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The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.

The proposed device, Vented Vial Adapter Transfer Device - 13mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The proposed device consists of two integrated parts, the 13mm vial adapter body intended to be attached to a standard 13 mm drug vial. The other end is intended to be connected to a Female Luer connection. The vial adapter body contains the dual lumen piercing spike and the second part of the device is an assembled 0.2um hydrophobic air path filter (100% expanded PTFE membrane over Non-woven polyester membrane support). This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/ released air through 0.2um air filter. The proposed device does not contain any medicinal substances.

The provided text describes a 510(k) premarket notification for a medical device called the "Vented Vial Adapter Transfer Device - 13mm". The document focuses on demonstrating substantial equivalence to a predicate device (Vented Vial Adapter Transfer Device, K062482) through design comparisons and performance testing.

Here's an analysis of the acceptance criteria and the study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that all testing met the required acceptance criteria, but it does not explicitly list specific numerical or qualitative acceptance criteria for each test. Instead, it lists the types of tests performed and generally states that the results met internal performance standards.

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

The document does not specify the sample sizes used for any of the performance tests. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective); it's implied the testing was conducted internally by Medimop Medical Projects Ltd. as part of their design control.

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

This information is not applicable to this type of device and study. The testing described is strictly focused on the physical and functional performance of a medical device (vial adapter), not on clinical diagnostic accuracy or interpretation by experts. Ground truth, in this context, refers to objective measurements and adherence to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert reviews or clinical outcomes where there might be disagreements in interpretation. The performance tests for this device involve objective measurements against predefined standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to assess diagnostic performance. The device here is a physical product for drug transfer, not an AI-powered diagnostic tool.

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

This information is not applicable as the device is a physical, mechanical medical device and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for the performance testing is based on internal performance standards and harmonized international standards (e.g., ISO 10993-1 for biocompatibility). For physical and functional tests, the ground truth would be precise measurements and observations confirming adherence to specified design parameters and functional requirements. For biocompatibility, the ground truth is conformance to the criteria outlined in ISO 10993-1.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires training data.

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

This information is not applicable. As stated above, the device does not involve a training set.

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The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

The proposed device, Vial2Bag" Direct Connect, consists of the Vial2Bag" piercing spike and cover, the twist-off connector and an integrated Vial Adapter for access to the drug/solution vial. It does not contain any medicinal substances and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.

The provided text describes the 510(k) summary for the Vial2Bag™ Direct Connect device, focusing on its substantial equivalence to predicate devices based on performance testing and biocompatibility assessments. Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All bench testing was performed following double EtO sterilization to ensure that the sterilization process does not have a detrimental effect on the proposed device, Vial2Bag™ Direct Connect performance. The following tests were completed and all of them passed the established acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria for each test. It simply states that they "passed."

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

The document does not specify the sample sizes used for each of the performance and biocompatibility tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective), but it can be inferred that the testing was conducted by or on behalf of Medimop Medical Projects Ltd. in Israel, as they are the company proposing the device. These tests are typically prospective, meaning they are designed and executed specifically for regulatory submission.

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

This information is not applicable and not provided in the context of device performance and biocompatibility testing for this type of medical device (IV administration set). "Ground truth" and expert consensus typically apply to diagnostic or AI-driven devices where human interpretation or a gold standard diagnosis is compared against the device's output. Here, the tests are objective, laboratory-based measurements against pre-defined engineering and biological safety standards.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 typically relate to conflicting expert opinions in diagnostic studies, which is not relevant here. The evaluation of test results against acceptance criteria is usually a straightforward pass/fail assessment.

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

An MRMC study is not applicable and was not performed or mentioned for the Vial2Bag™ Direct Connect device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images or data, often in conjunction with AI. The Vial2Bag™ Direct Connect is an IV administration set and does not involve "readers" or AI assistance in this context.

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

This is not applicable. The Vial2Bag™ Direct Connect is a physical medical device, not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance tests, the "ground truth" is defined by established engineering specifications and physical properties that the device must meet, often based on recognized standards (e.g., ISO for biocompatibility). For biocompatibility, the ground truth is the biological response observed in standardized in vitro and in vivo animal models compared against internationally recognized safety thresholds. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it would be for a diagnostic tool.

8. The Sample Size for the Training Set

This is not applicable. The Vial2Bag™ Direct Connect is a physical medical device. It does not employ machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

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

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Allow needle-free withdrawal, reconstitution and transfer of Bravelle® (urofolitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration on a single patient during a single procedure.

