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The PrisMax control unit is intended for:
• Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.

All treatments administered via the PrisMax control unit must be prescribed by a physician.

The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. The PrisMax System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous VenoVenous Hemodialysis (CVVHD), and Continuous Venovenous Hemodialfiltration (CVVHDF). The proposed device PrisMax consists of PrisMax Control Unit and accessories for removing effluent.

The provided text describes a 510(k) premarket notification for the PrisMax device, which is a high-permeability hemodialysis system. The core of this submission is to demonstrate the substantial equivalence of the PrisMax to a predicate device, the Prismaflex.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text. It's important to note that a 510(k) summary often summarizes extensive testing, so not all details of the actual studies might be present in this brief document.

First and foremost, this document describes a device comparison for substantial equivalence to a predicate, not a study evaluating clinical performance against a specific disease outcome or a MRMC study. Therefore, some of the requested information (like effect size of human readers improving with AI, or number of experts for ground truth) is not applicable to this type of regulatory submission. The acceptance criteria here are about equivalence to the predicate device's established performance parameters and safety.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally that the PrisMax device performs at least as well as or equivalently to the predicate Prismaflex device for various technical specifications. The reported device performance is the PrisMax's specification for that feature. The table below is extracted directly from the "Table 3. Substantial Equivalence Table Device Comparison" in the provided document. The "Acceptance Criteria" column reflects the predicate device's performance, as the goal is to demonstrate equivalence or improvement without raising new safety/effectiveness concerns.

Study Proving Device Meets Acceptance Criteria

The document states: "Performance testing was conducted on the PrisMax System to evaluate the functional performance of the system. The performance testing confirms PrisMax remains as safe and effective as Prismaflex and is substantially equivalent."

The nature of the "study" demonstrating this is predominantly nonclinical performance testing, verification, and validation against engineering and regulatory standards, and comparison to the predicate device's specifications.

Specifically, the document explicitly mentions:

• Design validation: The PrisMax design validation meets user needs and intended use and is substantially equivalent to the predicate.
• Compliance with IEC 60601-2-16 Hemodialysis Equipment: Testing confirmed by CSA, a recognized test laboratory, for essential performance.
• Electrical safety testing: According to IEC 60601-1 Edition 3.1. This includes reports for software, alarms, usability, safety, and performance.
• Electromagnetic compatibility (EMC) testing.
• Risk Assessment and risk control measures: Hazard analysis (therapy level, product level, process level) confirming the device does not perform in an unexpected or unsafe manner.
• Labeling, Software including cybersecurity, Human Factors: These have been successfully implemented.
• Verification and validation tests: These were performed subsequent to risk analysis and include Human Factors and Software Validation.

The key changes and their justification for not raising new safety/effectiveness concerns are footnoted in Table 3:

• Syringe Sizes (30ml removed): Due to infrequent use, device behavior unchanged.
• Dialysate Flow Rate / Replacement Solution Flow Rate Increment (50ml/hr to 10ml/hr): Allows for more precise settings, verified and validated to comply to updated specifications without new risks.
• Pre-Blood Pump Flow Rate (SCUF range clarification): Corrected the predicate's stated range to its actual operational range, showing PrisMax is equivalent. Verified and validated.
• Trans Membrane Pressure Alarms (Fixed default of +300 mmHg, removed user settable): Removes infrequent use case, reduces use-error risk, increases usability, lowers default to reduce risk. Verified and validated.
• Patient Fluid Removal Performance Increment (10ml/hr to 5ml/hr): Increases setting range, allows more precise setting. Verified and validated.
• The software update (version 1.0.6.0) was verified and validated subsequent to risk analysis and includes Human Factors and Software Validation.

Details based on the provided text:

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

  • Sample Size: Not explicitly stated in terms of patient count or device unit count for the validation tests. These are typically engineering performance tests, not clinical trials with "patients." The performance tests would use a relevant number of devices or test conditions to ensure specifications are met.
  • Data Provenance: The testing appears to be internal "performance testing" and "verification and validation" conducted by Baxter Healthcare Corporation and by a recognized test laboratory (CSA) for specific standards like IEC 60601-2-16. This is non-clinical, laboratory-based data, not patient data from a specific country.

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

  • Not applicable in the context of a 510(k) submission based on technical performance and equivalence to a predicate device, rather than a clinical diagnostic study requiring expert interpretation of results. The "ground truth" here is adherence to engineering specifications and safety standards.

