Search Results

Gri-Fill Peristaltic Set fluid transfer set is an ancillary device used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one solution source is delivered into a final IV container. This device is not intended to be directly connected to the patient.

Gri-fill Peristaltic Set is a disposable fluid transfer set for connection to a source container and to Gri-fill sets for use with the Gri-Fill Pharmacy Compounder. lt consists of a silicone tube linking a male luer-lock connector and a spike (with a 1.2 um hydrophobic air filter) for connecting to the source container, and a female luer-lock connection, for connecting to the Gri-fill set. The silicone tube allows the set to be used with a peristaltic pump. The Gri-fill Peristaltic Set is intended to be used by trained health-care personnel. The product is presented sterile (SAL = 1 x 10-6) in peel-pack pouches each containing 1 unit. Sterility is achieved using a validated ethylene oxide sterilization process. Gri-fill Peristaltic Set is not intended to be used for direct patient contact.

The provided document describes the 510(k) premarket notification for the Gri-fill Peristaltic Set, a fluid transfer set used in hospital pharmacies. It claims substantial equivalence to a predicate device, the KIRO Set (K152441).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner as typically seen in clinical performance studies of AI/diagnostic devices. Instead, the "acceptance criteria" are implied by the various performance tests conducted to demonstrate substantial equivalence to the predicate device and adherence to relevant standards. The "reported device performance" is described qualitatively as "All tests yielded correct results."

However, the closest equivalent to quantitative acceptance criteria and performance data are those related to Dose Range and Accuracy, which are compared between the subject device and the predicate.

Note: For most other performance tests (e.g., leakage, tensile strength, functionality, residuals, endotoxins), the document states "All tests yielded correct results," implying they met their respective standard-defined acceptance criteria, but these criteria are not numerically specified in the provided text.

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

The document does not provide specific sample sizes (e.g., number of devices tested) for the performance tests conducted. It only mentions that "Performance testing was conducted in accordance with 'FDA Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]' dated July 11, 2008."

The data provenance is implied to be from laboratory bench testing performed by the manufacturer, Laboratorios Grifols, S.A. (SPAIN). All studies were prospective bench tests rather than retrospective or prospective human data clinical studies.

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

This information is not applicable as the device is a physical medical device (fluid transfer set) and not an AI or diagnostic tool requiring ground truth established by human experts for interpretation of images or patient data. The "ground truth" for its performance is derived from physical and chemical measurements against established standards.

4. Adjudication Method for the Test Set

This information is not applicable as there are no human interpretations or classifications of data that would require an adjudication method. Performance is assessed through objective physical and chemical 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

This information is not applicable. The device is a physical medical device (fluid transfer set), not an AI or diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. The device is a physical medical device. It does not involve algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards, such as:

• ISO 11607-1 for individual packaging validation.
• ISO 11135:2014 for ethylene oxide sterilization process validation.
• ISO 10993-7:2008 for residuals of ethylene oxide sterilization.
• ANSI/AAMI ST72:2002 and FDA Guidance for Industry for bacterial endotoxin testing.
• ISO 8536-4 for chemical, physical, and functional performance (leakage, tensile strength).
• ISO 22413 for chemical, physical, and functional performance.
• ISO 594-1 and ISO 594-2 for physical testing of luer-locks.
• ISO 10993-1 for biocompatibility (hemocompatibility, cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device. It does not involve AI or machine learning models that require a "training set."

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

This information is not applicable for the same reason as above.

Ask a specific question about this device

Disposable transfer set through which substances from 2 different vials containing the same solution may be continuously delivered for:

• IV administration when used in conjunction with a gravity or pump infusion set, with a) luer-lock connection to the drip chamber, to channel the solution from the source vials to the infusion set, and
• Pharmacy Compounding when used in conjunction with the Grifill 3.0 pharmacy b) compounding device and associated transfer sets.

Equipped with a spike on each line and a 0.2 um hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large sufface area of the air-filter.

Set tubing is PVC with DEHP plasticizer. Do not use with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Pacitaxel, Etoposide, Carmustine, Propofol, Nitrogycerin, Isosorbide Dinitrate, Diazepam. For information concerning compatibility of substances, please consult the information provided by the manufacturer.

