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Elcam's High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended to serve as flow control and delivery devices for I.V fluids injection to the patient's vascular system. The devices are indicated for medium and high pressure injection of fluids such as, but not limited to, fluids used during angiography and angioplasty and during interventional radiology and cardiology procedures. Devices indication for medium and high pressure does not preclude its use for low pressure procedures. The High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended for single use only.

Stopcocks and Manifolds are generally used for administration of fluids into the human. body. There is a wide use of Stopcocks as flow controls and sampling sites in I.V sets, critical care applications and monitoring kits. Stopcocks are used individually or in the form of Manifolds, units comprised of several Stopcocks joined together ("gang"). High pressure Stopcocks and Manifolds are used in cardiac angiography and angioplasty procedures in which fluids are administered under pressure. These procedures require stopcocks and manifolds which are robust under high pressures. The line of pressure resistant Stopcocks and Manifolds presented in this file includes four (4) products: i. High Pressure (HP) Stopcocks ii. Medium Pressure (MP) Stopcocks High Pressure (HP) Manifolds iii. Premium High Pressure (PHP) Manifolds iv.

The provided document is a 510(k) summary for medical devices (stopcocks and manifolds), not an AI/ML device study. Therefore, most of the requested information (sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is not applicable or present in this type of regulatory submission.

However, I can extract the acceptance criteria and the stated performance relative to those criteria from the document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes substantial equivalence by comparing the proposed devices to legally marketed predicate devices, and by performing specific tests to demonstrate that the new devices, particularly in handling higher pressures, meet relevant safety and performance standards. The acceptance criteria are largely defined by adherence to specific ISO standards and the ability to withstand stated pressure ratings.

2. Sample size used for the test set and the data provenance:
Not applicable. This is a review of a 510(k) submission for physical medical devices, not a study involving a test set with patient data for an AI/ML algorithm. The "tests" mentioned are engineering and performance validation tests on the devices themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined in AI/ML studies is not relevant here. The "truth" is established by physical measurements and compliance with international standards.

4. Adjudication method for the test set:
Not applicable.

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:
The "ground truth" for the device's performance is established through physical testing and adherence to recognized international standards (e.g., ISO 8536-10, ISO 10993, ISO 11135-1, ISO 11607-1/2, ISO 594-1, ISO 594-2). These standards define the expected performance and safety characteristics.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

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

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Elcam Vital Signs Wireless System is indicated for use on patients requiring pressure monitoring. Elcam Vital Signs Wireless System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.

Elcam Vital Signs Wireless System utilizes the Bluetooth® communications Protocol in order to eliminate the multi-conductor, fixed length and shielded reusable cables that typically acts as the interface between the patient's bedside monitor and disposable transducer. The disposable transducer will simply plugs into the system's remote transmitter unit, which sends its output signal to the system's receiver unit affixed to the bedside monitor.

The wireless system is intended to operate at varying distances to accommodate typical layouts that exist within hospital operating rooms, critical care units, emergency rooms and catheterization lab suites.

Here's an analysis of the provided text regarding the Elcam Vital Signs Wireless System's acceptance criteria and studies:

Assessment of the Provided Information:

The document is a 510(k) summary for a medical device (Elcam Vital Signs Wireless System). 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than undergoing extensive de novo clinical trials with established acceptance criteria and detailed performance metrics.

Therefore, much of the requested information (like specific acceptance criteria, detailed study designs, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance with explicit metrics like sensitivity/specificity, or training set ground truth details) is not typically found in a 510(k) summary focused on substantial equivalence.

The document does mention "performance results provided (including test results and clinical data)" but does not provide the specifics of these results or the acceptance criteria for those tests. It highlights a reliance on the equivalence to the predicate device (Hospira. Vital Signs Wireless Monitoring System - K090610).

Based on the provided text, here's what can be extracted and what is missing or explicitly not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, explicit, quantified acceptance criteria and specific numerical performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the device's clinical operation are not detailed in this summary. Instead, the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate device, especially in design, materials, components, intended use, and labeling. The core "performance" reported is its ability to perform wireless transmission of pressure information, similar to existing methods.

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

• Sample Size: The document does not specify a sample size for any clinical or performance test set with explicit metrics.
• Data Provenance: The document mentions "performance results provided (including test results and clinical data)" but does not detail the provenance (e.g., country of origin, retrospective/prospective nature) of this data.