• 4. Adjudication method for the test set:

  • Not applicable, as this is not a study requiring human adjudication for diagnostic categorization. The "adjudication" is through engineering verification and validation processes against predefined technical specifications and standards.

• 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. This is a medical device for continuous renal replacement therapy, not an AI/diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study is not relevant here.

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

  • Not applicable in the way this question typically refers to AI algorithms. The device itself is a "standalone" system in its function, but its performance is verified through engineering tests against objective criteria, not an "algorithm only" performance separate from the device's integrated function. Its operation relies on physician prescription (human-in-the-loop for clinical application, but not for the device's technical performance evaluation).

• 7. The type of ground truth used:

  • Engineering Specifications and Performance Standards: The "ground truth" for this submission is compliance with established engineering specifications for flow rates, accuracy, pressure ranges, alarm settings, and adherence to international safety standards (e.g., IEC60601 series). Additionally, the predicate device's cleared performance serves as a comparative ground truth for equivalence.

• 8. The sample size for the training set:

  • Not applicable. This is not a machine learning or AI device that requires a "training set" in the conventional sense. The "training" for the device's development would be iterative engineering design and testing.

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

  • Not applicable, as there is no "training set" in the AI/ML context. The functional requirements for the device are derived from clinical needs, regulatory standards, and the performance of previous generations of such devices.

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To administer fluids with Baxter infusion pumps to a patient's vascular system from a container though a needle or catheter inserted into a vein, primarily used to admining the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.

The Paclitaxel Sets product line consists of single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular device, primarily for solutions containing the chemotherapeutic drug paclitaxel. These devices are the same as the current marketed devices, which were previously cleared under 510(k) premarket notification K981792 (cleared August 17, 1998).

The sets are each comprised of a non-DEHP drip chamber with a spike, 0.2 micron filter, non-DEHP polyvinyl chloride tubing pump segment, polyethylene (PE)-lined trilayer tubing, and a luer lock. On all sets there is a fixtured slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink or Clearlink), and type of spike (vented or non-vented).

The basis for this premarket notification is a change to the PE-lined trilayer tubing and the 0.2 micron filter currently used in this product line. The inner layer material of the trilayer tubing is changing from Low Density Polyethylene to Linear Low Density Polyethylene. The solution membrane material of the 0.2 micron filter is changing from a hydrophilic polyethersulfone (PES) to another equivalent hydrophilic PES. All changes have been previously cleared under 510(k) premarket notifications for other Baxter Intravascular (IV) Administration Sets.

The provided text describes a 510(k) premarket notification for "Paclitaxel Sets" by Baxter Healthcare Corporation. It outlines the changes made to an existing device, its intended use, and the nonclinical tests conducted to demonstrate equivalence to a predicate device.

However, the document does NOT describe the acceptance criteria and the study that proves a device (e.g., an AI algorithm, a diagnostic tool) meets the acceptance criteria in the context of improving human reader performance or a standalone algorithmic performance.

Instead, this document pertains to a resubmission for a physical medical device (intravenous administration sets) with material changes, and the "acceptance criteria" discussed are largely related to bench testing and material compatibility to ensure that the modified physical device performs equivalently to the original predicate device.

Therefore, many of the requested points, such as AI-assisted human reader improvement, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set details, and MRMC studies, are not applicable to this type of device submission.

Here's an attempt to answer the
questions based on the provided text, highlighting what is present and what is absent/not applicable:

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

The document lists various bench tests and their acceptance criteria, which are consistently stated as "Per Baxter test method" or "Equivalence to predicate device." The actual quantitative performance data that verifies these acceptance criteria are not reported in this summary document, only that the tests were conducted and the results met their criteria.

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

• Sample Size: The document does not specify the sample sizes (number of units) used for each of the bench tests.
• Data Provenance: Not applicable in the context of patient data for a diagnostic/AI device. The testing is bench testing of physical units.

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

Not applicable. This is not a study involving human interpretation of data where expert consensus is needed for ground truth (e.g., medical image interpretation). The "ground truth" for this device is its physical and chemical properties and performance, validated through standard engineering and laboratory tests.

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

Not applicable. There's no human interpretation or subjective judgment that would require adjudication for this type of bench testing.

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 an intravenous administration set, not an AI or diagnostic device that would assist human readers.

