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Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.

Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio® 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio® 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio® 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.

Qitexio® 4-Way Stopcock is made of a body with four ports (3 female and one male) and one handle with a L-Shape diverter. The L-shaped diverter opens two neighboring ports at the same time, creating a L-shaped communication channel. The male connector includes a mobile ring assembled on the end of male port, and it enables connection locking over female Luer. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock body. The neighboring female port(s) is connected to the I.V. set to accept the delivered drug or fluid. One female port, that is on the opposite side of the male port, does not directly communicate with the patient (male port). This extra port is designed to enable users to inject multiple I.V. fluids, if needed.

The operating mechanism is manual and with a simple twisting handle position to determine direction of the fluids. Qitexio® 4-Way Stopcock has only two ports communicating at a time.

This document is a 510(k) clearance letter for the Qitexio® 4-Way Stopcock, a physical medical device (an intravascular administration set), not an AI/Software as a Medical Device (SaMD).

Therefore, many of the requested criteria related to AI/SaMD performance studies (e.g., sample size for test/training sets, ground truth establishment for AI, expert adjudication, MRMC studies, standalone performance) are not applicable to this type of device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Bench testing: Verifying physical properties, mechanical integrity, and resistance to fluids.
• Biocompatibility testing: Ensuring the materials are safe for patient contact.
• Sterilization and packaging integrity testing: Confirming the device remains sterile and its packaging intact.
• User-related risk analysis: Assessing potential human factors issues.

Below is an attempt to address your request based only on the information provided, highlighting why certain sections are not applicable to this physical device.

Acceptance Criteria and Device Performance for Qitexio® 4-Way Stopcock

As the Qitexio® 4-Way Stopcock is a physical medical device, not a software or AI-based device, the concept of "acceptance criteria" and "device performance" in this context refers to meeting established engineering, material, and safety standards rather than diagnostic accuracy or algorithmic performance metrics. The information provided in the 510(k) summary focuses on demonstrating that the device meets these standards and is substantially equivalent to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not present a single, consolidated table of quantitative acceptance criteria with specific performance values. Instead, it refers to compliance with recognized consensus standards (e.g., ISO, ASTM, USP) and internal criteria. The "Conclusions" column in Table 2 (Performance Testing) serves as the "reported device performance" by stating that the test results were "satisfactory for the requirements" or "compliant with Medex internal criteria."

Here's an attempt to synthesize the closest equivalent based on the provided text, focusing on the key performance attributes mentioned:

Information Not Applicable to This Device Type (Physical Medical Device)

The following points are not applicable to this 510(k) submission as it pertains to a physical, non-AI/software medical device. If this were an AI/SaMD, this information would be critical.

• 2. Sample size used for the test set and the data provenance: Not applicable. Performance testing for a physical device refers to bench testing on physical samples, not a data test set for an algorithm. There is no "data provenance" in the sense of clinical data from patients.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and laboratory standards and measurements, not expert consensus on clinical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for resolving discrepancies in expert labeling of data, which is irrelevant for physical device 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. MRMC studies are used for evaluating the impact of AI on human reader performance, which doesn't apply to a mechanical stopcock.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance, not a physical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for this device is based on established engineering and material science standards (e.g., "Luer Lock standard," "ISO," "ASTM," "USP" requirements).
• 8. The sample size for the training set: Not applicable. There is no "training set" for a physical medical device.
• 9. How the ground truth for the training set was established: Not applicable. No training set for a physical medical device.

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The KARL STORZ suction and irrigation system (consisting of handle and suction/irrigation tubes, cannulae or needles) is intended for use by qualified surgeons to provide suction and/or irrigation function to help flush or remove blood, fluids, and tissue debris from the operation site during general, gynecologic, urologic, and thoracic laparoscopic surgical procedures.

The devices in the KARL STORZ Suction and Irrigation System are manually operated, reusable surgical devices consisting of handle, suction/irrigation tubes, cannulae or needles. The handle is intended to be used in combination with suction/irrigation cannulae and tubing and controls the suction and irrigation. Enabled by the handle with stop cock valve, the regulation of the irrigated quantity of fluids via the tubes, or rather the quantity of aspirated fluid (e.g., blood, fluids, and tissue debris) into or out of the patient is performed. Cannula and needle: Enabled by the pointed distal end, both puncture and injection/extraction cannulae and needles, perform puncturing of target organs or tissues and injecting fluids into operating site i.e. extracting blood or fluids from them. The prerequisite for suction is either a vacuum powered suction wall apparatus or a pump, which serve as impulse for the suction. The proximal end of the tube set is connected to the vacuum or pump. Either a pump is required as impulse for irrigation or the natural force of gravity, i.e., by positioning the flush bag at the appropriate height.

