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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:

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

• Sample Size for Test Set: Not specified. The document states "Performance, verification and validation testing was conducted," but no specific sample sizes for this testing are provided.
• Data Provenance: Not specified. The testing is referred to as "Non-Clinical Test/Performance Testing - Bench," implying internal lab testing, but no country of origin or whether it was retrospective or prospective is mentioned.

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

Not applicable/Not specified. This is a device modification for a hemodialysis system, not an imaging or diagnostic AI device where expert reads establish ground truth. The "ground truth" for this type of device relates to its adherence to engineering specifications and performance standards.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Since expert consensus on ground truth is not relevant here, no adjudication method would be mentioned.

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 is a component of a hemodialysis system and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable in the context of an AI algorithm. The device's performance is inherently "standalone" in its function of preparing dialysate, but this is mechanical/chemical performance, not AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on engineering specifications, design control requirements, and compliance with established industry standards (e.g., ANSI/AAMI/ISO 13959:2009, ANSI/AAMI/ISO 11663:2009, ANSI/AAMI/ISO 26722:2009, ANSI/AAMI/ISO 13958:2009). The device's performance against these standards constitutes its "ground truth."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is described as "Performance, verification and validation testing" (Section F). This testing was conducted to characterize the performance of the modified device. The submission states that "predetermined acceptance criteria were met. Results of this testing have documented that the proposed NxStage PureFlow SL is substantially equivalent to the predicate device and is suitable for the labeled indications for use."

The entire submission is a "Special 510(k) Device Modification" which means the focus is on certifying compliance to 21 CFR §820.30 Design Control Requirements and demonstrating that the modifications do not alter the safely and effectiveness, making it substantially equivalent to the cleared predicate device (K111174). The study is essentially the internal design verification and validation activities conducted by NxStage Medical, Inc.

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