(199 days)
The intended use of this pump is general suction. This is best described under 21 CFR 878.4780, which states that the pump is intended 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
" The Aspirator " is a suction pump with a 350mm Hg capacity. It is of low maintenance by design. It provides low noise level. It has an oversized vacuum gauge to allow easy reading. It has a detachable power cord with externally replaceable fuses, and positive detented vacuum lines for fewer leaks. It is available in both 110 and 230 volts. Only UL approved parts are used in the construction.
The provided text is a 510(k) summary for "The Aspirator" general aspiration pump, claiming substantial equivalence to a predicate device. This type of submission relies on comparative data rather than a detailed study with acceptance criteria and performance metrics typically seen for novel medical devices or AI-powered systems.
Therefore, many of the requested points cannot be found in the provided text, as this medical device (a general aspiration pump) does not involve AI, machine learning, or complex algorithmic performance that would necessitate acceptance criteria, ground truth determination, or MRMC studies in the way an AI diagnostic tool would.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided 510(k) summary in the format of specific, quantifiable acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to a predicate device, meaning its performance is considered acceptable if it is comparable to a legally marketed device.
The table below summarizes the comparison with the predicate device, which serves as the implicit "performance" comparison. The "acceptance criteria" are effectively that the new device's characteristics are "Equivalent" or "Similar" to the predicate.
| Characteristic | "The Aspirator" Performance (compared to Cook Aspiration Pump) | Implicit Acceptance Criteria (based on substantial equivalence) |
|---|---|---|
| Indications for Use | E (Equivalent) | Must be Equivalent to predicate |
| Target Population | E (Equivalent) | Must be Equivalent to predicate |
| Design | E (Equivalent) | Must be Equivalent to predicate |
| Materials | S (Similar) | Must be Similar or Equivalent to predicate |
| Performance | S (Similar) | Must be Similar or Equivalent to predicate |
| Sterility | S (Similar) | Must be Similar or Equivalent to predicate |
| Biocompatibility | N/A (Not Applicable) | Not applicable (implied by predicate) |
| Mechanical Safety | S (Similar) | Must be Similar or Equivalent to predicate |
| Chemical Safety | N/A (Not Applicable) | Not applicable (implied by predicate) |
| Anatomical Sites | E (Equivalent) | Must be Equivalent to predicate |
| Human Factors | S (Similar) | Must be Similar or Equivalent to predicate |
| Energy used and/or delivered | E (Equivalent) | Must be Equivalent to predicate |
| Compatibility w/ environment & other devices | E (Equivalent) | Must be Equivalent to predicate |
| Where used | E (Equivalent) | Must be Equivalent to predicate |
| Standards met | S (Similar) | Must be Similar or Equivalent to predicate |
| Electrical Safety | S (Similar) | Must be Similar or Equivalent to predicate |
| Thermal Safety | S (Similar) | Must be Similar or Equivalent to predicate |
| Radiation Safety | S (Similar) | Must be Similar or Equivalent to predicate |
The device further states:
- "The Aspirator " is safe and effective as other predicate devices cited above.
- It is made out of only UL approved parts.
- It has a 350mm Hg capacity.
- Provides low noise level.
- Has an oversized vacuum gauge.
- Detachable power cord with externally replaceable fuses.
- Positive detented vacuum lines for fewer leaks.
- Available in both 110 and 230 volts.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This submission is a 510(k) for a physical medical device (a pump), not an AI/ML algorithm. There isn't a "test set" of data in the sense of patient cases to evaluate algorithm performance. The "study" here is primarily a comparison of technological characteristics to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. As stated above, there is no "test set" and thus no ground truth established by experts for algorithmic evaluation.
4. Adjudication method for the test set
Not applicable/Not provided.
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, an MRMC study was not done. This device is a general aspiration pump, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. There is no standalone algorithm.
7. The type of ground truth used
Not applicable/Not provided. Performance is based on similarity to a legally marketed predicate device, rather than a "ground truth" derived from patient outcomes, pathology, or expert consensus on clinical cases. The ground truth for this type of device is implicitly "functions as a general aspiration pump with similar characteristics to existing approved devices."
8. The sample size for the training set
Not applicable/Not provided. There is no training set as it's not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable/Not provided.
§ 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.