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The Infusomat® Space Volumetric Pump Administration Sets are intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

The Infusomat® Space Volumetric Infusion Pump administration sets are sterile, nonpyrogenic, single-use devices for use with the B. Braun Infusomat® Space Volumetric Infusion Pump for pump and gravity administration of fluids.

Each administration set contains a segment of silicone tubing intended to interface with the linear peristaltic mechanism of the pump. There are two connectors at each end of the pump tube segment and a line loading guide to assist the user in loading the pump segment into the pump. Each set also contains a free flow protection clamp. The clamp is specifically designed to interface with a mating receptacle in the pump and is intended to prevent free flow of fluid when the pump door is opened and the set is removed. There are multiple set configurations including basic sets, burette sets, additive sets, filtered sets, epidural sets, low adsorption sets, add-on sets, and blood sets.

This 510(k) is making limited modifications to the predicate device. The subject changes of this 510(k) were related to updates to the tubing length, diameter, and material, as well as component updates to accommodate the changes to the tubing.

This document is a 510(k) clearance letter for the Infusomat® Space Volumetric Infusion Pump Administration Sets. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel device through a comprehensive study meeting specific acceptance criteria.

Therefore, the information requested in your prompt (especially regarding acceptance criteria, study design for proving performance, expert consensus, MRMC studies, etc.) is not applicable to this type of regulatory submission. This 510(k) does not describe a study that "proves the device meets acceptance criteria" in the sense of a clinical trial or performance study against pre-defined thresholds for a new technology. Instead, it relies on demonstrating that the modified device is functionally equivalent and safe compared to an existing, legally marketed device, despite minor changes in materials and specifications.

Here's why each point in your request is not directly extractable or applicable from this 510(k) document:

1. A table of acceptance criteria and the reported device performance: This document lists non-clinical testing (biocompatibility and device performance according to ISO standards, and associated device/pump testing) to demonstrate that the changes implemented do not negatively impact performance compared to the predicate. It does not present specific acceptance criteria in the format of a clinical study endpoint for a novel device. The "performance" is implicitly demonstrated by passing the listed engineering and material tests, showing it functions similarly to the predicate.

2. Sample sized used for the test set and the data provenance: Not specified in detail. The document mentions "non-clinical testing" but does not provide sample sizes for each test or details on data provenance (country of origin, retrospective/prospective). This is typical for 510(k) submissions for accessories or minor modifications where detailed clinical trial data is not required.

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 diagnostic device or an AI/ML algorithm requiring expert interpretation for ground truth. The "ground truth" here is compliance with engineering standards and material specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication process described, as it's not a study where human interpretation is the primary outcome.

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 medical device (infusion set), not an AI/ML diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's safety and performance is based on compliance with established international standards (ISO, USP) for medical devices, material biocompatibility, and functional performance (e.g., flow rates, pressure resistance). This is determined by engineering specifications and laboratory testing, not clinical outcomes or expert consensus on images.

8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is for a medical device (infusion set) and demonstrates substantial equivalence through non-clinical performance and biocompatibility testing against established standards. It does not involve the type of acceptance criteria, study design, or ground truth establishment that would be present for software as a medical device (SaMD) or an AI/ML-driven diagnostic tool.

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The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.

B. Braun Medical Inc. Omnifix Syringe NRFit configurations are sterile, single use syringes with ISO 80369-6 NRFit compliant fittings. They are available in 1mL, 3mL, 10mL, and 20mL lock and slip configurations. The NRFit tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a barrel with a printed graduated scale in milliliters (mL), a stopper and a plunger rod. The plunger rod is yellow to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.

The provided text describes a 510(k) premarket notification for a medical device, the Omnifix Syringe NRFit. This document focuses on demonstrating the substantial equivalence of the new device to a predicate device (B. Braun Piston Syringes, K071459) rather than presenting a traditional clinical study with acceptance criteria for an AI/algorithm-driven device.

Therefore, the request for a table of acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device meeting acceptance criteria by an AI/algorithm is not applicable to this document.

This FDA clearance is for a physical medical device (a syringe) that has been modified to include a new type of connector (NRFit) for neuraxial use. The "performance" being described in the document relates to mechanical and material properties of the syringe, and its biocompatibility, according to established ISO and ASTM standards, not to the performance of an artificial intelligence algorithm.

