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RMS High-FLO Super26™ Subcutaneous Needle Sets are indicated for subcutaneous infusion of medications in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling for the capacity for infusion of high flow rates including human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling for: Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); and Cuvitru™ Immune Globulin Infusion (Human) 20% (manufactured by Shire).

The RMS HIgH-Flo Super26™ Subcutaneous Needle Sets are sterile, non-pyrogenic, single use, Class II Subcutaneous Administration Set, per 21 CFR 880.5440, comprised of a Super 26-gauge needle assembly, combined with 24-gauge needle tubing and are intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set is a 90-degree, 26gauge stainless steel needle, mounted to a butterfly winged safety closure on one end which is used to close the set upon completion. The other end consists of a luer lock which connects to PVC medic al grade tubing (Figure I). Additionally, each tubing set is equipped with a slide clamp used to stop flow, immediately; as needed. RMS HigH-Flo Super 26TM Subcutaneous Needle Sets are available as a single-needle set, as well as 2-needle, 4- needle, 5-needle, 6-needle sets; through use of a Y-connector, 7-needle and 8-needle sets may also be assembled. The device is for single use only.

The provided document is a 510(k) premarket notification for a medical device (HIgH-Flo Super26™ Subcutaneous Needle Sets) and focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving acceptance criteria for a new AI/software-based device.

Therefore, many of the requested details regarding acceptance criteria for a study proving device performance (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not applicable to this document as it's primarily a regulatory submission for a physical medical device based on bench testing for an incremental design modification, not a study of an AI algorithm or a diagnostic tool requiring extensive human reader involvement or ground truth establishment in a clinical context.

However, I can extract information related to the acceptance criteria for this specific device, which are mainly focused on bench performance to demonstrate equivalence.

Here's an attempt to answer the questions based on the provided text, noting where specific questions are not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)

The study described here is a bench performance study designed to demonstrate that the redesigned device (HIgH-Flo Super26™ Subcutaneous Needle Sets) is substantially equivalent to its predicate device (Integrated Catch-up Freedom Syringe Driver Infusion System) despite differences in tubing diameter and needle set configurations. The primary performance metric assessed is flow rate.

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

Given that this is a 510(k) summary for a physical device where the "acceptance criteria" are implicitly meeting functional specifications and demonstrating performance comparable to a predicate, the "acceptance criteria" are not explicitly stated with numerical thresholds in the same way they would be for an AI algorithm's performance metrics (e.g., sensitivity > X%, specificity > Y%). Instead, the "conclusion" is that the device "performs as intended and is substantially equivalent to the predicate device" based on bench testing.

The reported device performance presented is the achievable flow rates under various conditions (different fluid types, number of needles, and pump settings). The tables themselves represent the performance data that presumably met the implicit acceptance criteria of demonstrating comparable or improved flow for the intended use.

Implicit Acceptance Criteria (derived from context):

• Biocompatibility: Device materials must meet ISO 10993 standards and be non-hemolytic.
• Flow Rate: The device must achieve flow rates suitable for the intended subcutaneous infusion of specified medications (Hizentra, Cuvitru) across various needle configurations and pump settings, and ideally meet or exceed drug manufacturer's recommended flow rates. The stated purpose of the design modification was to allow for "high flow rates."
• Sterility, non-pyrogenicity, single-use, safety features: These are standard performance and design criteria for such devices.

Reported Device Performance:

The document provides tables of "Achievable Flow Rates with Super26™ and Specific Medications/Indications." These tables are the reported performance data. For brevity, only a summary of insights from these tables is provided here, rather than reproducing them entirely:

Note on "Acceptance Criteria" for this submission: The document states, "Bench testing has been conducted to verify that the product performance of the subject device and predicate device are substantially equivalent." The tables of flow rates are the data used to demonstrate this equivalence, implicitly meeting the "acceptance criteria" that the new design performs effectively for its intended use.

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

• Sample Size: Not specified in terms of number of devices tested for flow rates. The text only mentions "Bench Performance Studies" and "Flow Rate Testing." Typical bench testing involves a statistically significant number of samples, but the exact count isn't in this summary.
• Data Provenance: The data is generated from bench testing conducted by the manufacturer, Repro-Med Systems, Inc. dba RMS Medical Products. It is not clinical data from patients.
• Retrospective or Prospective: N/A. This is bench testing, not a clinical study.

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

• N/A. This is a physical device (subcutaneous needle set) and the "ground truth" for flow rate performance is established through repeatable physical measurements using laboratory equipment (e.g., pumps, timers, volume measurements), not by expert human interpretation of images or other clinical data.

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

• N/A. See point 3.

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

• N/A. This is not an AI/diagnostic device.

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

• N/A. This is not an AI/diagnostic device.

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

• The "ground truth" for the performance (flow rate) is established via direct physical measurement during bench testing. For biocompatibility, it's based on laboratory test results (ISO 10993 series standards, Modified ASTM Hemolysis).