The device is a needless transfer device which enables reconstitution of one diluent vial and up to five vials of the fertility drugs Bravelle®, or Menopur® manufactured by Ferring using one MP Vial Adapter 13 mm.

The device is a single use sterile device which will be included into Ferring Pharmaceutical's Bravelle® and/or Menopur® drug kits to assist in the reconstitution of these lyophilized drugs for injection using one reconstitution diluent vial.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided text is a Traditional 510(k) Summary for a medical device called the "MP Vial Adapter 13mm." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive standalone clinical trials with predefined acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Therefore, the document does not contain a table of acceptance criteria for device performance with corresponding reported values in the typical sense of diagnostic or AI-driven devices. Instead, the "acceptance criteria" are implied by the demonstration of equivalence to predicate devices and successful completion of "bench testing."

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the 510(k) summary. Given it's a bench testing study for a physical device, the "test set" would refer to the number of devices or vials tested. The provenance of "data" (e.g., country of origin, retrospective/prospective) is typically associated with clinical studies involving human or patient data, which is not the case here.

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/provided. The "ground truth" for this type of device (a vial adapter) would be its physical functionality and ability to perform the intended actions (reconstitution, transfer). This is assessed through engineering and bench testing, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in interpreting clinical data, which is not relevant for the bench testing of this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study and this question is not applicable. This device is a manual medical device, not an AI-driven system that would involve human readers or AI assistance.

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

This question is not applicable. The device is not an algorithm seeking standalone performance evaluation. Its "standalone" performance refers to its ability to function as designed when used by a human user, which was assessed via bench testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was functional performance established through bench testing, likely against engineering specifications and industry standards for fluid transfer and reconstitution. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is not an AI algorithm that requires a "training set."

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

This information is not applicable/provided. As explained, there is no training set for this type of device.

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The proposed device is indicated for the transfer and mixing of drugs contained in a vial.

The proposed device, Vial Connector 13 mm Closed Collar, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The proposed device consists of two integrated parts, the first part is the 13mm vial connector body intended to be attached to a standard 13 mm drug vial neck and a male luer connection. The vial connector body contains the single lumen piercing spike and an assembled 5μm fluid path filter (Versapor® Hydrophilic membrane on a HDPE disc). The second part of the device is the closed collar which restricts the connection of the vial connector to standard 13 mm vials with a body diameter of up to 15 mm. The two integrated parts are injection molded as one single device. The proposed device does not contain any medicinal substances.

This looks like a 510(k) summary for a medical device. Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device clearance in the US. This type of submission relies on demonstrating that the new device has the same indications for use and principle of operation as a legally marketed device, rather than requiring new clinical trials or performance studies against predefined acceptance criteria for a novel device.

Here's why each point in your request cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document describes the device, its intended use, and argues for its similarity to a predicate. It does not contain performance metrics or acceptance criteria as would be found in a study report.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned because no performance study for this specific device is referenced.

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, as no test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical "Vial Connector," not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a non-AI, mechanical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth is established for this type of device submission.

8. The sample size for the training set: Not applicable, as this is a mechanical device and does not involve AI model training.

9. How the ground truth for the training set was established: Not applicable, same reason as above.

In summary, the provided text is a 510(k) summary demonstrating substantial equivalence for a medical device, which typically does not include detailed performance studies with acceptance criteria in the way a novel technology or an AI/software device often would. The clearance is based on its similarity to an already approved predicate device.

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Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials

The Medimop Mixject with Spray Head device enables injection of a diluent into a drug vial connected to the Dispensing pin (Vial adapter), for reconstitution and aspiration of the reconstituted drug into a syringe attached to the luer-lock end of the body. The vial and the Dispensing pin (Vial adapter) can be removed by turning the Dispensing pin (Vial adapter). The removal of the Dispensing pin (Vial adapter) turns the turning core from the aspiration position to the fixed spray position allowing spray application / delivery of the drug onto the desired surface.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medimop Mixject with Spray Head device:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific quantitative acceptance criteria or a detailed table of device performance results against such criteria. Instead, it relies on a statement of substantial equivalence to predicate devices and general performance claims.

Study Information

Based on the provided document, the study conducted was a non-clinical bench test.

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

   • The document does not specify the sample size (number of devices tested, number of repetitions, etc.) for the bench tests.
   • The data provenance is not explicitly stated in terms of country of origin, but the company is based in Israel, so it's likely the tests were conducted there or at a laboratory working with them. The study was non-clinical, meaning it focused on the device's physical performance rather than human subject data, so the "retrospective or prospective" designation isn't directly applicable in the typical clinical trial sense. It was a prospective bench study designed to evaluate the device.