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

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

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

The "ground truth" for this device is based on established engineering standards, validated laboratory tests, and equivalence to a legally marketed predicate device. For drug compatibility, it is based on observed equivalence in concentration, pH, color, and visual inspection to the predicate device. For sterility, it's based on a defined Sterility Assurance Level validated against ISO standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of Device Performance Study:

The studies described are non-clinical bench tests and biocompatibility assessments designed to demonstrate that the changes made to the "Paclitaxel Sets" (specifically, the inner layer material of the trilayer tubing and the solution membrane material of the 0.2 micron filter) do not negatively impact the intended use or fundamental scientific technology of the device. The reported performance is that "All test results meet their acceptance criteria," indicating successful demonstration of equivalence or performance according to internal Baxter test methods and relevant international standards (e.g., ISO-10993, ANSI/AAMI/ISO 11137-2, ASTM standards). The specific quantitative results are not included in this summary document.

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For the administration of fluids from a container into the patient's epidural space with Baxter infusion pumps.

The Solution Set for Epidural Use is a single use disposable device intended for the administration of fluids from a container into the epidural space. The set is used for epidural infusions of fluids (typically analgesic or anesthetic) as an intermittent or continuous infusion to reduce chronic or post-operative pain. The set consists of a nonvented spike, 60 drops per mL drip chamber, minidrip adapter, tubing, fixtured slide clamp, on-off roller clamp, and a male epidural lock connector. The connector is compliant to the provisional AAMI/CN6:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.

The provided text describes the Baxter Healthcare Corporation's "Solution Set for Epidural Use" (K161323) and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a traditional medical device (an epidural IV administration set), not an AI/ML device. Therefore, the questions regarding AI/ML device performance, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies are not applicable to this document.

The document focuses on:

• Substantial equivalence to an existing predicate device (Bard Epidural Spike Tubing Set, K925058).
• Nonclinical bench testing to evaluate functional performance (e.g., Drop Volume Test, Cannula Pull Out Test, Pump Tests).
• Biocompatibility testing (e.g., Cytotoxicity, Systemic Toxicity).
• Sterility testing.
• Shelf-life testing.

All these tests are reported to have "met the acceptance criteria," but the specific numerical acceptance criteria and the detailed results are not provided in this summary.

Therefore, I cannot fulfill your request using the provided text because it does not pertain to an AI/ML device and lacks the specific details about acceptance criteria and study results in the format you requested for an AI/ML model.

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For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

The Solution Administration Sets with a 0.2 micron filter product line consists of sterile, non-pyrogenic, single use disposable devices used for the administration of fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They are indicated for the retention of microorganisms and removal of air and particulate matter from infusion fluids. The filter consists of a 0.2 micron polyethersulfone (PES) solution membrane and 0.1 micron polyvinylidene fluoride air vent membrane enclosed in a copolyester housing.

The provided text is a 510(k) summary for a medical device (Solution Administration Sets with 0.2 Micron Filter) and, as such, focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than a comprehensive study evaluating device performance against established acceptance criteria in a research context.

This document does not contain the kind of detailed information about a study that would rigorously prove a device meets acceptance criteria in the typical scientific sense (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies). It is a regulatory submission, so the "studies" are verification tests to ensure the modified device is equivalent to the predicate.

However, I can extract the acceptance criteria mentioned and the reported "performance" based on the provided text, while noting the limitations in the depth of information available.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only states that "All tests met the acceptance criteria" without providing the specific numerical or qualitative thresholds for those criteria. It implies that these criteria were pre-established internally by Baxter Healthcare Corporation for their risk analysis and design verification.

Here's why the other requested information is largely not present in this type of regulatory document:

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

• Not explicitly stated. The document is a summary and does not include the detailed protocols, sample sizes, or statistical analysis reports from the bench tests or biocompatibility assessments.
• Data Provenance: The tests were conducted by Baxter Healthcare Corporation. The document doesn't specify the country of origin for the data beyond that. These are typically internal corporate studies (retrospective in the sense that they are conducted on manufactured samples, but prospective in terms of the test design).

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

• Not applicable/Not mentioned. This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical evaluations). For bench tests and biocompatibility tests of a physical device, the "ground truth" is typically defined by scientific principles, international standards (e.g., ISO-10993), and validated test methodologies. There's no "expert ground truth" in the sense of consensus from adjudicators.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. As above, adjudication is not a standard part of these types of engineering and biological safety tests. The results are typically quantitative measurements against defined specifications.

