Search Results

The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.

SIGMA Spectrum is a large volume pump within the SIGMA Spectrum infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.

The pump provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, blood, blood products, and mixtures of required patient therapy through administration sets at clinician's selectable rates and volumes.

The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.

The Master Drug Library (MDL) is a stand-alone (not embedded in the pump) software application installed on a hospital-provided computing platform and used to create a drug library file. MDL facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.

This submission includes software design and labeling changes to address the issues leading to recalls Z-0530-2022 and Z-2103-2023.

This FDA 510(k) clearance letter pertains to an infusion pump, not an AI/ML powered medical device. Therefore, many of the requested categories in your prompt (such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," and "Training set sample size/ground truth establishment") are not applicable to this type of medical device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of technical characteristics and verification of performance against established requirements.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the overall device in a quantifiable manner that would typically be found in an AI/ML context (e.g., specific sensitivity, specificity, or AUC targets). Instead, it demonstrates compliance with a range of technical specifications, which inherently act as acceptance criteria for the design and performance. The "Reported Device Performance" is implied by the statement that "Non-clinical testing met all acceptance criteria."

Below is a table summarizing key technical characteristics that function as performance criteria for the infusion pump. Since the subject device is deemed "substantially equivalent" to the predicate, and no new performance claims are made that deviate from the predicate, their performance characteristics are identical as presented.

Ask a specific question about this device

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, and blood products. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The Spectrum IQ Infusion System with Dose IQ Safety Software is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to reduce operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies. This automation is intended to reduce pump programming errors.

The Spectrum IQ Infusion System with Dose IQ Safety Software is intended to be used by trained healthcare professionals.

Spectrum IQ is a large volume pump within the Spectrum IQ infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.

The pump provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, blood and blood products through administration sets at clinician's selectable rates and volumes.

The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.

Dose IQ is a standalone software application installed on a hospital-provided computing platform and used to create a drug library file. Dose IQ facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file includes customers' dosing limits and additional pump configuration settings. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.

This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023.

The provided FDA 510(k) clearance letter for the Spectrum IQ Infusion System with Dose IQ Safety Software (K251636) does NOT describe a study involving an AI/Machine Learning algorithm for diagnostic or prognostic purposes, which would typically involve the criteria you've outlined.

Instead, this device is an infusion pump with safety software, intended to reduce operator interaction through guided programming to minimize "pump programming errors." The summary explicitly states: "This submission includes software design and labeling changes to address the issues leading to recalls Z-0529-2022 and Z-2104-2023." This suggests that the changes are primarily bug fixes, usability improvements, and potentially enhanced safety features rather than the introduction of a novel AI-driven diagnostic tool.

Therefore, many of the requested details about acceptance criteria and study design (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of device and submission. These criteria are typically relevant for AI/ML-enabled devices that perform interpretation of medical images, signals, or patient data for diagnostic or prognostic purposes where "ground truth" and human reader performance are central to validation.

The 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (K230041) through a comparison of technological characteristics and non-clinical performance and safety testing.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Device Performance (Based on the provided document)

The document doesn't present specific quantitative acceptance criteria in a table format for a "study" as you might expect for an AI/ML diagnostic device. Instead, "acceptance criteria" for an infusion pump typically refer to meeting defined performance specifications (e.g., volumetric accuracy, alarm thresholds, power consumption, environmental limits) and safety standards (e.g., IEC 60601 series).

The document states that "Non-clinical testing met all acceptance criteria, demonstrating that the device is safe and effective for its intended use." However, it does not provide the specific quantitative criteria or the numerical reported device performance for each. It assumes these were adequately documented in the full submission to FDA.

The "performance" described relates to the functional aspects of the pump and software:

Ask a specific question about this device

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

This is a 510(k) premarket notification for "Solution Administration Sets" by Baxter Healthcare Corporation. The document states that the devices are substantially equivalent to a predicate device (K203609 cleared on September 30, 2021).

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance values in the format usually seen for AI/ML devices. Instead, it describes general conformance to recognized standards and the positive outcomes of various tests.