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

   • This information is not provided in the document. As a non-clinical bench test, the "ground truth" would likely be established by engineering specifications, validated test methods, and potentially expert interpretation of results by engineers or scientists, rather than medical experts.

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

   • This information is not provided. Given that it was a bench test for a simple device, formal adjudication by multiple experts is unlikely to have been a primary methodology for determining test outcomes. Performance would be measured against pre-defined engineering criteria.

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, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, often with AI assistance. The Mixject with Spray Head is a drug delivery and mixing device, not an imaging or diagnostic device, and thus an MRMC study is inappropriate and wasn't conducted.

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

   • Yes, a standalone study was done in the form of "Bench testing" (non-clinical testing). The device performance was evaluated on its own merits and functionality (transfer, mixing, spray application) without human interaction specifically for the test. The device itself is designed for human use but the performance validation was done in a standalone manner for the device's technical capabilities.

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

   • The "ground truth" for this device's non-clinical bench testing would be based on engineering specifications, established physical and chemical principles, and validated measurement techniques. For example, drug transfer efficiency would be measured quantitatively, mixing effectiveness could be assessed by homogeneity measurements, and spray application characteristics (e.g., droplet size, spray pattern) would be measured against predefined operational parameters for a spray head. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

7. The sample size for the training set:

   • This information is not applicable and not provided. This device is a mechanical medical device, not a machine learning or AI-based algorithm that requires a "training set."

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

   • This information is not applicable and not provided. As mentioned above, there is no "training set" for this type of device.

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The Vial2Bag is indicated to serve as a cornecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve.

The Vial2Bag is designed to serve as a connecting part between the IV bag and an external IV Line while allowing safe and easy transfer of drugs/diluents from and into an IV bag. The product allows quick transfer of the contents of a syringe or vial into an IV bag. The Vial2Bag is an assembly of three components a spike, a Swabable valve and a twist-off.

The provided text describes the "Vial2Bag" device and its 510(k) submission, confirming its substantial equivalence to predicate devices. However, the document does not contain a detailed study demonstrating quantitative acceptance criteria or specific performance metrics.

Here's an breakdown of the information that can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text.

The document states: "All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing and visual examination (in-process and finished product)." However, it does not specify what these "required release specifications" or "acceptance criteria" are, nor does it report any quantitative performance data (e.g., flow rate, leak rates, durability metrics, etc.) for the Vial2Bag or the predicate devices.

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

Not available in the provided text.

The document mentions "testing" but does not specify sample sizes for any tests, nor does it describe the origin of any data (e.g., country of origin, retrospective or prospective nature).

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

Not applicable.

This information is relevant for studies involving the interpretation of data where a medical expert's judgment forms the ground truth (e.g., image analysis, diagnosis). The Vial2Bag is a medical device for fluid transfer, and its evaluation would typically involve engineering and functional testing rather than expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable.

As expertise-based ground truth is not relevant for this device, adjudication methods are also not applicable.

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

No, a MRMC comparative effectiveness study was not done.

The document focuses on substantial equivalence based on indications for use, design, material, sterility, and packaging compared to predicate devices. It does not describe any study involving human readers or an AI component, nor does it discuss human performance improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study was not done.

This device does not have an algorithm or AI component, so a standalone performance study in that context is not relevant.

7. Type of Ground Truth Used

Functional and Safety Testing.

While not explicitly called "ground truth" in the AI/data science sense, the "ground truth" for this device would be established through:

• Physical testing and visual examination: Ensuring the device meets its design specifications, is free from defects, and functions as intended (e.g., no leaks, proper connection, sterile).
• Material compatibility testing: Adherence to ISO 10993-1 and/or USP VI requirements.
• Sterility testing: Ensuring the product is sterile.

These are established standards and laboratory test results, not expert consensus, pathology, or outcomes data in the typical clinical study sense.

8. Sample Size for the Training Set

Not applicable.

A training set is relevant for machine learning algorithms. This device does not involve such algorithms.

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

Not applicable.

As there is no training set for an algorithm, this question is not relevant.

In summary, the provided submission focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory approval, rather than demonstrating performance against specific quantitative acceptance criteria through a detailed clinical or performance study with reported metrics.

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The Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial

The Swabable Vial Adapter is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.

The Swabable Vial Adapter is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a luer connection) is attached to the sub-assembly.