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. This is a completely different type of study, relevant for AI/radiology devices. This document is a 510(k) for an administration set with a filter, not an AI diagnostic tool.

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

• Not applicable. This question pertains to AI algorithms. The device discussed is a physical medical device.

7. The type of ground truth used:

• For Performance Data (e.g., flow rate, bacterial retention): The "ground truth" would be established by the validated test methods themselves, based on physical and microbiological principles, often referenced to international standards or established industry practices for filter performance.
• For Biocompatibility: The "ground truth" is defined by the requirements of international standards like ISO-10993-1 and FDA guidance, which specify the types of biological responses that are considered acceptable or unacceptable.

8. The sample size for the training set:

• Not applicable. This question refers to machine learning models. This device does not involve a "training set" in that context.

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

• Not applicable. As above, no training set for an AI model is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes a series of nonclinical bench tests and biocompatibility assessments conducted by Baxter Healthcare Corporation.

• Objective: To evaluate the effect of a material modification (change in solution membrane material from one hydrophilic polyethersulfone to another hydrophilic polyethersulfone) in the 0.2 micron filter within their Solution Administration Sets. The goal was to establish substantial equivalence to the previously cleared predicate device (K964850).
• Tests Performed:
  • Performance Data: Air diffusion, bubble point, gravity flow rate, flow rate post sterile water conditioning, flow rate post parenteral nutrition conditioning, and bacterial retention.
  • Biocompatibility: Cytotoxicity, Systemic Toxicity, Intracutaneous, Hemolysis, Pyrogen, Sensitization, and USP Physicochemical. These were conducted in accordance with ISO-10993 and FDA guidance.
• Results: The document states that "All tests met the acceptance criteria."
• Conclusion: Based on these tests, Baxter concluded that "The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed for the same intended use."

This is a regulatory study designed to show equivalence, not an independent research study to establish novel performance claims.

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FlexiCap Disconnect Cap with Povidone-Iodine Solution (5C4456): This device is intended for use in the treatment of patients with renal failure to isolate the Luer patient line connector of the Baxter APD (Automated Peritoneal Dialysis) disposable set during temporary disconnections and during the dwell phase of therapy.
MiniCap with Povidone-Iodine Solution (5C4466P): This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.

FlexiCap Disconnect Cap with Povidone-Iodine Solution (FlexiCap) is a single use device that connects to the patient line connector of the Baxter Automated Peritoneal Dialysis (APD) set and is designed to isolate the line during temporary disconnections and the dwell phase of peritoneal dialysis therapy sessions. The FlexiCap consists of a molded low density polyethylene cap which contains a polyurethane foam sponge and 10% povidone-iodine (PVP-I) solution.
MiniCap with Povidone-Iodine Solution (MiniCap) is a single use device that connects to a Baxter transfer set and is designed to isolate the line between peritoneal dialysis therapy sessions. The MiniCap consists of a molded low density polyethylene cap which contains a polyurethane foam sponge and 10% Povidone-Iodine (PVP-I) solution.

This document is a 510(k) premarket notification for two devices: the FlexiCap Disconnect Cap with Povidone-Iodine Solution and the MiniCap with Povidone-Iodine Solution, both manufactured by Baxter Healthcare Corporation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests met the acceptance criteria" for both devices, but it does not specify the quantitative acceptance criteria themselves. It only lists the types of tests performed.

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

The document does not explicitly state the sample sizes used for each specific test (Torque-On, Leak, Iodine Efficacy, Biocompatibility tests). It mentions "non-clinical tests" and "bench tests."

The data provenance is from non-clinical bench testing conducted by Baxter Healthcare Corporation. No information on country of origin for data or whether it's retrospective or prospective is provided for the non-clinical tests.

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 tests described are non-clinical bench tests (e.g., Torque-On, Leak, Iodine Efficacy, Biocompatibility). These types of tests do not typically involve human experts establishing ground truth in the same way clinical studies or image interpretation tasks would. The "ground truth" for these tests would be defined by the physical or chemical standards and specifications against which the devices are measured.

4. Adjudication method for the test set

This information is not applicable as the tests described are non-clinical bench tests. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or consensus is required (e.g., clinical trials, image reading).

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. This document describes the substantial equivalence of medical devices (disconnect caps for peritoneal dialysis) based on non-clinical performance and biocompatibility data, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely outside the scope of this submission.

