Search Results

The A-TAP is intended for use by healthcare professionals for general purpose fluid aspiration/injection.

The A-TAP device is a fluid switching medical device consisting of a clear plastic barrel body, a sliding rod, two 6% female Luer lock connections, and one 6% male Luer lock connection. The internal surface of the device barrel body is lubricated with polydimethylsiloxane (silicone). The A-TAP is a single-use only, disposable, non-pyrogenic and sterilized by Gamma irradiation.

The provided text is a 510(k) summary for the A-TAP device, which is a fluid switching medical device. The submission is a Special 510(k) due to modifications made to the previously cleared Arthrotap device (K201816) by Elcam Medical.

The acceptance criteria and study proving the device meets these criteria concern the physical and biological characteristics of the device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML performance metrics, sample sizes for training/test sets for AI, expert adjudication of ground truth, and MRMC studies are not applicable in this context.

This document details the tests performed to demonstrate that the modified A-TAP device is substantially equivalent to its predicate.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted to demonstrate substantial equivalence, implying that passing these tests served as the acceptance criteria. The "Reported Device Performance" is stated by the successful completion of all listed tests.

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

The document concerns a physical medical device and its components, not a data-driven AI/ML model for which test sets from patients are required. Therefore, typical "sample sizes" in the context of clinical data for AI are not applicable. The tests performed are laboratory-based, often involving a certain number of device units or material samples as specified by the respective ISO/ASTM standards. The data provenance is laboratory testing conducted by or for Elcam Medical. The document does not specify country of origin for the testing itself, nor if it was retrospective or prospective in the clinical sense, as it refers to engineering verification and validation testing.

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

Not applicable. Ground truth for a physical device's performance (e.g., material compatibility, structural integrity, sterility) is established by adherence to recognized international and national standards (ISO, ASTM, USP) and the results of the specified tests, rather than expert consensus on clinical data.

4. Adjudication Method for the Test Set:

Not applicable for a physical device. Performance is determined by meeting the pass/fail criteria defined within the referenced standards.

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

Not applicable. This type of study is relevant for diagnostic imaging AI, not for a fluid switching device.

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

Not applicable for a physical medical device without AI components.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is based on standardized test methods and their defined performance criteria. For example, biocompatibility is evaluated against specific biological responses according to ISO standards, and mechanical integrity is evaluated against criteria set by ISO or ASTM standards. This is not derived from expert consensus, pathology, or outcomes data in the typical clinical sense, but from engineering and material science principles.

8. The Sample Size for the Training Set:

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

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

Not applicable, as there is no training set for an AI/ML algorithm.

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

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

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

The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" -- 0.038" diameter guide wires.

The Y-Click connector is an accessory that can be connected, by a standard male luer-lock, to any standard Angiographic catheter, up to 9 Fr guiding catheters. The device has a septum that prevents blood loss. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without bleeding due to the intra-catheter human arterial pressure. The septum can be opened to an unsealed position in order to enable introducing of various angioplasty devices (such as; balloons and stents). Unlike similar devices, The Y-Click can also be opened to a semi unsealed position. The semi unsealed position reduces the friction during catheter manipulation and makes the device more ergonomic and easy to use. The septum is opened to a semi unsealed position by one push of the cover (a "click" is heard). Pushing the cover twice (two "clicks" are heard) opens the device to an unsealed position (full open position). In order to return to a closed position, the Y-Click's lever should be pressed once. A "click" is heard and the device returns to a closed position. The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm.

This 510(k) submission for the Elcam Y-Click Connector is a medical device application. Unlike AI/software-as-a-medical-device (SaMD) clearances, which typically involve extensive performance studies with specific statistical metrics, acceptance criteria, and ground truth establishment, this submission focuses on demonstrating substantial equivalence to a predicate device through device description and intended use.

Therefore, many of the requested categories in your prompt related to clinical study design, AI performance metrics, and human-in-the-loop analysis are not applicable to this type of traditional medical device clearance. The document does not contain information about acceptance criteria in the context of statistical performance, reported device performance in those terms, sample sizes for test or training sets, ground truth establishment for such sets, expert adjudication, or MRMC studies.

Here's an analysis based on the information provided, emphasizing where the requested categories are not applicable or not detailed in this type of submission:

Acceptance Criteria and Study for Elcam Y-Click Connector (K060759)

This 510(k) submission for the Elcam Y-Click Connector is a traditional medical device submission, not specifically for software or an AI-powered device. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating substantial equivalence to an existing predicate device rather than achieving specific quantitative performance metrics through extensive clinical trials as one might expect for a novel AI diagnostic tool.

The core of the study is the comparison of the Y-Click Connector's features, intended use, and principle of operation with the predicate device. The "acceptance criteria" are implicitly met by demonstrating that the device does not raise new questions of safety and effectiveness compared to the predicate.

Given the nature of the device (a Y-connector hemostatic valve), the performance evaluation would primarily involve bench testing and possibly animal or in-vitro studies to confirm functional aspects, rather than human-centric clinical trials with ground truth experts.