Note: This submission is for a traditional medical device (solution administration sets), not an AI/ML device. Therefore, the questions related to AI/ML specific studies (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC study, standalone performance, training set sample size, training set ground truth) are not applicable to this document. The "tests" described are standard engineering, biocompatibility, and sterilization validations for physical medical devices.

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

Not applicable, as this is a traditional medical device, not an AI/ML device. The testing described is bench testing and biocompatibility assessments, not a study involving patient data or a specific test set in the AI/ML context.

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)

Not applicable, as this is a traditional medical device, not an AI/ML device. Ground truth as typically defined for AI/ML models is not relevant here.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device. Instead of "ground truth," the device relies on conformance to established international and national standards (ISO, ASTM, USP) and predefined acceptance criteria for various physical, chemical, and biological tests.

8. The sample size for the training set

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

Ask a specific question about this device

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices are single use disposable devices intended for the administration of fluids from a container to the patient's vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.

This FDA 510(k) summary describes an intravascular extension set and accessories. The filing primarily focuses on demonstrating substantial equivalence to a predicate device (K192366) and the removal of a caution statement related to body weight. Therefore, the information provided does not detail a study involving AI or complex performance metrics as typically seen for AI/ML-enabled devices.

Based on the provided text, the acceptance criteria and study information are as follows:

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

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 a "test set" in the context of performance evaluation with a defined sample size for the device itself. The primary testing mentioned is biocompatibility. For biocompatibility, there is no information about sample size or data provenance provided in this summary.

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)

Not applicable. This device is a physical medical device (intravascular extension set and accessories), not an AI/ML-enabled device requiring expert ground truth for performance evaluation of diagnostic accuracy.

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

Not applicable. This device is a physical medical device, not an AI/ML-enabled device requiring adjudication of expert interpretations.

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. No MRMC study was performed as this is a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

Not applicable. For biocompatibility testing, the "ground truth" would be established by standardized testing methods and international standards (e.g., ISO 10993 series), not expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As there is no training set mentioned, there is no ground truth established for a training set.

Ask a specific question about this device

The Novum IQ Syringe Pump is intended to be used for the controlled administration of fluids. These include pharmaceutical drugs, parenteral nutrition, blood and blood products, and enteral nutrition.

The Novum IQ Syringe Pump is intended to deliver an infusion through the following clinically accepted routes of administration: intravenous, arterial, enteral and subcutaneous.

The Novum IQ Syringe Pump is intended to be used in conjunction with legally marketed and compatible administration sets, syringes, and medications provided by the user.

The Novum IQ Syringe Pump is suitable for patient care in hospitals and outpatient health care facilities.

The Novum IQ Syringe Pump is intended for use on adults, pediatrics and neonates.

The Novum IQ Syringe Pump is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors.

The Novum IQ Syringe Pump is intended to be used by trained healthcare professionals.

The Novum IQ Syringe Pump is a general purpose, syringe-based, smart pump within the Novum IQ syringe pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the Novum IQ Syringe Pump and its associated drug library are configured. The Novum IQ syringe pump is capable of delivering fluids in syringes ranging in size from 1 mL - 60 mL.

The Novum IQ Syringe Pump is a system that provides delivery of fluids into a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical syringe pump used for the controlled administration of fluids including pharmaceutical drugs, parenteral nutrition, blood products, and enteral nutrition through compatible syringes and administration sets at user selectable rates and volumes.

The provided text is a 510(k) summary for the Novum IQ Syringe Pump. It details the device's indications for use, technological characteristics, and non-clinical testing performed to support its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a table, or information about studies that prove the device meets said acceptance criteria in the way typically expected for an AI/ML device (e.g., performance metrics like sensitivity, specificity, or AUC).

This document describes a medical device (an infusion pump) and its regulatory clearance, focusing on software updates and labeling. It is not an AI/ML device in the context of diagnostic or predictive capabilities that would involve traditional "performance" metrics for acceptance criteria.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance in a table, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or how ground truth for the training set was established. These items are typically relevant for AI/ML-driven diagnostic or prognostic devices, which the Novum IQ Syringe Pump is not.