Instead, the document details nonclinical performance tests conducted to demonstrate the modified syringe's safety and effectiveness. Here's a breakdown of what is provided and why it doesn't fit the requested AI/algorithm performance criteria:

Summary of Device Performance (as presented in the document):

The document states that the Omnifix Syringe NRFit configurations are "equivalent to that of the predicate B. Braun Medical Inc. Omnifix Syringe in intended use, materials and performance characteristics." The differences primarily relate to the connector type (NRFit vs. Luer) and the
resulting change in indicated use (neuraxial vs. general purpose).

The device's performance is demonstrated through compliance with various international standards, which serve as the "acceptance criteria" for a physical medical device. These are detailed under "Functional Testing Summary of ISO 80369-6 compliant nonclinical tests" and other sections.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical device and not an AI algorithm, the "acceptance criteria" are the successful demonstration of compliance with the listed ISO and ASTM standards. The document explicitly states "Bench testing performed on the proposed devices supports substantial equivalence." This implies that the device successfully met the requirements of these tests.

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

• The document implies that standard test methods prescribed by each ISO/ASTM standard were followed. Therefore, the "sample size" would be the number of devices required by these standards for each respective test (e.g., number of syringes for leakage tests, number of samples for biocompatibility, etc.). These specific numbers are not provided in this high-level summary but would be detailed in the underlying test reports.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is internal lab testing of the manufactured product.

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. Ground truth for a physical device's mechanical integrity and biocompatibility is established by adherence to reproducible, standardized test methods, not by expert consensus (like in imaging diagnosis). The "experts" would be qualified laboratory technicians and scientists performing and interpreting these standardized tests.

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

• Not applicable. This concept applies to human reader studies or algorithmic output interpretation, not to physical device testing against objective 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:

• Not applicable. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this device's performance is objective compliance with engineering and biocompatibility standards (e.g., specific dimensions, leakage rates, material reactions in biological assays). It is not expert consensus for diagnostic interpretation or patient outcomes data in the sense of a clinical trial for an AI.

8. The sample size for the training set:

• Not applicable. There is no AI algorithm being trained.

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

• Not applicable. There is no AI algorithm being trained.

In conclusion, the provided FDA 510(k) clearance letter and its summary are for a modified physical medical device. The "study" proving it meets acceptance criteria refers to a battery of nonclinical, laboratory-based functional and biocompatibility tests against established international standards (ISO, ASTM, USP), not an AI algorithm validation study. Therefore, most of the specific questions posed are not relevant to the content of this document.

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The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours.

The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.

The FX catheters are regional anesthesia catheres intended to provide, via percutaneous administration, continuous and/or internittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. The catheters may remain indwwelling for up to 72 hours. Routes of administration are epidural (peripheral nerve block (PNB)). The catheter is available in both open and closed tip designs. The open-tip polyamide catheter is intended to facilitate continuous delivery of anesthetic fluid via one opening at the tip, while the closed-tip polyamide catheter facilitates the administration of anesthetic through three sideports. Both catheters have ink markings, which are located in 10 mm increments along the catheter. The ink markings provide a visual indication of the depth of catheter insertion. When used according to the conditions listed on the product labeling, the FX Catheters may remain in a patient while in an MR environment.

This document is a 510(k) summary for the Perifix FX Catheter and Contiplex FX Catheter manufactured by B. Braun Medical Inc. It concerns a traditional medical device (anesthesia conduction catheters) and does not involve Artificial Intelligence (AI). Therefore, the questions related to AI device performance, such as acceptance criteria for AI, training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to this submission.

The 510(k) submission (K231242) focuses on demonstrating substantial equivalence to predicate devices (K991879 and K113059). The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

"MRI testing was performed. Testing supports the device being labeled as MRI Conditional. No changes have been made to the device therefore, the device continues to be safe and effective and performs the same as the predicate device."

This indicates that the primary testing performed was related to MRI compatibility, and the unchanged nature of the device from its predicates means that prior safety and efficacy data for the predicates are considered applicable.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details because this 510(k) submission is not for an AI device.

