(259 days)
The ATMOS C 051 Thorax is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious material from a patient's respiratory system after surgery. The general indication of the ATMOS C 051 Thorax is thoracic drainage.
The ATMOS C 051 Thorax (317.0200.0) drainage system is a device for mobile, digital thoracic drainage. It is portable, mains-independent and has an electronic monitoring system with optical and acoustic display. The device takes medical effect as a system in combination with a secretion canister and a hose system. The system creates the (natural) vacuum in the pleural cavity by draining off air and secretion. The ATMOS C 051 Thorax is equipped with a rechargeable battery. A charging unit which is located within the suction device guarantees the secure charging of the battery. The hose system is rinsed with air at regular intervals to prevent the collection of debris in the hose. Bacterial and viral filters in the secretion canister and measuring hose prevent contaminated secretions from entering the device. The device is equipped with a disposable strap and a carrying handle. These enable mobility. A universal bracket or the standard rail bracket can be ordered separately as accessories. The ATMOS C 051 Thorax is a reusable device delivered in non-sterile state. The secretion canister and hose systems are single-use devices and delivered sterile. All other accessories subject to this submission are reusable and delivered non-sterile.
The provided document is a 510(k) clearance letter from the FDA for a medical device called "ATMOS C 051 Thorax," a powered suction pump for thoracic drainage. While it discusses performance tests and adherence to various standards, it does not contain the detailed clinical study data typically found in a clinical trial report or a comprehensive technical submission.
Therefore, I cannot extract answers for many of your specific questions related to acceptance criteria, ground truth, expert qualifications, adjudication methods, MRMC studies, or training set details from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance bench testing, software validation, biocompatibility testing, human factors validation, and risk management.
However, I can provide information on what is explicitly stated or can be inferred from the document regarding the acceptance criteria and the nature of the study.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Performance tests were carried out to ensure that the subject device functions as intended and meet design specifications." and "Risk analysis was carried out based on acceptance criteria established in accordance with ISO 14971." However, the specific numerical acceptance criteria or the direct reported performance values for each criterion are NOT provided in this summary.
The document lists the following categories of performance tests conducted with "no unexpected results or significant deviations":
| Acceptance Criteria Category (Details Not Provided) | Reported Device Performance (Qualitative) |
|---|---|
| Electrical, Mechanical, and Thermal Safety (in accordance with AAMI/ANSI and IEC 60601 standards) | Successfully tested and complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-4-2. |
| Software Validation (in accordance with FDA guidance "Content of Premarket Submissions for Device Software Functions," June 14, 2023) | Performed, documentation level "enhanced," cybersecurity aspects followed FDA guidance. |
| Biocompatibility Testing (according to ISO 10993-1 and FDA guidance) | Performed (details not explicitly stated). |
| Performance Bench Testing: | "No unexpected results or significant deviations." |
| - Maximum flow rate | (Specific values not provided) |
| - Function and accuracy of flow display | (Specific values not provided) |
| - Minimum to maximum vacuum | (Specific values not provided) |
| - Function, accuracy and control delay of vacuum display | (Specific values not provided) |
| - Battery operation at full power mode | (Specific values not provided) |
| - Battery charge time | (Specific values not provided) |
| - Over suction protection | (Specific values not provided) |
| - Weight | Subject device: 1.16 kg (predicate: 3.27 kg) |
| - Alarm sound and noise level | (Specific values not provided) |
| - Length of hose system | (Specific values not provided) |
| Human Factors Validation (in accordance with IEC 62366-1, IEC 60601-1-6, and FDA guidance) | "Use of the device is safe, especially with regard to the use by lay persons. The residual risks that remain...have been reviewed and determined to be acceptable." |
| Risk Management (in accordance with ISO 14971:2019) | "Overall benefits of using the device outweigh the risks. The device is safe and effective for use in the intended patient population." |
| Reprocessing, Sterility, and Shelf-Life (for certain components) | Cleaning and disinfecting procedures described. Sterile validation performed for secretion canister and hose systems according to ISO 11135. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and validation activities rather than a typical clinical study with a "test set" of patient data. Therefore, the concept of sample size as it applies to patient data is not relevant here. The "tests" refer to engineering and quality assurance activities. No country of origin for data or retrospective/prospective nature is mentioned as it's not a clinical data study.
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 as there is no mention of clinical "ground truth" derived from expert interpretation in this document. The tests performed are technical and engineering-focused (e.g., flow rates, vacuum levels, battery performance), with human factors validation likely involving usability experts or human factors engineers, but their specific qualifications and number are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as it's relevant for clinical adjudication of medical images or diagnoses, not for the technical bench testing described.
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
No MRMC study was conducted or mentioned. This device is a powered suction pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device (suction pump), not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests mentioned are engineering specifications, international standards (IEC, ISO), and regulatory guidance documents (FDA guidance). For example, for flow rate, the "ground truth" would be the measured flow rate compared against the predefined design specification. For human factors, it would be the assessment of safety and effectiveness of use against defined usability goals and risk analysis.
8. The sample size for the training set
This question is not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the reason stated above.
In summary, the provided document details a 510(k) submission for a non-AI medical device (powered suction pump). The "studies" proving it meets acceptance criteria are predominantly non-clinical bench tests and validation activities against established engineering specifications, international standards, and regulatory guidelines, rather than clinical trials that generate patient data and require expert ground truth establishment.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.