This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.

Disposable fluid transfer set for connection to a gravity or pump 1.V. administration set with drip chamber with luer lock connector or for use with the Gri-fill 3.0 pharmacy compounder.

Equipped with a spike on each line and a 0.2 um hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large surface area of the air-filter.

Set tubing is PVC with DEHP plasticizer. Do not use with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Paclitaxel, Docetaxel, Etoposide, Carmustine, Propofol, Nitroglycerin, Isosorbide Dinitrate, Diazepam, For information concerning compatibility of substances, please consult the information provided by the manufacturer.

The provided document describes the predicate devices comparison for the FLEBOSET DOUBLE and does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria beyond general non-clinical bench testing.

Based on the provided text, I can infer the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in quantitative terms (e.g., "flow rate must be X mL/min ± Y%"). Instead, it broadly states that "All tests yielded correct results" for the non-clinical bench testing.

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

The document does not specify the sample size used for the non-clinical bench tests.
The data provenance is not explicitly stated as retrospective or prospective, but it refers to materials, packaging, and manufacturing processes identical to the predicate device, implying that some data might be drawn from previous evaluations of Grifols' existing devices. However, the non-clinical bench testing for FLEBOSET DOUBLE itself would be prospective testing of the new device. The country of origin of the device manufacturer is Spain.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This was a non-clinical bench study, not a clinical study involving expert interpretation of data or images.

4. Adjudication Method:

Not applicable. As this was a non-clinical bench study, there was no need for expert adjudication.

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

No. The document explicitly states: "No clinical data presented in this submission." This type of study would fall under clinical data.

6. Standalone Performance Study:

Yes, in the sense that the device itself underwent non-clinical bench testing to demonstrate its performance characteristics. The document mentions "Non-clinical bench testing performed on FLEBOSET DOUBLE included leakage testing, infusion flow-rate testing and functional checking as per its intended use." This represents a standalone evaluation of the device's physical and functional properties.

7. Type of Ground Truth Used:

For the non-clinical bench testing, the ground truth would be based on engineering specifications and established test methods for medical device performance (e.g., standards for leakage, flow rates, sterility, and residual levels).

8. Sample Size for the Training Set:

Not applicable. The description is for a physical medical device (fluid transfer set), not an AI/algorithm-based device that would require a 'training set'.

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

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

Ask a specific question about this device

SET GRI-FILL 3.0 6 to 1 is a fluid transfer set to be used in conjunction with SETS GRI-FILL 3.0 1 WAY or 2 WAY through which the same substance from up to 6 rubberstoppered glass vials may be delivered into a final IV container.

SET GRI-FILL 3.0 6 TO 1 is an ancillary device used as a fluid pathway in conjunction with the Gri-fill 3.0 Pharmacy Compounder and associated 1 way or 2 way transfer sets through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. Equipped with a spike on each line and a 0.2 µm hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large surface area of the air-filter.

This device should not be used with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Paclitaxel, Docetaxel, Etoposide, Carmustine, Propofol, Nitroglycerin, Isosorbide Dinitrate and Diazepam. For information concerning compatibility of substances, please consult the information provided with the substance.

Fluid transfer set consisting of PVC tubing linking 6 minispikes to be used in conjunction with SETS GRI-FILL 3.0 1 Way or 2 Way transfer sets through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.

This document, K093182, describes the SET GRI-FILL 3.0 6 to 1, a fluid transfer set. The information provided outlines the device's technical specifications and a summary of non-clinical data used to establish substantial equivalence to predicate devices, rather than a detailed study demonstrating quantitative performance against specific acceptance criteria. This submission focuses on comparing the new device against existing, legally marketed predicate devices (QUICKPIN and FLEBOSET MULTIPLE).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document refers generally to "bench testing" and "functional laboratory bench testing" (Page 3). It does not provide specific numerical sample sizes for these tests.
• Data Provenance: The studies were non-clinical, functional laboratory bench tests. The submitter is Laboratorios Grifols, S.A. in Barcelona, Spain. The data is thus likely from retrospective internal testing performed by the manufacturer in Spain.

