(153 days)
The K Series CPAP with Heated Humidifier System is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.
The K Series CPAP Systems with heated humidifier are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems are available in two models: Curasa model and Floton model. The CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier works only with the K Series CPAP Systems and provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The K Series systems also include the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier.
The provided text describes the K Series CPAP Systems for treating Obstructive Sleep Apnea. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria based on algorithm performance, sample sizes for test sets (beyond what can be inferred from the comparison table), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone studies, training set details, or how training ground truth was established.
This document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device (Respironics Remstar Pro M Series) for a physical medical device (CPAP machine), not a software algorithm that requires performance metrics against a defined ground truth. The "Summary of Performance Data and Substantial Equivalence" section states that tests confirmed the product met "predefined acceptance criteria" and was "compliant with the following standards documents," but it does not specify what those criteria were in a numerical sense for algorithmic performance or provide the study details you're looking for.
Here's an attempt to answer your questions based only on the provided text, highlighting where information is missing:
Acceptance Criteria and Device Performance
The provided document does not specify acceptance criteria and device performance in the context of an AI/algorithm-based study with metrics like sensitivity, specificity, or accuracy compared to a ground truth. Instead, the "acceptance criteria" referred to in this 510(k) summary are related to the manufacturing conformance and safety/effectiveness of a physical medical device (CPAP machine) against established industry standards and its predicate device.
The table below summarizes the comparison parameters between the K Series CPAP and its predicate device, which serves as the "performance" demonstrated for substantial equivalence rather than algorithmic performance.
| Parameter | Acceptance Criteria (Predicate Device Performance) Respironics Remstar Pro M Series (K072996) | Reported Device Performance Curative Medical Inc. K Series CPAP |
|---|---|---|
| General Device | ||
| Device Size (cm) | 19x12.7x7.9 | Curasa: 17x11.7x9.3; Floton: 18x21x10.5 |
| Weight (kg) | 1.0 | Curasa: 1.4; Floton: 1.6 |
| Product Use, Transport, Storage(°C) | 5 to 35 | 5 to 35 |
| Operation (°C) | 5 to 35 | 5 to 35 |
| Transport & Storage (°C) | -20 to 60 | -20 to 60 |
| Atmosphere Pressure (Operation) | 77 to 101 kPa | 70 to 106 kPa |
| Mode of Operation | Continuous | Continuous |
| Type of Protection Against Electric Shock | Class II Equipment | Class II Equipment |
| Degree of Protection Against Electric Shock | Type BF Applied Part | Type B Applied Part |
| Degree of Protection Against Ingress of Water | IPX1 | IPX1 |
| Pressure Range (cm H2O) | 4-20 | 4-20 |
| Pressure Stability (cm H2O) | 4-20 cm H2O, +/- 1.0 cm H2O | 4-20 cm H20 +/- 2.0 cm H20 |
| Maximum Flow (LPM) | 35 | 35 |
| Humidifier | ||
| Water reservoir | 1 2/3 cup | 240 ml |
| Dimensions: | 8.25" x 8.75" x 4" | 6.5" x 3.3" x 4" |
| Weight | 2.2 lbs |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).