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510(k) Data Aggregation
(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 | < 0.9 lbs |
| Electrical shock protection: | Class II | Class II |
| Drip Proof Equipment | IPX1 | IPX1 |
| Heater Setting | 1 - 5 | continuous |
| Standards Compliance | ||
| IEC-60601-1 | Yes | Yes |
| IEC-60601-2 | Yes | Yes |
| ISO 17510-1 | Yes | Yes |
| ISO 8185 | Yes | Yes |
Note: The "acceptance criteria" here are essentially the performance characteristics of the predicate device, against which the new device (K Series CPAP) demonstrates "substantial equivalence" based on similar specifications or compliance with the same regulatory standards.
Additional Requested Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the document. The testing mentioned refers to general product verification rather than a clinical trial with a defined patient sample size for performance evaluation in the context of an AI/algorithmic device.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
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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):
- Not applicable. This device is a physical CPAP machine, not an AI/algorithmic device that generates diagnostic outputs requiring expert-established ground truth. The "testing" referred to appears to be engineering and compliance testing (e.g., electrical safety, pressure stability).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is typically relevant for evaluating agreement among human experts or between AI and human experts in diagnostic tasks.
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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:
- No MRMC study was mentioned. This type of study is not relevant for a physical CPAP machine.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a CPAP system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of algorithmic performance. The "ground truth" for this device would be its adherence to engineering specifications and regulatory standards, evaluated through various tests (e.g., electrical, mechanical, humidification performance).
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable.
Conclusion based on the provided text:
The provided 510(k) summary for the Curative Medical Inc. K Series CPAP Systems focuses on demonstrating substantial equivalence to a predicate device (Respironics Remstar Pro M Series) through a comparison of design, operating principles, intended use, and compliance with recognized standards (e.g., IEC, ISO). The performance data presented relates to the physical and functional characteristics of the CPAP device and its humidifier, not to the performance of an AI or algorithm in image analysis or diagnostic tasks. Therefore, most of the specific questions regarding acceptance criteria for AI algorithms, expert ground truth, and study methodologies (like MRMC or standalone performance evaluations) are not addressed in this type of regulatory document.
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