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

This type of information is not provided in the 510(k) summary. For devices relying on substantial equivalence, ground truth is often established by adherence to existing engineering standards, bench testing, and comparisons to the predicate device's established performance, rather than a reader study with expert adjudication.

4. Adjudication Method for the Test Set

This information is not provided as there is no described reader study or expert-adjudicated test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC study was not described. This device is a wireless transmission system for physiological signals, not an AI-assisted diagnostic or interpretive tool that would involve human readers and AI assistance. Therefore, this question is not applicable to the Elcam Vital Signs Wireless System described.

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

• The document implies that performance testing was done on the device's ability to transmit signals, which would be a form of "standalone" functional testing. However, specific details of such standalone performance (e.g., latency, signal integrity, transmission range, battery life in various scenarios, and their acceptance criteria) are not provided in this summary. The focus is on demonstrating its functional equivalence to a wired system and the predicate wireless system.

7. The Type of Ground Truth Used

• The implicit "ground truth" for this substantial equivalence submission appears to be the established performance and safety of the predicate device (Hospira Vital Signs Wireless Monitoring System - K090610), along with adherence to relevant engineering and performance standards for wireless communication and medical devices (which would be detailed in other sections of the full 510(k) submission, not this summary). Bench testing results and clinical data were stated to be provided, implying functional validation against expected outputs from transducers and acceptable display on monitors.

8. The Sample Size for the Training Set

• This information is not applicable as the described device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware device utilizing a communication protocol.

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

• This information is not applicable as there is no "training set" for this type of device.

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Elcam Disposable Integrated Pressure Transducer is intended for direct measurement and monitoring of blood pressure. The disposable Transducer is intended for single use only.

Indications for the Disposable Integrated Pressure Transducer (DIPT) include:

Direct arterial blood pressure monitoring - central and peripheral
Pulmonary artery monitoring
Venous pressure monitoring
Left atrial monitoring when used with an air eliminator
Cardiac catheterization

The disposable Transducer in an extravascular blood pressure transducer that convert mechanical changes in pressure into electrical current that can be input into a pressure monitor. The disposable Transducer consists of an extravascular pressure transducer module that interfaces between an intravascular catheter and pressure monitor. One of the major components that the transducer include is an integral flush valve and Luer connector that can connect a flashing fluid source to the intravascular catheter.

The provided text is for a 510(k) summary for a medical device that does not involve AI/ML technology or image processing. The device is an "Elcam Disposable Integrated Pressure Transducer (DIPT)" used for direct measurement and monitoring of blood pressure.

Therefore, the requested information about acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this document.

The document states:

• Rationale for Substantial Equivalency: "Elcam is the manufacturer of the Disposable integrated pressure transducer substantially equivalent to the predicate device and also the manufacture of the predicate device. Both products are the same products. The claim for substantial equivalence is supported by the information provided in the 510(k) submission" (Page 1)
• Safety & Effectiveness: "The proposed and predicate devices are similar in design, materials of construction, components, intended use and labeling. Based on the performance results provided (including test results and clinical data) and the analysis of similarities and differences presented above. Elcam Medical believes that the proposed device safe & effectiveness is substantially equivalent to the predicate device without raising new safety and/or effectiveness issues." (Page 1)

This indicates that the device's approval is based on its substantial equivalence to a predicate device (K052828), which is also manufactured by Elcam, meaning they are essentially the same product. The "performance results" mentioned are likely standard engineering and bench testing for pressure transducers, not AI/ML performance metrics.

To answer your specific questions, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of AI/ML. The 510(k) relies on substantial equivalence to an existing device, implying it meets the same performance standards of that predicate.
2. Sample sized used for the test set and the data provenance: Not applicable/not provided for AI/ML. Any "test results and clinical data" mentioned are for the physical transducer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided for AI/ML.
4. Adjudication method: Not applicable/not provided for AI/ML.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
7. The type of ground truth used: Not applicable/not provided for AI/ML. For a physical device like this, performance would be validated against established physical standards and measurements.
8. The sample size for the training set: Not applicable/not provided for AI/ML.
9. How the ground truth for the training set was established: Not applicable/not provided for AI/ML.

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The Flexi-Q DV Auto-injector is indicated for the transfer and automated subcutaneous injection of FDA approved drugs and biologics in compatible vials.

The Flexi-Q DV Auto-injector is intended for use in the home environment by the patient or care-giver after training by a Health Care Professional.

