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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 CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses.

The CADD™-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis VIP Ambulatory Infusion Pump, CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD™-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software - Administrator to the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0 ("CADD"-Solis Version 3.0 Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 1.0 (K072144) and CADD -Solis VIP Ambulatory Infusion Pump, Version 2.0 (K111275). The user activates CADD® Solis Version 3.0 Pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The CADD®-Solis Version 3.0 Pump consists of components, such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, onboard memory, and pump log. The CADD® Solis Version 3.0 Pump exterior surface components include the pump housing, LCD lens, labels, and keypad, and the materials of construction for these components are widely used in the medical industry. The CADD -Solis Version 3.0 Pump is designed to be used with a CADD® Infusion Disposable, such as Medication Cassette Reservoir.

The CADD™-Solis Medication Safety Software System consists of the Administrator and the Point of Care software applications. This software allows the user to create therapy-based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The provided text describes the CADD®-Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, and the CADD™-Solis Medication Safety Software, Version 3.1. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.

Here's a breakdown of the requested information based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" against those criteria in a table format. Instead, it relies on demonstrating equivalence through design verification, software validation, and human-factors engineering studies, concluding that "All testing met pre-established specifications."

Instead of a typical acceptance criteria table for a diagnostic device, the document presents a comparison table between the new device and predicate devices for various characteristics and infusion specifications. This table essentially defines the design and functional characteristics that were evaluated for equivalence.

Since direct "acceptance criteria" and "reported performance" like sensitivity/specificity for a medical device are not specified for this infusion pump and software, I cannot create that table. However, I can infer from the comparison tables that the acceptance for this 510(k) submission primarily involved demonstrating that the new device's characteristics and performance are comparable to the predicate devices.

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

The document does not specify a "test set" in the context of a clinical study or a dataset for evaluating an AI algorithm. The testing described is "design verification and software validation testing" and "human-factors engineering studies."

• Sample Size: Not applicable/not provided for a "test set" in the context of clinical performance evaluation. The testing would have involved engineering and software quality assurance methods.
• Data Provenance: Not applicable/not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is typically relevant for studies validating diagnostic algorithms or interpretations. For an infusion pump and its associated software, "ground truth" would be established through engineering specifications, regulatory standards, and functional testing protocols rather than expert consensus on medical findings.

• Number of Experts: Not applicable/not provided.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method

This is also typically relevant for studies involving human interpretation. For design verification and software validation of an infusion pump and software, adjudication methods (like 2+1, 3+1) are not typically used. Testing outcomes are usually determined by passing or failing pre-defined engineering and functional requirements.

• Adjudication Method: Not applicable/not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. The document explicitly states: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the CADD®-Solis Version 3.0 Pump. CADD™ Solis Medication Safety Software-Administrator and POC."
• Effect Size with AI vs. without AI assistance: Not applicable, as there was no MRMC study and the devices are an infusion pump and its safety software, not an AI diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Yes, in a sense, as design verification and software validation would assess the device's inherent performance capabilities without direct human-in-the-loop performance measurement against a clinical outcome. However, this is not in the context of an "algorithm" in the way it's usually asked for AI diagnostic devices. The performance testing was of the "algorithm" of the pump's operating system and the software's functionality. The "Testing Conclusion" states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended."

7. Type of Ground Truth Used

The "ground truth" for this type of device would be based on:

• Engineering Specifications: Pre-defined functional requirements and performance parameters for mechanical, electronic, and software components.
• Regulatory Standards: Compliance with relevant national and international medical device standards.
• Functional Testing Protocols: Measured outputs and behaviors of the pump and software across various operating conditions.

8. Sample Size for the Training Set

This product is not described as an AI/ML device that requires a "training set" in the conventional sense (e.g., for image classification or prediction tasks). Therefore:

• Sample Size for Training Set: Not applicable/not provided.

9. How Ground Truth for the Training Set was Established

As this is not an AI/ML device requiring a training set with medical "ground truth":

• How Ground Truth for Training Set was Established: Not applicable/not provided.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study described is a combination of:

• Design Verification and Software Validation Testing: This rigorously evaluated the CADD®-Solis Version 3.0 Pump and the CADD™-Solis Medication Safety Software-Administrator and Point of Care against pre-established engineering specifications and software requirements. This type of testing ensures that the device and software function as intended and meet all design inputs.
• Human-Factors Engineering Studies: These studies assessed the usability and user interface of the device and software, ensuring that they can be operated safely and effectively by users.
• Substantial Equivalence Comparison: The submission primarily relies on demonstrating that the new devices are substantially equivalent to previously cleared predicate devices (CADD®-Solis Ambulatory Infusion Pump, Models 2100/2110 Version 1.0, and CADD®-Solis VIP Ambulatory Infusion Pump, Model 2120 Version 2.0; and CADD™-Solis Medication Safety Software Versions 1.2 and 2.0). The detailed comparison tables (pages 4-8 and 9-10 of the original document) highlight the similarities in intended use, technological characteristics, and performance features between the new and predicate devices.

The "Testing Conclusion" states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended. The testing results allowed for a conclusion to be made that the CADD® -Solis Version 3.0 Pump, and CADD™ Solis Medication Safety Software-Administrator and POC were as safe and effective as the predicate devices."

This indicates that the "acceptance criteria" were essentially the fulfillment of all design and software requirements and the demonstration of substantial equivalence to predicate devices through comprehensive non-clinical testing. No clinical studies were deemed necessary.

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