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

• This information is not provided. The evaluation relies on "functional laboratory bench testing" and "chemical and biological testing" rather than human expert interpretation of results. The ground truth for device performance would be established by the physical and chemical properties of the device itself and its interaction with fluids, as measured in a lab setting, not by human experts.

4. Adjudication Method for the Test Set

• An adjudication method is not applicable here as the "ground truth" is determined by objective physical and chemical testing, not by expert consensus on subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a medical device (fluid transfer set), not an imaging or diagnostic AI tool that would typically involve human readers.

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

• This is not applicable as the device is a physical medical device, not a software algorithm. The "performance" refers to the device's physical function and material compatibility, which is inherently "standalone" in its operation.

7. The Type of Ground Truth Used

• The ground truth used primarily involves the physical and chemical performance measurements of the device components and the assembled system in a laboratory setting. This includes:
  • Verification of fluid transfer functionality.
  • Measurement of aerosol minimization (implied by the 0.2 µm hydrophobic filter).
  • Assessment of spike puncturing capability.
  • Evaluation of fluid addition/extraction speed.
  • Chemical and biological compatibility testing of materials.

8. The Sample Size for the Training Set

• This concept is not applicable here. This is a physical medical device, not a machine learning model 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 a physical medical device.

Ask a specific question about this device

QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and / or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multidose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances. This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.

QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multi-dose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances.

The provided document is a 510(k) summary for a medical device (QUICKPIN), focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in the format requested. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, is not present.

However, I can extract information related to the device's functional validation, which serves as a form of acceptance in the context of a 510(k) submission.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided document. The text mentions "bench tests performed on the proposed QUICKPIN device" and "Functional laboratory testing."
• Data Provenance: The document implies in-house laboratory testing conducted by Grifols or a contracted lab. The exact country of origin and whether it was retrospective or prospective is not specified, but typically bench testing for device validation is prospective.

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

• Not applicable/Not provided. This type of information is typically related to clinical studies or performance evaluations where human judgment forms the ground truth, which is not the primary focus of this 510(k) summary (which relies on bench testing for substantial equivalence).

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

• Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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 MRMC study was done/reported. The device is a Luer-lock spike, not an AI-assisted diagnostic tool.

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

• Not applicable. The device is a physical medical device, not an algorithm. However, its "standalone" performance in terms of functionality was evaluated via bench testing.

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

• For materials: Conformance to established standards (USP physicochemical tests, ISO 10993-1 biological tests) serves as the "ground truth."
• For functional performance: The "ground truth" is the device operating correctly according to its intended use in simulated or laboratory conditions. This would be based on predefined engineering specifications and functional requirements.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model that requires a training set.

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

• Not applicable. This device is not an AI/machine learning model.

Ask a specific question about this device

SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to provide a fluid pathway through which one or two source substances are delivered into a final IV container or syringe.

SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways in conjunction with the GRI-FILL 3.0 pharmacy compounder and associated 1 WAY or 2 WAY transfer sets through which the same substance from up to 6 source containers may be delivered into a final IV container.

This device should not be used with lipids.

This device is intended to be used by trained health-care personnel. It is restricted to sale by or on the order of a physician.

SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1WAY / 2WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1WAY / 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SETS GRI-FILL 3.0 device:

Acceptance Criteria and Device Performance Study for SETS GRI-FILL 3.0

The provided text focuses on establishing substantial equivalence for the SETS GRI-FILL 3.0 with predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel medical diagnostic algorithm. The information pertains to fluid transfer sets used in pharmacy compounding.

Based on the document, the "acceptance criteria" can be inferred from the comparison with predicate devices and the functional testing performed. The device's "performance" is reported qualitatively as demonstrating "correct operation" and meeting "applicable requirements."

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (fluid transfer sets) and the documentation provided (510(k) summary for substantial equivalence), the "acceptance criteria" are primarily related to functional and material specifications that ensure safe and effective fluid transfer, consistent with predicate devices.

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

The document does not detail a specific "test set" in the context of a typical AI/algorithm study (e.g., patient data). The testing described is functional laboratory testing of the device itself.