The Flexi-Q DV Auto-injector (also called: FUDAI DV)) is designed to allow people with or without minor dexterity problems (or with a help of a care giver) to aspirate a drug in solution form from a standard 13mm vial and automatically inject themselves subcutaneously with the drug.

The device is comprised of the following parts;

• -Housing: The outer shell/covering of the device. The Housing which encloses and protects the inner components including the syringe, is designed to be used while held with one hand and provides the user with visibility of the solution/ drug before, during and after injection via a window.
• -Syringe: A standard 1mL long glass syringe is assembled within the Housing. The syringe includes a staked 1/2 27G needle and an elastomeric syringe piston. The syringe is marked with a single graduation line indicating the dose volume to be aspirated and delivered (any dosage between 0.3 to 1.0mL is possible; e.g., 0.3 or 0.4 or 0.5 or 0.6 etc. up to 1.0mL). i.e., different Flexi-Q Auto-injector versions will be available, each for a single dosage volume, and according to physician prescription, the patient will use the Flexi-Q Auto-injector version specifically marked for his/her prescribed dose volume. The "single dose - single device" Flexi-Q auto-injectors are illustrated in page 11-13, Figure I. The syringe needle is used to penetrate the Vial Adaptor septum (for solution/reconstituted drug aspiration) and then to administer the subcutaneous injection to the patient.
• -Needle Shield: The needle shield covers the needle before injection. When depressed against the skin, the shield "unlocks" the Trigger Button to allow activation and injection. After the injection is completed, the shield locks in place, keeping the needle from being accessible and helping protect the user from accidental needle stick injury.
• Plunger Rod: A rigid rod that is connected to the syringe piston and protrudes out of the Auto-injector's Housing. The Plunger Rod is used to aspirate the solution/reconstituted drug into the syringe and adjust the volume to be injected to the predefined dosage.
• Trigger Button (Red INJECT Button): This button enables the user to activate the injection process after is has been unlocked by the user pressing the shield against the skin at the injection site. Once pressed the device advances the injection needle into the subcutaneous tissue followed by injection of the drug.
• One Vial Adaptor (Gray Connector): The Sterile, Single use Vial Adaptor . functions as a connector between the Auto-injector and the drug vial and provides a fluid path to enable aspiration of the drug. The syringe needle penetrates a septum (assembled inside the Vial Adaptor) made of thermoplastic elastomer while a plastic spike (part of the Vial Adaptor) penetrates the vial stopper. While attached to the Auto-injector, the Vial Adaptor conceals the Needle Shield and thus preventing inadvertent activation.

In certain cases when additional vial may be used (per drug prescription), additional sterile vial adaptor(s), may be used.

The provided 510(k) summary for the Flexi-Q DV Auto-injector (K111467) does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria, especially in the context of an AI-powered device or a direct clinical effectiveness study with human readers.

Based on the document, the device is a mechanical auto-injector, not an AI-powered medical device. Therefore, many of the questions related to AI performance, ground truth establishment for AI models, and multi-reader multi-case studies are not applicable.

The document primarily focuses on establishing substantial equivalence to predicate devices (Mixject Dispensing Pin and Autoject 2) based on intended use and principle of operation. It does not describe specific performance studies with quantitative acceptance criteria for the Flexi-Q DV Auto-injector itself beyond stating that the "evaluation of the Flexi-Q DV Auto-injector does not raise any additional concerns regarding safety and effectiveness."

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document for the Flexi-Q DV Auto-injector. The document establishes substantial equivalence by comparing its intended use and principle of operation to predicate devices, implying that if it functions similarly, it meets acceptable performance. Quantitative performance metrics or specific acceptance criteria are not detailed in this summary.

• Visibility of solution/drug via a window.
• Syringe marked with a single graduation line for dose volume (0.3 to 1.0mL).
• Needle shield covers the needle before injection, "unlocks" trigger when depressed against skin, and locks after injection to prevent accidental needle stick injury.
• Plunger rod for aspiration and volume adjustment.
• Trigger Button for activating injection after being unlocked.
• Vial Adaptor for connecting to drug vial and concealing needle shield to prevent inadvertent activation. |

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

Not explicitly stated. The document does not describe a specific "test set" in the context of clinical or performance validation data for the device. The evaluation mentioned is likely a part of the regulatory submission process, which may involve bench testing and engineering analysis rather than a human-user test set as typically understood for AI or diagnostic devices.