The document states:

• "Clinical testing is not applicable for this submission."
• The testing performed was "Unit testing was composed of software actor requirements verification and static analysis," "Integration testing of software requirements, performed as "black box" testing," and "System requirements verification testing was performed as "black box" testing with the Novum IQ Syringe Pump Software/hardware configuration."
• "All verification and validation testing was successfully completed. The non-clinical testing performed demonstrates that the device is as safe and effective as the legally marketed predicate device meets that the device meets the performance requirements set out as part of the design control process."

This indicates that the "acceptance criteria" were related to software and system functionality and safety, rather than diagnostic accuracy or clinical outcomes that would be assessed using the requested metrics.

Ask a specific question about this device

ACTIFUSE ABX, ACTIFUSE SHAPE and ACTIFUSE MIS:

Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware and intervertebral disc space. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

When used in the intervertebral disc space, Actifuse must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE:

ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). ALTAPORE can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE SHAPE:

ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE SHAPE can be used by itself or with autograft as a bone graft extender in posterolateral spinal fusion procedures. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space. ALTAPORE SHAPE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE MIS: ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE MIS can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE MIS resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE MIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS

Actifuse is a phase-pure, porous, silicate-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse is similar to human cancellous bone. After it is implanted, ACTIFUSE undergoes physiologically-mediated resorption and is replaced by natural bone

ACTIFUSE is osteostimulatory based upon in vitro studies that show cellular responses, such as metabolic activity and proliferation, are accelerated when compared to an identical that did not contain 0.8% silicon by weight..

ACTIFUSE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ACTIFUSE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses.

The Actifuse bone void filler is presented in multiple product variants:

ACTIFUSE ABX

ACTIFUSE ABX presents the ACTIFUSE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable aqueous gel carrier packaged in a wide-bore applicator. ACTIFUSE ABX is a sterile, single-use device available in volumes of 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml.

ACTIFUSE ABX is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood, autologous bone marrow aspirate, or autologous bone at the discretion of the surgeon.

ACTIFUSE MIS

ACTIFUSE MIS System is an ACTIFUSE ABX packaging configuration in which the ACTIFUSE ABX implant material is supplied in a sterile 7.5ml cartridge packed with ACTIFUSE ABX implant material is presented with a delivery applicator and as a separate 7.5ml refill cartridge.

ACTIFUSE SHAPE

ACTIFUSE SHAPE supplies the ACTIFUSE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable Alkylene Oxide co-polymer carrier as a shaped wax-like putty in a sterile pouch. ACTIFUSE SHAPE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ACTIFUSE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

ALTAPORE

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca. P. O. H. Si).

ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available in 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml configurations.

ALTAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE undergoes cell-mediated remodeling and is replaced by natural bone.

ALTAPORE MIS

ALTAPORE MIS System is an ALTAPORE packaging configuration in which the ALTAPORE implant material is supplied in a sterile 7.5ml cartridge is presented with a delivery applicator and as a separate 7.5ml refill cartridge.

ALATAPORE MIS System (hereafter referred to as "Altapore MIS) is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE MIS is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE SHAPE

ALTAPORE SHAPE supplies the ALTAPORE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable Alkylene Oxide co-polymer carrier as a shaped wax-like putty in a sterile pouch. ALTAPORE SHAPE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

ALTAPORE SHAPE is bioactive based on in vitro studies that show it forms a surface apatitelayer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE SHAPE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE SHAPE undergoes cell-mediated remodeling and is replaced by natural bone.

The provided document describes a 510(k) premarket notification for several bone void filler devices (Actifuse ABX, Actifuse MIS, Actifuse Shape; ALTAPORE, ALTAPORE SHAPE; ALTAPORE MIS) by Baxter Healthcare Corporation. The submission aims to expand the indications for use to include intervertebral disc space applications.

Crucially, the document explicitly states that "no additional non-clinical data was needed to support the expanded indications proposed in the current submission" because "the subject device is identical to the previously cleared primary predicate device (K232315)." This means that the current submission relies entirely on the performance data of the predicate device (Catalyst Bone Void Filler, OssDsign AB, K232315) and existing reference devices (Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575; Altapore, Baxter, K192363; Altapore Shape, Baxter, K200640; Altapore MIS, Baxter, K201464).

