(11 days)
The ANTLIA II™ Suction Pump System is indicated for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.
The ANTLIA IIm Suction Pump System, an AC-powered, portable suction device with battery back-up, provides localized negative pressure when used with the Aquarius IITM dressing to remove fluids and infectious materials from the wound to promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds.
The system consists of a powered suction pump device with a built-in placement holder for a fluid collection canister, the Aquarius II TM polyurethane foam dressing, and canister tubing with clamps and connectors, and two polyurethane drapes with adhesive.
The provided text is a 510(k) summary for the ANTLIA II™ Suction Pump System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or accuracy of an AI algorithm.
Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement are not applicable to this type of regulatory submission for a physical medical device like a suction pump system. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
However, I can extract the relevant information from the document based on the context of a 510(k) submission for a non-AI/diagnostic device:
1. A table of acceptance criteria and the reported device performance
For a physical medical device like a suction pump, "acceptance criteria" generally refer to engineering specifications, performance standards, and safety requirements. The document states:
| Acceptance Criteria (Implied by 510(k) Submission for this device type) | Reported Device Performance |
|---|---|
| Technological Characteristics: Must be substantially equivalent to predicate devices (Medela Invia™ Healing System, K061435; BlueSky Medical Versatile 1™ Wound Vacuum System, K052456). | "The ANTLIA II™ Suction Pump Therapy Unit has the same technological characteristics as the predicate's powered suction pump. The individual dressing components consists of materials that are either identical or substantially equivalent to the predicate's dressing components." |
| Indications for Use: Must align with predicate devices. | "The ANTLIA II™ Suction Pump System is indicated for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials." (This matches common indications for wound vacuum systems). |
| Safety and Effectiveness: Must be as safe and effective as predicate devices. | The FDA's substantial equivalence determination implies that the device is deemed as safe and effective as the predicate devices for its stated indications. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) summary does not describe a clinical study with a test set of data or human subjects for performance evaluation in the context of AI or diagnostics. The submission primarily relies on comparisons to predicate devices for technological characteristics, materials, and intended use. Performance testing, if conducted, would typically be bench testing to technical specifications, not human data.
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)
- Not Applicable. As there is no "ground truth" establishment in the context of an AI/diagnostic study, no experts were involved for this purpose in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring adjudication in this context.
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
- Not Applicable. This device is a physical medical device (suction pump system), not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The concept of "ground truth" in the context of AI/diagnostic evaluation does not apply to this device. The regulatory approval is based on demonstrating equivalence to predicate devices, which means meeting similar performance specifications and safety profiles as established, legally marketed devices.
8. The sample size for the training set
- Not Applicable. This device is not an AI model, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth to establish for one.
In summary, the provided document is a 510(k) submission for a non-AI physical medical device. The "study" proving the device meets acceptance criteria is the overall 510(k) submission itself, which primarily demonstrates substantial equivalence to existing predicate devices based on technological characteristics, indications for use, and material composition, rather than conducting a separate clinical performance study with human data or AI-specific evaluations.
§ 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.