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

This information is not applicable. The devices are physical medical products and do not involve any algorithms or AI for standalone performance evaluation.

7. The type of ground truth used

For the non-clinical tests (Torque-On, Leak, Iodine Efficacy), the ground truth is based on pre-defined technical specifications and performance standards. These standards would dictate what constitutes an acceptable torque value, an acceptable leak rate, or an effective iodine concentration/release.

For Biocompatibility tests (Cytotoxicity, Irritation/Intracutaneous, Sensitization), the ground truth is established against standardized biological evaluation criteria, specifically ISO-10993 Part 1 and FDA Blue Book Memorandum #G95-1. These standards define the acceptable biological responses for device materials in contact with the body.

8. The sample size for the training set

This information is not applicable. The devices are physical products, not AI models that require a training set. The "training" in this context refers to manufacturing and quality control processes to meet specifications, not an algorithmic training set.

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

This information is not applicable. As these are physical medical devices and not AI algorithms, there is no "training set" in the context of machine learning. The focus is on ensuring the manufactured products consistently meet established design specifications and performance criteria through quality control and testing processes.

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

The proposed devices, which are the subject of this Traditional 510(k) premarket notification, consist of Nitroglycerin Sets with DUO-VENT Spike. They are single use disposable devices intended for the administration of Nitroglycerin solution from a container into the patient's vascular system through a vascular access device. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notification K832284 (cleared on December 29, 1983).

Baxter's Nitroglycerin Sets with DUO-VENT Spike are comprised of non-DEHP drip chamber with a vented spike. PVC tubing pump segment, polyethylene (PE) lined trilayer tubing, and a luer lock. On all sets there is a fixture slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink, Clearlink, needle-accessed, or none), and type of drip chamber (10 or 60 drops per minute).

Polyethylene lined tubing is used to administer Nitroglycerin due to the compatibility issues between the drug and polyvinyl chloride (PVC). Nitroglycerin concentration can be significantly reduced when infused using standard PVC administration sets, due to absorption into the tubing. For this reason, trilayer tubing with an inner polyethylene layer is used in Baxter's line of Nitroglycerin Sets with DUO-VENT Spike.

The basis for this premarket notification is a modification to the PE lined trilayer tubing used in Baxter's Nitroglycerin Sets with DUO-VENT Spike. The modification consists of a change to the Polyethylene material used in the inner layer of the PE lined trilayer tubing.

Along with this modification, the needle-accessed injection site (y-site) is changing from a latex-containing y-site to one that is not manufactured with latex. This proposed needle-accessed y-site is currently used in Baxter's Intravascular (IV) Administration Sets with y-site(s) and has been previously cleared under 510(k) premarket notification K142011 (cleared on August 18, 2014).

These modifications do not impact the intended use or the fundamental scientific technology of the device. No other materials of construction are being introduced into this device as part of this update. The product labels are also being updated to add the indications for use statement of the device, revise statements regarding latex and references to pump devices, and make any other changes to comply with Baxter's labeling standards.

The provided document is a 510(k) premarket notification for a medical device (Nitroglycerin Sets with DUO-VENT Spike). This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a new device meets specific acceptance criteria through a clinical study in the way an AI/ML device would. Therefore, most of the requested information regarding AI/ML study design, ground truth, experts, and sample sizes is not applicable to this document.

However, I can extract the acceptance criteria and performance related to the bench tests conducted for this device.

Here's the information that can be extracted or stated as not applicable:

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

Note: The document explicitly states "All tests met the acceptance criteria" for the performance tests and "shown to be biocompatible and appropriate for its intended use" for biocompatibility. Specific numerical acceptance criteria are not detailed in this summary, but are implicitly part of the underlying test protocols.

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

• Sample Size: Not explicitly stated for each test. The document refers to "bench tests" and "biocompatibility assessments" which typically involve a predetermined number of samples per test type according to relevant standards (e.g., ISO, ASTM).
• Data Provenance: This is not relevant for bench testing of a physical device. The tests are conducted in a laboratory setting.

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 administration set, not an AI/ML diagnostic or predictive device requiring expert-established ground truth from a dataset. The "ground truth" for these tests is defined by engineering specifications and biocompatibility standards.

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

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data (e.g., medical images for AI ground truth). This is a physical device being evaluated against objective bench test criteria.

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 is a physical medical device, not an AI or AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an AI algorithm.