8. The sample size for the training set

• N/A. This is not an AI/machine learning device that requires a training set. The device is a physical product for which performance is verified through engineering bench tests.

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

• N/A. See point 8.

In summary: The provided document is a 510(k) premarket notification for a physical medical device, not an AI or software-based medical device. Therefore, many of the questions related to AI study design, expert ground truth, and human reader studies are not applicable. The "study" proving the device meets acceptance criteria is primarily bench testing to demonstrate functional equivalency, particularly concerning flow rates and biocompatibility, compared to a legally marketed predicate device.

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RMS HigH-Flo™ Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.

The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are a Class II Intravascular Administration Set per 21 CFR 880.5440 and intended for the delivery of medication to the subcutaneous tissue. Each set consists of a sterile packaged kit including the infusion set and a commercially available adhesive dressing used to hold the device in place. The infusion set has a 90-degree stainless steel grade needle mounted to a butterfly assembly on one end, and a luer lock on the other end, connected by medical grade tubing. The needles are available in 24 and 26 gauges and in lengths of 4mm, 6mm, 12mm and 14mm. The 4mm and 14mm lengths are added for children and obese adult patients, respectively. The optional convenience 24" Extension Set is used to add length to a needle set when desired.

There is a snap closure to safely capture the needle after use. This minimizes the potential for a needlestick injury. Each leg in a set is equipped with a slide clamp to stop flow immediately, if needed. The RMS HIgH-Flo™ Subcutaneous Safety Needle Sets are available for up to 8 infusion sites using our basic sets of one, two, three or four legs ganged together using a low residual "Y-Connector" (for example to achieve a 7 site infusion, a RMS 4 set will be ganged with a RMS 3 set using a Y-Connector). All needle sets, regardless of combination, are for single use only.

The provided text describes the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets and the studies performed to demonstrate its substantial equivalence to predicate devices, particularly focusing on performance, biocompatibility, and safety.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for individual tests within the "Clinical Simulated Use Study" or the flow rate studies. It mentions "medical professionals participated" in the clinical study and "comparative tests" and "flow tested" for the performance studies without giving specific numbers of devices or test runs.

• Provenance: This is a 510(k) summary submitted to the FDA (United States). The studies appear to be internal RMS Medical Products studies ("RMS internal procedure (SOP 8001)") or performed in accordance with international (ISO) and national (USP) standards, indicating the data is likely from studies conducted by or for the manufacturer. The document doesn't specify countries of origin for the test data beyond the manufacturer's location in New York, USA.
• Retrospective/Prospective:
  • Biocompatibility and Sterilization/Shelf Life: These are typically prospective laboratory/animal studies.
  • Clinical Simulated Use Study: This was a prospective study ("medical professionals participated in an RMS Clinical Simulated Use Study, per FDA guidance documents with FDA review of the proposed protocol").
  • Performance Testing (flow rate, residual volume, material/device characteristics): These were prospective laboratory tests.

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

The document mentions "medical professionals participated" in the RMS Clinical Simulated Use Study. However, it does not specify the number or qualifications of these medical professionals, nor does it explicitly define their role in establishing a "ground truth" in the way one might for diagnostic accuracy studies. Their role was to evaluate the device during simulated use, and their subjective and statistical data contributed to the safety determination.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth from multiple experts. For the "Clinical Simulated Use Study," it states, "An analysis of all subjective and statistical data concludes that the RMS HIgH-Flo™ Subcutaneous Safety Needle Sets met the criteria set." This implies an analysis of the collected data rather than a consensus or adjudication process among multiple reviewers to determine a 'truth' independently.

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 MRMC Comparative Effectiveness Study: This device is a medical device (subcutaneous needle set), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed. The studies focus on the physical performance, biocompatibility, and safety of the needle set itself.

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

• Not applicable: As this is a physical medical device and not an AI algorithm, a standalone performance study in the context of AI is not relevant. The device's performance is standalone in the sense that its physical properties (flow rate, material, etc.) are tested without human intervention impacting the measurement of those properties, but it is ultimately used by a human.

7. The Type of Ground Truth Used

The concept of "ground truth" in the context of this device's evaluation is primarily based on:

• Established Scientific Standards: For biocompatibility (ISO standards), pyrogenicity (USP limits), and sterilization (ISO 11137).
• Pre-defined Acceptance Criteria: For the Clinical Simulated Use Study, criteria were "set" and the device "met the criteria."
• Direct Measurement and Comparison: For flow rates, residual volumes, material characteristics, device dimensions, and mechanical properties, the "ground truth" is the measured physical data, which is then compared against predicate devices and internal performance expectations.

8. The Sample Size for the Training Set

• Not applicable: This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable: As there is no training set for an AI algorithm, this question is not relevant.

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