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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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The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intraarterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, V medication, epidural medication, blood and blood products.

The Sapphire 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 ground transportation.

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

The enhanced Sapphire Infusion Pump with and without the WiFi capability is the result of modifications to the FDA cleared Sapphire Infusion pump (K123049). The modifications are the addition of WiFi to allow the pump to communicate wirelessly with compatible systems and additional Software enhancements. There are no changes to the basic infusion pump technology.

The Q Core Sapphire infusion pump is a single-channel, volumetric infusion pump that is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. It is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products and includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump has alarms for occlusions, air in the line, administration set installment issues, and internal battery issues. The Pump includes software and is powered by an external power source or by an internal battery. It is intended to be used by both licensed health care professionals in the clinical environment, and home users in an ambulatory environment. The Sapphire 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 provided sterile and are for single- use and single-patient use only. Components from the previously cleared administration sets were used to make sets with new configurations, all within the parameters (e.g. length, diameters, materials) of the sets cleared with the Sapphire Infusion Pump. These new configurations are substantially equivalent to the administration sets that were cleared under K123049, having identical indications for use and technological characteristics.

Here's a breakdown of the acceptance criteria and study information for the Q Core Medical Sapphire Infusion Pump, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical trial report with specific acceptance criteria and performance metrics for a novel AI algorithm. Therefore, the information that can be extracted will primarily relate to engineering and software validation, not necessarily a human-in-the-loop AI effectiveness study as might be expected for an AI-powered diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an infusion pump with WiFi enhancements, the "acceptance criteria" discussed are primarily related to safety, performance against established standards, and equivalence to a predicate device, rather than diagnostic accuracy metrics typically seen in AI studies.

• Basic infusion pump hardware/mechanism
• Delivery modes
• Safety features
  (Modifications: addition of WiFi, additional software enhancements. No changes to basic infusion pump technology.) |
  | Substantial Equivalence to Plum A+® Infusion System with Hospira MedNet™ Software (K042081) | Determined to be substantially equivalent with respect to the WiFi function (both have WiFi function). |
  | Substantial Equivalence of New Q Core Administration Sets to those cleared under K123049 | Determined to be substantially equivalent with respect to: - Dedicated use with Q Core pumps
• Indicated for intravenous infusion
• Prescription use
• Standard, conventional components
• Same material characteristics (biocompatible, non-DEHP, latex-free)
• Same free flow protection (cassette with AFFV)
• Sterile, non-pyrogenic, single patient/use
• Intended for hospital or home use |

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

This document does not specify a "test set" in the context of an AI algorithm's performance on clinical data samples. The testing described is primarily engineering and software validation. Therefore, details like data provenance or sample size for a clinical test set are not applicable here.

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

This information is not applicable as the document describes validation for an infusion pump, not an AI diagnostic or prognostic device requiring expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

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 information is not applicable as the document describes validation for an infusion pump, not an AI-powered diagnostic product that would typically involve human readers.

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

While the pump contains software and the new functionality is WiFi to communicate wirelessly, the document describes the entire device (hardware and software) as the subject of the submission. It's not a standalone AI algorithm in the typical sense. The "Software Verification and Validation" constitutes testing of the algorithm/software within the device, but it's not described as a separate "standalone" performance study on clinical data.

7. The Type of Ground Truth Used

For the software and engineering validation tests listed:

• Electrical Safety, EMC, FCC Testing, Shelf Life: Ground truth is established by the specified international standards (IEC 60601-1, IEC 60601-1-2) or internal quality control specifications for the administration sets.
• Software Verification and Validation: Ground truth is established by the device's functional and performance requirements specifications, as well as the FDA Guidance for medical device software.
• Human Factors Testing: Ground truth relates to usability standards and the ability of users to operate the device safely and effectively, typically assessed through user studies.

There is no mention of "expert consensus, pathology, or outcomes data" as ground truth in this submission, as it's not a diagnostic device.

8. The Sample Size for the Training Set

This information is not applicable. The device described is an infusion pump with software, not a machine learning model that undergoes "training" on a dataset in the AI sense.

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

This information is not applicable for the reasons stated above.

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

The dedicated Q Core Administration Sets for the Sapphire infusion pump are provided sterile and are for single-use and single-patient use only. Components from the previously cleared administration sets were used to make a set with new configuration, all within the parameters (e.g. length, diameters, materials) of the sets cleared with the Sapphire Infusion Pump. This new configuration is substantially equivalent to the administration sets that were cleared under K123049, having identical indications for use and technological characteristics. In addition, this set includes a pressure activated back check valve ("PAV") that has the same cracking pressure as the back check valve that was cleared with administration sets under K031749 (Bodyguard Infusion System). The PAV valve has been added to make it consistent with other sets on the market.

The provided text is a 510(k) summary for the Q Core Administration Set, indicating device clearance based on substantial equivalence to predicate devices. It describes the device, its intended use, and pre-clinical testing performed. However, it does not contain the specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria, as typically presented in a scientific publication.

The document states that "Preclinical testing included in the submission to demonstrate that the new administration set is safe and performs as intended involved the following: Visual tests, Dimensional testing, Physical requirements, Flow accuracy." It then concludes that the new administration set "is substantially equivalent... with respect to the indications for use, technological characteristics and materials."

