(269 days)
For the collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations, To evacuate air and/or fluid from the chest cavity or mediastinum, To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum, To help re-establish and maintain normal intra-thoracic pressure gradients, To facilitate complete lung re-expansion to restore normal breathing dynamics.
Provided as a sterile unit and intended for single patient use, the S-1150-08LF Pleurevac Sahara® Plus Continuous Reinfusion Autotransfusion System is a threechamber, collection/reinfusion system used for the collection and continuous reinfusion of autologous blood. By attaching a blood transfer bag, which is available as an accessory item, the S-1150-08LF Pleur-evac Sahara® Plus serves as a bag reinfusion system with a non-pyrogenic fluid path. When autotransfusion is complete, the S-1150-08LF Pleur-evac Sahara® Plus can serve as a dry seal/dry suction chest drainage collection unit.
The provided document is a 510(k) Pre-Market Notification for a medical device called the "Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System." It discusses the device's indications for use, comparison to a predicate device, and performance data to establish substantial equivalence, NOT acceptance criteria or a study proving a device meets acceptance criteria.
Therefore, the requested information (1-9) about acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, and MRMC studies or standalone algorithm performance cannot be extracted from this document. The document describes bench testing for mechanical properties and integrity, not clinical performance or diagnostic accuracy typically associated with acceptance criteria in the context of AI/algorithms.
However, I can extract the information provided about the device's performance testing as described in the summary:
The Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System did not undergo a study that establishes acceptance criteria in the typical sense for diagnostic or AI devices, nor does it have acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. It underwent bench testing to demonstrate substantial equivalence to a predicate device for mechanical and functional integrity.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
| Test Parameters | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Inter-Chamber Leak Test | All compartments must hold the indicated volumes with liquid spillover occurring only at the spillover level. | Pass |
| Leak Integrity Test | The unit shall be airtight when operated at negative pressure 60 cm H20. | Pass |
| Burst Test | The unit shall have a minimum burst strength of 5 psig (PSI Gauge) at welded joints with all openings to atmosphere sealed. | Pass |
| Reinfusion Tube Separation Force Test | The separation force of the tube and spring from the reinfusion port and the tube from the spike port shall be a minimum of 10 lbs axially. | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The tests were bench tests, not clinical studies involving patient data.
- Sample size for each test: 60 units.
- Data provenance: Not applicable in the context of clinical or diagnostic data. These are results from internal bench testing of the device hardware.
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. These are engineering/mechanical pass/fail tests, not based on expert-adjudicated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The tests are objective measurements against defined engineering specifications.
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 comparative effectiveness study was not done. This device is an autotransfusion system, not a diagnostic or AI-driven decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for these tests is the physical measurement of the device's performance against engineering specifications (e.g., whether it leaks, bursts at a certain pressure, or tube separates with a specific force).
8. The sample size for the training set:
Not applicable. This device does not use a training set as it is not a machine learning or AI algorithm.
9. How the ground truth for the training set was established:
Not applicable.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).