(92 days)
The TM-Oxi device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult patients. The TM-Oxi software uploads the data of the device and displays the data into a computer for enhanced data management. The TM-Oxi software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results. TheTM-Oxi device is intended for spot-checking of patients. The TM-Oxi system does not report any diagnosis but provides values. It is the physician's responsibility to make proper judgments based on these numbers. Prescription Use: Federal law restricts this device to sale by or on the order of a physician.
The TM-Oxi is a programmable electro medical system using one oximeter and one noninvasive blood pressure device (NIBP). The system comprises: a. Hardware: Non- invasive blood pressure, pump and valve boards and connections, tube, bladder and cuff 510k cleared (K093013) not modified. USB HUB DC converter with 3 features. Power supply of NIBP board via USB hub connected to USB port of the PC and microchip converter 5V to 6 V. microchip converter 510k cleared (K090671) not modified via USB hub > connected to USB port of the PC. connected to USB port of the connected to USB port of the PC. > b. Software: The used software are ESO software 510k K102442 for data analysis and ES Complex software 510k number k 113264 for data management. software 310k humber K 115204 for addinations of the data from oximeter (ESO) and blood pressure device (Contec 08A K110774). pressure device (Contect 687 ATT 10777). Therefore the TM-Oxi system will be a combination of the 2 separate devices.
The provided text describes the TM-Oxi device, its intended use, and its equivalence to legally marketed predicate devices, but it does not contain a detailed study report that specifically outlines acceptance criteria and subsequently proves the device meets them with specific performance metrics from a study.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices by comparing their technical specifications and by stating that the TM-Oxi uses cleared components and software from previously cleared devices.
Here's an analysis of the information provided, addressing your points where possible, and highlighting what is not available in the text:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table (page 4) between the TM-Oxi hardware and a predicate device (MD2000B Vital sign monitor K100740), which lists technical specifications. These can be inferred as performance criteria that the TM-Oxi is designed to meet or be equivalent to.
| Acceptance Criteria (from Predicate Device/OEM Specifications) | Reported Device Performance (TM-Oxi Hardware) |
|---|---|
| Intended Use | The TM-Oxi device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult patients in medical facilities. The TM-Oxi device is intended for spot-checking of patients. |
| SpO2 % | YES |
| Oximeter Wave form and Pulse rate | YES |
| Systolic pressure | YES |
| Diastolic pressure | YES |
| Output Current | 100 mA |
| Output Power | 25VA |
| Voltage | 5V DC |
| Oximeter Technical Specifications | |
| SpO2% Measuring range | 0 to 100% |
| SpO2% Accuracy | 70%~100%: ±2%, Below 70% unspecified |
| Pulse rate measuring range | 30 to 250bpm |
| Pulse rate accuracy | ± 2 bpm during the pulse rate range of 30 |
| Wavelength Red | 660 nm |
| Wavelength IR | 880 nm |
| Radiant Power Red | 1.8 mW |
| Radiant Power IR | 2 mW |
| BP Technical Specifications | |
| Measuring principle | Oscillometric |
| Measurement mode | Controlled by software |
| Measuring range Systolic | 30-255 mmHg |
| Measuring range Diastolic | 15-220 mmHg |
| Other specifications | |
| Target population | Adult |
| Application site | Finger |
| Display | LCD (oximeter) and PC screen |
| Power supply | USB |
| Safety Class | BF |
| Data transmission | USB |
| Testing bench | 60601-1-1, 60601-1-2 |
Note regarding "Reported Device Performance": The document states that "The TM-Oxi hardware has same intended use and same performances and effectiveness" as the predicate. It then uses the technical specifications of the predicate and OEM components as a proxy for the TM-Oxi's performance. The detailed study proving these specific metrics for the TM-Oxi as a system is not presented in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily relies on the fact that existing 510(k) cleared components were used. It refers to ISO 9919 reports from the OEM oximeter and ANSI/AAMI SP10:2002/A1:2003/A2: 2006 reports from the OEM blood pressure device. These reports would contain the sample size and data provenance for the original component clearance, but these details are not included in this K130056 summary.
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)
This information is not provided. The document states that the TM-Oxi system "does not report any diagnosis but provides values. It is the physician's responsibility to make proper judgments based on these numbers." The clinical assessment and ground truth establishment would likely have been part of the original OEM component clearances, but no details are given for the TM-Oxi system specifically.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The TM-Oxi is a physiological patient monitor providing objective measurements (SpO2, PR, NIBP) and data management, and not an AI-assisted diagnostic tool that would typically involve human readers interpreting results for improved diagnostic effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "Integration tests for oximeter and blood pressure device" and "Software structural testing using CRC (Cyclic redundancy check) Coding was performing to accurately capture, store, and analyze the data measured by the hardware." (Page 5).
It also states: "The TM-Oxi software uploads the data of the device and displays in clinical settings as an enhanced data management. The TM-Oxi software is intended for use in clinical settings as an aid for health care professionals to review, and evaluate the historical tests results." (Page 2).
This suggests the software performs data processing and display independently. However, a formal "standalone performance study" with specific metrics (e.g., accuracy against a gold standard) for the integrated system's measurements is not detailed. The reliance is heavily on the pre-cleared status of the hardware components which have their own performance data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided for the TM-Oxi system specifically. For the original oximeter and NIBP components, the ground truth would typically be established against highly accurate reference devices (e.g., co-oximetry for SpO2, invasive blood pressure for NIBP) during their respective ISO 9919 and ANSI/AAMI SP10 validations.
8. The sample size for the training set
This information is not provided. The software "ESO software 510k K102442 for data analysis and ES Complex software 510k number k 113264 for data management" are pre-cleared components. Details on their training data (if any machine learning was involved, which is unlikely for basic data analysis/management software) are not included.
9. How the ground truth for the training set was established
This information is not provided.
Summary of the "Study" (or rather, justfication for substantial equivalence):
The document argues for substantial equivalence by stating that the TM-Oxi device is a combination of previously 510(k) cleared hardware components and software.
- Hardware: It utilizes an oximeter and a non-invasive blood pressure device (NIBP) where the PCB boards, pump, valve, tube, bladder, cuff, and oximeter are from OEM subcontractors and were "cleared for use together" or are themselves 510(k) cleared devices (e.g., MD 200A K093013, CMS50E K090671).
- Software: It uses pre-cleared software components: ESO Software (K102442) for data analysis and ES Complex Software (K113264) for data management, which are described as using the "same source codes" as the TM-Oxi software for data of the oximeter and blood pressure device.
- Testing:
- Integration tests for the oximeter and blood pressure device were performed.
- Software structural testing (CRC) was done to ensure accurate data capture, storage, and analysis.
- Laboratory testing for electrical safety (IEC 60601-1-1) and EMC (IEC 60601-1-2) was conducted for the components.
- Software verification (SRS/SDS/STD/STR) was performed.
- A Clinical Test was deemed NOT required: The document explicitly states: "Since the TM-Oxi is using 510K cleared devices clinically tested (ISO 9919 and SP10) and with regard of the testing describe above, the TM-Oxi do not required additional clinical test." This means that the clinical performance data for the individual components (oximeter and NIBP) from their original clearance processes (which included adherence to ISO 9919 and ANSI/AAMI SP10 standards) were sufficient, and no new clinical study was performed for the integrated TM-Oxi system to prove its performance against the listed acceptance criteria.
§ 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).