Search Results

The TREND 200 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.

The TREND 200 device provides continuous positive airway pressure.

The TRENDset PC Software is a program for reading the TREND CPAP device patient compliance data.

The Hoffrichter TREND 200 device provides mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH2O.

The TREND 200 CPAP device is modification of the TREND 110 CPAP device which adds the following features:

• Real time clock with wake-alarm support. .
• Audible tone generator with audible alert functions. .
• EEPROM capacity increased to store times of device use (patient compliance . data).
• Serial port which can transmit the stored times of device use. .
• TRENDset PC software which may be used by the clinician to communicate . TRENDSETT O sollware which may be and print the patient compliance data (times of use).
• DC power inlet for alternate power source option. .

The TREND 200 CPAP device is provided in a compact lightweight THE TREND 200 OF .. See and utilizes the same form factor and enclosure for Casy bodolae acce, and 16 character LCD display with keys accessones as the 7 (END 170 the user with displayed information about on the operator panel provides the access to menus for soft-start ramp, clinical the treathern (set by doctor, PIN code protected), day/date/wake-alarm, prescription (SCL by doctor) nower supply automatically supply adapts to regional mains voltage (115 to 230 VAC).

Standard accessories include treatment tubing with integrated Standard - aoceoonoo - including - including available masks and swivels are specified.

As in the TREND 110, TREND 200 treatment pressure is measured as As in the 7AEND 110, 178, 1782AB by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of megrated into the therapy tabing.
pressure and accounts for losses due to the therapy delivery circuit.

Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.

Here's an analysis of the provided 510(k) summary, specifically addressing the device's acceptance criteria and the study proving it meets them.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It usually doesn't include detailed clinical study results with specific acceptance criteria, sample sizes, or ground truth methodologies in the same way a PMA (Pre-Market Approval) application or a clinical trial report would. Instead, 510(k)s often rely on bench testing, comparison to predicate performance, and adherence to recognized standards.

Therefore, many of the requested fields below will indicate "Not explicitly stated" or "Not applicable" based on the nature of a 510(k) summary for a CPAP device modification.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) submission summary for a device modification. For such submissions, the primary "study" is often a comparison to a predicate device alongside bench testing and adherence to recognized standards, rather than a large-scale clinical trial with formal acceptance criteria in the sense of accuracy, sensitivity, or specificity.

• Nature of the Study: The "study" described in the 510(k) summary is a demonstration of substantial equivalence to the predicate device, the HOFFRICHTER TREND 110 CPAP Device (K041035). This involves:
  • Description of Modifications: Detailing the added features (real-time clock, audible tone, increased EEPROM, serial port, TRENDset PC software, DC power inlet).
  • Functional Comparison: Showing that the core therapeutic function (CPAP delivery at 4-18 cmH2O, pressure measurement via integrated tubing) remains identical to the predicate.
  • Intended Use and Indications: Demonstrating that the intended use and indications for use are the same as the predicate (treatment of obstructive sleep apnea in adults >30kg, not for ventilator-dependent patients).
  • Performance Data: While not explicitly detailed as a formal 'study' in this summary, the implicit data includes:
    • Bench Testing: To verify the functionality of the new features and ensure the existing core functions (like pressure delivery) are not adversely affected and meet the 4-18 cmH2O range.
    • Software Validation: For the TRENDset PC Software to ensure it correctly reads, communicates, and prints compliance data. (No details provided on this specific validation).
    • Electrical Safety and EMC Testing: (Not detailed in the summary but required for a medical device).
    • Biocompatibility Assessment: (Not detailed in the summary but required for patient-contacting parts).

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

• Test Set Sample Size: Not explicitly stated. For device modifications and 510(k)s, this typically refers to the number of devices tested on the bench for functionality and safety, rather than a patient cohort.
• Data Provenance: Not explicitly stated. Likely internal company testing (Hoffrichter GmbH) in Germany. Retrospective/Prospective is not applicable as it's not a clinical study on patient outcomes.