Therefore, I cannot provide detailed acceptance criteria or study results for the currently submitted devices directly from this document, as no new performance testing specific to this submission's expanded indication for these devices is reported. The information requested below would typically come from the original 510(k) submission for the predicate device (K232315) or the reference devices.

However, I can extract the available information as specifically related to this submission's approach to demonstrating substantial equivalence.

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

As stated above, no new performance data or acceptance criteria are provided in this specific submission for the expanded indications. The submission argues for substantial equivalence based on the device being identical to a predicate (K232315) and similar to reference devices (K082575, K192363, K200640, K201464).

Acceptance Criteria (Implicit via Substantial Equivalence to Predicate): The device is considered to meet acceptance criteria if its technological characteristics, intended use, and performance are substantially equivalent to the cleared predicate and reference devices, implying it is as safe and effective.

Reported Device Performance:
The document describes the characteristics and prior in vitro/in vivo findings of the devices, which would have supported their initial clearances, but does not present new performance test results against new acceptance criteria for the expanded indication.

• ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS:
  • Osteostimulatory: Based on in vitro studies showing accelerated cellular responses (metabolic activity and proliferation) compared to an identical product without 0.8% silicon by weight.
  • Bioactive: Based on in vitro studies showing formation of a surface apatite layer in simulated body fluid.
  • Osteoconductive: Based on in vivo animal studies demonstrating bone healing in a critical defect model, confirmed by radiographic, histopathological, histomorphometric, and mechanical analyses.
• ALTAPORE, ALTAPORE SHAPE, ALTAPORE MIS:
  • Bioactive: Based on in vitro studies showing formation of a surface apatite layer in simulated body fluid.
  • Osteoconductive: Based on in vivo animal studies demonstrating bone healing in a critical defect model, confirmed by radiographic, histopathological, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone.

The remaining points cannot be fully addressed from the provided text for this specific K-submission, as it explicitly states that no additional non-clinical data was needed. This implies that the current submission relies on previous data and FDA's prior determinations of substantial equivalence for the predicate and reference devices.

To answer points 2-9, one would need to access the original 510(k) submissions for:

• Primary Predicate: Catalyst Bone Void Filler, OssDsign AB, K232315
• Reference Devices:
  • Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575
  • Altapore, Baxter, K192363
  • Altapore Shape, Baxter, K200640
  • Altapore MIS, Baxter, K201464

Without those specific predicate/reference 510(k) summaries, I cannot provide the requested details regarding sample sizes, data provenance, ground truth establishment, or specific study methodologies.

Summary based on information provided for the current K241564 submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A: No new test set data was reported as needed for this submission. Reliance on previously cleared predicate (K232315) and reference devices (K082575, K192363, K200640, K201464).

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)
* N/A: No new ground truth establishment reported as needed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* N/A: No new test set reported as needed for this submission.

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 device is a bone void filler, not an AI/imaging device, so MRMC studies are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* N/A: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A: No new ground truth reported as needed for this submission. However, for the original clearances of the predicate/reference devices, the descriptions mention "radiographic, histopathological, histomorphometric, and mechanical analyses" in animal studies, which serve as forms of ground truth for osteoconductivity.

8. The sample size for the training set
* N/A: This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established
* N/A: Not applicable for a physical medical device.

Ask a specific question about this device

Dose IQ Safety Software is intended to be used with the Novum IQ Syringe Pump and Novum IQ Large Volume Pump to support the controlled administration of fluids.

Dose IQ Safety Software is intended to allow users to create and maintain drug libraries, including the configuration of pump settings for the compatible pumps.

Dose IQ Safety Software is intended to allow users to establish the facility-defined syringe list, which is a subset of Baxter's approved compatible syringes, for the Novum IQ Syringe Pump.

Dose IQ Safety Software is intended to be used by licensed pharmacists.

Dose IQ Safety Software is intended to be used in hospitals and outpatient health care facilities.