• Sample Size: Not specified in terms of number of devices or number of test runs, but it's implied that sufficient testing was done to ensure "correct operation."
• Data Provenance: The "study" (functional laboratory testing) was conducted by Laboratorios Grifols, S.A. (Spain). The data is retrospective in the sense that the results are being presented after the tests were concluded.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. The ground truth for this type of device (fluid transfer set) is established through engineering and functional testing against predefined specifications and industry standards, not expert consensus on diagnostic images or clinical outcomes.
• Qualifications of Experts: N/A. The "experts" would be the engineers and technicians involved in the design, manufacturing, and testing of the device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense of clinical studies requiring expert review. The "adjudication" is inherent in the laboratory testing, where results are compared against pre-defined engineering and performance specifications.

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

• MRMC Study Done: No. This device is not an AI diagnostic tool that would typically involve human readers.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

• Standalone Study Done: Yes, in the sense that the device's functional performance was evaluated independently without human intervention during the fluid transfer process itself (though humans operate the compounding system). The "algorithm" here is the physical design and manufacturing of the transfer set, and its performance was assessed directly.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications and performance standards. The device's functionality (accurate fluid delivery, no leakage, sterility, material compatibility) serves as its own "ground truth" when tested against these established criteria.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI or machine learning algorithm. There is no "training set" in the context of developing an intelligent system. The design and manufacturing process would involve iterative testing, but not a formal "training set" as understood in AI.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an algorithm. The "ground truth" for the device's design and manufacturing is derived from industry standards, regulatory requirements, and the intended function of a fluid transfer system in pharmacy compounding.

Ask a specific question about this device

FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for:

• (a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and
• (b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set.
  The device should not be used with lipids.
  This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (uninterrupted) delivery of drug solutions from 6 glass source containers. It is used in pharmacy compounding or for I.V. fluid transfer to minimize tubing manipulation when working with small volume source containers. The device is made up of 6 spikes connected in series with flexible tubing segments, each segment with an individual clamp. The set terminal, for connection to pharmacy compounding device sets or the administration sets (gravity or pump) consists of a spikeable twist-off valve connector.

This firm did not perform a clinical study to prove substantial equivalence. Instead, they relied on non-clinical data. They compared the technological characteristics of their device (FLEBOSET MULTIPLE) to three predicate devices that are already legally marketed. All materials used in the construction of FLEBOSET MULTIPLE were subject to chemical and biological testing in accordance with applicable requirements, taking into account its intended use, and functional laboratory testing was performed in foreseeable operating conditions that showed correct operation of the device as per its intended use.

Here's the information requested based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a quantitative or measurable format typical for device performance metrics. Instead, the demonstration of equivalence is based on the device's characteristics being "very similar" to existing predicate devices and having passed chemical, biological, and functional laboratory testing. The "reported device performance" is described qualitatively.

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

• Sample size for test set: Not applicable. No clinical test set data is described. The evaluation was based on non-clinical (laboratory and materials) testing and comparison to predicate devices.
• Data provenance: Not applicable for a test set. The non-clinical data would originate from the manufacturer's internal laboratory testing. The document does not specify a country of origin for this testing data, only the submitter's address is Spain.

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

• Not applicable. No ground truth for a clinical test set was established as no clinical study was performed.

4. Adjudication method for the test set

• Not applicable. No clinical test set and thus no adjudication method were used.

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

• Not applicable. This is a medical device for fluid transfer, not an AI-based diagnostic or imaging device. No MRMC study was conducted.

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

• Not applicable. This is a medical device for fluid transfer, not an algorithm.

7. The type of ground truth used

• Not applicable for a clinical ground truth. The "ground truth" equivalent in this submission is the established performance and safety profiles of the predicate devices and the results of laboratory-based chemical, biological, and functional testing.

8. The sample size for the training set

• Not applicable. This is a medical device for fluid transfer, not an AI/algorithm-based device requiring a training set.

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

• Not applicable. This is a medical device for fluid transfer, not an AI/algorithm-based device.

Ask a specific question about this device

All models of GRI-BAG are flexible I.V. bags, with incorporated 0.2 urn filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL, pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set. This device is intended to be used by trained health care personnel. It is restricted to sale by or on order of a physician. The device should not be used with lipids.

GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 um filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml. 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRI-BAG AP models have a conus vial output connector.

The provided text describes a 510(k) summary for the GRI-BAG device, focusing on its substantial equivalence to predicate devices, rather than a study designed to explicitly meet pre-defined acceptance criteria for a new, standalone device performance claim. The key objective of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove a specific performance level against a set of quantitative metrics.

Therefore, several requested sections of your prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are typically not part of a 510(k) submission focused on substantial equivalence. Instead, the submission relies on demonstrating comparable technological characteristics and intended use to predicate devices, supported by non-clinical functional and biocompatibility testing.

Here's an attempt to answer based on the provided text, acknowledging the limitations for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of explicit "acceptance criteria" for specific performance metrics in the context of a 510(k) for substantial equivalence is different from a performance study for a novel device. For the GRI-BAG, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices and by showing that the device functions correctly as per its intended use during functional testing.

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

The document does not explicitly state a "test set" in the traditional sense of a clinical or performance study with a quantified sample size for statistical analysis of user performance or diagnostic accuracy. Instead, the evaluation focuses on:

• Comparison of Technical Characteristics: This is based on design specifications and material properties, not a "sample size" of devices tested empirically against a specific metric.
• Biocompatibility Testing: According to the text, this was performed on "all materials." No specific sample size for a biological study is provided.
• Functional Testing: Performed "in foreseeable operating conditions" and "in accordance with applicable clauses of [...] standards." No specific sample size for functional tests is provided.

The data provenance is from the manufacturer, Laboratorios Grifols, S.A. (Spain), and the testing appears to be non-clinical (laboratory/bench testing) rather than retrospective or prospective human subject data.

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

Not applicable. The ground truth for a 510(k) submission like this is primarily based on compliance with established standards (ISO 10993, ISO DIS 15747, ISO 8536-4, ASTM F838-83, AOF-0011) and demonstration of functional equivalence to predicate devices, rather than expert consensus on diagnostic or clinical outcomes from a test set.

4. Adjudication Method for the Test Set

Not applicable, as there is no described test set requiring expert adjudication for clinical or diagnostic performance.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a device intended for drug solution preparation and filtration, not a diagnostic imaging device typically evaluated with MRMC studies.

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

This question is not applicable to the GRI-BAG device. It is a physical medical device (I.V. bag with a filter), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is based on:

• Compliance with recognized standards: ISO 10993 (biocompatibility), ISO DIS 15747, ISO 8536-4, ASTM F838-83 (filter pore size rating), AOF-0011 (functional testing).
• Demonstrated functional performance according to the device's intended use and comparison with the established performance of the predicate devices.
• Material specifications against predicate device materials.

8. The Sample Size for the Training Set

Not applicable. This is not a study involving a "training set" for an algorithm.

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

Not applicable. This is not a study involving a "training set" for an algorithm.

Ask a specific question about this device

All models of SETS GRI-FILL 2.0 fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 2.0 pharmacy compounding device in hospites in hospites for a macy to provide a fluid pathway through which one or more source solutions are delivered into a single Gri-bag or Gri-flex container or into a standard syringe or pump. The device should not be used with lipids. It is restricted to sale by or on order of a physician.

SETS GRI-FILL 2.0 are fluid transfer sets for use with the GRI-FILL 2.0 pharmacy compounding device in order tc compound or mix different multi-ingredient solutions and to channel them into a final suitable container. The set is a disposable component of the compounding device made up of a syringe, a distributor and tubing to channel the fluid. Sets are available for 1 or 2 source solutions. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The model Luer Connection Tube can be joined to the 1 way or 2 ways sets as prolongation for connection to source solution containers with luer terminals.

Here's a breakdown of the acceptance criteria and the study information for the SETS GRI-FILL 2.0 based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "sample size" for the test set in terms of number of devices or number of tests conducted for each functional parameter. It broadly mentions "Functional laboratory testing performed in foreseeable operating conditions." The data provenance is not explicitly mentioned as country of origin, but the submission is from Laboratorios Grifols, S.A. in Spain. The study appears to be prospective as it's a submission for premarket notification, indicating the tests were conducted for the purpose of demonstrating substantial equivalence.

