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The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.

The Terumo Syringe with/without needle is a hypodermic standard piston syringe, available in volumes from 1 ml, 2 ml, 10 ml and 50 ml, with a luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The needle is made from stainless steel.

The provided text describes a 510(k) submission for a medical device, the Terumo® Syringe with/without Needle. It focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than presenting a study of the device's diagnostic performance or algorithm effectiveness. As such, many of the requested categories for acceptance criteria and study details are not relevant or cannot be extracted from this type of regulatory document.

However, I can extract information related to the device's performance testing against a recognized standard, which serves as its primary acceptance criteria in this context.

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:

• Sample Size: Not explicitly stated. The document mentions "testing" and "data" but does not quantify the sample sizes used for each specific test (e.g., how many syringes were tested for dimensional accuracy, or how many batches for sterility).
• Data Provenance: The device is manufactured by Terumo Europe N.V., in Belgium. The submission states the device "was tested in accordance with EN ISO 7886-1 (1993)", suggesting the testing was performed, or overseen, by the manufacturer or a certified testing facility in relation to its European operations. The description is of the device's inherent physical and material properties, rather than clinical data from human subjects. It's a laboratory/engineering performance study, not a clinical study.

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

• Not applicable. This document describes laboratory and engineering performance testing against established international standards. There is no "ground truth" established by human experts in the sense of clinical diagnoses or interpretations. The "truth" is defined by the objective pass/fail criteria of the scientific/engineering standards.

4. Adjudication method for the test set:

• Not applicable. This relates to clinical studies with human review, which is not what this document describes. Performance is assessed against quantitative metrics and methods specified within the referenced ISO/EN standards.

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 manual syringe, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.

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

• Not applicable. This device is a manual syringe, not an algorithm.

7. The type of ground truth used:

• For the performance testing, the "ground truth" is defined by the objective, quantitative criteria and test methods specified in the referenced international standards (e.g., EN ISO 7886-1, EN ISO 10993 series, EN 550, ISO 11135, EN 556-1). This includes measurements of physical properties, chemical residual levels, and biological responses.

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" for this device.

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The Terumo syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The Terumo 30 and 60cc/mL Syringes consist of 3 main parts, a barrel, plunger, and gasket. Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material. The syringes are individually packed in a peel blister that ensures the sterility of the device until the package is opened. The product is sterilized by electron beam sterilization. The product is for single use only and is not intended for reuse.

The provided document is a 510(k) summary for the TERUMO® Syringe with/without needle, which is a medical device. This type of device is a physical product and not an AI/ML-driven software device. Therefore, the questions related to AI/ML specific performance, such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance, are not applicable to this submission.

However, I can extract the acceptance criteria and performance information relevant to this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the Terumo Syringe without needle, 30 and 60cc/mL, was "subjected to the following tests." While explicit numerical acceptance criteria values are not provided in this summary, the completion of these tests with acceptable results is implied for substantial equivalence.

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

This information is not applicable as this is a physical device submission, not an AI/ML software submission involving data sets. Device testing would typically involve a sample size of physical units to perform the listed tests. The document does not specify the exact number of units tested for each criterion, but it confirms the tests were conducted. The device manufacturer is Terumo (Philippines) Corporation, and the product is manufactured in Biñan, Laguna, Philippines.

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)

This is not applicable as there is no "ground truth" in the context of an AI/ML algorithm for a physical syringe. The tests are directly measuring the physical properties and performance of the device against established standards.

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

This is not applicable as there is no "adjudication" in the context of an AI/ML algorithm for a physical syringe. Device testing results are typically objectively measured against specifications.

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 is not applicable as this is a physical device and does not involve human readers or AI assistance.

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

This is not applicable as this is a physical device and does not involve a standalone algorithm.

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

This is not applicable. The "ground truth" for a physical syringe is its adherence to engineering specifications and performance standards established by regulatory bodies (e.g., ISO, FDA).

8. The sample size for the training set

This is not applicable as this is a physical device and does not involve a training set for an algorithm.

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

This is not applicable as this is a physical device and does not involve a training set or its associated ground truth establishment.

