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The Clearum™ HS 17 is intended for use in acute or chronic renal failure patients requiring hemodialysis

The Clearum™ HS 17 dialyzer is consisting of a cylindrical polypropylene body containing a bundle of microporous hollow fibers made of polyethersulfone (PES) secured to the ends by means of hot-melt polyurethane resin.
The modifed Clearum™ HS 17 dialyzer is substantially equivalent to the predicate Clearum™ HS 17 dialyzer manufactured by Bellco (K193542, cleared on October 8, 2020).
The device is characterized by a membrane surface area equivalent to 1.7 m², and by an outer housing total height of 306 mm and a maximum outside diameter of 44 mm.
ldentical to the predicate Clearum™ HS 17, blood and dialysate flow in a countercurrent in their respective compartments. In this process, toxins and fluid are transferred across the semipermeable membrane from the blood to the dialysate compartment.
The dialyzers are sterilized using moist heat with saturated steam, have a non-pyrogenic fluid path, and are labeled for single use.

The provided text describes a 510(k) premarket notification for a medical device called Clearum™ HS 17, a high permeability hemodialysis system. The submission seeks to demonstrate substantial equivalence to a predicate device (also Clearum™ HS 17, K193542) despite a minor modification in fiber undulation amplitude and effective fiber length.

This document does not contain information about an AI/ML-based medical device or a study involving human readers and AI assistance. Therefore, it is impossible to extract the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML context.

The document focuses on the equivalence of a physical medical device (a dialyzer) based on in-vitro test results. The "study" referenced is a series of non-clinical, in-vitro tests comparing the modified device to its predicate.

To directly address your request as if it were for an AI/ML device, I would need a different source document. However, based solely on the provided text, I can only report on the non-AI/ML aspects related to the Clearum™ HS 17 dialyzer.

Here's a breakdown of what can be extracted, framed within the closest possible interpretation of your request for this non-AI/ML device:

Acceptance Criteria and Device Performance (for a physical hemodialyzer)

The document states that "The modified Clearum™ HS 17 has the same fundamental technological characteristics, principles of operation and control mechanisms as the predicate device." The acceptance criterion, implicitly, is that the modified device performs comparably to the predicate device in key in-vitro performance metrics, demonstrating substantial equivalence and not raising new safety or effectiveness concerns.

Study Details (for a physical hemodialyzer)

• 1. A table of acceptance criteria and the reported device performance: (See table above)

• 2. Sample size used for the test set and the data provenance:

  • Sample Size: Not explicitly stated for each test, but in-vitro testing was conducted on "both the modified and predicate Clearum™ HS 17 for comparative purpose." This implies multiple units were tested to generate the reported performance data. Specific numbers of dialyzers tested for each metric are not provided.
  • Data Provenance: The tests were conducted internally by Bellco S.r.l. or a contracted lab. The country of origin is Bellco S.r.l. in Mirandola (MO), Italy. The data is from in-vitro testing, not retrospective or prospective human clinical data.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • This question is not applicable as the "ground truth" for a physical device's performance is established by standardized in-vitro measurements, not expert consensus or human reading. The "experts" would be the scientists and engineers conducting and interpreting the physical and chemical tests, presumably adhering to ISO standards.

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

  • Not applicable. This concept applies to human interpretation or algorithm output, not to objective physical measurements of a device.

• 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 is not an AI/ML device. No MRMC study was performed.

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

  • Not applicable. This is not an AI/ML device, so there is no algorithm to evaluate in standalone mode.

• 7. The type of ground truth used:

  • In-vitro performance metrics: The "ground truth" for this device's performance is derived from objective physical and chemical measurements (e.g., clearance rates, ultrafiltration coefficients, pressure drops) performed in controlled laboratory settings according to established scientific and engineering principles and international standards (ISO 8637-1:2017).

• 8. The sample size for the training set:

  • Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning. The device design and manufacturing process are based on engineering principles and material science.

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

  • Not applicable. As above, there's no training set for an AI/ML model.

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The Clearum™ HS dialyzer family is intended for use in acute or chronic renal failure patients requiring hemodialysis.

The Clearum™ HS family consists of dialyzers comprised by a cylindrical polypropylene body containing a bundle of microporous hollow fibers made of polyethersulfone (PES) secured to the ends by means of hot-melt polvurethane resin.

The devices are available in different models which differentiate by membrane surface area, ranging from 1.3 to 2.2 m², and for the dimensions of the outer cylindrical body in terms of length and height (306 x 41 mm for the surface areas in the range 1.3-1.5 m², 306 x 44 mm for the surface area 1.7 m² and 366 x 44 mm for the surface areas in the range 2.0-2.2 m²).

Similar to other commercially available hemodialyzers, blood and dialysate flow in a countercurrent in their respective compartments. In this process, toxins and fluid are transferred across the semipermeable membrane from the blood to the dialysate compartment.

The dialyzers are sterilized using moist heat with saturated steam, have a non-pyrogenic fluid path, and are labeled for single use.

The provided text describes the Clearum™ HS family of dialyzers and their comparison to a predicate device, the Polyflux H models, to demonstrate substantial equivalence for FDA 510(k) clearance. This report does not describe acceptance criteria for an AI/ML powered medical device, but rather for a physical medical device. It focuses on in-vitro test results and comparison to a predicate device.

Here's an analysis of the provided information, noting where specific requested details (like those for AI/ML studies) are not available in this physical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a table format for each performance metric, but rather states that "The results of the testing met the performance specifications demonstrating that the Clearum™ HS family performs as intended." It also aims to demonstrate substantial equivalence to the predicate device.

The "performance specifications" are implicitly derived from the established performance characteristics of the predicate device and the industry standards (ISO 8637-1:2017).

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

• Sample Size for Test Set: The document states "In vitro testing was conducted on the entire Clearum™ HS dialyzers family" and "For comparative purposes, the same testing, was also conducted on the Polyflux H predicate device, when applicable." However, the exact number of units tested (sample size) for each model or for the overall family is not specified in the provided text.
• Data Provenance: The testing was "in-vitro," meaning it was conducted in a laboratory setting. There is no mention of human subject data, retrospective or prospective studies in the context of device performance. The manufacturer, Bellco S.r.l., is located in Mirandola MO, Italy, suggesting the tests were likely conducted there or at an affiliated lab.

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

This information is not applicable to this type of device submission. For physical medical devices like dialyzers, "ground truth" is established through physical and chemical testing against recognized standards (e.g., ISO, FDA guidance) and comparison to the predicate device's established performance. It does not involve expert adjudication of clinical data in the way an AI/ML device would.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of data, typically in AI/ML validation studies. For this physical device, performance is measured objectively through lab tests.

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 information is not applicable. This is a submission for a physical medical device (hemodialyzer), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-assisted human reader improvement metrics are relevant or discussed.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on:

• Industry Standards: Compliance with ISO 8637-1:2017 ("Cardiovascular implants and extracorporeal systems - Hemodialysers, hemodiafilters, hemofilters and hemoconcentrators") and ISO 10993-1 ("Biological evaluation of medical devices").
• FDA Guidance: "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers" (1998) and "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
• Predicate Device Performance: The established, legally marketed performance characteristics of the Polyflux H dialyzer family. The new device demonstrates "substantial equivalence" to the predicate.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device.

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

This information is not applicable as there is no training set for an algorithm.

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