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The ProfojectTM Disposable Syringe and the ProfojectTM Disposable Syringe with Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

The ProfojectTM Disposable Syringe is available in a sterile state. It is a single-use device comprising a polypropylene barrel with a Luer slip or Luer lock nozzle, a polypropylene plunger, and a polyisoprene rubber plunger stopper. Syringes are available in various volume specifications, ranging from 1mL to 60mL. The syringe barrel is printed with a legible graduated scale in milliliters. The syringe is compatible with U.S. legally marketed devices featuring Luer slip or Luer lock connectors that comply with ISO 80369-7. The syringe is intended for manual use only. The plunger of the syringe is pulled back to aspirate fluids or depressed to inject or expel fluids.

The ProfojectTM Disposable Syringe with Needle is supplied in a sterile state. It is a single-use device comprising a Luer slip or Luer lock syringe and a hypodermic needle. The hypodermic needle consists of a stainless steel needle tube, a polypropylene needle hub, and a polypropylene needle cap. The hypodermic needle is available in variety of combinations of needle gauge (18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G) and needle length (15mm, 20mm, 25mm, 30mm, 38mm). Needle hubs are color-coded to identify the gauge of the needle tube. The Disposable Syringe with Needle is available in various combinations of syringe volume and needle size. It is intended for manual use only. The plunger of the syringe is pulled back to aspirate fluids or depressed to inject or expel fluids.

The provided FDA 510(k) clearance letter and summary for the Profoject™ Disposable Syringe and Profoject™ Disposable Syringe with Needle focuses on establishing substantial equivalence to a predicate device (K211211) through non-clinical testing. It does not describe a study involving an AI component, human readers, or a ground truth established in the way typical for AI/ML medical devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this is a traditional medical device submission without an AI/ML component.

Instead, the submission relies on a comparison of technological characteristics and performance testing against recognized international standards for syringes and needles to demonstrate substantial equivalence.

Here's a summary based on the provided document, addressing the relevant points and noting where information is not applicable due to the nature of the device:

Acceptance Criteria and Study Details for Profoject™ Disposable Syringe

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with a comprehensive set of international standards rather than specific performance metrics directly stated in a table for each criterion. The "reported device performance" is indicated by the statement that the tests met the requirements of these standards.

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

The document does not specify exact sample sizes for each test. It states that "the following tests have been performed" and that "the testing results demonstrate that the proposed device complies with the applicable standards requirements." For biocompatibility, performance, sterilization, package, and shelf-life testing, samples of the device were used as required by the specific standards.

• Sample Size: Not explicitly stated as a single number for a "test set." Samples were drawn and tested according to the requirements of each individual standard (e.g., ISO, ASTM, USP).
• Data Provenance: The tests were conducted by the manufacturer (CMT Health Pte. Ltd., based in Singapore) or their designated testing facilities to demonstrate compliance with international standards. This is prospective testing performed on manufactured devices.

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

N/A. This device is a traditional medical device (syringes) and not an AI/ML device requiring expert-established ground truth for a diagnostic test. The "ground truth" here is compliance with established engineering and biological safety standards.

4. Adjudication Method for the Test Set

N/A. Not applicable to engineering performance and biocompatibility testing of a physical device. Test results are compared directly against the quantitative or qualitative pass/fail criteria defined within the referenced international standards.

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

N/A. This is a traditional medical device (syringe), not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies are not relevant.

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

N/A. This device does not involve an AI algorithm. Its performance is evaluated through bench testing against established standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is defined by the objective, measurable requirements and pass/fail criteria specified within the referenced international and national standards (ISO, ASTM, USP) for its physical, chemical, and biological properties. This includes:

• Engineering specifications (e.g., dimensions, force required for operation, leak integrity).
• Material safety (biocompatibility, leachable substances).
• Sterility assurance.
• Packaging integrity.
• Shelf-life stability.

8. The Sample Size for the Training Set

N/A. This is a traditional medical device and does not involve machine learning algorithms requiring a training set.

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

N/A. No training set is applicable for this device.

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The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

Profoject™ Enteral Feeding Syringe provided in a variety of sizes from 0.5mL to 60mL. It consists of plunger, plunger stopper, barrel, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector.

The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10⁻⁶ and supplied sterility maintenance package. The shelf life of both sterile and non-sterile proposed devices has been validated as 5 years.

This looks like a 510(k) clearance letter for a medical device that is NOT an AI/ML device. Therefore, the questions related to AI/ML device evaluations (such as test set, ground truth, expert qualifications, MRMC studies, and training set) are not applicable.

The document describes the non-clinical test conclusions for the Profoject™ Enteral Feeding Syringe.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was evaluated against several ISO and ASTM standards, as well as USP-NF monographs. The acceptance criteria are implicitly those defined by these standards, and the reported performance is that the device "Complied with" these standards.

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

The document indicates that non-clinical verification was performed. This typically involves laboratory testing on device prototypes or production samples. The specific sample sizes for each test are not provided in this summary. Data provenance would be from laboratory testing conducted by or for CMT Health PTE. Ltd. (Singapore), likely in a controlled, prospective manner as part of the device development and validation process.

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

This question is not applicable as the device is a physical medical device (enteral feeding syringe), not an AI/ML device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for non-clinical performance and safety relates to adherence to recognized standards and specifications, which are typically evaluated by engineers and quality assurance professionals, not clinical experts for ground truth establishment.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies for AI/ML algorithms. This document describes non-clinical performance and biocompatibility testing.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant.

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

Not applicable. This is not an AI/ML device.

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

For non-clinical testing of a physical device, the "ground truth" is defined by the technical specifications, performance limits, and safety requirements outlined in the referenced ISO, ASTM, and USP standards. For example, for dose accuracy, the ground truth is the specified ±10% accuracy. For sterility, it's the SAL of 10⁻⁶. For biocompatibility, it's the absence of cytotoxicity, irritation, or sensitization as defined by the ISO 10993 series. These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data in the usual sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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