The provided document is an FDA 510(k) Premarket Notification for medical devices, specifically KARL STORZ suction and irrigation systems. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance data and does not typically include studies involving artificial intelligence (AI) or machine learning (ML) components, nor does it present "acceptance criteria" and "device performance" in the context of an AI/ML model's diagnostic or predictive capabilities.

Therefore, the requested information regarding AI/ML-related acceptance criteria and study details (such as sample sizes for test and training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth establishment, etc.) cannot be extracted from this document, as it is not relevant to the type of device and submission described.

The document focuses on:

• Device Description: Manually operated, reusable surgical devices (handle, suction/irrigation tubes, cannulae, needles).
• Intended Use: Suction and/or irrigation to flush or remove blood, fluids, and tissue debris during laparoscopic surgical procedures.
• Basis for Substantial Equivalence: Comparison to predicate KARL STORZ devices (K945059 and K951190) based on technological characteristics and non-clinical performance data.
• Non-Clinical Performance Data Provided:
  • Biocompatibility testing: Compliance with ISO 10993.
  • Reprocessing Validation: Compliance with standards like ANSI/AAMI/ISO 14937, 11138-3, 11607-1, 11737-1, 17664, 17665-1 regarding cleaning and sterilization.
  • Bench Top Performance Testing: Leak Test, Flow Incoming Test, Flow Outgoing Test.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."

In summary, this document does not contain information about an AI/ML device or its associated performance studies.

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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 consist of Intravascular Administration Sets. They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

The proposed devices consist of a spike tip protector, non-vented spike, drip chamber, tubing, check valve, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), Interlink injection site, 3 Port Manifold, Stopcock, female Luer, two-piece male Luer lock and male Luer cap. The proposed devices are used to administer solution directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.

This document is a 510(k) summary for the Baxter Healthcare Corporation's Intravascular Administration Sets with Stopcock and Manifold (K223175). It does not contain information about a study comparing device performance against specific acceptance criteria in the context of an AI/human-in-the-loop setting. This type of submission is for medical devices that are substantially equivalent to a predicate device, and the focus is on demonstrating that the new device's technological characteristics do not raise new questions of safety or effectiveness.

Therefore, many of the requested items (e.g., reporting device performance against acceptance criteria, sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not present in this document because they are generally applicable to the evaluation of AI/ML-enabled medical devices or those requiring de novo classification, not typical 510(k) submissions for physical devices like administration sets.

However, I can extract information related to the device's performance testing which demonstrates its safety and effectiveness, as well as the types of studies conducted for substantiation.

Here's an attempt to answer based on the provided text, acknowledging that many requested fields are not applicable:

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

The document states: "All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use." However, specific quantitative acceptance criteria and corresponding reported device performance values are not explicitly provided in a table format in this summary. Instead, it lists the types of tests performed and the standards they conform to.

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

The document does not specify sample sizes for the various bench tests. Data provenance in terms of country of origin is not mentioned, and the tests are described as non-clinical bench tests or evaluations of materials. This is not a study involving human patient data, so "retrospective or prospective" doesn't apply in the same way as for AI/clinical studies.

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

Not applicable. This is not an AI/ML device requiring expert ground truth for image/data interpretation. Ground truth for these tests is based on adherence to established international standards (ISO, USP) and validated testing protocols.

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

Not applicable. This is not an AI/ML device requiring adjudication of expert interpretations for ground truth.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for the performance of these Intravascular Administration Sets is established through adherence to recognized international standards and validated scientific testing protocols. For example:

• Luer connectors: Conformance to ISO 80369-7, ISO 594-1, ISO 594-2.
• Biocompatibility: Conformance to ISO 10993-1 and FDA guidance.
• Particulate matter: Conformance to USP .
• Sterility: Conformance to ANSI/AAMI/ISO 11137-2.
• Microbial ingress: Baxter's internally validated "testing strategy."

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable. This is not an AI/ML device.

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SafePort(TM) Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.

Elcam modified SafePort™ Manifold (also identified as SafePort™ Manifold) is used in Operating Room (OR) and Intensive Care Unit (ICU) to assist the physician and mainly the anesthesiologist in delivering IV drugs and fluids during and after operation.

