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B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.

B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system.

B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system.

B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.

B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system.

B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system.

B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device. These devices are not to be used for the compounding of chemotherapy and oncology drugs.

B Dispensing Line is a disposable medical device used for the transfer of liquids from an initial container to a final one, by means of the action of a peristaltic pump. It is a sterile tube, with sections designed to be inserted in peristaltic pump and with specific terminal connectors for the connection of the device with the different containers.

The tube section to be inserted in the peristaltic pump presents a larger diameter than the other sections of tube.

The device is intended to be used with the purpose of pharmacy compounding in the automated system APOTECAbag.

The device is manufactured with biocompatible materials and it is provided sterile by EO sterilization method.

This document describes the regulatory submission for the "B Dispensing Line" device (K203674). This device is an IV fluid transfer set designed for use with the APOTECAbag automated pharmacy compounding system. The provided information focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, the KIRO Set (K152441).

No AI/ML device is mentioned in this documentation. The device is a physical medical device (IV fluid transfer set). Therefore, questions related to AI/ML specific studies, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable.

Here's the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "AEA srl has performed the following non-clinical/design verification testing." This refers to laboratory-based testing on the physical device itself, not a dataset in the context of an AI/ML model. Therefore, "sample size" and "data provenance" (country of origin, retrospective/prospective) as concepts related to data analysis for AI/ML are not applicable here. The tests were performed on physical samples of the B Dispensing Line.

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

Not applicable as this is a physical medical device and no AI/ML model requiring expert-established ground truth data is involved. The ground truth for the performance tests would be established by measuring the physical properties and functionality of the device against predefined engineering and quality standards.

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

Not applicable for a physical medical device's non-clinical performance testing. The "adjudication method" traditionally refers to how conflicting expert opinions are resolved in establishing ground truth for evaluating diagnostic or prognostic algorithms.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm-based device.

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

For the non-clinical tests, the "ground truth" is defined by established engineering standards, regulatory guidelines (e.g., ISO, USP), and documented performance specifications for the device. For example:

• Performance tests: Measured physical accuracy, absence of leakage, structural integrity.
• Biocompatibility tests: Absence of adverse biological reactions as defined by ISO 10993 standards.
• Sterilization tests: Validation against ISO 11135.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or ground truth for it.

In summary, the provided document details the non-clinical performance and safety testing of a physical medical device, the B Dispensing Line. It does not involve any AI/ML components, and therefore, many of the requested specific details related to AI/ML study design are not relevant to this submission.

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The S Dispensing Line is intended for transfer of liquid drug from bag to syringes through the APOTECAsyringe automated system. The device is used inside an automatic system APOTEC Asyringe that tightens the tube with the syringe, while the connection with the bag is done manually. The transfer of liquid takes place by depression through the mechanical action on the piston of the syringe of a manipulator equipped with a gripping device.

Sdispensinglineisadevice for the transferofiquids, with the purpose of preparation of in drugs. The device is intended to be used with APOTECAsyringe automatic compoundingsystem. Thedeviceissingleuse, sterilizedbyEOandsingle-packagedinablister. The device is not manufactured with natural rubber latex. Medical grade plastics are used, according to ISO 10993 series standards. Sdispensingline is a non-vented infusion setused as a connecting part be rock syringe without hypodermic needle. The tip in contact with the syringe must perfectly by means of a pressure connector (not by screwind). in ordertoavoidloss ofmedication; the connectoris to be assembled atthe endof the line. The short line enables the transfer of drug from a bag to a luer lock syringe through the APOTECAsyringe automated system. The line is intended for the connection of the spike perforator; a check valve prevents the flow back towards thebag.

The provided text describes the regulatory clearance for the "S dispensing line" device, which is an intravascular administration set. The information focuses on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies involving human patients or complex algorithms.

Therefore, many of the requested categories for acceptance criteria and study details (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set ground truth) are not applicable as they pertain to clinical or AI algorithm performance, which was not the basis for this regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for performance or biocompatibility tests. The "100 usages" for connection/disconnection/leakage tests indicates a sample of 100 operations for these specific tests. Other tests likely followed the sample size requirements dictated by the respective ISO standards.
• Data Provenance: Not specified. These are non-clinical bench and lab tests.