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The AQUAbase nX is intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients. The AQUAbase nX is to be used at dialysis clinics or hospitals.

The AQUAbase nX is a reverse osmosis unit intended to be a component in a complete water purification system, and is not a complete water treatment system. This reverse osmosis unit must be preceded by pre-treatment devices. Whether a particular device is included in an individual water treatment system will be dictated by local conditions. The reverse osmosis unit may need to be followed by post-treatment devices as well.

The AQUAbase nX is designed to meet current AAMI/ISO and Federal (U.S.) standards.

The AQUAbase nX is a single stage reverse osmosis system. A graphical touchscreen allows access and monitoring of all operating parameters at any time. Customized parameters make a high water vield possible, even under poor raw water conditions. Raw water consumption is based solely on the end user's permeate needs. The touchscreen makes it possible for the user to monitor all production parameters as well as design every system function, including disinfection mode, individually and reproducibly.

The AQUAbase nX works on the reverse osmosis principle. Reverse osmosis describes the process of pressure-operated cross-filtration. Water flows at high pressure tangentially over a semipermeable membrane. As is the case with normal filtration, the system is cleaned by allowing one component (water) of the mixture to be separated to pass through the membrane with almost no hindrance, while other components (dissolved and undissolved water contents) are held back to a greater or lesser extent and leave the filtration unit in the concentrate flow. This is a purely physical separation process in the molecular range which does not change the components being separated either chemically, biologically or thermally.

The provided document is a 510(k) summary for the AQUAbase nX, a water purification system for hemodialysis. It details the device's characteristics, intended use, and comparison to a predicate device, along with performance data.

However, the information provided does not contain the details required to describe the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI-powered medical device.

The document discusses "performance data" which includes:

• Biocompatibility testing (ISO 10993-1)
• Electrical safety and electromagnetic compatibility (EMC) testing (IEC 60601-1, IEC 60601-1-2)
• Software verification and validation testing (FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as well as the draft FDA guidance recently issued)
• Additional performance bench testing (ISO 23500-3 for performance, chemical and heat disinfection testing, bacterial count and endotoxins)

These are standard engineering and medical device performance tests. There is no mention of an AI algorithm, a test set for AI, ground truth establishment by experts, MRMC studies, or standalone AI performance.

Therefore, I cannot fulfill the request as the provided text does not contain any information about an AI component or a study proving an AI device meets acceptance criteria. The device described is a physical water purification system, not an AI-powered diagnostic or assistive tool.

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The Introcan Safety® 2 IV Catheter is inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, administer fluids and blood intravascularly. The catheters maybe used intravascularly with power injectors at a maximum pressure of 300 psi with a luer lock connection only.

The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated one directional septum, and a passive safety needle-shielding mechanism. Introcan Safety® 2 is designed to reduce blood exposure at insertion until first connection of an infusion line or luer device to protect clinicians and patients from blood exposure. During needle withdrawal through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The passive safety needle-shielding mechanism of the Introcan Safety® 2 is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle which aids in the prevention of catheter shearing. This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. The catheters may be used intravascularly with power injectors for which the maximum pressure setting is 300 psi with a luer lock connection only.

The provided text is a 510(k) Summary for the B. Braun Introcan Safety® 2 IV Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about an AI/ML powered device. As such, information typically found in acceptance criteria and study descriptions for AI/ML devices (like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies) is not present.

However, I can extract the acceptance criteria and the types of studies performed that validate the device's performance based on the provided FDA 510(k) summary.

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 provides no information regarding sample sizes for test sets. The studies performed were bench tests and biocompatibility evaluations, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the studies conducted were non-clinical bench tests and biocompatibility assessments, which do not typically involve human experts establishing ground truth in the way described for AI/ML performance evaluation.

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

This section is not applicable. Adjudication methods are relevant for studies involving subjective human interpretation, which is not the case for the bench testing 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

No MRMC study was performed. The device is a physical intravascular catheter, not an AI-powered diagnostic or assistive tool. The document explicitly states, "No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device."

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

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

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

For the bench tests, the "ground truth" consisted of established engineering and medical device standards (e.g., ISO 10555-1, ISO 10993-1) and internal specifications. For instance, flow rate was measured against an expected flow rate for that catheter size, and burst pressure was tested against a standard definition of failure.