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

Not applicable. This question is typically relevant for studies involving the interpretation of data (e.g., medical images) where expert consensus is needed to define the "ground truth" against which an algorithm is evaluated. The Flexi-Q DV Auto-injector is a mechanical device, and its performance would be assessed through engineering tests and usability evaluations, not by establishing a ground truth in the same manner.

4. Adjudication Method for the Test Set

Not applicable. As the document doesn't describe a test set or ground truth establishment relevant to data interpretation, an adjudication method is not described.

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

No, an MRMC comparative effectiveness study was not done or described. This type of study is typically performed for diagnostic devices (especially those involving image interpretation) to evaluate the impact of an AI system on human reader performance. The Flexi-Q DV Auto-injector is a mechanical auto-injector, not a diagnostic AI system.

• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The Flexi-Q DV Auto-injector is a mechanical device, not an algorithm. There is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

Not applicable in the context of AI or diagnostic interpretation. For a mechanical device like an auto-injector, "ground truth" might refer to engineering specifications, physical measurements (e.g., injection volume accuracy, injection force, needle penetration depth), or successful drug delivery as per design. These specific performance metrics or their "ground truth" type are not detailed in the summary.

8. The Sample Size for the Training Set

Not applicable. The device is a mechanical auto-injector and does not rely on a "training set" in the machine learning sense. Its design and manufacturing are based on engineering principles and quality systems, not data-driven model training.

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

Not applicable. As there is no training set for an AI model, there is no corresponding ground truth for it.

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Safeport Manifold 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 1.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation

Modified SafePort Manifold (or Stopcock) is a redesign of Induction & Sampling Manifold (or Stopcock). It has the same appearance and intended use while several design modifications were introduced in order to contribute to the device's convenience of use and robustness. The device will be available in two (2) versions swabable or standard ports configurations. The first version, standard port configuration is similar to the predicate device but with more robust design. The second version, besides of the design changes have an additional feature. The feature is the swabable valves which can be incorporated into the female side ports and function as a closed luer activate valve. The swabable valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap in order to avoid leakage and/ or port's contamination and serves as a needleless injection site integrated in the stopcock. Devices having the swabable valves have been demonstrated in a 510(k) submission for Elcam's Closed Stopcock.

SafePort Manifold or Stopcock is composed of the following components:

• -One piece injected body having a side female ports. (with or without swabable valves according to the end user request)
• Handles assembled into the female side ports. ー
• -Elastomer placed between each handle and side female port body, which is placed to function as a pressure activated valve activated valve.
• Rotor assembled to the male port (connected toward the patient ) for . " connection locking.
• -Check valve assembled to the male port which is connected toward the patient in order to enable connection locking. (this part will not be included, unless otherwise requested by the end user)
• Port covers and colored buttons. (if requested by an end user) -

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SafePort Manifold (or Stopcock).

It's important to note that the provided document is a 510(k) summary for a medical device, which generally focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed performance acceptance criteria and study results in the same way one might for a novel, higher-risk device or a more comprehensive clinical trial report.

Based on the information given:

Acceptance Criteria and Reported Device Performance

The document states that a series of non-clinical tests were conducted to address the functionality of the SafePort Manifold's different variations. The general acceptance criterion implied is that the modified device is as safe and as effective as its predicate.

Study Details

The document refers to "non-clinical tests" as the primary evidence.

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

   • Sample Size: Not explicitly stated. The document mentions "a series of non-clinical tests" but doesn't quantify the number of devices or iterations tested.
   • Data Provenance: Not explicitly stated as country of origin, but the applicant is Elcam Medical ACAL, located in Kibbutz BarAm, Israel. The tests would likely have been conducted by them or a contracted lab. It's a retrospective summary of tests conducted for the submission.

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

   • This concept of "ground truth" established by experts is typically associated with clinical studies or performance assessments where human interpretation (e.g., of images or patient conditions) is involved. For non-clinical, functional testing of a physical device like a manifold, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards. Therefore, the document does not mention experts establishing ground truth in this context.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Adjudication methods (like 2+1, 3+1) are relevant when multiple human readers or evaluators are making subjective assessments that need reconciliation, which is not the nature of non-clinical device testing described here.

4. 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 physical medical device (intravascular manifold/stopcock), not an AI diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.

5. 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.

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

   • For the non-clinical tests, the "ground truth" would be objective engineering standards, performance specifications, and established test methods designed to verify mechanical integrity, fluid flow properties, resistance to pressure, sterilization efficacy, and other functional aspects. These are typically defined by engineering and quality control departments.