Dose IQ is a standalone (not embedded in pumps) browser-based software application that is installed on a hospital-provided computing platform. It provides the hospital's pharmacists the ability to create and configure a facility-specific drug library file for the either the Novum IQ Large Volume Pump or the Novum IQ Syringe Pump. Dose IQ stores the created drug library for future transfer to an infusion pump that is compatible with the drug library file through the IQ Enterprise Gateway, or via a USB. It is intended to be used by multiple users simultaneously. Authorized users access the software though a Google Chrome web browser (build 76.0.3809.100 and above).

Creating a facility-specific drug library in Dose IO is one method to implement a Dose Error Reduction System (DERS) – a safety system intended to reduce medication errors. A hospital-defined drug library defines medications with individual concentrations, concentration limits, dosing units, dosing limits, alarm configuration settings, and administration requirements that are specific to each patient care area. Pump programming values are checked against these hospital-defined limits. The pump alerts clinicians if programmed values exceed these limits. Also included in the drug library are hospital-defined individual care area settings and general pump settings. DERS is not active when programming an infusion using Basic Mode, which requires the pump user to manually specify the parameters for the infusion on the pump, therefore only individual Care Area settings, general pump settings, and pump default settings apply.

Dose IQ does not directly interface with or control the compatible infusion pump. It solely provides the ability to create a drug library file that can then be loaded to the compatible infusion pump. Dose IO does not deploy the file to the pump; this is done by USB media or the IQ Enterprise Gateway software. A copy of the drug library file is stored in each pump, so that the pump can operate, without real-time interaction, with other components of the Novum IQ Platform.

Baxter provides a list of syringe containers that are permissible with the Novum IQ Syringe pump based on specific syringe brands and sizes. The Approved Syringe List is available on Baxter's Technical Service Portal and must be uploaded into Dose IQ. The Approved Syringe List cannot be modified in Dose IQ. The pharmacist selects the required syringe brands and sizes from this Approved Syringe List to create the Facility Syringe List for use within the hospital. Dose IQ incorporates the Approved Syringe List and the Facility Syringe List as part of the drug library file for the Novum Syringe pump.

The provided text describes the 510(k) premarket notification for the Baxter Dose IQ Safety Software. However, it explicitly states, "No clinical testing was performed in support of this premarket notification." Therefore, there is no information in the provided document about "acceptance criteria" based on clinical performance, a "study that proves the device meets the acceptance criteria" in a clinical context, or details like sample size, expert ground truth establishment, MRMC studies, or standalone performance.

The document primarily focuses on non-clinical testing, verification, and validation to demonstrate substantial equivalence to a predicate device. It details software testing and a human factors evaluation.

Based on the provided text, here's what can be extracted regarding acceptance criteria and performance, primarily from a non-clinical testing and verification/validation perspective:

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

Since the document does not present clinical acceptance criteria, the "acceptance criteria" implied here are related to software verification and validation, and meeting design inputs and user needs. The reported performance is a general statement of successful completion of these tests.

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

• Test Set Sample Size: Not applicable in the context of clinical data, as no clinical testing was performed. For non-clinical software testing, the "sample size" would refer to the number of test cases, which is not specified but implied to be comprehensive enough for "functional testing, regression testing, smoke & sanity testing, code review, static analysis, and unit testing."
• Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by Baxter Healthcare Corporation. The document does not specify the country of origin of the test data (e.g., specific testing labs or environments), but it implies internal company testing or external contracted testing. The testing is non-clinical verification and validation, not retrospective or prospective clinical data.

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

• Not applicable as no clinical ground truth was established from expert readings or similar methods for a clinical test set. The "truth" for software testing is defined by the functional and non-functional requirements and design specifications.
• For the human factors study, it was conducted "with the intended user population." The number and specific qualifications of these users (e.g., licensed pharmacists, as per the indications for use) are not detailed.

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

• Not applicable as no clinical test set requiring adjudication of expert opinions was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states, "No clinical testing was performed."

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

• Again, no clinical performance studies were conducted. The device itself is "standalone (not embedded in pumps) browser-based software application that is installed on a hospital-provided computing platform." Its primary function is to create drug libraries for infusion pumps, not to directly perform real-time patient-facing actions or diagnoses that typically warrant standalone algorithm performance metrics. It's a tool for pharmacists to configure other medical devices.