Elcam's SafePort™ Manifold is designated for single use only (disposable) and its recommended maximal use duration is up to 24 hours.

Liquid compatibility: Elcam's SafePort™ Manifold is compatible with common fluids used in I.V. therapy, anesthesia and monitoring, including blood transfusion. The SafePort™ Manifold is made of a body with 1-5 side ports and 1-5 handles (depends on the number of ports).

Each port has a male or female connector (luer). Male connectors also include a nut (rotator) for locking over the female luer of the connected component. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock/Manifold body.

Operating mechanism is manual and simple operated by twisting the handle position to determine fluid direction.

Between each handle and port housing an Elastomer may be placed to function as a pressure Luer Activated Valve (LAV) as an option to standard open female luer. The LAV is welded to the manifold body's fluid line at the female side port(s) in order to avoid back flow (reflux) and to serve as closed port. A rotator is assembled on the proximal male port (which is connected toward the patient) in order to enable connection locking. The distal female port is connected to the I.V Set to accept the delivered drug or fluid. Open ports (female and male) may be provided with or without covers.

Design wise, the modified SafePort™ Manifold relies on Elcam legally marketed SafePort™ Manifold cleared under K111016 that was modified as follow:

The SafePort™ Handle was modified for better producibility: Elastomeric material was changed, a cone-shape was added to the handle stem at the sealing area, as well as "door" shape fluid entrance added instead of around the entire stem. Cosmetic/visual non-functional changes were also implemented. The SafePort™ Body was changed to fit the handle changes: The stopper, dimensions luer compliance with ISO 80369-7, side port LAV female thread connection improvements and cosmetic/visual changes. Additional green colorant was added to the existing Caps' colorants.

Transfusion use was added to the SafePort™ indications for use statement to align Elcam SafePort™ with all other Stopcock and Manifold products (as in the primary predicate device cleared under K060231) that share the same indications for use, basic fluid path design and material types. Labeling materials were revised to include the additional transfusion claim.

All modifications were evaluated using well-established tests' methods previously utilized by Elcam or conducted per FDA recognized consensus standards and provided as summary tabulated in a risk analysis format.

The SafePort™ Manifold (or Stopcock) is a medical device used for flow control and fluid delivery in IV therapy. Based on the provided document, the device did not undergo clinical studies, therefore, there is no information about reader studies, effect sizes, training sets, or expert qualifications. The performance data is derived from non-clinical laboratory testing.

Here's the summary of the acceptance criteria and device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to a predicate device and lists various non-clinical performance tests. The acceptance criteria for most tests remained the same as previously established. A specific difference in handle door burst pressure is noted but deemed clinically non-sensible. Since specific numerical acceptance criteria are not provided for all tests, the table below will describe the test and the reported outcome.

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

The document does not explicitly state the specific sample sizes for each non-clinical test. It mentions that "Performance tests were conducted successfully by Elcam in order to validate the changes presented in this 510(k) Submission using well established methods." These are laboratory tests conducted by the manufacturer, Elcam Medical ACAL, based in Kibbutz Baram, Merom HaGalil, Israel. The data is prospective, generated specifically for this 510(k) submission.

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

This information is not applicable as the document explicitly states: "No clinical Study was performed for the purpose of this submission." The evaluation relies on non-clinical performance testing against recognized standards and internal protocols, not expert-derived ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical study or human reader evaluation was performed.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission is based on non-clinical performance testing.

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

This information is not applicable. The device is a physical medical device (SafePort™ Manifold or Stopcock) and not an AI algorithm.

7. The Type of Ground Truth Used

For non-clinical performance testing, the "ground truth" is defined by adherence to established, recognized consensus standards (e.g., ISO, ASTM, USP, AAMI TIR) and Elcam's internal, previously validated test methods and specifications. These standards provide objective criteria for device performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.

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

This information is not applicable as there is no training set for an AI algorithm.

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The Everest 20cc Inflation Device/Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adanter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.

The document describes a 510(k) premarket notification for Medtronic's Everest™ Inflation Device and Survival Kits. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing related to packaging and shelf-life, rather than clinical efficacy. Therefore, a traditional "study" proving the device meets acceptance criteria in terms of clinical performance or an AI algorithm's performance isn't applicable here.

Instead, the document details the acceptance criteria for packaging performance and shelf-life, and the tests conducted to show the device meets these criteria. The approval is based on the device being "substantially equivalent" to an existing, legally marketed predicate device, not on demonstrating new clinical efficacy.

