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The Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System, is a sterile, non-pyrogenic, single use, three chamber collection/reinfusion device that is intended for collection and continuous reinfusion of autologous blood.

The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, used for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System.

The Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System is a new chest drainage system that incorporates features from the Thora-Klex Model 0077000 Chest Drainage System, the Pleur-evac Model A-6000 Chest Drainage System, and the Pleur-evac Plus Model A-9150 Continuous Reinfusion Autotransfusion System. Key features transferred from predicate devices include the dry one-way seal, negative pressure indicator, automatic high negative pressure relief valve, dry suction regulator, air leak meter, positive pressure relief valve, manual high negative pressure relief valve, floorstand, hangers, patient drainage tube configuration, reinfusion port, reinfusion tube, and spike port. Minor design changes were made to the collection/reinfusion chamber to increase its capacity. The patient drainage tube components (tube, snap lock connectors with injection site, and universal connector) are the same as the Pleur-evac Model A-6000 and A-9150, but the material for the tube and injection site has been changed to be latex free. A Pleur-evac Sahara Model S-100 Autotransfusion Bag or a blood transfer bag can be attached for bag reinfusion. The Model S-100 Autotransfusion Bag includes a rigid top plate assembled onto a flexible vinyl bag, mounted over a wire support frame. The frame is removed for reinfusion. The S-100 bag comes with an Easy-Link Adaptor, which is removed to attach the bag directly to the S-2150 unit using the metal frame and hooks. Tubing connectors are provided and are color coded. Tubing clamps are located on the bag ports. An injection site is on one set of connectors for adding anticoagulants or taking samples. A hanger strap is on the top of the unit for suspending the bag during reinfusion. The components, manufacturing processes, and specifications for the S-100 bag are the same as the A-1500 bag, except for the Easy-Link Adaptor and the latex-free materials for the patient drainage tube and injection site.

Here's a breakdown of the requested information based on the provided text, focusing on the Pleur-evac Sahara Plus Model S-2150 Continuous Reinfusion Autotransfusion System:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample size for the functional performance testing. It refers to "each of the units" for suction control accuracy, implying multiple units were tested but not providing a specific number. The data provenance is retrospective, as the testing was performed on the new device (Pleur-evac Sahara Plus Model S-2150) and compared against already marketed predicate devices. The country of origin of the data is not specified, but the submitter is based in Fall River, MA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The performance evaluation relies on engineering and functional testing against design specifications and comparison to predicate devices, rather than expert-derived ground truth as might be applicable in diagnostic AI studies.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. The testing described is functional and comparative to predicate devices, not requiring an adjudication method involving human experts interpreting results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, with Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human interpretation (e.g., medical imaging diagnostics). The Pleur-evac Sahara Plus Model S-2150 is a medical device for fluid management, not a diagnostic AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This concept is not applicable to this device. The Pleur-evac Sahara Plus Model S-2150 is a physical medical device, not an algorithm. Its "performance" is its functional operation.

7. The Type of Ground Truth Used:

The "ground truth" for the device's functional performance是在 design specifications and the established performance of its predicate devices. For biocompatibility, the ground truth is adherence to ISO 10993 standards and the previously cleared biocompatibility of identical materials in predicate devices. There is no "external" ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. This device is not an AI/ML algorithm that is "trained." It is a manufactured physical product.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable/not provided for the same reason as above (not an AI/ML algorithm).

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