7. The type of ground truth used:

• For non-clinical software testing: The ground truth is effectively the design requirements, specifications, and established functional behavior of the software as defined by the developers and verified against those specifications.
• For the Human Factors evaluation: The "ground truth" would be the successful completion of tasks by intended users in a simulated environment, demonstrating the usability and safety in typical use scenarios.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that learns from a "training set" of data in the typical sense (e.g., image datasets). It's a configuration and management software.

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

• Not applicable, as there is no "training set" for an AI/ML model described.

Ask a specific question about this device

The Novum IQ Large Volume Pump (LVP) is intended for use on adults and pediatric subpopulations, except for neonates, for the controlled administration of fluids, pharmaceutical drugs, parenteral nutrition, blood products through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural.

The Novum IQ LVP is intended for use on neonates, for the controlled administration of fluids and parenteral nutrition through the following clinically accepted routes of administration: intravenous and arterial.

The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user.

The Novum IO LVP is suitable for patient care in hospitals and outpatient health care facilities.

The Novum IQ LVP is intended to aid in the reduction of operator interaction through guided programming, including a way to automate the programming of infusion parameters and documentation of infusion therapies with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors.

The Novum IQ LVP is intended to be used by trained healthcare professionals.

The Novum IQ Large Volume Pump (LVP) is a large volumetric smart pump within the Novum IQ infusion platform. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.

Novum IQ LVP provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, parenteral nutrition, blood and blood products through administration sets at clinician's selectable rates and volumes.

The Novum IQ LVP is intended to be used in conjunction with legally marketed and compatible administration sets, and medications provided by the user. The Novum IQ LVP is suitable for patient care in hospitals and outpatient health care facilities. The Novum IO LVP is intended to aid in the reduction of operator interaction through guided programming, including a way to automate programming of infusion parameters and documentation of infusion therapies when integrated with an Electronic Medical Record (EMR) system. This automation is intended to aid in the reduction of programming errors. The Novum IQ LVP is intended to be used by trained healthcare professionals.

The Novum IQ LVP employs a feedback controlled, motorized pumping mechanism that works based on peristaltic action and uses inlet and outlet valves for flow control. To deliver medication correctly, the Novum IQ LVP peristaltically compresses the administration set. The pump channel is designed to interface to a Baxter standard administration set. The pumping mechanism interfaces with the keyed slide clamp and tubing to prevent free flow of drug.

The Novum IQ LVP is designed to detect and react to situations that could impact patient safety. When a situation that could impact patient safety is detected. the Novum IO LVP will notify the clinician with a visual alert and an audible alarm tone.

The Novum IQ LVP is designed to operate on Alternating Current (AC) power with an internally mounted rechargeable battery pack to facilitate the continuation of therapy during patient transport or AC power loss.

The provided document is a 510(k) Premarket Notification for the Novum IQ Large Volume Pump. It primarily discusses the device's substantial equivalence to a predicate device based on non-clinical testing and engineering evaluations. It explicitly states that "No clinical testing was performed in support of this premarket notification."

Therefore, I cannot provide information regarding acceptance criteria based on clinical studies, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these would typically be derived from clinical trials, which were not conducted for this submission.

However, based on the non-clinical tests and the device comparison provided, I can infer the acceptance criteria relate to meeting the performance, physical attributes, environmental conditions, and safety requirements of relevant international standards and FDA guidance documents. The "reported device performance" would be that the device successfully met these requirements.

Here's a breakdown of what can be extracted and what cannot:

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

Based on the "DISCUSSION OF NONCLINICAL TESTS" and "DEVICE COMPARISON AND SUBSTANTIAL EQUIVALENCE" sections, the acceptance criteria are primarily derived from regulatory standards and the performance of the predicate device.