Here's the information requested, adapted to the context of this device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device relate to its packaging and shelf-life, ensuring it maintains sterility and integrity. The document states that "No new safety or effectiveness issues were raised during the testing. The test data demonstrated that the modified Medtronic's Everest™ Inflation Devices is as safe and effective as the legally marketed predicate device." This implies that all tested criteria were met.

Due to the nature of the document detailing specific tests rather than numerical performance metrics for each acceptance criterion, a direct table of "performance" for each against a criterion is not provided with exact values. However, the document lists the performed tests, which serve as the acceptance criteria. The "Reported Device Performance" is broadly stated as successful.

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

The document does not explicitly state the numerical "sample size" for the non-clinical packaging and shelf-life tests. This type of information is typically found in the full test reports, which are not included in this summary.

The "data provenance" is internal to Medtronic (manufacturer), based on testing performed on the modified Everest™ Inflation Devices. It is retrospective in the sense that the tests are performed on manufactured devices to confirm design and material changes maintain equivalence.

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

This question is not applicable to this type of device submission. The tests are physical and chemical property tests on packaging and product integrity, not diagnostic or clinical assessments requiring expert human interpretation or "ground truth" establishment in the medical sense. The "ground truth" here is the physical measurement or observation of the packaging and device components against engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. Physical performance tests on a device's parts and packaging do not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes. The results are obtained directly from laboratory measurements and observations.

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 (inflation balloon and accessories) is a mechanical tool used in interventional procedures. It is not an AI-powered diagnostic or assistive tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. This device does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

For the non-clinical tests (packaging and shelf-life), the ground truth is established by engineering specifications, industry standards (e.g., ISO 15223-1 mentioned for symbols), and regulatory requirements for medical device packaging integrity and sterility. The outcome of these tests determines if the device meets these pre-defined physical and performance benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. There is no training set for this device.

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Sheath with integrated stopcocks are used in conjunction with a hysteroscope to permit direct viewing of the cervical canal and the uterine cavity to perform diagnostic and surgical procedures.

The subject device is a reusable sheath (Part WA4777A) and stopcock (Part WA47778A), provided non-sterile and labeled for reprocessing via cleaning and steam sterilization. The sheath is a rigid instrument made from stainless steel. The sheath has a working length of 206.7 ± 0.15 mm. The sheath has a single lumen shaped to allow for both, insertion of one 3 mm hysteroscope as well as a 5 Fr instrument channel for the instrument and irrigation inflow. There are three ports, one for irrigation, one for instruments, and one for the hysteroscope. There is no outflow channel for the irrigation fluid; the irrigation fluid flows out between the sheath and the cervix channel. A hysteroscope can be inserted into the hysteroscope channel of the sheath from the proximal end to provide an endoscopic image during the procedure. The endoscopic image can be viewed using the ocular or by connecting a compatible camera head. Compatible surgical instruments can be inserted into the instrument channel of the sheath. The irrigation stopcock made from stainless steel and polyether ether ketone (PEEK) can be used to control the inflow of the irrigation fluid. The instrument stopcock controls the passage of the surgical instruments.

The provided text describes the 510(k) premarket notification for a "Sheath and Stopcock Accessory" and does not contain information about an AI/ML powered device, therefore the request cannot be fully answered. This document purely focuses on a traditional medical device, specifically a reusable sheath and stopcock for hysteroscopes.

However, based on the information provided regarding the "Sheath and Stopcock Accessory," here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not specify exact sample sizes for each test set. It mentions "comparative validation testing" for mechanical performance and "risk analysis" for electrical/thermal safety, and "method validation testing" for reprocessing. The provenance of the data is from internal testing conducted by Olympus Winter & Ibe GmbH. No country of origin for the data is explicitly mentioned, but the manufacturer is based in Hamburg, Germany. The studies are assumed to be prospective experiments or tests designed specifically for this regulatory submission.

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

This information is not provided because the device is a physical medical instrument, not an AI/ML diagnostic tool requiring human expert interpretation for ground truth. The "ground truth" for this device is established through objective physical, chemical, and electrical measurements and adherence to recognized standards.

4. Adjudication method for the test set

Not applicable, as this is not an interpretive diagnostic device requiring adjudication of human-labeled data.

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, not an AI/ML system, so no MRMC study or AI assistance evaluation was performed.