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. Ground truth, in this context, refers to a clinical diagnosis or outcome, typically established by medical experts for AI/clinical studies. This submission is for a physical medical device and relies on engineering and laboratory testing protocols against established international standards.

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

• Not Applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in image interpretation/AI algorithm development where human reviewers may disagree. This is a non-clinical device clearance.

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 non-clinical submission for a physical medical device (intravascular administration set), not an AI algorithm or a diagnostic tool requiring human reader studies.

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

• Not Applicable. This is a physical medical device; there is no algorithm involved.

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

• The "ground truth" for this device's performance is based on objective measurements and assessments against established engineering and biocompatibility standards (e.g., ISO 8536-4:2010, ISO 10993 series, USP standards). For specific tests like "Right connection/absence of ruptures," the ground truth is a direct observation of the device's physical integrity and functional performance under defined conditions.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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The APOTECA® Drug Compounding Dosing Device is indicated for use by pharmacists or other healthcare professionals for the preparation of chemotherapy drugs, for the transfer of drug from vials to IV bag for infusion. The drug transfer through the device can be performed manually or through an automatic pharmacy compounding system. The specific assembly configuration of the needle allows a robotic arm to manage the device and an automatic dosing device to transfer drug from a vial to a bag by applying pressure on the syringe plunger. The APOTECA® Drug Compounding Dosing Device is intended for use with APOTECAchemo automatic compounding system or for manual drug compounding.

The APOTECA® I.V. Transfer Set is a non-vented infusion set indicated to be used as a connecting part between the IV bag and an external IV line when the drug preparation is performed through an automatic pharmacy compounding system. The APOTECA® I.V. Transfer Set is intended for use with APOTECAchemo automatic compounding system.

The APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set is a system for preparation and administration of drugs intended for use with APOTECAchemo automatic compounding system.

APOTECA® Drug Compounding Dosing Device: a single use piston syringe that consists of a syringe (3ml, 5ml, 10ml, 20ml, 50ml) with a luer lock connector bonded to a needle. The syringe consists of a plastic barrel with a graduated scale, a synthetic rubber stopper and a plastic plunger rod. The needle is a Huber point non-coring needle with 16G thin wall cannula (0.5" plus 0.5" inside the vented hub). The device is not manufactured with natural rubber latex. The device is designed to be handled manually or by automatic pharmacy compounding system for the preparation and admixture of drugs in healthcare establishments.

APOTECA® I.V. Transfer Set: a non-vented infusion set used as a connecting part between an IV bag and an external infusion line. The device comprises of the following components: Non-vented spike, Connecting tube, Spike port adaptor with Twist-Off cap and safety membrane, Luer lock adaptor with protective cap.

The provided 510(k) summary for the APOTECA® Drug Compounding Dosing Device and I.V. Transfer Set details performance data primarily related to biocompatibility and basic physical properties, rather than diagnostic accuracy or comparative effectiveness with human readers. This device is a medical fluid transfer system, not an AI/ML-based diagnostic tool. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable to the information provided.

However, I can extract the acceptance criteria and reported performance for the characteristics that were evaluated.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample sized used for the test set and the data provenance:
The document does not specify the exact sample sizes for each bench test conducted for the APOTECA® devices. The tests were "bench tests" performed based on risk analysis to verify the device's compatibility with the APOTECAchemo automatic pharmacy compounding system and general safety. Data provenance (country of origin, retrospective/prospective) is not applicable to these types of bench tests, as they are laboratory evaluations of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/ML-based diagnostic device requiring expert consensus for ground truth. The performance data relates to material biocompatibility and physical integrity, evaluated through standardized laboratory tests.

4. Adjudication method for the test set:
Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML-based diagnostic device, so MRMC studies involving human readers and AI assistance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system. Its performance relates to its physical and material properties.

7. The type of ground truth used:
For biocompatibility tests (Hemolysis, Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, EO Residual, Bacterial Endotoxins), the "ground truth" is defined by the objective pass/fail criteria established by international standards (ISO, USP) for specific biological responses or chemical levels. For physical tests (Leak proof, Airtight), the "ground truth" is observable evidence of passage (leaks, smoke) or lack thereof.

8. The sample size for the training set:
Not applicable. This is not a machine learning device and therefore does not have a "training set."

9. How the ground truth for the training set was established:
Not applicable. See point 8.

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