Search Results

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.

Ask a specific question about this device

3-way stopcocks are indicated for venous or arterial use, as IV add-on devices used for simultaneous infusions. intermittent drug injections, for central venous pressure measurements, and as arterial add-on devices used for invasive pressure measurements, flushing with normal saline.

Three Way Stop cock is composed of a Body, Rotating Handle, Luer Ports – with 2 female luer lock & 1 male luer lock with Rotating Nut. Compatible with 6% Luer combination devices. Transparent, lipid resistant body, provides easy visualization, and indicates fluid path.

The device is designed and tested as per its device specific guidance: "Intravascular Administration Sets Premarket Notification Submissions [510(k)]".

3- Way Stop Cock is used for pressure infusion, for selective running of one or two paths intravenous lines & for measurement & also for monitoring of central venous pressure. 3- Way Stop Cock lipid-resistant is for infusing lipid-fluids & other intravenous fluids. Maximum use duration of the device is not beyond 5 days.

The provided document is a 510(k) summary for a medical device called "Three Way Stop Cock." This document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance, rather than presenting a study proving a device meets specific acceptance criteria for AI/ML performance.

The acceptance criteria and study detailed in the document are related to the physical and biological safety and performance of the hardware device, not the performance of an AI/ML algorithm. There is no mention of AI or machine learning in the entire document.

Therefore, I cannot extract the requested information about AI/ML acceptance criteria and a study proving an AI device meets them from this document. The document describes:

• Acceptance Criteria for the hardware device: These are met through compliance with various ISO and ASTM standards covering physical properties (e.g., proper luer lock fitting, flow rate, blockage, leakage) and biocompatibility (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, residuals from sterilization).
• Study that proves the device meets the acceptance criteria (non-clinical testing): The document states that "testing was conducted in accordance with 'Intravascular Administration Sets Premarket Notification Submissions [510(k)]' guidance, ASTM and ISO standards." It lists several specific standards (e.g., ISO 8536-10, ISO 80369-7, ISO 10993 series, ASTM F1980-16, ASTM F 1929-15, USP ). The results "demonstrate fulfilment of requirements" and "substantial equivalence with predicate."

The request's specific points regarding AI/ML (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, effect size) are not applicable to this document as it pertains to a physical medical device (a stopcock valve), not an AI/ML diagnostic or therapeutic device.

Ask a specific question about this device

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

The proposed devices 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.

Ask a specific question about this device

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.

Ask a specific question about this device

Clicky Cros™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.

Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids. Yomura Clicky Cross™ is a new medical device using as flow control switch and is developed by Yomura Technologies Inc. Click-release process via one-handed operation Less leakage issue than currently commercial products Stopcock system for I.V. set and other application Suitable for all current pressure infusion system There are two types of fitting end (Barb /Luer) for normal I.V. infusion sets. In order to meet the requirement of I.V. infusion set, here we provide two different types of fitting end (Barb/Luer).

The provided FDA 510(k) summary for the Clicky Cross™ device details its substantial equivalence to a predicate device, the Safeport Manifold™ (K111016). It primarily focuses on demonstrating that the new device is as safe and effective as the predicate.

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

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

The document doesn't explicitly present a table of "acceptance criteria" in a typical quantitative format for algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating equivalence to a predicate device by meeting established performance and safety standards for medical devices of this type.

The reported device performance is indicated by its compliance with various ISO and ASTM standards relevant to infusion equipment and biocompatibility.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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

Ask a specific question about this device

Elcam Stopcocks and Manifolds with Safe2 Rotator 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 with Safe2 Rotator are an additional variation in the Elcam's Stopcocks and Manifolds product-family. The Safe2 Rotator component is male luer with a mounted and internally threaded rotator that is fixed on the stopcocks body with a modified male connector. Both components create a uniform straight fluid path. The device uniqueness is that the Safe2 Rotator can freely rotate on the stopcock male connector axis preventing the formation of kinks and twists in the IV sets during or following manipulations. In addition, the rotation ability of the Safe2 Rotator provides health care providers with a convenient access to a stopcock side (vertical) port during injection and aspiration.

The provided document describes a 510(k) submission for Elcam Medical Stopcocks and Manifolds with Safe2 Rotator. This is a medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document discusses performance data in the context of the device's physical functionality and substantial equivalence to a predicate device.

Here's the relevant information extracted from the document:

1. Table of acceptance criteria and the reported device performance:

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

• The document states that "non-clinical tests" were conducted.
• It does not specify the sample sizes used for each test.
• The data provenance (country of origin, retrospective/prospective) is not detailed. However, the manufacturer, Elcam Medical, is based in Israel, so it can be inferred that testing was conducted either internally or by a contracted lab, adhering to international standards.

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

• This question is not applicable as the document describes physical device testing for functionality, not diagnostic/prognostic algorithm performance requiring expert-established ground truth. The "ground truth" here is objective physical measurements against established engineering standards (ISO 594-2).

4. Adjudication method for the test set:

• This question is not applicable for the same reasons as #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 question is not applicable as this is not an AI/ML device.

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

• This question is not applicable as this is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for this device's performance testing is defined by established engineering standards (specifically ISO 594-2 for various mechanical properties like twisting force, liquid pressure resistance, and disconnection force). These are objective, measurable criteria.

8. The sample size for the training set:

• This question is not applicable as this is not an AI/ML device, and therefore there is no "training set."

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

• This question is not applicable as this is not an AI/ML device, and therefore there is no "training set."

Summary of what the study did prove:

The study conducted for the Elcam Medical Stopcocks and Manifolds with Safe2 Rotator involved a series of non-clinical bench tests. These tests were designed to evaluate the physical functionality and safety of the modified device, particularly the new Safe2 Rotator component. The tests demonstrated that the device meets its specifications and complies with the functional requirements outlined in ISO 594-2 for lock fitting (initial twisting force, secondary twisting force, liquid pressure resistance, and disconnection force). Based on these results, the manufacturer concluded that the "modified device is as safe and effective as its predicate."

Ask a specific question about this device

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.

Ask a specific question about this device