical	The mathematical analysis of Photoelectrical
	Plethysmography and HRV ARE NOT intended	Plethysmography and HRV ARE NOT intended
	use for diagnosis.	use for diagnosis.
	The software provides a visual alarm for the	The software provides a visual alarm for the
	values of the heart rate and/or SpO2 percent out	values of the heart rate and/or SpO2 percent out
	of the normal range and for the bad quality	of the normal range and for the bad quality
	signal transmission. The data are stored in PC in	signal transmission. The data are stored in PC in
	the Backup system of the ESO software.	the Backup system of the ESO software.
Prescription for use	The device is intended use only for adult	The device is intended use only for adult
	subjects (> 20 years old) This Oximeter is	subjects (> 20 years old) This Oximeter is
	intended to be used in spot-checking ( 5	intended to be used in spot-checking ( 5
	minutes) The device is intended use in licensed	minutes) The device is intended use in licensed
	practitioner's office	practitioner's office
	This device is no intended to be used at home, in	This device is no intended to be used at home,
	hospital or out-of-hospital transport	in hospital or out-of-hospital transport
	The device is not intended use in support life	The device is not intended use in support life
	and not for continuously monitoring	and not for continuously monitoring
	The system will be used by practitioner.	The system will be used by practitioner.
Material in contact withthe patient	Reusable SPo2 probe PTU latex free	Reusable SPo2 probe PTU latex free
Scientific Background	Based on the red and infrared light absorption	Based on the red and infrared light absorption
	characteristics of oxygenated and deoxygenated	characteristics of oxygenated and deoxygenated
	hemoglobins.	hemoglobins.
Placement of the prove	Index finger	Index finger
Powersupply	5V (power supply by USB port)	5V (power supply by USB port)
Classification	Class II	Class II
Degree of protectionagainst electric shocks	BF	BF
Operating mode	Continuous use	Continuous use
IR light features
Wavelength:	905 +10 nm	880nm +10 nm
Radiant Flux:	2.0mW	6.75mW
Spectral Bandwidth:	50nm	50nm
Forward Voltage:	1.7V	1.7V
Reverse Voltage:	5V	5V
RED light features
Wavelength:	660nm+2nm	660nm +2nm
Radiant Flux:	1.8mW	6.65mW
Spectral Bandwidth:	25nm	25nm
Forward Voltage:	2.4V	2.4V
Reverse Voltage:	5V	5V
Pulse wave
Resolution	1%	1%
Signal Strength	0-15	0-15
Bargraph	0-15	0-15
Plethysmogram	0 - 100, auto-gained for highest resolution	0 - 100, auto-gained for highest resolution
Pulse rate
Measuring NO AlarmRange	30~235 bpm	30~235 bpm
Resolution	1bpm	1bpm
Serial CommunicationLogic Levels	3.3V CMOS voltage levels	3.3V CMOS voltage levels
Voltage	$+3.3 \pm 0.17$ V DC	$+3.3 \pm 0.17$ V DC
Average Current	15mA	15mA
DEVICE MODIFICATIONS
Standard met	60601-1 2nd Ed60601-1-2 2nd EdISO 9919	60601-1 3th Ed60601-1-2 3th EdISO 80601-2-61
Module oximeterCircuit board	OEM from Beijing Choice Electronic TechnologyCo. Ltd.( MD300I K072825)	OEM from Contec medical Ltd (CMS50 EK090671)
Circuit board size	128 (L) x 143 (W) x 33 (H) mm	57(L) × 32(W) × 30 (H) mm
Circuit board weight	1.2 Kg	50 g
Data transmissionSpeed	4800 Bauds	19200 Bauds
Probe connection	LEMO	NELLCOR
Mathematical analysisof the heart rate	At rest	At rest and during Ewing tests

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7. Contra-indications

Σ Patients undergoing external defibrillation

A Patients connected to electronic life support devices, or any implanted electronic device.
2 Do not use this device in the presence of magnetic resonance imaging (MR or MRI) equipment. MRI equipment may cause induced current to the SpO2 sensor resulting in patient injury.
This device should not be used on pregnant women. The effects on the fetus, as well as accuracy of readings are unknown.
2 When using the finger probe, utilize the arm not in use for blood pressures, arterial lines, or having an AV fistula or pressure dressing.
2 Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein
Sigmificant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methhemoglobin, will affect the accuracy of the SpO2 measurement.
2 Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings
2 Operation of this device may be adversely affected in the presence of strong electromagnetic sources, such as electro surgery equipment.
2 Operation of this device may be adversely affected in the presence of computed tomography (CT) equipment.
2 Do not use this device in the presence of flammable anaesthetics; a spark hazard exists which may result in explosion.
Fingernail polish or false fingernails: Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

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8. Undesirable side effects:

Side effects or adverse reactions are none known to date.

9. Substantial equivalence

Predicate legally marketed device

Electro Sensor Oxi K102442 Applicant: LD Technology LLC. Product code MWI

Similarities:

V Same intended use
V Same technological characteristics as the predicate device
√ Same safety and effectiveness

New characteristic:

Size and weight of the circuit board
Data transmission speed (Baud)
Probe connection
Additional mathematical analysis of the heart rate variability during tests.
Updated standards

10. Performances and Effectiveness

1. Calibration tests (simulator oximeter)
  2., Software verification (SRS/SDS/STD/STR/ Software algorithms tests with input data from the MIT-BIH database)
1. Peer reviews for the photoelectrical plethysmography mathematical analysis.
1. Peer review reference for the heart rate variability mathematical analysis.

The new characteristics:

Size and weight of the circuit board
Data transmission speed (Baud)
Probe connection
Addition mathematical analysis of the heart rate variability during tests.
V Updated standards

Do not affect the performances and effectiveness of the modified device

11. General Safety Concerns

I.e.-LD-Oxi Risk management

The new characteristics:

√ Size and weight of the circuit board
Data transmission speed (Baud)
V Probe connection
Addition mathematical analysis of the heart rate variability during tests.
V Updated standards

Do not affect the general safety of the modified device as shown by the laboratory testing using the updated standards

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12. Standards

V IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Third Edition December 2006
IEC60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. Third Edition 05/17/2007
V IEC 80601-2-61: Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of oximeters. 04/11/2011
V Guidance for: Industry; FDA staff; and Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005
√ ISO 14971: Medical devices Application of risk management to medical devices. March 01 2007

Conclusions

LD-Oxi is equivalent in performances, technology, safety and efficacy to the legally marketed predicate device.

Signature:

Albert MAAREK

Premarket notification [510K] Number: K160956

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).