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The Terumo syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The Iml Terumo Syringe with/without Needle consists of 3 main parts or 4 parts, i.e., a barrel, plunger, gasket and a hypodermic needle (for with needle type). Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material. The needle is made from stainless steel. The 1 ml Terumo Syringe with/without Needle is individually packed in peel blister that ensures the sterility of the device until the package is opened. The product is sterilized by electron beam sterilization. The product is for single use only and is not intended for reuse.

Here's an analysis of the provided 510k summary regarding the acceptance criteria and the study that proves the device meets those criteria:

This document is a 510(k) premarket notification for a medical device that demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a clinical study. Therefore, many of the requested fields related to AI/MRMC studies or detailed ground truth establishment for novel algorithms are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states that the "1ml Terumo Syringe with/without needle submitted in this premarket notification was subjected to the following tests," listing the performance criteria mentioned above. It also explicitly states, "The 1ml Terumo Syringe with/without needle is substantially equivalent in intended use, materials, design, technology and principles of operation and performance to cleared Terumo Syringes with/without needle cleared under K023271."

This indicates that the "study" proving acceptance criteria is bench testing for the listed performance characteristics and material biocompatibility/sterility validation as per international standards, followed by a demonstration of substantial equivalence to an already cleared predicate device (K023271). The specific numerical results or detailed methodology for each test are not provided in this summary but would have been part of the full submission.

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

The document does not specify the sample sizes for the bench tests. Data provenance is not applicable in the context of bench testing for a physical medical device; the tests would have been performed in a laboratory setting by the manufacturer.

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

This is not applicable since this is a physical medical device undergoing bench testing and not an AI/diagnostic device requiring expert ground truth establishment for a test set.

4. Adjudication method for the test set

This is not applicable as there is no 'ground truth' in the sense of expert review for diagnostic output. Bench testing results would be objective measurements against defined specifications.

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

No, an MRMC comparative effectiveness study was not done. This device is a manual syringe and does not involve AI or human "readers" in its operation.

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

No, a standalone algorithm performance study was not done. This device is a physical, manually operated syringe.

7. The type of ground truth used

The "ground truth" for this device's performance is based on predefined engineering specifications and international standards, such as ISO 10993-1 for biocompatibility and ISO 11137-1995 for sterilization. For example, for "deadspace," the ground truth is a specific maximum allowable volume. For "leakage," the ground truth is a pass/fail against a specific pressure or volume.

8. The sample size for the training set

This is not applicable as there is no "training set" for a physical medical device like a syringe.

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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The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

The Terumo Syringe with/without needle consists mainly of 3 parts or 4 parts: a barrel, a plunger, a gasket and a needle (for the needle type). Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material facilitates smooth movement of the plunger and aids the user in controlling dosage. The needle is made from stainless steel and the needlepoint is carefully designed to minimize resistance at the skin surface and aids in smooth, easy insertion. The Terumo Syringe with/without Needle is individually packed in peel blister that ensures the sterility of the device until the package is opened.

This document describes the 510(k) summary for the Terumo Syringe with/without Needle. It demonstrates substantial equivalence to a predicate device, K980181, rather than proving performance against specific acceptance criteria in a quantitative study. Therefore, some of the requested information, such as sample sizes, expert qualifications, and specific effect sizes, are not applicable or not provided in the given text.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of specific quantitative acceptance criteria with corresponding performance metrics. Instead, it lists various tests performed to demonstrate safety and efficacy and asserts that the device is "safe and effective during handling and for the duration of its expiration." The implicit acceptance criterion for each test is that the new device performs acceptably and equivalently to the predicate device.

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

The document does not specify the sample sizes used for the various performance tests. The data provenance is Terumo (Philippines) Corporation, and the tests were likely conducted prospectively as part of the device development and validation process.

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

Not applicable. This is a medical device clearance based on substantial equivalence, not an AI or diagnostic tool requiring expert ground truth for a test set. The "ground truth" here is compliance with established performance standards and equivalence to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device clearance based on substantial equivalence, not an assessment requiring adjudication of diagnostic outcomes.

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 a manual syringe, and its performance evaluation does not involve human readers interpreting diagnostic cases.

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

Not applicable. The device is a manual syringe, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Compliance with recognized standards: For tests like cleanliness, leakage, and sterility (ISO 11137).
• Engineering specifications and design requirements: For physical and mechanical properties.
• Demonstrated performance of the legally marketed predicate device: The new device must perform comparably to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this device.

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