7. The sample size for the training set:

   • Not applicable. This is a 510(k) for a physical device, not an AI/machine learning model that requires a "training set."

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

   • Not applicable, as there is no training set for a physical device in this context.

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The Haskal™ Torque Device is intended to facilitate steering of guidewires during interventional procedures.

The Haskal™ Torque Device is a one-piece molded unit with rows of interlocking "teeth". When the sides of the device are squeezed, the "teeth" line up and a groove is exposed in the center. The device is then positioned with the guidewire in the groove. When the sides are released, the device "teeth" close onto the guidewire to secure it firmly. The Haskal™ accommodates guidewires with diameters between 0.010 inches to 0.038 inches.

The Haskal™ is designed to be mounted onto the guidewire from the side with one hand, eliminating the need for threading along the wire starting from the distal end. It can also be released from the guide wire or repositioned as the guide wire advances by squeezing it on both sides to release the wire.

The Haskal™ is a sterile, non-pyrogenic single use device. It is manufactured in several colors.

The provided text describes the Haskal™ Torque Device, a medical device intended to facilitate steering of guidewires during interventional procedures. The text primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k) K100425).

Here’s an analysis of the acceptance criteria and the study information based on the provided text, while explicitly noting what information is not available:

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

The document does not explicitly present specific numerical acceptance criteria (e.g., minimum torque force, maximum operational force thresholds) or corresponding reported performance values in a table. It states that "Results of nonclinical testing demonstrated that the device is as safe, as effective, and performs as well as the legally marketed devices identified in paragraph 5 of this section," implying that the device met internal or regulatory expectations for each test.

The studies performed are listed as:

• Packaging Environmental Endurance
• Dimensions Verification
• Device and Guidewire Axial Force
• Torque Force
• Device Operational Force
• Performance During Exposure to Fluids
• Usability
• Sterility Integrity and Shelf life
• Biocompatibility (Cytotoxicity, Systemic toxicity, Sensitization, Irritation, Subchronic toxicity, Genotoxicity, Haemocompatibility- Hemolysis)

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

• Sample size for test set: Not specified. The document repeatedly refers to "in-vitro/bench studies," which typically involve a certain number of units or measurements, but these numbers are not provided.
• Data provenance: Not specified, other than being "in-vitro/bench studies." It does not mention country of origin, nor whether the studies were retrospective or prospective.

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 information is not applicable to the type of studies described. The "Haskal™ Torque Device" is a mechanical tool used to manipulate guidewires. Its performance is evaluated through bench testing (e.g., force measurements, usability assessment), not by interpretation of images or patient data requiring expert clinical judgment as "ground truth." Therefore, there were no experts establishing ground truth in the sense of clinical diagnoses or interpretations.

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

Not applicable. Adjudication methods are typically used in studies where human readers or experts are disagreeing on interpretations (e.g., image readings). Since this device underwent bench testing, not a reader study, no adjudication method was relevant or performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC study: No. The document describes laboratory bench testing and mechanical performance evaluation for a physical medical device (a torque device), not an AI algorithm or an imaging diagnostic tool. Therefore, an MRMC study was not conducted.
• Effect size of human reader improvement: Not applicable, as no MRMC study was performed.

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

• Standalone performance: Not applicable. The Haskal™ Torque Device is a physical, hand-operated tool. It is not an algorithm, and it always functions with human interaction to "steer guidewires." The "performance" described refers to the mechanical and physical characteristics of the device itself (e.g., torque force, operational force, biocompatibility), which are inherently "standalone" in the sense that they are properties of the device, not an algorithm's output.

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

The concept of "ground truth" as clinical diagnosis or outcomes data is not applicable to this device's evaluation. For mechanical device testing, the "ground truth" would be established by:

• Reference standards for dimensions and material properties.
• Calibrated instruments for measuring forces (axial, torque, operational).
• Standardized protocols for evaluating usability.
• Laboratory tests (e.g., ISO standards) for biocompatibility and sterility.
  Essentially, the ground truth is derived from objective, quantifiable measurements against established engineering and safety standards.

8. The sample size for the training set

Not applicable. The Haskal™ Torque Device is a physical medical device. It does not involve any artificial intelligence or machine learning component, therefore there are no "training sets" in the context of an algorithm.

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

Not applicable, as there is no training set for this device.

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Elcam Antimicrobial Closed Stopcocks (DSS and TSS) 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.

Both configurations have a feature of an antimicrobial agent using a compound containing silver.

