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The Press-Mate PM-2100 patient 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 capable of monitoring:

Pulse rate (via oximetry data) Non-invasive pressure (systolic, diastolic and mean oscillometric NIBP) Temperature Blood oxygen saturation (Sp02 via finger oximeter)

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

The Press-Mate PM-2100 Series Monitor is a fully portable multiparameter monitoring device which provides the capability for nonitoring of adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings. It is a prescription device intended for use only by health care professionals. The oscillometric method, upper arm measurement is employed. The PM-2100 includes, temperature via ALARIS® electronic predictive thermometry and Nellcor® oxygen saturation (Pulse Oximetry) utilizing the finger for the placement of the sensor. The monitor uses a single tube reusable cuff or may be optionally used with a disposable single tube cuff.

The PM-2100 has an optional replaceable and rechargeable battery as well as an optional thermal printer to print displayed data, waveforms and trend information. A liquid crystal display (LCD) and (LED) provides high visibility and clarity in most light conditions. The available parameters displayed will depend on the mode selected by the user.

Visual and audible alarms are provided to alert the user to monitor operational conditions or should patient values exceed default or operator-set high/low limits.

Model 2100: Non - Invasive Blood Pressure and Pulse Rate

Model 2110: Non - Invasive Blood Pressure and Pulse Rate; and Nellcor® Pulse Oximetry and Pulse Rate

Model 2120: Non – Invasive Blood Pressure and Pulse Rate; and Monitor/Predictive Oral/Rectal Temperature

Model 2140: Non - Invasive Blood Pressure and Pulse Rate; and Monitor/Predictive Oral/Rectal Temperature and Nellcor® Pulse Oximetry and Pulse Rate

This portable device includes an optional integrated printer and is capable of operation from an external AC power source or an internal rechargeable battery. The device uses the same technology and materials as the predicate devices, the Press - Mate 8800 (K890876 cleared 6/22/89) and the Press - Mate Advantage (K 973637 cleared 9/25/98)

The following accessories are available for use with the device:

• 1. Power cord
• 2. Printer Paper
• 3. Operations Manual
• 4. Disposable cuffs
• 5. Reusable cuffs
• 6. Cuff extension hose
• 7. Temperature probe
• 8. Finger Probe
• 9. Extension Cable

Here's a breakdown of the acceptance criteria and study information for the Press-Mate PM-2100 Vital Signs Monitor, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

A new accuracy study was performed on the PM-2100 according to AAMI SP-10 for 85 adult and pediatric subjects, and the device passed. |
| Stability (Voltage Range, Life) | ANSI/AAMI SP10-1992 (4.2.4.1, 4.2.4.2) | Passed all tests. |
| Safety (Max Cuff Pressure, Deflation, Electrical, Conductive Components) | ANSI/AAMI SP10-1992 (4.3.1.1, 4.3.2, 4.3.2, 4.3.3) | Passed all tests. |
| Performance (Pressure Indicator Accuracy, Battery-Powered Devices) | ANSI/AAMI SP10-1992 (4.4.1, 4.4.3) | Passed all tests. |
| Environmental Performance | FDA Draft Reviewer Guidance (Nov 1993) | Met the requirements. |

Note: The provided document focuses heavily on the NIBP function's validation and substantial equivalence claims based on predicate devices. While other parameters like Pulse rate, Temperature, and SpO2 are listed as capabilities, detailed acceptance criteria and specific performance data for each in a standalone study for the PM-2100 are not explicitly provided in this summary. The inference is that these parameters are also substantially equivalent to the predicate devices due to shared technology (e.g., Nellcor® oximetry, ALARIS® thermometry).

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • NIBP Algorithm Accuracy: A new accuracy study was performed on the PM-2100 with 85 adult and pediatric subjects.
  • For the predicate devices (Press-Mate 8800 and Press-Mate Advantage), clinical studies for NIBP accuracy were established for adult, pediatric, and neonatal populations, but specific sample sizes for these prior studies are not detailed in this summary.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data for the PM-2100 or its predicate devices. It also doesn't specify if the data was retrospective or prospective, though "clinical study for accuracy" typically implies prospective data collection.

3. Number and Qualifications of Experts for Ground Truth

• The document does not specify the number of experts used to establish ground truth or their qualifications. For NIBP studies conforming to ANSI/AAMI SP10, ground truth is typically established by trained observers taking auscultatory measurements simultaneously with the device measurements. The qualifications of these observers (e.g., specific medical training, experience) are crucial but not detailed here.

4. Adjudication Method

• The document does not specify an adjudication method. For NIBP studies following ANSI/AAMI SP10, a comparison is made between the device readings and simultaneous auscultatory readings from human observers. Discrepancies might be handled through established protocols within the standard, but specific adjudication (e.g., 2+1, 3+1) is not mentioned.

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

• No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI devices where human readers interpret and compare with and without AI assistance. This device is a vital signs monitor, which typically involves direct measurement and comparison to reference methods rather than diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done for the NIBP algorithm. The "new accuracy study... according to AAMI SP-10 in which 85 adult and pediatric subjects were tested" assesses the device's (algorithm's) performance against a reference standard. The fact that "the NIBP parameter of the new monitor has the same NIBP algorithm... as the Press - Mate 8800... and the Press - Mate Advantage" further supports that the algorithm's performance was evaluated independently during the predicate device's clearance and subsequently confirmed for the new device.

7. Type of Ground Truth Used

• For NIBP, the ground truth used for the clinical accuracy studies (both for the current device and predicate devices as per ANSI/AAMI SP10) is auscultatory measurement performed by human observers. This is considered the reference standard for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

• The document does not provide information about a training set since it explicitly states that the NIBP algorithm is the same as in the predicate devices. Therefore, the algorithm itself was developed and "trained" (if machine learning was involved, which is unlikely for early 2000s oscillometric NIBP algorithms) and validated significantly during the development and clearance of the Press-Mate 8800 and Press-Mate Advantage. The PM-2100's study served as a confirmatory accuracy study for its implementation of this existing algorithm.

9. How Ground Truth for Training Set Was Established

• As a training set is not mentioned in the context of the PM-2100 (which reuses an existing algorithm), information on how ground truth was established for algorithm development is not provided in this summary. For the original algorithm development, it would have been established through a similar process of comparing oscillometric readings to auscultatory reference measurements across a diverse patient population.

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