The Terumo RN Syringe is a sterile, single use device designed to be similar to present single use products. A needle retraction feature allows the user to withdraw the needle into the barrel of the syringe immediately after use.

AI/ML Overview

The provided text is a 510(k) Summary for the Terumo Retractable Needle (RN) Syringe. It describes the device, its intended use, comparison to predicate devices, and safety information. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, etc.).

The document focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a detailed performance study with quantitative acceptance criteria.

Here's an analysis based on the available information and a clear indication of what is not present:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, a formal table of quantitative acceptance criteria and reported numerical performance statistics cannot be created. The document discusses general safety and performance aspects but does not offer specific measurable criteria for the retraction mechanism, for instance.

The "Performance Data" section discusses non-clinical tests and conclusions, but not specific metrics or acceptance thresholds.

Here's what can be inferred or rephrased as a criterion and the general reported performance:

Acceptance Criteria (Inferred from text)	Reported Device Performance
Sterility Assurance Level (SAL)	10⁻⁶ (sterilized by gamma radiation)
Biocompatibility	Found to be biocompatible (tested as whole device in accordance with FDA's modification of ISO 10993 for external communicating device; blood path, indirect; short term exposure)
Pyrogenicity	Found pyrogen free (tested in accordance with U.S.P. XXIII)
Needle Retraction Functionality	Needle remains retracted within the barrel of the device (tested with a lock-out and drop test)
Prevention of Accidental Reuse	Retraction feature prevents accidental reuse (similar to predicate device)
Equivalent Feel and Function to Standard Syringe	Similar in design, feel and function to a standard Terumo hypodermic syringe with needle; requires little or no change in technique
Shelf Life	Based on experience with Terumo's standard syringes; additional accelerated test program intended to confirm full dating period. (No specific numerical shelf-life reported as "met" yet)

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

Sample Size: Not specified. The document mentions non-clinical tests but does not provide details on the number of devices tested.
Data Provenance: The tests are described as non-clinical and conducted by Terumo (based in Elkton, Maryland, USA). The specific origin of underlying experimental data (e.g., suppliers of materials, specific labs) is not detailed.
Retrospective/Prospective: Not applicable in the sense of clinical data. These appear to be laboratory-based engineering and safety 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 / Not specified. Establishing "ground truth" with human experts is typically relevant for interpretative tasks (e.g., medical imaging diagnosis). For a syringe, the performance is evaluated through physical and chemical tests against established standards (e.g., ISO, USP). The experts involved would likely be engineers, microbiologists, and toxicologists, but their number and specific qualifications are not detailed in this summary.

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

Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on a "ground truth" (e.g., in diagnostic studies). This is not relevant for the type of device testing described (sterility, biocompatibility, mechanical function).

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 is designed to compare human performance (e.g., diagnostic accuracy) with and without assistance from a tool, often AI. This is a medical device, not an AI diagnostic tool, so such a study is not relevant or mentioned.

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

Not applicable. The device is a physical medical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not a concept that applies here.

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

The "ground truth" for this device's performance is established by:

Industry Standards: Compliance with an SAL of 10⁻⁶ for sterility, biocompatibility according to FDA's modification of ISO 10993, and pyrogenicity according to U.S.P. XXIII.
Engineering Specifications: Mechanical tests for needle retraction and lock-out.
Comparability: Demonstration that its design, feel, and function are similar to standard hypodermic syringes and its retraction mechanism is essentially equivalent to the predicate product.

8. The sample size for the training set

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

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

Not applicable. As there is no training set for an AI/ML model, this question does not apply.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence. It highlights safety and general performance characteristics by referencing adherence to established standards and similarity to predicate devices rather than providing detailed, quantitative study results with the types of metrics and methodological details typically found in an AI/ML device study report.

Summary

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TERUMO MEDIC CORPORATION

MAN 2 1 1996

EGULATORY AFFAIRS DEPARTMENT 25 BLUF BALL ROAD ELKTON, MARYLAND 2192 TELEPHONE: (410) 392-723 FAX: (410) 398-6079

510(k) SUMMARY

Name of the Device:

Terumo Retractable Needle (RN) Syringe

Predicate Product:(s):

There are two products referenced as predicates for the Terumo RN Syringe:

Terumo Hypodermic Syringes with Needles, K771205 and K771203.
U.S. Medical Instruments SafeSnap™ syringe, K925039.

Description of the Subject Device:

Intended Use of the Device:

The intended use of the Terumo Medical Corporation (Terumo) RN Syringe is to inject fluids into, or withdraw fluids from, the body below the sufface of the skin for medical purposes.

Comparison of Subject Device to Predicate Device(s):

The Terumo RN Syringe is similar in design, feel and function to a standard Terumo hypodermic syringe with needle. This syringe provides the user with a product similar to a standard disposable syringe that will require little, or no change in the technique that is presently used.

The materials in the subject device are the same as Terumo's standard hypodermic syringe and needle with the exception of the addition of an "O" ring made of silicone. These materials have been tested and as a part of the whole product biocompatibility testing in accordance with the current CDRH guidance.

The needle retraction mechanism of the "crumo RN Syringe locks the needle hub with an adapter on the distal end of the plunger after injection, and allows the needle to be withdrawn into the barrel of the syringe. The predicate syringe requires the user to ensure that the plunger rod has locked into the needle carrier and then to disengage an external locking ring after the completion of the injection. The withdrawal of the plunger rod retracts the needle within the barrel of the syringe. The user then snaps off the plunger rod and inserts the broken segment of the rod into the open end of the barrel and, disposes of the unit in an appropriate sharps container. The needle retraction mechanism of the Terumo RN Syringe is similar to that of the predicate product, except there is no need to disengage a locking ring. The retraction feature of both devices prevents the accidental reuse of the device.

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Safety Information:

· The Terumo RN Syringe is sterilized by gamma radiation to provide a Sterility Assurance Level (SAL) of 10-6.

· Blood or fluid contacting materials were tested as the whole device for biocompatibility using the FDA's modification of the ISO 10993 Standard as a external communicating device; blood path, indirect; short term exposure and found to be biocompatible.

· The product was found pyrogen free when tested in accordance with U.S.P. XXIII.

· Shelf life for the RN Syringe is based on our experience with Terumo's standard syringes. An additional accelerated test program will be intended that will confirm the full dating period.

Performance Data:

Discussion of Non-Clinical Tests

The non-clinical tests performed on the Terumo RN Syringe are the same protocols and standards used for the evaluation of our standard syringe products. In addition the needle retraction feature was tested with a lock - out and drop test to assure that the needle would remain retracted within the barrel of the device.

Discussion of Clinical Tests

An analysis of the similarities in design, materials, use and function of the Terumo RN Syringe with the predicate products, establishes that the need for simulated clinical use and actual clinical use testing is unnecessary.

Conclusions Drawn from Testing

Since the device is similar to current single use syringes and the needle retraction function is essentially equivalent to the predicate product, there are no new issues of safety or effectiveness involved in the use of the Terumo RN Syringe.

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TMC's statement that these devices are substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug, and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.

Submitter's Information:

Alan B. Hershman, R.A.C. Manager of Regulatory Affairs Terumo Medical Corporation Regulatory Affairs Department 125 Blue Ball Road Elkton, MD 21921

Phone 410/392-7231 410/398-7069 Fax

Date of Summary: 08/14/95

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).