The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.

The device is NOT intended to be used as a treatment for patient infections.

Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS) are a similar version of Elcam legally marketed stopcocks, cleared under 510(k) numbers K053405 and K060231, as identified in paragraph number 3 above. Our Antimicrobial DSS and TSS combine two or three features of our legally marketed devices into one product contains these two or three protection lines as following described:

The Double Safe Stopcock (DSS) consists of our antimicrobial stopcock combined with our closed swabable luer-activated valve stopcock.

The closed swabable valve functions as a microbial barrier and the antimicrobial agent, impregnated in the stopcock body acts to prevent/reduce the growth of contaminants.

This configuration presents a stopcock with two protection lines; (1) impregnated antimicrobial agent; (2) closed swabable valve.

The Triple Safe Stopcock (TSS) consists of the same platform of the antimicrobial stopcock together with our legally marketed MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) design. The two protection lines described above for the DSS exist in the TSS yet, the TSS has a third protection line which is the unique design of the MRVLS handle enables fluid flow around the handle and thus enables more thorough and continuous flushing of the entire stopcock fluid path. This configuration presents a stopcock with three protetion lines:

(1) impregnated antimicrobial agent; (2) closed swabable valve; (3) MRVLS handle unique design.

The provided text describes a Special 510(k) summary for Elcam Medical's Antimicrobial Closed Stopcocks (DSS and TSS). This is a regulatory submission, not a research study, and therefore it does not contain the information typically found in a study proving device performance against acceptance criteria relating to diagnostic accuracy for AI/ML devices.

The document states that the modified device was tested in accordance with Elcam's legally marketed device specifications and "all acceptance criteria were met." However, it does not detail what those specific acceptance criteria were, nor does it provide a full study report with data to prove meeting them.

Here's a breakdown of the requested information based on the provided text, and where the information is not available because this is not a diagnostic AI/ML study:

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

A table of specific acceptance criteria and reported device performance is not provided in the document. The text states:

• "Design verification tests results are supporting all labeling claims and substantial equivalency."
• "The modified device was tested with accordance to Elcam's legally marketed device specification and all acceptance criteria were met."

However, the actual criteria and results are not detailed.

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

Not applicable/Not provided. This document describes a medical device in the context of a 510(k) submission, not an AI/ML algorithm or a diagnostic test involving patient data. The "tests" mentioned are likely performance tests for fluid flow, antimicrobial properties, material compatibility, and structural integrity, not a test set of patient cases.

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/Not provided. As this is not an AI/ML diagnostic study, there is no "test set" requiring expert ground truth establishment.

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

Not applicable/Not provided. There is no test set or adjudication process described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is not a study involving human readers or AI assistance.

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

Not applicable/Not provided. Elcam's Antimicrobial Closed Stopcocks are physical medical devices, not an AI/ML algorithm.

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

Not applicable/Not provided. For the types of tests indicated (biocompatibility, chemical, material characterization, risk assessment, and device specifications), the "ground truth" would be established by relevant industry standards, material properties, and engineering specifications, not by medical expert consensus or patient outcomes in the context of a diagnostic test.

8. The sample size for the training set

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

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

Not applicable/Not provided. This is not an AI/ML algorithm that requires a training set with established ground truth.

In summary, the provided document is a regulatory submission for a physical medical device (stopcocks), not a study demonstrating the performance of an AI/ML diagnostic device. Therefore, most of the requested information regarding acceptance criteria and study details for AI/ML performance is not present. The document broadly states that "all acceptance criteria were met" for design verification tests, but does not provide the specifics of these tests or criteria.

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Elcam Antimicrobial Stopcock [or Manifold] is 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 Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver.

The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.

The device is NOT intended to be used as a treatment for patient infections.

Elcam Antimicrobial Stopcock [or Manifold] is identical to Elcam conventional legally marketed Stopcocks. A model of typical Stopcock is illustrated in Figure 1, section 11, page 33 of this submission.

Stopcocks and Manifolds have port(s) that provide access for medications injection, IV administration and blood sampling. The Stopcock usually has three ports and a handle that directs the fluid flow. It has one female side port that is used for medication injection or blood sampling. Both opposite ports (female/male) are connected to the IV line. The Manifold is assembled from two to five stopcocks bonded to each other to create a "stopcocks line" so the Manifold can have between two to five side ports for injection or sampling. Naturally, when the port is open, it can be a potential portal of entry for microorganisms into the device fluid path.