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

• Sample Size: Not specified for any specific component or system-level test. The document refers to "testing" and "verification and validation" efforts, but not the number of units or test cases used.
• Data Provenance: Not applicable in the context of clinical data. For non-clinical tests, the data provenance would be internal laboratory testing and controlled simulated environments conducted by Baxter Healthcare Corporation. The document does not specify country of origin for the non-clinical data, but the submission is to the US FDA by Baxter Healthcare Corporation in Deerfield, Illinois.

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

This information is typically relevant for studies involving human interpretation (e.g., radiology for AI algorithms). Since no clinical testing was performed and the ground truth for engineering and V&V tests is based on design specifications and standard requirements, this question is not applicable to the provided document.

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

Not applicable, as no clinical study involving human readers or interpretation requiring adjudication was performed.

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, as no clinical testing or studies involving human-in-the-loop performance were conducted or reported.

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

Not applicable. This device is an infusion pump, not an AI algorithm intended for diagnostic or interpretive tasks. Its performance is measured by its mechanical and electronic functionality, safety features, and accuracy in fluid delivery, not by an independent algorithm's diagnostic output.

7. The type of ground truth used:

• For performance, physical attributes, environmental conditions, safety (non-clinical testing): The ground truth was established by adherence to recognized international standards (e.g., IEC 60601 series, UL standards) and FDA guidance documents, as well as internal design specifications and requirements.
• For human factors/usability: The ground truth was the ability of intended users to safely and effectively operate the device in simulated clinical scenarios, as evaluated against predefined criteria.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set in the typical sense (e.g., image datasets for deep learning). The device undergoes design, development, and engineering verification.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

Ask a specific question about this device

The CleanCart A cartridge is intended for preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine's fluid circuit. The CleanCart A cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine. The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine's fluid circuit. The CleanCart C cartridge must be used in combination with the heat disinfection program of the corresponding dialysis machine. The Baxter AK 98 Dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician.

CleanCart A and Cleancart C products are accessories for the maintenance of the dialysis fluid pathway of hemodialysis machines equipped with a compatible cartridge holder. CleanCart products are compatible with the BiCart holder of the AK 98 Dialysis Machine (K201809). The AK 98 Dialysis Machine and CleanCart products will be used in chronic care dialysis or hospital care environments. The CleanCart products are used in combination with a heat disinfection cycle; the patient is not connected with the hemodialysis machine during this process. The CleanCart A cartridge contains 13 grams of anhydrous sodium carbonate powder. The CleanCart A cartridge is intended for the preparation of a sodium carbonate solution used for removing organic deposits, fats and proteins from the dialysis machine's fluid circuit. The diluted solution has a pH of approximately 11. The CleanCart C cartridge contains 32 grams of citric acid anhydrous powder. The CleanCart C cartridge is intended for preparation of a citric acid solution used for removing calcium and magnesium precipitation from the dialysis machine's fluid circuit. The diluted solution has a pH of approximately 2.

The provided text describes a 510(k) submission for Baxter Healthcare Corporation's CleanCart A, CleanCart C, and AK 98 Dialysis Machine. The submission aims to add CleanCart A and CleanCart C as accessories to the AK 98 Machine, as they were previously cleared for use with the Phoenix Dialysis System. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested details about acceptance criteria, extensive study methodologies, sample sizes, expert involvement, and ground truth establishment are not present in this document. The document primarily relies on technical characteristics comparison and design reviews of existing data.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in the typical sense of quantitative performance metrics for a new device's function. Instead, it focuses on demonstrating that the proposed device (CleanCart A and C used with AK 98) is substantially equivalent to predicate devices. The "acceptance criteria" here implicitly relate to maintaining the safety and effectiveness characteristics of the predicate devices.

The reported "device performance" is also not in terms of specific numerical outcomes for efficacy or accuracy, but rather a statement of no significant differences in various technical characteristics and intended use.

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

The document states: "No design changes were required for CleanCart products to be compatible for use with the AK 98 Dialysis Machine, therefore no additional testing has been performed in support of this change. The data demonstrating that CleanCart and AK 98 products can be used together was part of the AK 98 510(k) submission (K201809)."

This indicates that no new specific test set was used for this particular 510(k) submission to assess the combined use of CleanCart with AK 98. The justification relies on previous testing for the AK 98 (K201809) and the CleanCart products (K001156) individually, and a design review.

