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The UltraConcentrator™ Permeability Hemodialyzer is indicated for use as an ultrafiltrator for the selective removal of undesirable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.

The UltraConcentrator Permeability Hemodialyzer is a device that is used to remove plasma water from dilute blood plamsa proteins, increasing the concentration of plasma proteins and formed cellular elements. The UltraConcentrator is constructed of semi-permeable hollow fibers which divide the device into two compartments. An inner pathway for diluted blood perfusate is defined by the inlet and outlet connectors and flow dispersion headers which are connected through the inner lumen of semi-permeable, hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water.

When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semi-permeable membrane walls into the annular ultrafiltrate compartment to then be discarded.

The UltraConcentrator may be used manually or it may be used with the UltraConcentrator Processor, a pneumatically driven device that provides automatic processing of the UltraConcentrator.

The UltraConcentrator Permeability Hemodialyzer is not intended for use with direct patient connection, nor is it intended for use as a dialyzer. Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraConcentrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary.

The provided document is a 510(k) summary for the UltraConcentrator™ Permeability Hemodialyzer, a conventional hemodialyzer used as an ultrafiltrator. It contains information about the device's specifications, indications for use, contraindications, warnings, and precautions, as well as a comparison to a predicate device.

However, this document does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The 510(k) submission states that "The UltraConcentrator is technologically substantially equivalent to the predicate in every respect," which is the basis for its clearance, rather than proof through a formal study meeting specific acceptance criteria as might be expected for novel devices or software.

Therefore, I cannot fulfill your request for the specific information points regarding acceptance criteria and a study to prove they are met because those details are not present in the provided document.

To be explicit, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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The UltraCon™ Ultrafiltrator is indicated for use as an ultrafiltrator for the selective removal of undesireable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.

The Ultracon™ Ultrafiltrator is constructed of semipermeable hollow fibers, which divide the device into two compartments. An inner pathway for diluted blood perfusate is defined by the inlet and outlet connectors and flow dispersion headers, which are connected through the inner lumen of semipermeable hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water.

When dilute blood or a blood component is allowed to pass through the perfusate pathway, the device acts as an ultrafilter, removing a percentage of the plasma water and small solutes from the perfusate. When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semipermeable membrane walls into the annular ultrafiltrate compartment, to then be discarded. This results in the concentration of formed elements and proteins as they pass along the perfusate pathway.

The UltraCon™ Ultrafiltrator is built with dry cellulose diacetate membranes, a unique material which has been shown to have a high level of biocompatibility. The absence of any bore fluid provides the convenience of using the device without the need for rinsing. Each device is supplied in a sealed plastic and foil package, to maintain a sterile, non-pyrogenic perfusate pathway.

Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraCon™ Ultrafiltrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary. Average ultrafiltration rate will vary directly according to perfusate flow rate, transmembrane pressure, or temperature, and inversely according to its protein concentration and hematocrit.

The provided document is a 510(k) Summary for the UltraCon™ Ultrafiltrator, dated February 24, 1998. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.

Therefore, much of the requested information, such as detailed acceptance criteria, specific performance metrics from a study against those criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC study details, is not present in the provided document.

However, based on the information available, I can extract and infer the following:

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

The document does not explicitly present a table of acceptance criteria linked to a study's performance results. Instead, it lists "UltraCon™ Ultrafiltrator Specifications" which serve as design specifications and implicitly, as targets for acceptable performance. The comparison to predicate devices also implies that performance similar to these predicates would be acceptable.

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

This information is not present in the provided 510(k) Summary. 510(k) summaries typically focus on substantial equivalence based on design, materials, and intended use, often without detailed clinical study data.

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)

This information is not present. The document doesn't describe a ground truth establishment process for a test set.

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

This information is not present.

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

This is not applicable as the device (UltraCon™ Ultrafiltrator) is a medical device for ultrafiltration, not an AI-assisted diagnostic tool involving human readers.

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

This is not applicable for the type of device described.

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

This information is not present. The document relies on engineering specifications and comparison to predicate devices. For this type of device, "ground truth" would likely refer to physical measurements of its performance characteristics (e.g., actual ultrafiltration rate, pressure limits, molecular weight cutoff) under controlled laboratory conditions, rather than clinical outcomes or expert consensus on diagnostic images.

8. The sample size for the training set

This information is not present.

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

This information is not present.

Summary of what the document does provide regarding device performance and acceptance:

The document primarily demonstrates substantial equivalence by showing that the "Product design, materials of construction, and function as an ultrafiltrator are substantially equivalent to FDA cleared predicate devices." The listed specifications for the UltraCon™ Ultrafiltrator define its intended performance parameters, which are implicitly accepted as meeting the required standards because they are comparable to established predicate devices (Altra FLUX™ 140 Hemodialyzer, Minifilter™ Hemofilter, Hemocor HPHTM 400 Hemoconcentrator). The acceptance criteria are therefore largely based on matching or being within acceptable ranges of these established specifications and the similar performance characteristics of the predicate devices.

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