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

• Number of Experts: Not applicable. For this type of device modification, "ground truth" typically refers to engineering specifications, national/international standards, and the performance characteristics of the predicate device.
• Qualifications of Experts: Not applicable in the context of clinical ground truth. For technical evaluations, internal Hoffrichter engineers and potentially third-party testing labs would be involved.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since this is not a clinical study with subjective assessments (like image interpretation), there's no need for an adjudication method for a test set in that sense. Acceptance is based on meeting technical specifications and demonstrating equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for AI-powered diagnostic devices where human reader performance is being evaluated with and without AI assistance on a set of clinical cases. This 510(k) is for a therapeutic CPAP device with added features, not a diagnostic tool where reader performance is a key metric.
• Effect Size of AI Improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone Study (Algorithm Only Without Human-In-The-Loop Performance) Was Done

• Standalone Study: Yes, in an indirect sense. The "algorithm" here refers to the device's operational software and the new TRENDset PC software. The device's ability to deliver CPAP, and the software's ability to read/store/transmit data, would have been tested in a "standalone" (device-only, benchtop) manner to ensure they meet specifications. There is no "human-in-the-loop" component for the standalone performance of a CPAP delivery algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For a CPAP device, the "ground truth" for performance relates to:
  • Engineering Specifications: The device's ability to accurately deliver and measure specified pressure levels (4-18 cmH2O).
  • Predicate Device Performance: Performance of the TREND 110 (K041035) serves as a benchmark for equivalence.
  • Regulatory Standards: Adherence to recognized standards for safety, electromagnetic compatibility, and biocompatibility.
  • Functional Verification: For new features, the "ground truth" is whether they perform their intended function (e.g., real-time clock keeps accurate time, software accurately displays usage data).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. CPAP devices are not (typically) machine learning/AI diagnostic devices that require a "training set" of clinical data in the conventional sense. The device's internal algorithms are based on established control theory and engineering principles for pressure delivery. The software functionality (TRENDset PC) is developed and validated through traditional software engineering methods, not machine learning training.

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

• Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the context of machine learning. The "ground truth" for the device's operational parameters is established through engineering design, physiological principles of respiration, desired therapeutic outcomes for OSA, and performance of the established predicate device.

Ask a specific question about this device

The TREND 110 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.

The TREND 110 device provides continuous positive airway pressure.

The AquaTREND Humidifier accessory provides humidification of the air delivered to the patient.

Hoffrichter TREND 110 devices provide mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH₂O.

The TREND 110 CPAP device is provided in a compact lightweight enclosure for easy bedside use. A 2 x 16 character LCD display with keys on the operator panel provides the user with displayed information about the treatment level as well as access to menus for soft-start ramp, clinical prescription (set by doctor, PIN code protected) and hours of operation. TREND 110's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC).

Heated humidification is available by installing the AquaTREND /// heated humidifier accessory. A key with LED indicator permits the user to select the humidification level. Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements.

Treatment pressure is measured as close as possible to the patient mask Freathern of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit.

TREND 110 has a user selectable ramp function, which starts with a reduced pressure and gradually increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time in 10 minute increments to 0 (no ramp), 10, 20, or 30 minutes.

Standard accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified.

Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.

This 510(k) summary describes a CPAP device and humidifier accessory. The provided text does not include the typical structure of acceptance criteria and a detailed study report that would fully answer your request.

Medical device approval (especially for 510(k) submissions) often relies on demonstrating substantial equivalence to a predicate device rather than strictly meeting pre-defined performance acceptance criteria in the same way a new drug might. Therefore, the "acceptance criteria" here are generally implied to be "comparable performance to the predicate devices" across various technical and safety benchmarks.

Based on the provided document, here's the information that can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests. The document refers to testing "the TREND 110 and AquaTREND III devices" and comparisons "with predicate devices," implying a laboratory or engineering test environment rather than a patient-based test set.
• Data Provenance: Not explicitly stated, but the tests were conducted by the manufacturer, HOFFRICHTER GmbH, in Germany. These are non-clinical engineering and bench tests, not clinical data from patients.

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

• Not applicable. This document describes non-clinical engineering and bench tests for device functionality and safety. The "ground truth" for these tests would be established by engineering specifications, regulatory standards, and performance characteristics of predicate devices, not by expert medical consensus on patient data.

4. Adjudication Method for the Test Set

• Not applicable. As the tests described are non-clinical engineering tests, there is no mention of an adjudication method in the way it would apply to clinical expert reviews.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. The document explicitly states "Clinical Tests Submitted: (None)". Therefore, no MRMC study was conducted.

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

• Not applicable. This device is a CPAP machine, a physical device that delivers therapy, not an algorithm or AI system for diagnosis or interpretation. The "software" mentioned refers to the embedded control software for the physical device, not a diagnostic algorithm.