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

The document does not mention the use of experts to establish ground truth for a "test set" in the context of clinical or diagnostic performance. The evaluation is focused on the device's functional integrity and material compatibility, which would typically be assessed through engineering and laboratory testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions or interpretations.

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

No, an MRMC comparative effectiveness study was not done. This device is an I.V. fluid transfer set, and its evaluation focuses on functional and material equivalence, not diagnostic or clinical accuracy requiring human interpretation of cases.

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

Yes, the evaluation described is essentially a standalone (algorithm only, if "algorithm" refers to the device's inherent design and function) performance assessment. The device itself performs the function of fluid transfer, and its performance was evaluated in this standalone capacity through laboratory functional testing. There is no human-in-the-loop component in the performance of the device itself (though human operators operate the compounding device with which it is used).

7. The type of ground truth used

The "ground truth" for this device's evaluation is based on engineering specifications, material compatibility standards (chemical and biological testing), and functional performance criteria (e.g., accurate fluid delivery, no leakage). It is not based on expert consensus, pathology, or outcomes data in the clinical sense, as the device's function is mechanical fluid transfer.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device with a "training set." The evaluation is based on the physical and functional properties of the manufactured device.

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

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

Ask a specific question about this device

All models of GRI-FLEX are flexible I.V. bags, with incorporated 0.2 um filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.

GRI-FLEX is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µm filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GRI-FLEX device:

Important Note: The provided document is a 510(k) summary for a medical device. These summaries primarily focus on demonstrating substantial equivalence to existing predicate devices, rather than comprehensive standalone performance studies that would typically be conducted for a novel device or to establish specific performance metrics against clinical endpoints. Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC studies, ground truth for training data) are not typically detailed in these types of submissions because the study design is geared towards showing equivalence based on known performance of the predicate.

Acceptance Criteria and Device Performance for GRI-FLEX

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a device demonstrating substantial equivalence to predicates, the "acceptance criteria" are primarily based on meeting the established performance characteristics and safety profiles of the predicate devices. The study conducted is a non-clinical evaluation to demonstrate these equivalences.

Study That Proves the Device Meets the Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as a "Summary Discussion of Non-Clinical Data." This involves a series of tests to demonstrate material compatibility, sterility, and functional performance, benchmarking against relevant international standards and the predicate devices.

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For non-clinical functional and biological testing of a device like this, sample sizes would typically be determined by statistical methods or regulatory standards for engineering tests, but are not specified here.
• Data Provenance: The tests were conducted according to international standards (ISO, USP, ASTM), implying that the data was generated specifically for this device submission within a controlled testing environment, likely by the manufacturer (Laboratorios Grifols, S.A.) or a contracted testing laboratory. The country of origin for the data is not explicitly stated, but the manufacturer is based in Spain. The data is prospective in that it was generated for the purpose of this 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 document. For non-clinical device performance and safety testing, "ground truth" is established by adherence to physical, chemical, and biological testing standards and specifications, not by expert human interpretation in the way it would be for diagnostic imaging or clinical studies.

4. Adjudication Method for the Test Set

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies for human interpretation of data where there might be disagreement (e.g., radiologists reviewing images). This document describes non-clinical engineering and biological tests which do not involve such adjudication.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically clinical studies evaluating human reader performance for diagnostic devices, often with and without AI assistance. This submission focuses on the non-clinical performance and safety of a medical container with an integrated filter.

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

Not applicable. This device is a physical medical component (an IV bag with a filter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm only performance" does not apply. The functional tests performed (e.g., filter efficacy, material integrity) are analogous to "standalone" performance for a physical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's non-clinical evaluation is based on:

• Reference Standards and Specifications: Adherence to established international standards (ISO 10993 for biocompatibility, ISO DIS 15747, USP , ISO 8536-4, ASTM F838-83 for functional performance).
• Predicate Device Performance: The characteristics and demonstrated safety/efficacy of the legally marketed predicate devices (VIAFLEX PLASTIC CONTAINER and PALL SUPOR AEF filter).
• Material Science and Engineering Principles: Ensuring materials meet appropriate properties and the device design functions as intended.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As stated above, there is no "training set" for this type of device submission.

Ask a specific question about this device