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

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

7. The type of ground truth used

The ground truth for this device's performance evaluation is based on objective physical measurements, chemical analyses (for biocompatibility), and adherence to established international and national standards (ISO, AAMI/ANSI, IEC, FDA guidance documents). For example, "non-cytotoxic" is a measurable outcome, and "comparable flow" is determined by direct measurement during bench testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML powered device.

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

Not applicable. There is no "training set" as this is not an AI/ML powered device.

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MonuMedical TurnSignal® Stopcocks and Manifolds are indicated for fluid flow directional control and providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

MonuMedical TurnSignal® Stopcocks and Manifolds are composed of a stopcock with three port three way and or three port four way body and a handle. Male connectors also include a nut for locking over the female connector or another component. A small amount of lubricant is applied between the stopcock body and handle. The manifolds contain a Halkey Roberts Swabable Port on each stopcock. MonuMedical Stopcocks will be available in a wide variety of configuration for use according to a particular situation and the clinician's preference. Duration of use should not exceed 24 hours and 7 activations of the swabable ports. The devices are provided sterile and non-sterile.

The MonuMedical TurnSignal® Stopcocks and Manifolds are indicated for fluid flow directional control and providing access port(s) for the administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, and transfusion.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

• Falling drop Positive pressure liquid leakage testing.
• Sub atmospheric pressure Air Leakage.
• Stress Cracking.
• Resistance to Separation from Axial Load.
• Resistance to Separation from Unscrewing.
• Resistance to overriding. |
  | Thread Gauge Testing (ISO 80369-20) | Compliance with ISO 80369-20. |
  | Leak Testing | Successful leak testing was performed. |
  | Taper Block (ISO 594-1) | Compliance with ISO 594-1 (go/no-go taper block 6% taper). |

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

The document does not explicitly state the exact sample sizes used for each individual test. However, it indicates "performance testing completed" and "design verification testing" were performed.

The data provenance is from non-clinical bench testing conducted by MonuMedical, LLC. The location of the testing is not specified, but it aligns with the submission from a US-based company (MonuMedical, LLC, Roseville, CA). These tests are typically prospective, designed specifically to evaluate the device's performance against established standards.

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 to this type of submission. The performance assessment for material compatibility, sterile barrier integrity, and functional performance of medical devices like stopcocks and manifolds is typically based on adherence to recognized international and national consensus standards (e.g., ISO, ASTM, ANSI AAMI) and their respective test methods, not on expert consensus for "ground truth" in the same way an imaging AI algorithm would be evaluated. The standards themselves define the "ground truth" for acceptable performance.

4. Adjudication method for the test set:

This is not applicable. As stated above, performance is evaluated against established standard test methods and acceptance criteria, not through an adjudication process involving multiple experts for diagnostic accuracy.

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 is not applicable. This document describes the substantial equivalence of a physical medical device (stopcocks and manifolds), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance evaluation is irrelevant.

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

This is not applicable. This document describes the substantial equivalence of a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" used for all the performance tests is adherence to established international and national consensus standards and specifications. These standards define the acceptable range of performance for each physical and material characteristic of the device.

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for this type of physical medical device. The device itself is manufactured, and its performance is verified through testing, not trained.

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

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

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Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Stopcocks and Manifolds (*including MRVLS, Closed Stopcock and S2R)

I am sorry, but the provided text from the FDA 510(k) clearance letter for "Elcam Stopcocks and Manifolds" (K190489) does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/MRMC studies.

The document is a standard FDA clearance letter, primarily confirming substantial equivalence to a predicate device and outlining regulatory information. It describes the device's indications for use but does not delve into the specific technical studies or performance data typically associated with software-as-a-medical-device (SaMD) or AI-powered devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

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This device is intended to regulate flow through the working channel of a ureteroscope, cystoscope, or other endoscope.

The San Antonio Stopcock is a one-way stopcock with a male luer lock adapter (MLLA) and a barbed fitting. The device is comprised of a polycarbonate body, a nylon barbed adapter, and a polyethylene valve stem. The polycarbonate stopcock body has a MLLA and a female luer adapter (FMLA). The nylon barbed fitting has a MLLA that is attached to the FMLA of the stopcock body. The polyethylene valve stem assembly is seated within the polycarbonate stopcock body and controls the flow of liquids. The San Antonio Stopcock is operated by fitting the male luer end to the female connection of the endoscope and the barbed end to an irrigation set or other tubing. The device is sold sterile and is intended for one-time use.

