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The Sapphire Infusion pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial, perineural and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood and blood products.

The Sapphire Infusion pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

It is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home. The pump is intended to be used by both licensed health care professionals and by lay users.

The Sapphire and the administration sets are indicated for use by both adult and pediatric populations.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-use only.

The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The SapphireInfusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial, perineural and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood and blood products. The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be used by both licensed health care professionals and lay users. The pump is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home use.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are sterile and intended for single-patient use and single-use only.

The pump software includes the following infusion modes, but any one can be disabled: Continuous, Intermittent, TPN (Total Parenteral Nutrition), PCA (Patient Controlled Analgesia), Multi-Step and Epidural.

The Sapphire Infusion Pump offers an optional preprogrammed drug library which can be programmed using an additional software program "Drug library editor". The preprogrammed range limits are associated with certain drugs and/or certain modes and/or certain care areas.

Sapphire Infusion Pump accessories include the mini cradle with IPS, PCA lock boxes (100, 250, and 500ml), PCA/PCEA bolus handle, battery charger, battery case for extra battery source, administrations sets, a backpack, multi-pump mounting bracket, and an AC adapter.

Updates included in this submission:

• 1. Addition of a new administration route Perineural Adding an administration route, Perineural, to the indications for use of the device. This update did not require any modification to the pump technology or design.
• 2. Additional updates (catchup changes) that did not change the basic functionality or technological characteristics of the pump or the administration sets
  • . Software (SW) - e.g., minor enhancements, back to spec corrections, cybersecurity enhancements including implementation of digital code signing, reorganization of alarm priorities and audio and visual alarm characteristics, addition of low battery alarm at 10 minutes, addition of air-in-line alarm off option.
  • Pump cradle (accessory) added ●
  • Administration sets, including sets with NRFit connectors. ●

This document is a 510(k) Summary for the Sapphire Infusion Pump and Sapphire administration sets. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the supporting study:

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

The document details various technological characteristics and their performance parameters, comparing the subject device to the predicate device. For many characteristics, the performance is stated as "Same," indicating it meets the established performance of the predicate. Where there are updates or new features, the testing confirms that safety and effectiveness are maintained.

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 sample sizes or data provenance for the individual bench tests or performance testing. It states that "Accuracy testing under anticipated environments of use and routes" was performed, and administration sets performance testing was done per ISO 80369-6:2016, but without details on sample size. Similarly, human factors studies were conducted with the "intended user population, use environment and use scenarios," but specific numbers are not provided. The testing is bench testing and human factors testing, not clinical studies involving patient 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 section is Not Applicable as the document discusses testing of a medical device (infusion pump and administration sets) for performance and safety characteristics, not a diagnostic algorithm where expert ground truth is typically required for image or data interpretation. The ground truth for performance testing is established by engineering specifications, regulatory standards (e.g., IEC, ISO), and risk analysis.

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

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among experts for establishing ground truth in diagnostic studies, which is not relevant to the performance and safety testing described for an infusion pump.

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 section is Not Applicable. The document describes a medical device (infusion pump) and its administration sets, not an AI-assisted diagnostic or treatment planning system. Therefore, MRMC studies or human reader improvement with AI are not relevant here.

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

This section is Not Applicable. The product is a physical device (infusion pump) with embedded software, not a standalone algorithm without human interaction. Performance testing was done on the device itself and its accessories.

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

The ground truth for the performance and safety testing of the Sapphire Infusion Pump and administration sets is based on several factors:

• Regulatory Standards: Compliance with established international standards such as IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (Alarms), IEC 62133-2 (Battery Safety), ISO 10993-11 (Biocompatibility), ISO 80369-6 (Administration sets performance, specifically for NRFit connectors), ASTM F2503-13 (MR Safety).
• FDA Guidance Documents: Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Infusion Pumps Total Product Life Cycle, Applying Human Factors and Usability Engineering to Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, and Reprocessing Medical Devices in Health Care Settings.
• Predicate Device Performance: The primary ground truth for many characteristics is the established safety and effectiveness of the previously cleared Sapphire Infusion Pump (K161667) and administration sets (K141389, K123049). The subject device demonstrates "Same" performance for a majority of parameters.
• Risk Analysis and Verification/Validation: For any new features or modifications (e.g., perineural route, 10-minute low battery alarm, option to disable air detection, mini cradle with IPS, NRFit connectors, sleeve removal, length/priming volume changes), the ground truth is established through internal risk analyses and subsequent verification and validation testing to confirm they do not introduce new questions of safety or effectiveness and meet their design requirements.

8. The sample size for the training set

This section is Not Applicable. The Sapphire Infusion Pump is a hardware device with controlling software, not an AI/ML model that undergoes a training phase with a specific dataset.

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

This section is Not Applicable for the same reasons as point 8.

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The Q Core Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products.

