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The Pleur-evac Sahara Plus Model S-1150 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-1150 Continuous Reinfusion Autotransfusion System is a chest drainage system that incorporates features from the Thora-Klex Model 0077000, the Pleur-evac Model A-6000, and the Pleur-evac Plus Model A-9150 systems. It includes a 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, and a patient drainage tube configuration. It also has a reinfusion port, reinfusion tube, and spike port for continuous reinfusion. The collection/reinfusion chamber is shorter and deeper than the Pleur-evac Plus Model A-9150 to increase capacity. The patient drainage tube components are latex-free. The system can be used with a Pleur-evac Sahara Model S-100 Autotransfusion Bag or a blood transfer bag for reinfusion. The Model S-100 Autotransfusion Bag is a flexible vinyl bag with a rigid top plate and a wire support frame, designed for collection and reinfusion of blood. It includes an Easy-Link Adaptor and tubing clamps.

This 510(k) submission (K963850) is for a medical device seeking clearance through substantial equivalence to previously cleared devices, rather than establishing de novo safety and effectiveness through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for proving performance against those criteria, and AI-specific details is not applicable in this context.

Here's why and what information can be extracted based on the provided text:

Key Takeaways from a 510(k) of this Nature:

• Substantial Equivalence: The primary goal of this submission is to demonstrate that the new device (Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System and Pleur-evac Sahara Model S-100 Autotransfusion Bag) is as safe and effective as already legally marketed predicate devices. This typically involves showing similar design, materials, intended use, and functioning, often supported by bench testing, rather than extensive clinical studies with human subjects.
• No AI Component: The device described is a mechanical medical device (chest drainage and autotransfusion system), not an AI/ML-driven device. Therefore, questions about AI assistance, standalone algorithm performance, training sets, or expert ground truthing for an AI model are not relevant.
• Bench Testing over Clinical Trials for Performance: The "study" mentioned is a series of bench tests designed to compare functional aspects and material safety with predicate devices. This is a common approach for 510(k) submissions where the technology is well-established, and the device represents modifications or combinations of existing cleared technologies.

Based on the provided text, here is an articulation of the closest equivalent information to your request, with an emphasis on why certain aspects are not applicable:

1. A table of acceptance criteria and the reported device performance

Study Proving Acceptance Criteria:

The "study" was a series of bench tests (laboratory-based performance evaluations) comparing the new device's functional aspects to its predicate devices. The objective was to demonstrate substantial equivalence, meaning the new device performs similarly and is as safe and effective as the predicate devices that are already legally marketed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the number of units/samples tested for each performance metric (e.g., how many S-1150 units were tested for suction control accuracy). For bench testing of this nature, usually, a defined number of production units are subjected to each test, but specific quantities are often not detailed in the public 510(k) summary.
• Data Provenance: The data is from prospective bench testing conducted by the manufacturer, Deknatel DSP Worldwide Inc., likely at their facilities (implied, no specific country mentioned, but the submitter is based in Fall River, MA, USA). The data is not clinical data from patients.

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. This is a mechanical device, and its performance is assessed against engineering specifications and comparison to predicate devices, not against a "ground truth" derived from expert clinical assessment in the way an AI/diagnostic device would be. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices, as determined by previous FDA clearances.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As there are no human-readout interpretations or diagnostic classifications involved in this type of device's performance testing, adjudication methods like 2+1 or 3+1 are not relevant. Performance is measured objectively via instruments and engineering standards.

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 does not involve human readers, diagnostic imaging, or AI assistance. It is a mechanical chest drainage and autotransfusion system.

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

• Not Applicable. There is no AI algorithm in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For functional performance, the "ground truth" is implied by the established specifications and validated performance of the predicate devices (Thora-Klex Model 0077000, Pleur-evac Model A-6000, Pleur-evac Plus Model A-9150). The new device's performance is gauged against these known benchmarks for comparability.
• For biocompatibility, the "ground truth" is adherence to ISO 10993 Part-1 standards and the previously cleared biocompatibility of identical materials in predicate devices.

8. The sample size for the training set

• Not Applicable. There is no AI component, and thus no "training set." The device's design is based on the features of existing, cleared predicate devices.

9. How the ground truth for the training set was established

• Not Applicable. As there is no AI component or training set, this question is not relevant.

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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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