Elcam's Antimicrobial Stopcock [or Manifolds] provides an effective solution in preventing/reducing bacterial colonization in the device.

The antimicrobial agent is based on silver like in Medex's antimicrobial stopcock legally marketed device, cleared by 510(k) number K954970.

All body/fluid contact materials that composed the Antimicrobial Stopcock were tested widely for chemical and biocompatibility in accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing with acceptable results.

The Elcam Antimicrobial Stopcock [or Manifold] received 510(k) clearance (K053405) based on its substantial equivalence to predicate devices and performance in non-clinical testing.

Here's an analysis of its acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact numerical sample sizes for the antimicrobial effectiveness tests or mechanical tests. It states "Extensive tests were performed with a variety of organisms" for antimicrobial effectiveness and "Mechanical tests were performed according to Elcam conventional stopcock specification."
• Data Provenance: The studies were conducted by Elcam Medical (Israel). The data is retrospective in the sense that it was collected and submitted for the 510(k) application, but the tests themselves would have been prospective experiments designed to evaluate the device.

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

The provided document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic imaging studies. The assessment of the device's performance was based on laboratory testing against established specifications and standards (e.g., "at least 2 log reduction" for antimicrobial effectiveness, "according to Elcam conventional stopcock specification" for mechanical, and ISO 10993-1:2003 for biocompatibility). The "ground truth" for these types of devices is typically defined by the objective results of these standardized tests.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "truth" for these non-clinical performance studies is derived from objective laboratory testing against pre-defined criteria, not from expert consensus or adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically associated with diagnostic imaging AI devices where human readers interpret medical images, and the AI assists or performs the interpretation. The Elcam Antimicrobial Stopcock is a physical medical device, and its effectiveness is determined through laboratory performance tests, not through human reader interpretation.

6. Standalone Performance Study (Algorithm Only)

Yes, in essence, the "non-clinical performance data" described (mechanically and microbiologically) constitutes a standalone performance study of the device. The antimicrobial stopcock's effectiveness in preventing/reducing bacterial colonization and its mechanical functionality were tested independently of human intervention during its operation in a simulated environment. The device's antimicrobial feature is an inherent property of its material composition, not an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on objective laboratory test results against predefined performance specifications and industry standards. Specifically:

• For antimicrobial effectiveness, the ground truth was a "significant reduction of bacteria levels (at least 2 log)."
• For mechanical functionality, the ground truth was "Elcam conventional stopcock specification."
• For biocompatibility and chemical properties, the ground truth was compliance with "FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data. Its performance is due to its physical design, materials, and the incorporation of an antimicrobial agent. Development and optimization of a physical device would involve design iterations and testing, but not in the sense of an algorithm training on a dataset.

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

Not applicable, as there is no "training set" for this physical device.

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Elcam Closed Swabable Stopcock and MRVLS is 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 Medical's Closed Swabable Stopcock and MRVLS is a similar version of Elcam legally marketed stopcock. cleared under 510(k) number K022895.

The Closed Swabable Stopcock includes an addition of a component that functions as a closed luer-activated valve.

The valve enables the female port (luer) to be closed when it is not in use and saves the need to close it with a cap, in order to avoid leakage and/or port's contamination. Once a male luer is introduced into the closed port the fluid path automatically opens to allow injection or blood sampling. Once the male luer is taken out, the female port is automatically closed.

The valve actually serves as a needleless injection site integrated in the stopcock. The only change from the end user point of view is the need to swab the valve's top (injection site) with aseptic fluid such as alcohol prior to male luer insertion.

The MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock) feature, is an additional option that can be added to the Closed Swabable Stopcock, described above, and provides a stopcock with a minimal residual volume.

Conventional stopcocks are made of a body and a handle with a fluid path bore that allows the fluid to flow only through the handle. Therefore, it leaves other areas in the stopcock without a continuous flow through the stopcock fluid path and especially through the side port female luer. The MRVLS feature enables fluid flow around the handle so the fluid constant flow accesses the entire stopcock's internal volume and enables a continuous flow through the stopcock fluid path and through the side female luer during the medical procedure. This feature significantly reduces the "residual volume" in the stopcock and helps to keep the cleanliness of the stopcock's fluid path when it is in use.

The feature of minimal residual volume is achieved thanks to a modification in the stopcock handle design, which changes the fluid path and a flow guide formed therein.

The minimal residual volume design, together with the luer-activated valve creates the Minimal Residual Volume Luer-activated Swabable-stopcock (MRVLS).