8. The sample size for the training set

This is not applicable as there is no training set for a physical medical device.

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

This is not applicable as there is no training set for a physical medical device.

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The Microvolume Luer Access Device is a valve intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Microvolume Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec.

The Microvolume Luer Access Device (LAD) consists of a body, piston, spike/nut, and a male luer lock cover. The Microvolume LAD is a neutral displacement needleless connector intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The Microvolume LAD may be used with a power injector. The Microvolume LAD is individually packaged and supplied as a sterile, nonpyrogenic, single use disposable device.

The provided text describes a 510(k) premarket notification for a medical device (Microvolume Luer Access Device) and its comparison to a predicate device, focusing on demonstrating substantial equivalence. However, it does not contain information about the acceptance criteria and study proving device performance as requested in the prompt. The document states that the device was evaluated using "Functional performance bench testing" and "No clinical was performed" because the device does not require clinical studies to demonstrate substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample size (test or training set), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as these aspects relate to clinical studies or a more detailed performance evaluation that is not present in this 510(k) summary.

The document lists several standards and tests performed, but these are part of the bench testing to show the device meets certain functional requirements and not specifically "acceptance criteria" against which a study directly proves performance in the context of clinical outcomes or diagnostic accuracy.

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IV Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are gravity, single use, disposable, IV sets and extension sets. IV Administration Sets are used to deliver fluids from a container into a patient's vascular system. Extension sets are connected to primary IV administration sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter and are used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, tubing, luer connections (connector/adaptor), y-connector, and flow regulator.

This is a 510(k) summary for IV Administration Sets by B. Braun Medical Inc. The document discusses the substantial equivalence of their proposed device (K202618) to two predicate devices (K170595 and K153293). It details the non-clinical performance testing conducted.

Here's an analysis of the provided text in response to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific quantitative performance metrics as typically seen in device efficacy studies (e.g., Sensitivity, Specificity, Accuracy for diagnostic devices). Instead, it lists various non-clinical tests performed to demonstrate substantial equivalence to predicate devices and conformity to established standards. The "performance" is reported as a conclusion that the tests were "successfully completed" or that "verification results confirm that the differences in the set components do not raise new or different questions of safety and effectiveness."

Here's a compilation of the tests and the implicit performance:

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

The document does not specify the sample sizes used for the non-clinical tests. Non-clinical studies for devices like IV administration sets typically involve testing a statistically significant number of units to ensure reliability, but the exact numbers are not disclosed in this summary.

The data provenance is from non-clinical performance testing conducted by B. Braun Medical Inc. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission. There is no information regarding the country of origin of the data beyond the manufacturer being B. Braun Medical Inc. (located in Allentown, Pennsylvania, USA).

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 in the context of this 510(k) summary. The ground truth for the non-clinical performance tests is based on objective measurements against established engineering standards (e.g., ISO, USP) and internal B. Braun procedures, not on expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and mechanical performance tests with objective pass/fail criteria based on 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

There was no MRMC comparative effectiveness study done. This device is an IV administration set, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.

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

There was no standalone (algorithm only) performance study done. As mentioned, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is derived from established industry standards (ISO, USP) and internal B. Braun procedures, which outline specific test methodologies, parameters, and pass/fail criteria. For instance, for flow rate, the ground truth would be the expected flow rate range defined by the standard under specific conditions. For tensile strength, it would be the minimum force the material must withstand.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, and the evaluation involves non-clinical performance testing, not machine learning or AI that requires a "training set" of data.

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

This is not applicable for the same reasons as point 8.

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An IV additive dispensing pin for aspiration from single-dose containers with a 20 mm vial closure diameter and a 22mm vial body diameter (6R/8R).

