(153 days)
The Automatically Retractable Safety Syringes with Fixed Needle (Iml, 3ml, 10ml with 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, or 20G) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.
The Automatically Retractable Safety Syringes with Fixed Needle devices are piston syringes, intended for medical purposes and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. The Automatically Retractable Safety Syringes with Fixed Needle are sterile, single use, disposable and non-reusable.
This document is a 510(k) premarket notification for an "Automatically Retractable Safety Syringe with Fixed Needle". It is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the context of an AI/algorithm-driven device.
Therefore, many of the requested categories related to AI/algorithm performance studies (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a physical medical device.
However, I can extract information related to "acceptance criteria" through the lens of performance testing conducted to show substantial equivalence.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance
The document does not provide a table of explicit, quantitative "acceptance criteria" and their corresponding "reported device performance" values in the format typically seen for algorithm validation. Instead, it refers to general performance testing to demonstrate substantial equivalence.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Design Verification | Test results concluded that the modified device passed appropriately. |
| Design Validation | Test results concluded that the modified device passed appropriately. |
| Biocompatibility | Test results concluded that the modified device passed appropriately. |
| Sterilization | Test results concluded that the modified device passed appropriately. |
| Substantial Equivalence | Product performance is substantially equivalent to the predicate device due to no changes in product performance specifications or device functional technology. |
Explanation of "Acceptance Criteria" in this context: For a physical medical device like a syringe seeking 510(k) clearance, "acceptance criteria" are typically defined by recognized standards (e.g., ISO standards for syringes, biocompatibility standards) and the internal design specifications of the manufacturer. The document states that testing was done "appropriately for design verification, design validation, biocompatibility and sterilization," implying that the device met these established criteria without specifying the exact numerical thresholds.
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 for Test Set: Not specified in the document. The document mentions "performance testing" but does not detail the number of units tested.
- Data Provenance: Not specified. It's likely the testing was conducted by the manufacturer, Shantou Wealy Medical Instrument Co. Ltd, in China, given their location. The nature of the testing (design verification, biocompatibility, etc.) suggests it would be prospective testing of newly manufactured devices.
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. This device is a physical medical instrument, not an AI/algorithm-driven diagnostic device that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/algorithm study requiring adjudication of diagnostic outputs.
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/algorithm-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI/algorithm sense. For a physical device, "ground truth" would be established by objective measurements against engineering specifications and relevant ISO/ASTM standards (e.g., fluid delivery accuracy, plunger force, needle retraction force, material biocompatibility test results). The document refers to "test results" concluding the device passed these standards.
8. The sample size for the training set
Not applicable. There is no AI/algorithm training set for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/algorithm training set for this physical device.
§ 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).