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

• Not Applicable. The "ground truth" for this device's performance is based on established engineering specifications, material properties, and regulatory standards for safety and function of intravascular administration sets and biocompatibility (e.g., ISO-10993, USP).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML model is involved.

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To provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an I.V. solution container without mixing the vial contents with the diluent until immediately before administration of the patient.

The VIAL-MATE Reconstitution Device is intended for use by the pharmacist or health practitioner in the reconstitution and transfer of drugs into Baxter solution containers. The VIAL MATE Reconstitution Device provides a means of connecting a standard 20 mm single dose powdered drug vial to an I.V. solution container without mixing the vial contents with the diluents until immediately before reconstitution and administration of the drug to the patient. This device has been previously cleared under 510(k) premarket notification K973654 (cleared on October 24, 1997).

The basis for this premarket notification is a modification to the labeling of the product. This modification will update the label to clarify the description of the product and user instructions. Additionally, Baxter will update the product labeling to comply with Baxter's labeling standards and add the indications for use statement that was previously cleared for this device under 510(k) premarket notification K973654. The modification to the labeling does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update.

This document is a 510(k) premarket notification for the VIAL-MATE Reconstitution Device, where the basis for the submission is a modification to the labeling of an already cleared device (K973654). Therefore, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or algorithm accuracy as would be typical for AI/ML devices.

Instead, the "acceptance criteria" and "study" refer to bench tests conducted to evaluate the functional performance and safety of the device, particularly in ensuring its physical integrity and proper operation.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for each individual bench test. The phrase "All tests met the acceptance criteria" implies that a sufficient number of devices were tested to draw this conclusion, but the exact numbers are not provided. These are bench tests, not clinical studies, so "data provenance" in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for patient data.

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

Not applicable. This device is a physical reconstitution device, and the "ground truth" for its functional performance is established through defined engineering and quality control specifications and measurements, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements of physical properties and functional aspects, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is a physical medical device, not an AI/ML algorithm requiring an MRMC study.

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

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

7. The Type of Ground Truth Used

The "ground truth" for these tests would be objective, measurable engineering specifications and performance standards (e.g., specific force ranges for removal, defined integrity thresholds for seals, quantifiable flow rates, measurable residual volumes).

8. The Sample Size for the Training Set

Not applicable. This is a physical device submission based on labeling changes to an existing device. There is no AI/ML model or "training set" in this context.

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

Not applicable. As there is no AI/ML model or training set, this question is not relevant to the provided information.

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

The proposed devices, which are the subject of this Special 510(k) premarket notification, consist of IV administration sets, some of which include a needle-accessed injection site (y-site). They are single use disposable devices intended for use for the administration of fluids from a container into the patient's vascular system through a vascular access device. These devices are the same as the current marketed devices, including extension sets and solution sets. The extension sets have been previously cleared under 510(k) premarket notification K811078 (cleared on July 2. 1981) and the solution sets have been previously cleared under 510(k) premarket notification K961225 (cleared on June 21, 1996).

The basis for this premarket notification is a proposed design change to the y-site component currently used in Baxter IV administration sets. The design change is intended to eliminate latex in the current y-site as well as to optimize the manufacturing process. This proposed change does not impact the intended use or the fundamental scientific technology of the device. The product labels are also being updated to add the indications for use statement of the device, update the description to comply with Baxter's labeling standard, update the statement regarding latex, and update references to pump devices.

This document describes the 510(k) premarket notification for Baxter Healthcare Corporation's Solution Sets and Extension Sets. The core of the submission revolves around a proposed design change to the y-site component of these intravenous administration sets.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results meet their acceptance criteria". However, the specific acceptance criteria values for each test are not explicitly provided in the text. Only the type of tests conducted and the general outcome (meeting criteria) are stated.

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

• Sample Size: The document does not specify the sample sizes used for each of the bench tests (e.g., how many y-sites were subjected to the Puncture Test or Burst Test).
• Data Provenance: The tests are described as non-clinical bench tests. The data was generated by Baxter Healthcare Corporation to evaluate the effect of a design modification. There is no mention of country of origin for test data, but it can be inferred the testing was conducted internally by Baxter. These are prospective tests conducted to validate the new design.

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

• Not Applicable: For non-clinical bench tests of an IV administration set, the "ground truth" is defined by predefined engineering specifications and performance standards rather than expert consensus on medical images or clinical outcomes. The tests evaluate the physical and functional properties of the device against these objective criteria. Therefore, no medical experts are required to establish ground truth in this context.