Therefore, specific sample sizes and data provenance (country of origin, retrospective/prospective) for a new test set are not provided because such a study was not conducted for this submission. The data provenance would refer back to the original studies for K201809 and K001156, which are not detailed 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 provided because no new "ground truth" or expert-driven case reviews for device performance are described in this submission. The "evaluation" was a "Design Review" by the manufacturer.

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

Not applicable, as no new test set requiring expert adjudication is described.

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 medical apparatus (dialysis machine and cleaning cartridges), not an AI-assisted diagnostic or imaging tool involving human readers.

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

Not applicable. This device does not involve an AI algorithm in the context of diagnostic performance.

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

The "ground truth" for this submission relies on:

• Previously established safety and performance data: From the original 510(k) clearances of the predicate devices (CleanCart A/C under K001156 and AK 98 under K201809).
• Design reviews: Conducted by the manufacturer to ensure that the combined use of CleanCart products with the AK 98 machine is covered by existing data, specifically for microbiological disinfection verification and human factors studies.

There is no mention of expert consensus, pathology, or outcomes data being used to establish a new ground truth for this specific 510(k) submission.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set."

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

Not applicable. As above, there is no training set mentioned.

Ask a specific question about this device

The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes; intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to hospitals and outpatient care areas.

The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.

The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is a large volume infusion pump system that provides for safe and effective delivery of fluids into a patient in a controlled manner, as identified in 21 CFR, 880.5725. The pump is a software controlled, electromechanical device used for the infusion of pharmaceutical drugs, blood, blood products and mixtures of required patient therapy through administration sets at user selectable rates and volumes. The feedback-controlled, motorized pumping mechanism is of linear peristaltic design and uses inlet and outlet valves for flow control. The pump utilizes a primary and secondary processor to assure safe operation while providing infusion pump capabilities for a wide range of applications.

The pump is specifically manufactured and calibrated for the application of a manufacturer's brand of standard gravity administration sets, as indicated in the device labeling. For use, the administration set is loaded into the infusion pump. After acceptance of program parameters, the pump is started and fluid is propelled by the peristaltic action of the pumping mechanism against the outside surface of the administration set tubing. The pump is controlled to create smooth fluid dynamics, precision volumetric accuracy and uniformity of flow rate. None of the pump materials contact the administration set's fluid path.

The infusion pump is small in comparison to the traditional Large Volume Parenteral (LVP) infusion pumps currently on the market. It is designed to be used in a variety of patient care environments such as, but not limited to hospitals and outpatient care areas using an IV pole mounted configuration.

The Master Drug Library (MDL) Editor is a software application that allows the generation, configuration and management of a downloadable drug library into a SIGMA Spectrum infusion pump.

The drug library can be loaded directly into the SIGMA Spectrum infusion pump through a wireless network host or through an Infrared Data Association (IrDA) device. The MDL Editor software operates on a Microsoft Windows® platform.

Using the MDL Editor software application, a facility can provide preprogrammed delivery profiles, advisories and limits for a corresponding drug that is intended for a specific use classification or clinical care area, thus reducing the risk of medication errors.

The MDL Editor software application allows the ability to generate both standard or customized drug and fluid reports by clinical care area. The MDL Editor software application also provides a feature to restrict/limit the access of data to only appropriate personnel, providing additional security and rights to specific users.

The provided text is a 510(k) summary for the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library. Its purpose is to demonstrate substantial equivalence to a predicate device, not to detail the full acceptance criteria and study proving its performance.

The document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI or a clinical effectiveness study.

Instead, the document focuses on:

• Identifying the device and its predicate.
• Describing the device's function as an infusion pump.
• Stating its indications for use.
• Explaining that the specific 510(k) notification is to "update the algorithm and labeling related to the upstream occlusion alarm of the pump" and that "Performance testing for the software was completed."

Therefore, I cannot provide the requested information based on the given text. The prompt asks for details that would typically be found in a detailed validation report or clinical study summary, which is not present in this 510(k) summary.

Ask a specific question about this device