(274 days)
to inject fluids into, or withdraw fluids from, the body below the sufface of the skin for medical purposes.
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.
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.
§ 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).