The provided document is a 510(k) Premarket Notification for the "San Antonio Stopcock" device. It outlines the regulatory submission, device description, indications for use, and a comparison to a predicate device. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, this document is a regulatory approval letter and summary, not a clinical study report. It states that performance and biocompatibility testing was conducted and met "pre-determined acceptance criteria," but it does not specify what those criteria were, nor does it describe the study design, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be fully provided. The document states:

• "Compatibility and Leakage Testing – Testing demonstrated that the San Antonio Stopcock met the compatibility requirements with supporting devices and that the device does not leak under a gravity flow test setup."
• "Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, Sensitization, and Intracutaneous Reactivity demonstrated that the devices are biocompatible."
• "For these tests, all pre-determined acceptance criteria were met."

However, the specific acceptance criteria (e.g., "leakage rate must be less than X mL/hr") and quantitative reported performance (e.g., "leakage rate was Y mL/hr") are not detailed in this document.

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

Cannot be provided. The document mentions "testing" but does not specify sample sizes for any test sets, nor does it provide information on data provenance (country of origin, retrospective/prospective). While "Cook Incorporated" is based in Bloomington, IN, USA, this doesn't tell us about the test data origin.

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/Cannot be provided. These types of details are relevant for studies involving subjective interpretation or diagnostic accuracy assessments (e.g., image-based AI tools). The "San Antonio Stopcock" is a physical medical device (a valve) intended to regulate fluid flow. Its performance is assessed through objective engineering and biological tests (leakage, compatibility, biocompatibility), not through expert interpretation of data points that establish a "ground truth" in the diagnostic sense.

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

Not applicable/Cannot be provided. As above, this concept typically applies to studies where multiple experts evaluate ambiguous cases and an adjudication method is used to resolve discrepancies for ground truth establishment. This is not relevant for the objective performance testing described for a physical device like a stopcock.

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 type of study (MRMC for AI assistance) is completely irrelevant for a mechanical device like a stopcock. No such study would have been performed or would be necessary for this kind of product.

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

Not applicable. This question pertains to AI/algorithm performance. The San Antonio Stopcock is a physical medical device, not an algorithm. Therefore, no standalone algorithmic performance was evaluated.

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

Not clearly defined within the document. For the types of tests described (compatibility, leakage, biocompatibility), "ground truth" would be established by predefined engineering specifications, industry standards (e.g., ISO for biocompatibility), or direct physical measurements. For instance, a "no leakage" acceptance criterion inherently defines its own ground truth through the objective measurement of fluid escape.

8. The sample size for the training set

Not applicable/Cannot be provided. This question is relevant for machine learning or AI models which require training sets. The San Antonio Stopcock is a physically manufactured device, not an AI model. Therefore, there is no "training set" in this context.

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

Not applicable. As stated above, there is no training set for this device.

Summary of what's provided for the San Antonio Stopcock:

• Device Type: Mechanical medical device (stopcock) for regulating fluid flow.
• Purpose of Tests: To ensure reliable design, performance, and biocompatibility in comparison to a predicate device.
• Tests Performed: Compatibility and Leakage Testing, Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity).
• Outcome: All pre-determined acceptance criteria were met, supporting substantial equivalence to the predicate device.

The provided document is a regulatory piece stating that the device passed certain tests, but it does not delve into the granular details of those tests, which would typically be found in an internal design verification report or a full test protocol, not a 510(k) summary.

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The Dynarex Three-Way Stopcock multiple port device is indicated to serve as a flow control and a conduit for I.V. fluid delivery to a patient's vascular system. This device is intended for delivering I.V. drug solutions or fluids, allowing gravity feed, sampling, bolus injection, and elimination or reflux of solutions and fluids during operation. The device may be used for a limited contact duration (24 hours or less).

The Dynarex Three-Way Stopcock is a multiple port and needless access device that can be attached to other intravascular administration set devices by the user at the point of use during infusion therapy or sampling. The single-use disposable device intended for use on continuous or intermittent fluid administration or withdrawal of fluids. An in-line access site and can be connected to female luer adapters to allow needless access to fluid or vascular fluid path, and can control fluid flow by rotating flow control taps. The multiple access sites can be used for administration of drugs and solutions to a common fluid path or patient vascular system through a needle or catheter inserted into a vein.

The provided text describes the submission of a medical device, the Dynarex Three-Way Stopcock, for FDA 510(k) clearance, indicating its substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate this equivalence.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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