1. Table of Acceptance Criteria and Reported Device Performance:

   Criterion Type	Acceptance Criteria	Reported Device Performance
   Substantial Equivalence	The device has the same intended use and the same principle of operation as the predicate device (EasyPass™ US Y-Connector Haemostatic Valve from Millimed A/S, K042060), and does not raise new questions of safety or effectiveness.	The Y-Click Connector has the same intended use and the same principle of operation as the EasyPass™ of Millimed A/S (K042060). "The evaluation of the Y-Click Connector does not raise any additional concerns regarding safety and effectiveness." (Conclusion in document)
   Intended Use	Intended to maintain hemostasis during introduction, use, and withdrawal of diagnostic and interventional devices used in angioplasty procedures; compatible with 9 Fr or smaller guide catheters and 0.014" - 0.038" diameter guide wires.	"The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" - 0.038" diameter guide wires." (Indications for Use)
   Functionality	- Prevent blood loss through a septum.

• Allow introduction of common guide-wires (0.014" to 0.038") through the slit septum without bleeding.
• Septum can be opened to semi-unsealed and full-unsealed positions.
• Allow injection of contrast media, saline flush, and blood pressure monitoring through the Y side arm. | The device description outlines these functionalities: "The device has a septum that prevents blood loss. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without bleeding..." "The septum can be opened to an unsealed position... The Y-Click can also be opened to a semi unsealed position." "The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm." |
  | Mechanical Design | Connectable by a standard male luer-lock to any standard Angiographic catheter, up to 9 Fr guiding catheters. | "...can be connected, by a standard male luer-lock, to any standard Angiographic catheter, up to 9 Fr guiding catheters." |

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

   • Not applicable / Not specified in this 510(k) summary. This type of device clearance typically relies on bench testing, comparison to the predicate, and adherence to relevant standards, not a "test set" in the context of AI or diagnostic accuracy studies. No specific sample sizes for a "test set" are mentioned in the provided document.

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

   • Not applicable / Not specified in this 510(k) summary. The clearance process described here does not involve establishing ground truth for a diagnostic test set by human experts. The "ground truth" for this device's safety and effectiveness is established by its similarity to a legally marketed predicate device and conformance to generally accepted engineering and medical device principles.

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

   • Not applicable. There is no "test set" or diagnostic reading adjudication method described in this submission.

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

   • No. An MRMC study is not relevant for this type of medical device (a hemostatic connector). This device does not involve human readers interpreting images or data, nor does it incorporate AI.

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

   • Not applicable. This device is a mechanical connector, not an algorithm.

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

   • The concept of "ground truth" in this context is primarily related to the device's functional performance, material biocompatibility, and sterilization effectiveness (which would be assessed via standard laboratory testing, not human expert consensus for a diagnostic task). The primary "ground truth" for regulatory clearance is that the device is substantially equivalent to a legally marketed predicate, meaning it performs as intended and is as safe and effective as the predicate.

8. The sample size for the training set:

   • Not applicable / Not specified. This device does not employ machine learning or AI, and therefore does not have a "training set."

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

   • Not applicable. No training set exists for this mechanical device.

In summary, the provided 510(k) summary is for a physical medical accessory (a connector), not a diagnostic or AI-powered device. Therefore, the criteria and study details are focused on technical specifications, intended use, and comparison to a predicate device, rather than the types of performance metrics and ground truth establishment typically associated with AI/SaMD products.

Ask a specific question about this device

Elcan Induction & Sampling Manifold for Stopcock] is a one or 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, bolus injection and elimination of reflux of fluids during operation.

Elcam I&S Manifold is composed of a body that fits for number of ports assembly (by bonding) and handles which are assembled into the ports bodies. Between each handle and port body an Elastomer is placed to function as a pressure activated valve. A small amount of UV Adhesive is applied in order to bond the product body to the female side ports. A check valve is assembled to the product body end (which is connected to the I.V Set) in order to eliminate back flow (reflux). A Rotor is assembled to the male luer (which is connected toward the patient) in order to enable connection locking. A small amount of lubricant is applied between the Elastomer and the port body. Same concept can be available for one single Stopcock (single I&S Stopcock will not include Check Valve unless otherwise required by end user). Elcam I&S Manifold will be available in a wide variety of configurations for use according to particular situation and the clinician's preference.

This looks like a 510(k) summary for a medical device submitted to the FDA. However, the provided document does not contain details about acceptance criteria, specific performance studies (other than general statements), sample sizes, ground truth establishment, or clinical study methodologies (like MRMC studies) typically found in a comprehensive study report.

The document states that "Standard testing relating functionality of the new product has been conducted on Elcam I&S Manifold, including testing related to product label claims and testing comparing performance with the predicate devices." and "A biocompatibility assessment was performed on the patient-contact and fluid path materials of Elcam I&S Manifold with satisfactory results." However, it does not elaborate on these tests or provide any quantitative results.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other detailed study information. The provided text is a regulatory submission summary, not a detailed technical report of a performance study.

To provide the information you're asking for, a different type of document, such as a test report, a clinical study summary, or a more detailed performance data section from the 510(k) submission, would be necessary.

Ask a specific question about this device