7. The type of ground truth used

• For the non-clinical tests (e.g., pressure, humidification, safety), the "ground truth" was based on:
  • Applicable industry standards (e.g., for electrical safety, EMC).
  • Manufacturer's internal specified requirements.
  • Performance characteristics of the predicate devices for comparison.
• No patient-derived ground truth (e.g., pathology, outcomes data) was used, as no clinical studies were submitted.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware product with embedded control software, not an AI or machine learning model that requires a "training set" of data in the typical sense. The software was verified and validated against requirements and intended use, which is a different process than machine learning model training.

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

• Not applicable. As there is no "training set" for an AI or machine learning model, this question does not apply. The "ground truth" for the device's control software would be its functional specifications and intended performance parameters.

Ask a specific question about this device

The Scalar, Scalar Plus, Vector, and Vector Plus devices are for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.

The Scalar, Scalar Plus, Vector Plus devices provide continuous positive airway pressure. The Scalar Plus and Vector Plus devices provide humidification of the air delivered to the patient.

Hoffrichter SCALAR and VECTOR CPAP devices provide mono-level CPAP treatment levels over the clinician settable range of 3 to 18 cmH2O.

All devices are constructed on a common platform, including case, mechanical and pneumatic components, operator panel, and electronic control system. A 2 x 16 character display with keys on the operator panel provides the user with displayed information about the treatment level as well as access to menus for time/date, ramp and other functions.

VECTOR's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC), whereas SCALAR is set to the region (115 or 230 VAC) by rear panel switch.

Models with a Plus designation include integrated heated humidification. An adjustment dial permits the user to select the humidification level. Moisture contacting materials in the breathing circuit meet biocompatibility requirements.

Treatment pressure is measured as close as possible to the patient mask by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit.

Hoffrichter CPAP devices have a user selectable ramp function, which starts with a reduced pressure and slowly increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time from 0 to 60 minutes. A mask test may be initiated at the full treatment pressure before the ramp begins to check for mask leaks.

Accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified.

A serially connected remote control device, the MULTI 20, supplied for clinician use during patient tests, emulates operator panel functions.

Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.

The provided document describes the Hoffrichter Vector, Vector Plus, Scalar, and Scalar Plus CPAP devices. Based on the submission, here's a breakdown of the acceptance criteria and the study information:

Description of the Study and Acceptance Criteria

The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a previously legally marketed device (the predicate device). This means the study's primary goal is to show that the new device is as safe and effective as the predicate device. For CPAP devices, this typically involves demonstrating that the device can deliver the intended therapy (continuous positive airway pressure) within specified ranges and that it meets relevant safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table with specific numerical acceptance criteria for pressure accuracy or other performance metrics, nor does it report precise measured values for the Hoffrichter CPAP devices. Instead, the performance is described in comparison to the predicate device.

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

• Sample Size: Not explicitly stated. The document refers to "the Hoffrichter CPAP devices" being tested, implying a representative number of units, but no specific count is given for the test set of devices or patients.
• Data Provenance: The document does not provide details on data provenance (e.g., country of origin, retrospective/prospective). Given the nature of a 510(k) for device performance testing, it's highly likely these were bench tests (non-clinical) and not conducted on human subjects as part of this submission. The address of the submitting company (Hoffrichter GmbH) is in Germany, suggesting the tests were conducted in Germany or Europe.

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

This section is not applicable to this submission. The tests performed were non-clinical (bench testing) and compared the device's technical performance against established standards and the predicate device's specifications. There was no "ground truth" derived from expert consensus on medical conditions or interpretations.

4. Adjudication Method for the Test Set

This section is not applicable. Since no human interpretation or ground truth establishment based on expert consensus was involved, there was no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical Tests Submitted: (2) (None)". The study focused on non-clinical (bench) testing of the device's technical specifications and safety.

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

This is partially applicable in the sense that the device's performance was evaluated purely on its own technical capabilities (standalone) during bench testing. However, it's important to note that this is not an "algorithm only" in the context of AI/software performance. It's the performance of a physical medical device. The "software" component was verified and validated to requirements, which implies its performance characteristics were evaluated in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" or reference standards used for the non-clinical tests were:

• Applicable standards for medical devices: e.g., for Electrical Safety, Electromagnetic Compatibility, Heated Humidifiers, Shock and Vibration, Environmental Temperature and Humidity.
• Performance specifications of the predicate device: The Fischer and Paykel HC200 Nasal CPAP with Heated Humidifier (K973161).

8. The Sample Size for the Training Set

This section is not applicable. The device is a hardware medical device with embedded control software, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The software was verified and validated, meaning it met its specified requirements and functions as intended, but this doesn't involve a machine learning training phase.

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

This section is not applicable for the reasons stated in point 8.

Ask a specific question about this device