The Mini Spike Plus 6/8 R is an IV additive dispensing pin for aspiration from single-dose containers with the size 6R* or 8R*. It is intended for withdrawal and injection from/in vials. The Mini Spike Plus 6/8 R transfer device is used for the preparation of medications contained in vials with a 20 mm vial closure diameter and a 22mm vial body diameter. The device is for single use and to only be used with single use drug dose vials. The device is configured with a snap cap covering a luer lock female access, a grip plate which features an integrated air filter (0.45 um) and a standard plastic piercing spike. The device provides two separate internal channels: One for injection and withdrawal of fluids, One for the pressure equalization between the vial and the environment. When the device's spike is pierced into a rubber stopper of a drug vial, these channels enable a fluid transfer between a syringe (that is connected with the device's luer connector on the top) and the vial. The vial adapter enables a permanent connection between the Mini Spike Plus 6/8 R and the vial. During the pressure equalization process there is an air exchange with the environment. In order to prevent any contamination of drugs being stored in the vials the air passes a 0.45um bacteria retentive air filter.

The provided text describes a 510(k) premarket notification for a medical device called "Mini Spike Plus 6/8R." This document is for a medical device that does not utilize AI/machine learning. Therefore, the requested information pertaining to AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets in AI studies, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details, and ground truth establishment methods, is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (Mini-Spike Plus) based on traditional medical device performance testing and biocompatibility.

Here's the information that is available from the provided text, related to the device's acceptance criteria and studies:

Acceptance Criteria and Device Performance (based on traditional medical device testing):

The document states that the Mini Spike Plus 6/8R device "has met all established acceptance criteria for performance testing and design verification testing." While specific numerical acceptance criteria values are not explicitly presented in a table alongside performance results, the document lists the tests performed, implying that the device passed these tests according to predefined criteria.

Based on the provided text, a table can be constructed to show the types of tests performed, which inherently represent the areas where acceptance criteria were applied. No numerical performance data is given to populate a "Reported Device Performance" column with specific results, only that the device "met all established acceptance criteria."

• Particle Contamination
• Fragmentation
• Air Tightness
• Free Flow
• Penetration Force
• Tensile Load
• Visual Inspection
• Chemical Analysis
  ISO 80369-7:2016:
• Luer Connector Leakage, Stress Cracking & Resistance Testing
• Dimensional Accuracy
  Internal device performance test methods:
• Fluid burst pressure of air filter membrane
• Dynamic tensile load between Mini Spike and Vial Adapter | "met all established acceptance criteria for performance testing and design verification testing." |
  | Sterile Barrier System | ISO 11607-1: 2006/Amd1:2014, ASTM F 1980-16, ASTM F1886/F1886M-16, ASTM D4169-16, ASTM D4332-14, ASTM F88/F88M-15, ASTM F1929-15, ASTM F2096-11, ASTM F2252/F2252M-13, DIN 58953-6:2016, ISO 11607-2: 2006/Amd:2014:
• Sterile Barrier System Validation | "met all established acceptance criteria for performance testing and design verification testing." |
  | Microbiological/Contamination| USP , USP :
• Bacterial Endotoxin (LAL Gel Clot Test)
  USP :
• Particulate Contamination | "met all established acceptance criteria for performance testing and design verification testing." |
  | Biocompatibility | ISO 10993-1:2009 (evaluated according to this standard), performed tests:
• Cytotoxicity (ISO 10993-5:2009)
• Sensitization (ISO 10993-10:2010)
• Intracutaneous Reactivity / Irritation (ISO 10993-10:2010)
• Acute Systemic Toxicity (ISO 10993-11:2006)
• Hemolysis (ISO 10993-4:2002/Amd1, ASTM F756 (2013))
• Material Mediated Pyrogenicity (ISO 10993-11:2006, USP 38 ) | "met all established acceptance criteria for performance testing and design verification testing." |

Information Not Applicable or Not Provided for AI/ML Devices:

• Sample sizes used for the test set and the data provenance: Not applicable. This is a traditional device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Study Proving Device Meets Acceptance Criteria:

The document states: "Functional performance bench testing was conducted to demonstrate that the Mini Spike Plus 6/8R device performs as intended. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

• Type of Study: Bench testing (in vitro mechanical and material testing).
• Reason for no clinical testing: The device's substantial equivalence was demonstrated through bench testing and biocompatibility testing, compared to a legally marketed predicate device with similar intended use and technological characteristics. The differences (primary "new component" being the Vial Adapter and a change in sterilization method) were addressed through specific performance testing to confirm they don't "raise new questions on safety and effectiveness."

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