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The NxStage PureFlow SL module is an optional accessory to the NxStage System One™ that prepares dialysate for use during hemodialysis, as prescribed by the physician.

The NxStage PureFlow SL module is an optional accessory to the NxStage System One used to prepare water for hemodialysis that meets ANSI/AAMI/ISO 13959:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PureFlow SL consists of the Control Unit (CU), the water Pre-Treatment Unit, the optional OPTA Kit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document is a 510(k) Summary for a device modification, not a comprehensive study report with detailed performance data. Therefore, many of the requested details about specific acceptance criteria, study sizes, ground truth establishment, and MRMC effectiveness are not explicitly stated. The document focuses on demonstrating substantial equivalence to a predicate device based on design control requirements and general performance verification.

Here's a breakdown of the available information structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed numerical performance results. Instead, it makes a general statement about meeting design specifications and being suitable for its intended use.

However, based on the Technological Characteristics Comparison Table (Table 1) and the description, we can infer some qualitative "acceptance criteria" through comparison with the predicate device and relevant standards:

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The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.

The NxStage PFSL module is an optional accessory to the NxStage System One that is used to treat water for hemodialysis per ANSI/AAMI/ISO 13959:2009 and ANSI/AAMI/ISO 26722:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the optional OPTA Kit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.

Here's a breakdown of the acceptance criteria and study information for the NxStage PureFlow SL Subsystem, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.

The NxStage PFSL module is an optional accessory to the NxStage System One that is used to treat water for hemodialysis and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI RD52:2004 and ANSI/AAMI RD62: 2006. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.

The provided text describes a Special 510(k) submission for a device modification, which primarily focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies on design control requirements and performance testing to ensure the modified device meets design specifications and remains as safe and effective as the original. As such, the information you've requested regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, and expert qualifications for ground truth establishment is not typically present in a 510(k) summary for such a modification.

The 510(k) summary focuses on demonstrating that the NxStage PureFlow SL (PFSL) module with modifications is substantially equivalent to the legally marketed predicate device (cleared through K060296).

Here's an analysis based on the provided text:

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

The document does not provide a specific table of acceptance criteria with detailed reported performance metrics. Instead, it states:

"Performance, verification and validation testing was conducted to characterize performance of the proposed PFSL to provide a basis of comparison to the predicate device as all features are not identical. Results of this testing have documented that the proposed PFSL module is substantially equivalent to the predicate device and is suitable for the labeled indications for use."

This indicates that internal performance specifications were met to ensure substantial equivalence, but the specific numerical acceptance criteria and results are not disclosed in this summary. The general acceptance criterion is that the modified device performs comparably to the predicate device and meets its design specifications, preparing dialysate per ANSI/AAMI RD52:2004 and ANSI/AAMI RD62: 2006.

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

The document does not specify the sample size used for any test set or the data provenance. The testing mentioned is "Performance, verification and validation testing," which typically refers to bench testing rather than 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 applicable and not provided. The study described is a non-clinical, bench-testing comparison for substantial equivalence, not a clinical study requiring expert-established ground truth.

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

This information is not applicable and not provided. The study described is a non-clinical, bench-testing comparison for substantial equivalence.

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, an MRMC comparative effectiveness study was not done. This device is an accessory for hemodialysis, and the evaluation is non-clinical, focusing on technological characteristics and performance rather than human reader interpretation.

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

A "standalone" performance evaluation in the context of an algorithm or AI would not apply here. However, the non-clinical "Performance, verification and validation testing" can be considered a standalone evaluation of the device's functional performance against its design specifications and the predicate device.

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

The "ground truth" for this device modification is its design specifications and compliance with relevant industry standards (ANSI/AAMI RD52:2004 and ANSI/AAMI RD62: 2006) for preparing dialysate. The performance was characterized to demonstrate substantial equivalence to the predicate device.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

In summary:

This 510(k) focuses on a "Special 510(k) Device Modification" which primarily relies on demonstrating compliance with 21 CFR §820.30 Design Control Requirements and conducting performance, verification, and validation (bench) testing to confirm that the modified device remains substantially equivalent to its predicate device. This type of submission does not typically involve the detailed clinical study metrics, expert consensus, or AI-specific evaluation criteria often associated with novel medical devices or AI-powered diagnostics.

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