4. Adjudication Method for the Test Set

• Not Applicable: Since these are objective bench tests against engineering specifications, there is no need for an adjudication method by human observers. The tests produce quantifiable results that are either within or outside the predetermined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: An MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve interpretation by human readers. The current submission is for an IV administration set, which is a therapeutic/delivery device, and its safety and effectiveness are assessed through bench testing and biocompatibility rather than reader studies.

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

• Not Applicable: This product is a physical medical device (IV administration set), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

• The ground truth for these tests is based on predefined engineering specifications, performance standards, and regulatory guidelines (e.g., ISO-10993-1 for biocompatibility). The tests objectively measure parameters like puncture resistance, burst pressure, and leakage, which are then compared against these established technical requirements.

8. The Sample Size for the Training Set

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

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

• Not Applicable: As there is no training set for an AI/ML algorithm involved, this question is not relevant.

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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.

This document describes the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) (Model 35700) and its substantial equivalence to a predicate device (K042121). The information provided focuses on the device's technical characteristics, intended use, and the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Baxter SIGMA Spectrum Infusion Pump with MDL are primarily established by demonstrating substantial equivalence to the predicate device and meeting various non-clinical testing requirements. The document presents a comparison of characteristics between the proposed device and the predicate. The "Reported Device Performance" column reflects the specifications for the proposed device, which, by satisfying the non-clinical testing criteria, meet the necessary acceptance.

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ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. These osseous defects are 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.

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 macroand 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 docs not set in-situ following implantation. ALTAPORE is available in 1.5ml, 2.5ml, 5ml, 10ml, and 20ml configurations.

AI,TAPORE 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 bony healing in a critical defect model as confirmed with radiographic, histolopatholgical, histomorphometric, and mechanical analyses. ALTAPORE undcrgocs ccll-mediated remodeling and is replaced by natural bone.

Here's an analysis of the acceptance criteria and study information for the ALTAPORE device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for ALTAPORE primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantifiable acceptance criteria that are then met by performance metrics. The "acceptance criteria" here are implied by the comparison to predicate devices and the general safety and effectiveness requirements for bone void fillers.

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

• Test Set Sample Size: Not explicitly stated as a numerical count of subjects or defects. The text refers to "in vivo animal studies" and "critical size defect implantation in-vivo animal studies" but does not provide specific numbers for the animals or defects studied.
• Data Provenance: The studies mentioned ("in vivo animal studies") suggest prospective animal studies. The country of origin for the data is not specified in the provided text.

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

• The concept of human "experts" establishing ground truth for evaluating the device's performance in a diagnostic or interpretive context (e.g., radiologists interpreting images affected by AI) is not applicable to this device. ALTAPORE is a bone void filler, and its performance is assessed through objective biological and material properties, as well as animal studies. Evaluation methods mentioned include radiographic, histopathological, histomorphometric, and mechanical analyses, which typically involve trained professionals interpreting results, but not in the context of defining "ground truth" for a labeling or classification task.

4. Adjudication Method for the Test Set

• Not applicable in the context of this device's evaluation. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert opinions during diagnostic AI evaluations. This device's evaluation relies on objective measurements and scientific analysis in animal models.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers are involved in interpreting medical images or data. ALTAPORE is a medical device (bone void filler), and its performance is not assessed through human reader interpretation of AI output.

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

• Not applicable. This device is not an algorithm or AI system. It is a physical bone void filler. The "standalone" performance here refers to the device's inherent properties and biological interactions as assessed in in vitro and in vivo (animal) studies, without human intervention in its function. The studies evaluate the material itself.

7. The Type of Ground Truth Used

• The "ground truth" for evaluating ALTAPORE's performance in animal studies was established through a combination of objective scientific analyses:
  • Radiographic analysis: Imaging confirming bone formation.
  • Histopathological analysis: Microscopic examination of tissue to assess new bone growth and remodeling.
  • Histomorphometric analysis: Quantitative microscopic analysis of tissue structures.
  • Mechanical analysis: Testing the strength and integrity of the repaired bone.
  • In vitro studies: Demonstrating apatite layer formation in simulated body fluid.

8. The Sample Size for the Training Set

• Not applicable. The concept of a "training set" is relevant for machine learning algorithms. ALTAPORE is a physical medical device, not an AI or algorithm that requires training data.

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

• Not applicable. As mentioned above, there is no "training set" for this device.

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