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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 Models S-1100, S-1200, S-2100, and S-2200 covered by this submission are sterile, single use devices, that are intended for postoperative chest drainage.

The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, intended for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Chest Drainage,

Pleur-evac Sahara Adult/Pediatric Chest Drainage System Models S-1100, S-1200, S-2100, and S-2200

Deknatel DSP Worldwide, Inc. has recently acquired the Thora-Klex® Chest Drainage System product lines from Davol Inc., C.R. Bard, Inc. Deknatel DSP Worldwide, Inc. has incorporated certain features of the currently marketed Model 0077000 Thora-Klex Chest Drainage System with the features of the currently marketed Model A-6000 Pleur-evac Chest Drainage System into a new chest drainage system, the Pleur-evac Sahara Adult/Pediatric Chest Drainage System. Combining the proven technologies from the Thora-Klex and the Pleur-evac into one unit, creates a new, completely dry Pleur-evac Chest Drainage Unit. Features from the Thora-Klex and the Pleur-evac were transferred to the Pleur-evac Sahara unit without design changes.

There are two basic Pleur-evac Sahara Chest Drainage models: the S-1100 Chest Drainage Unit which is shorter, wider and deeper than the standard Pleur-evac unit but more like the Thora-Klex Model 0077000 shape: and the S-2100 Chest Drainage Unit which carries the standard dimensions of the Pleur-evac Model A-6000 Chest Drainage unit. The S-1100 and S-2100 Chest Drainage Units are capable of autotransfusion option, by attaching a Pleur-evac Sahara Model S-100 Autotransfusion Bag. The Models S-1200 and the S-2200 are identical to the Models S-1100 and S-2100, but are provided with a Model S-100 Autotransfusion Bag attached. The Pleur-evac Sahara Chest Drainage are three bottle systems that include a means for integral suction control, a one way seal via a check valve, and a chamber for collecting fluids,

Hangers are located on the right and left sides of the chest drainage unit to provide support for the chest drainage unit when it is suspended from a hospital bed rail.

The Pleur-evac Sahara Models S-2100 and S-2200 are provided with an integral rotating floorstand. These units free stand when placed on a leveled surface with the floorstand in the open position. The floorstand rotates freely from the closed position to the open position. Once open, the floorstand requires the actuation of a lever to return to the closed position. The design of the Pleur-evac Sahara Models S-1100 and S-1200 does not require a rotating floorstand, since the base of the unit acts as a floorstand.

Pleur-evac Sahara Model S-100 Autotransfusion Bag

The Pleur-evac Sahara Autotransfusion Bag, includes an Autotransfusion Bag that contains a rigid top plate assembled onto a flexible vinyl bag. The Autotransfusion Bag is mounted over a wire support frame. The wire frame maintains the bag in an open position during the collection phase of operation. The frame is removed from the bag during the reinfusion phase to allow the bag to collapse and the reinfusion of the collected blood to occur.

The Pleur-evac Sahara Autotransfusion Bag operates with either suction drainage or gravity drainage. During operation with suction drainage, the Autotransfusion Bag is connected to an appropriate Pleur-evac Sahara Chest Drainage unit that is connected to a vacuum source. The patient vacuum is controlled by the Pleur-evac Sahara Chest Drainage System. During operation with gravity drainage, the Autotransfusion Bag is connected to an appropriate Pleur-evac Sahara Chest Drainage unit that is not attached to a suction source.

The Pleur-evac Sahara Autotransfusion Bag is connected to the Pleur-evac Sahara S-1100 Chest Drainage Unit by means of the Easy-Link Adaptor. The adaptor, which is attached to the Autotransfusion Bag, locks into the Easy-Link receptor on the Pleurevac Sahara Chest Drainage unit. For the Pleur-evac Sahara Model S-2100 Chest Drainage Unit, the Easy-Link Adaptor is removed from the Model S-100 Autotransfusion Bag by the clinician, and the Autotransfusion Bag is attached directly to the side of the Pleur-evac Chest Drainage Unit, using the metal frame on the bag and the hooks provided on the chest drainage unit. This means of attachment is employed by the currently marketed Pleur-evac Model A-6000 Chest Drainage System. Tubing connectors are provided for attaching the Pleur-evac Sahara Autotransfusion Bag to the appropriate Pleur-evac Sahara Chest Drainage Unit. The connectors are color coded for ease of proper connection.

Tubing clamps are located on each of the tubing ports on the Autotransfusion Bag. The tubing clamps must be closed in order to occlude the patient drainage tube prior to disconnecting the connectors. An injection site is located on one set of connectors through which anti-coagulants may be added to the Autotransfusion Bag or from which samples of the drainage fluid mav be taken.

A hanger strap located on the top of the unit provides a means for suspending the Autotransfusion Bag from an I.V. pole during reinfusion.

The Models S-100 and the A-1500 Autotransfusion Bags have similar face graphics, j box graphics, and instructions for use. The labeling for the Model S-100 Autotransfusion Bag also includes reference and use of the Easy-Link Adaptor.

This is a 510(k) summary for a medical device cleared in 1996. The provided text describes the device, its intended use, and argues for substantial equivalence to previously cleared predicate devices. It does not contain information about the performance or acceptance criteria in the format requested for AI/ML device studies. The "performance equivalence" section discusses engineering and functional comparisons to predicate devices, not clinical efficacy or diagnostic accuracy as would be expected for modern AI/ML submissions.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided document.

Here's an attempt to extract what is available, with explanations for what is missing:

Acceptance Criteria and Device Performance Study

This submission describes the Pleur-evac Sahara Adult/Pediatric Chest Drainage System and the Model S-100 Autotransfusion Bag. The device is a traditional medical device (a chest drainage system), not an AI/ML device. Therefore, the acceptance criteria and study details discussed in the document relate to engineering performance and substantial equivalence to predicate devices, rather than diagnostic accuracy or clinical effectiveness typically evaluated in AI/ML products.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Found in the Document (Relevant to AI/ML Device Submissions)

The document does not provide the following information as it pertains to a traditional, non-AI medical device:

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device engineering performance test, not a clinical data-driven study in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm (e.g., diagnostic labels) is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the engineering tests, the "ground truth" would be established engineering standards and measurements, compared against the predicate devices. For biocompatibility, it's compliance with ISO standards.
8. The sample size for the training set: Not applicable. This device does not have a "training set" in the AI/ML context.
9. How the ground truth for the training set was established: Not applicable.

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