This document outlines a Special 510(k) Summary for Elcam Medical's Closed Swabable Stopcock and MRVLS (Minimal Residual Volume Luer-activated Swabable-stopcock). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than an independent performance study of a new medical device with explicit acceptance criteria and corresponding study results in the traditional sense.

Therefore, the requested information categories may not directly apply as they would for a novel device where diagnostic performance (e.g., sensitivity, specificity) is being evaluated. This submission focuses on non-clinical performance data to show the modified device is as safe and effective as its predicate.

Here's an attempt to populate the requested table and answer the questions based solely on the provided document, acknowledging the limitations for an "acceptance criteria" and "study" as typically understood for diagnostic AI/ML devices:

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

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 any of the non-clinical tests (biocompatibility, material characterization, functional performance, risk assessment). These are typically bench tests or material tests, not observational or interventional studies with patient data.

Data provenance (country of origin, retrospective/prospective) is not applicable or specified since the tests described are non-clinical, likely conducted in a laboratory setting. The company is based in Israel.

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 is not applicable. The device is a medical accessory (stopcock), not a diagnostic device where expert ground truth would be established from patient data. Performance is evaluated against engineering specifications and industry standards.

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

This is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The described tests are non-clinical and rely on objective measurements and established protocols.

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. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools. This submission is for a medical device (stopcock) and does not involve AI or human "readers" in the context of diagnostic interpretation.

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

This is not applicable. The device is a physical medical accessory, not an algorithm or AI system.

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

For the non-clinical tests described:

• Biocompatibility: Ground truth is established by adherence to and successful completion of tests outlined in ISO 10993-1:2003 and FDA guidance, with acceptable results.
• Material Characterization: Ground truth is established by material specifications and validation against intended use.
• Functional Performance: Ground truth is the device meeting Elcam's own "legally marketed device specification."

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The tests performed are for the physical device's non-clinical performance.

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

This is not applicable, as there is no training set for an AI/ML device.

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The device is an Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications.

The H-Flow Valve developed by Elcam Medical ACAL can be connected, by a standard male luer-lock, to any standard Angiographic catheter. The device has a septum that prevents blood loss when nothing is connected to the female port of the device. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without the need to open the valve and without bleeding due to the intra-catheter human arterial pressure. When connecting a standard male luer to the device's female port (for injection of contrast media or flushing with saline), the septum opens (with the aid of the actuator) to allow fluid flow. An accessory called 'Stylet' is added to the device and has two purposes: a) to make sure the slit is open prior to initial use. b) To aid with insertion of small and angled guide wires.

The provided text describes a 510(k) summary for the "H-Flow Valve" manufactured by Elcam Medical ACAL. While it states that "Performance tests related to functionality and biocompatibility of both new and predicate device were performed. Tests results showed that the product met all established acceptance criteria and therefore has equivalent performances capabilities and properties," it does not provide specific details on the acceptance criteria themselves, nor the specific results or methodology of the study.

Therefore, I cannot directly populate the requested table or answer most of the questions as the specific information is not present in the provided text.

Here's an attempt to answer based on the given information, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document states that performance tests were conducted and the device met all established acceptance criteria. However, the specific criteria (e.g., maximum leakage rate, pressure resistance, flow rates, number of cycles) and the quantitative results achieved by the H-Flow Valve are not detailed.
• The comparison is against a predicate device, Floswitch® HP, implying that the acceptance criteria would be based on demonstrating equivalence or non-inferiority to the predicate's known performance.

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were performed to demonstrate substantial equivalence to a predicate device.

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

This section is not applicable as the provided document pertains to a medical device's performance testing for functional and biocompatibility characteristics, not a diagnostic algorithm or imaging study requiring expert ground truth for classification.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3.

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 section is not applicable as the document describes a physical medical device (valve), not an AI-powered diagnostic tool.

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

This section is not applicable as the document describes a physical medical device (valve), not a software algorithm.

7. The type of ground truth used

For functional performance testing of a physical device, the "ground truth" would typically refer to objective measurements obtained through standardized testing methods, comparing the device's performance against predefined specifications or against the performance of a predicate device. The document mentions "functionality and biocompatibility tests" but does not detail the specific ground truth or reference standards used.

8. The sample size for the training set

This section is not applicable as the document describes a physical medical device (valve), not a machine learning model that requires a training set.

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

This section is not applicable as the document describes a physical medical device (valve), not a machine learning model.

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