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The hemoconcentrators are intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient physiological hematocrit. The choice of hemoconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

DHF and SH Hemoconcentrators are single-use, non-toxic and nonpyrogenic fluid path devices; they are supplied sterile and individually packaged. The devices are made of plastic materials and are recommended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit: The choice of hemoconcentrator depends on the protocol being used and required filtration rate. The device can be used up to 6 hours.

The DHF and SH hemoconcentrators are the modified version of the disposables currently marketed in the Dideco DHF hemoconcentrators (K021732) and the SH 14 hemoconcentrators (K081313).

The provided FDA 510(k) clearance letter for the DHF and SH Hemoconcentrators does not describe a study that proves the device meets specific acceptance criteria in the manner of an AI/ML algorithm or diagnostic device.

Instead, this document details a change to an existing, cleared medical device (hemoconcentrators used in cardiopulmonary bypass circuits). The core of the 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish performance against new, quantitative clinical acceptance criteria as one would find for a novel diagnostic or AI-powered system.

The "study" described here is a non-clinical performance evaluation focused on demonstrating that a material change (from Santoprene to Silicone for O-rings) does not introduce new questions of safety or effectiveness.

Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device clearance.

Here's an analysis based on the provided document, highlighting what is (and isn't) present:

Analysis of Acceptance Criteria and Device Performance for DHF and SH Hemoconcentrators

The information provided describes a 510(k) clearance for hemoconcentrators, which are physical medical devices, not an AI/ML or diagnostic software. The "acceptance criteria" and "study" are therefore framed around demonstrating substantial equivalence to existing predicate devices, particularly after a material change to a component, rather than performance metrics for a diagnostic algorithm.

This document explicitly states: "No clinical testing was conducted in support of the DHF and SH hemoconcentrators, as the indications for use and technical characteristics are unchanged with respect to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."

The "study" instead focuses on non-clinical performance data to ensure that the device still complies with applicable standards and performs as expected after the specified design change.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission, acceptance criteria are generally met through compliance with recognized standards and demonstrating that the device's fundamental characteristics and performance are maintained despite the change. The document does not list specific quantitative performance criteria in a table format, but rather states compliance.

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

• Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" because this was non-clinical performance testing (e.g., bench testing of prototypes or manufacturing samples), not a clinical study on patient data.
• Data Provenance: The testing was conducted by Sorin Group Italia S.R.L. and is "non-clinical," implying laboratory or bench testing. The country of origin would be Italy (where Sorin Group Italia S.R.L. is located). It is not retrospective or prospective in the sense of a clinical trial; it is product performance verification.

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

Not Applicable. This is a physical device, and the testing involved demonstrating compliance with engineering and safety standards, not establishing a "ground truth" for diagnostic purposes by human experts.

4. Adjudication Method for the Test Set

Not Applicable. There was no human adjudication process involved in assessing diagnostic performance. The evaluation was based on engineering and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was NOT done. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess how human readers perform with and without AI assistance. This device is a hemoconcentrator, not an imaging or diagnostic AI system.

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

Not Applicable. This is not an algorithm. Performance was assessed for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, recognized national and international standards (e.g., for dialyzers), and performance parameters (e.g., filtration rates, material integrity, biocompatibility, sterility assurance). It is not based on expert consensus, pathology, or outcomes data from patients in the context of a new diagnostic claim. The "ground truth" is that the device, with the new material, still meets the same performance and safety requirements as the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm, so there is no concept of a "training set."

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

Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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The SH14 hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemiconcentrator depends on the protocol being used and required filtration rate. The device is intended to be used for six hours of less.

The SH14 Hemoconcentrator is a hollow fiber type hemoconcentrator available for adult patients consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing. Diluted blood is drawn, from the patient, inside the fibers of the plasma water is removed across the semi-permeable hollow fibers from the blood pathway to the filtrate side. The SH hemoconcentrator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.

Here's an analysis of the acceptance criteria and supporting study for the SH14 Hemoconcentrator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each performance metric in a pass/fail format. Instead, it indicates that the results of the tests "met established specifications" or "met established specifications." For comparative purposes, it also states that data collected show that functional and biocompatibility parameters exhibited by the currently marketed predicate devices (Sorin Group USA HC1400 Maxi and DHF 0.6) apply to the SH14.

Therefore, the table below will list the tests performed and the general outcome as reported. The implication is that the performance of the SH14 was either equivalent to or within the established specifications of the predicate devices.

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

The document does not explicitly state the specific "sample size" for the in vitro tests (e.g., number of SH14 devices tested for priming volume). It generally states "a complete battery of tests were carried out" and "in vitro testing were carried out."

Regarding data provenance:

• Country of Origin: Not explicitly stated for each test, but the submitter is Sorin Group Italia S.r.I. (Italy).
• Retrospective or Prospective: These were laboratory "in vitro" tests, implying they were prospective tests conducted specifically for this submission. The biocompatibility tests were performed on the SH14, aged up to three years ("accelerated aging").

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

This information is not applicable and is not provided. The "ground truth" for device performance in this context is based on objective, measurable physical, chemical, and biological properties evaluated through standardized laboratory tests, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation by multiple readers) to establish a consensus ground truth. Here, the "truth" is derived directly from quantitative measurements in laboratory settings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, and the AI's impact on their performance is being evaluated. This device is a medical device for hemoconcentration, not a diagnostic AI.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the studies described are standalone performance studies of the device itself (not an algorithm in the typical AI sense). The "in vitro test results" and "biocompatibility test results" sections detail these standalone performance evaluations against established specifications and comparison with predicate devices.

7. The Type of Ground Truth Used

The "ground truth" in this context is the objective performance of the device as measured by established scientific and engineering methods, guided by:

• Standardized Test Methods: ISO 10993-1.1995 for biocompatibility and "Guidance for the content of premarket notifications for conventional and high permeability hemodyalizers, August 7, 1990" for in vitro functional performance.
• Predicate Device Performance: The functional and biocompatibility parameters of the Sorin Group USA HC1400 Maxi and DHF 0.6 served as a comparative benchmark, implying that the SH14's performance should be substantially equivalent to these legally marketed devices.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

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

This information is not applicable, as there is no "training set" for a physical medical device like the SH14 Hemoconcentrator in the context of AI.

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