The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.

The dedicated Q Core administration sets for the Sapphire Infusion Pump are intent use and singleuse only.

The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products. The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be used by both licensed health care professionals in the clinical environment, and home users in an ambulatory environment. The Sapphire Infusion Pump is designed to follow the patient through the various care areas, and is suitable for use in the different settings.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are sterile and intended for single-patient use and single-use only.

The pump software includes the following infusion modes, but any one can be disabled: Continuous, Intermittent, TPN (Total Parenteral Nutrition), PCA (Patient Controlled Analgesia), Multi-Step and Epidural.

The Sapphire Infusion Pump offers an optional preprogrammed drug library which can be programmed using an additional software program "Drug library editor". The preprogrammed range limits are associated with certain drugs and/or certain modes and/or certain care areas.

The Q Core Sapphire Infusion Pump includes Wiff functionality that is compatible with MedNet. The WiFi feature can be turned on or off, via an authorized Technician. As such, the Sapphire Infusion Pump is available with and without the WiFi functionality.

Sapphire Infusion Pump accessories include the mini cradle, PCA lock boxes (100, 250, and 500ml), PCA/PCEA bolus handle, battery charger, battery case for extra battery source, administrations sets, a backpack, multi-pump mounting bracket, and an AC adapter.

The modifications are the expansion of the pre-hospital medical transport environment to include another means of medical transport (air), an additional cleaning and disinfection agent, additional Software enhancements and additional accessories.

The provided text describes a 510(k) premarket notification for the Sapphire Infusion Pump (K161667). This submission is for modifications to a previously cleared device (K141389). Therefore, the study focuses on demonstrating substantial equivalence rather than a new device meeting specific acceptance criteria in a comparative effectiveness study.

Here's an analysis of the acceptance criteria and study information based on the provided document:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical trial or performance study for a novel device. Instead, it details that the modified device maintains substantial equivalence to its predicate device. The acceptance criteria are implicitly that the modified device's performance, especially for the new features/environments, should be comparable to or meet the safety and effectiveness standards of the predicate device and relevant industry standards.

The table in the document (pages 5-6) is a comparison between the Predicate Device (K141389) and the Subject Device (K161667), highlighting similarities and differences. The "Reported Device Performance" for the subject device is implied to be "Same" as the predicate for most attributes, or "Supported by literature and/or bench testing/validation" for differences.

Here's a restructured table based on the information provided, focusing on changes and how they meet criteria (implicitly, the criteria are "equivalent to predicate" or "validated"):

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

The document does not specify discrete "sample sizes" in terms of number of patients or cases for the various validation tests. The testing described is primarily non-clinical bench testing, software verification/validation, and human factors evaluations. For these types of tests, sample size generally refers to the number of test units (pumps, accessories) or test runs. These details are not provided in the summary.

Data provenance: The testing was carried out by the manufacturer, Q Core Medical Ltd., in Netanya, ISRAEL. The studies are prospective as they are conducted to validate modifications to an existing device for regulatory submission.

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

This information is not provided. The document details that some changes (e.g., maximum clinician bolus, maximum epidural hourly volume) are "supported by literature and a reference device." This implies reliance on established medical knowledge and previously cleared device specifications rather than new expert consensus for ground truth on these specific parameters for the current submission. For human factors testing, experts (e.g., clinicians) would typically be involved, but their number and qualifications are not specified.

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

This information is not applicable and therefore not provided, as the studies described are primarily technical performance validations and verifications, not clinical trials requiring independent expert adjudication of diagnostic outcomes.

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 was done. This is an infusion pump, not an AI-powered diagnostic imaging device. The concept of "human readers improving with AI assistance" is not relevant to this device.

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

This concept is not directly applicable to an infusion pump. The device itself is a "standalone" algorithmic system in the sense that it performs its infusion functions based on its programming. The software verification and validation activities essentially cover the "standalone" performance of the algorithm without human intervention in the infusion process itself. Human factors testing focuses on the human-device interface and user interaction.

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

The "ground truth" for this device's validation is primarily based on:

• Engineering specifications and design requirements: For pump accuracy, delivery modes, alarm thresholds, physical characteristics, and material compatibility.
• Industry standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-12 (Electrical Safety in medical environment), IEC 60601-1-2 (EMC testing).
• Regulatory guidance: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
• Literature references: For increased bolus volumes and hourly epidural volumes.
• Predicate device's established performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness profile of the K141389 Sapphire Infusion Pump.

8. The sample size for the training set

Not Applicable. As described, this is a modification to an existing infusion pump, and the studies mentioned are verification and validation activities for hardware, software, and changes in use environment. There is no mention of "training sets" in the context of machine learning or AI algorithm development, which is typically where such terminology applies.

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

Not Applicable, as there is no training set for a machine learning model mentioned in the document.

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