Therefore, based only on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and a study demonstrating compliance. The document is a regulatory approval letter and summary, not a detailed scientific study report.

However, I can extract the information that is present and indicate what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

• Indications for Use
• Technological Characteristics
• Materials
• Cracking pressure of the back check valve | - Passed Visual tests
• Passed Dimensional testing
• Passed Physical requirements
• Passed Flow accuracy

Conclusion: The new administration set is "substantially equivalent" to predicate devices K123049 (primary predicate) and K031749 (for back check valve cracking pressure). |

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

• Sample size used for the test set: Not specified in the provided document. The document only mentions "Preclinical testing" but does not detail the number of units tested for Visual, Dimensional, Physical, or Flow accuracy.
• Data provenance: Not specified. The document indicates Q Core Medical Ltd. is located in Netanya, ISRAEL, but does not state where the testing was conducted or the origin of the data.
• Retrospective or prospective: Not specified.

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 present in the document. The testing described (Visual, Dimensional, Physical, Flow accuracy) for an administration set does not typically involve expert review for "ground truth" establishment in the manner of medical image analysis or clinical diagnosis. These are engineering and performance tests against specifications.

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

• Not applicable/Not specified. Adjudication methods like "2+1" are typically used in clinical studies or expert reviews to resolve discrepancies, which isn't described for the preclinical engineering tests 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 document describes a medical device (infusion administration set) that does not involve "human readers" or "AI assistance" in its direct function. It is a physical medical component, not a diagnostic or AI-powered system.

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

• Not applicable. This is not an algorithm-based device.

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

• For the preclinical testing mentioned (Visual, Dimensional, Physical, Flow accuracy), the "ground truth" would be the engineering specifications and performance standards for the device, and compliance with these standards (or equivalence to predicate device performance) would be the measure. No expert consensus, pathology, or outcomes data is mentioned as ground truth for these tests.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI development.

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

• Not applicable. This device does not use a "training set."

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The Q Core Sapphire infusion pump is intended for the 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 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 ground transportation.

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

The Q Core Sapphire infusion pump the result of modifications to the FDA cleared AP 34 Infusion pump (K082182). The modifications were changes to the user interface and additional functions that include new delivery modes and the Drug Library feature. There are no changes to the basic infusion pump technology. Like its predicates, the Sapphire is a single-channel, volumetric infusion pump that is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. It is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products and includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump has alams for occlusions, air in the line, administration set installment issues, and internal battery issues. The Pump includes software and is powered by an external power source or by an internal battery. It is intended to be used by both licensed health care professionals in the clinical environment, and home users in an ambulatory environment. The Sapphire pump is designed to follow the patient through the various care areas, and in pre-hospital medical ground transportation.

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

This document, K123049, is a 510(k) summary for the Q Core Sapphire Infusion Pump System. It details the device description, indications for use, technological characteristics, and pre-clinical testing performed to establish substantial equivalence to predicate devices. The document does not contain acceptance criteria for specific performance metrics or detailed study results that "prove the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with defined sensitivity/specificity targets.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a series of pre-clinical tests and comparisons of technical characteristics.

Here’s a breakdown of the information based on your request, highlighting what is (and isn't) present in this 510(k) summary:

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

The document does not provide a table of acceptance criteria with reported performance values in terms of specific sensitivity, specificity, accuracy, or similar quantitative metrics for a diagnostic claim. The "performance" is demonstrated through compliance with recognized standards and comparison to predicate devices, rather than a direct measurement against a predefined criterion table.

The preclinical testing section lists the types of tests performed and the standards they adhere to. These standards implicitly contain acceptance criteria that the device must meet, but the specific numerical results of these tests (e.g., how accurate the pump was in terms of percentage deviation) are not included in this summary.

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

This information is not provided in the 510(k) summary. The document describes the types of preclinical tests performed (e.g., electrical safety, pump accuracy), but does not detail sample sizes for these tests or the provenance of any data used. This is typical for submissions focused on mechanical/electronic device performance and compliance with a standard, rather than clinical efficacy studies.

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 therefore not provided. This 510(k) summary is for an infusion pump, which is a hardware device for drug delivery, not a diagnostic device that requires expert adjudication for ground truth (e.g., medical imaging analysis). The performance evaluation relies on engineering tests against established standards.

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

This information is not applicable and therefore not provided. As explained above, this is not a diagnostic device involving expert consensus.

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 information is not applicable and therefore not provided. An infusion pump does not involve human readers interpreting data, nor does it incorporate AI in a way that would lead to an MRMC study.

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

This information is not applicable and therefore not provided. The device is a physical pump, not an algorithm, so a standalone algorithm performance study is irrelevant.

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

The "ground truth" for the tests mentioned (e.g., pump accuracy, electrical safety) would be established by the specifications and criteria outlined in the respective IEC and ISO standards. For example, for pump accuracy, the ground truth would be the expected flow rate vs. the measured flow rate within acceptable deviations defined by IEC 60601-2-24. This is a technical specification compliance model, not a clinical "ground truth" derived from patient data or expert consensus.

8. The sample size for the training set

This information is not applicable and therefore not provided. The Q Core Sapphire Infusion Pump is not an AI/ML-driven device that utilizes a training set in the conventional sense.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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