This document is a 510(k) summary for the "Swabable Vial Adapter" by Medimop Medical Projects Ltd. It describes the device, its intended use, and claims substantial equivalence to predicate devices. It does not contain information about a medical device that performs a diagnostic or prognostic function capable of being proven through a study. Therefore, the information needed to answer the comprehensive questions about acceptance criteria and a study proving device performance is not present in the provided text.

Specifically, the document focuses on:

• Device Description: How the Swabable Vial Adapter works (allowing safe and easy transfer of liquid drugs from and into vials).
• Indications for Use: To allow multiple needleless accesses to an injection medication vial for facilitating withdrawal or addition of drugs/solutions.
• Technological Comparison to Predicate Devices: Claims substantial equivalence in indications for use, design, material, sterility, and packaging with predicate devices like the Robertsite Vial Adapter and Smartsite Vented Vial Access Device.
• Safety and Effectiveness: States that finished products are tested to meet required release specifications, including physical testing and visual examination.
• Conclusion: Asserts substantial equivalence to predicate devices and that it introduces no new issues of safety and effectiveness.

Key Missing Information:
The document does not describe:

• Specific acceptance criteria for "performance" as one would for a diagnostic or prognostic device (e.g., sensitivity, specificity, accuracy). The "acceptance criteria" mentioned are related to release specifications for manufacturing and safety (e.g., meeting ISO 10993-1, USP VI, physical testing, visual examination), not clinical performance.
• A study that proves the device meets specific performance criteria related to diagnostic or prognostic capabilities. The "study" mentioned is conformity to safety standards and comparison to predicates for substantial equivalence.
• Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or details about training sets. These are all irrelevant for a device whose primary function is drug transfer and access rather than diagnostic interpretation.

Therefore, I cannot populate the table or provide the requested details about a study focusing on performance metrics like accuracy, sensitivity, or specificity. The provided document concerns a medical device accessory whose "performance" is primarily assessed through engineering, material, and safety standards, and equivalency to existing devices, rather than clinical diagnostic efficacy.

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The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in vials.

The Vented Vial Adapter Transfer Device is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials while keeping the process in pressure equilibrium with the ambient pressure. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.

The Vented Vial Adapter Transfer Device is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a lucr connection) is attached to the subassembly.

The provided text describes a 510(k) submission for a medical device called the "Vented Vial Adapter Transfer Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study related to strict acceptance criteria and performance metrics in the way one might for a diagnostic AI device.

Therefore, many of the requested categories for AI device studies (e.g., sample size, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable to this type of medical device submission.

Here's an adaptation of the requested information based on the provided document:

Acceptance Criteria and Device Performance for the Vented Vial Adapter Transfer Device

The "acceptance criteria" for this device, within the context of a 510(k) submission, are primarily focused on demonstrating substantial equivalence to already cleared predicate devices regarding its intended use, technological characteristics, and safety and effectiveness. The "study" proving this largely relies on comparisons, material testing, and manufacturing quality controls.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A): This submission is for a medical device, not an AI/diagnostic software. There isn't a "test set" in the sense of a dataset for algorithm evaluation. Instead, the "testing" refers to manufacturing quality control and material biocompatibility.
• Data Provenance: The device is manufactured by Medimop Medical Projects Ltd. in Ra'anana, Israel. The material testing (ISO 10993-1 and USP V1) would generate data, but specific details on the provenance of these material tests beyond the standards themselves are not provided. The comparison is retrospective to existing predicate devices.

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

• N/A: Not relevant for this type of device submission. Ground truth as typically understood for AI models is not established.

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

• N/A: Not relevant for this type of device 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

• N/A: Not relevant for this type of device submission. This is a physical medical device.

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

• N/A: Not relevant for this type of device submission.

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

• N/A (Indirectly): The "ground truth" for this type of device is implicitly the established safety and effectiveness of its predicate devices, as well as adherence to recognized material and manufacturing standards (ISO 10993-1, USP V1, internal release specifications). The FDA's substantial equivalence determination acts as the validation.

8. The sample size for the training set

• N/A: Not relevant for this type of device submission.

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

• N/A: Not relevant for this type of device submission.

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The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Mix2vial Transfer Device". This document does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria in the computational or AI sense.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA granted clearance based on the device being substantially equivalent to a predicate device, rather than requiring performance data from a specific study against predefined acceptance criteria for the new device. The FDA process for 510(k) clearance primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot extract the requested information (acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from the provided text, as it pertains to a different type of regulatory review that doesn't involve these elements in the context of AI/computational device performance validation.

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