(288 days)
SUNGSHIM® Sterile single use Insulin Syringe is hypodermic insulin syringe for subcutaneous injection of U-100 insulin. (Unit scale : U-100)
SUNGSHIM® Sterile single use Insulin Syringe is a disposable, single use syringe which consists of a calibrated hollow barrel, plunger, gasket, cap and fixed needle is a fixed and the needle cap is intended to provide physical protection to the needle. The cap is color coded orange for U-100 insulin, same as equivalent insulin syringes. The SUNGSHIM Sterile single is available in 0.5ml/cc and 1ml/cc sizes in gauges 28g to 31g.
The provided document is a 510(k) premarket notification for the SUNGSHIM® Sterile Single Use Insulin Syringe. It focuses on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and performance data based on established standards. This type of document does not typically include information about acceptance criteria and studies in the way you've outlined for AI/ML-based medical devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the context of AI/ML. The acceptance criteria here are related to meeting established standards for insulin syringes and demonstrating substantial equivalence, not statistical performance metrics of an AI algorithm.
Here's why and what information can be extracted:
- No AI/ML Component: The device described is a physical insulin syringe. There is no mention of an algorithm, AI, or machine learning in its function or evaluation.
- Performance Data Type: The "Performance data" section refers to bench tests against ISO standards, particulate matter tests against USP standards, and biocompatibility tests against ISO and USP standards. These are physical, chemical, and biological tests, not statistical performance metrics of an AI.
- "Acceptance Criteria" in this context: For this device, "acceptance criteria" generally refers to meeting the specifications outlined in the referenced standards (e.g., ISO 8537:2007 for sterile single-use syringes, USP for particulate matter, ISO 10993 for biocompatibility). The document states that "The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device." This is the general "reported performance" against these implicit acceptance criteria, but specific numerical results for each criterion are not provided in this summary.
Therefore, I cannot populate the table or answer most of your specific questions because they are geared towards the evaluation of AI/ML devices, which is not what this document describes.
However, I can provide what is available regarding the "performance data" from the document:
1. A table of acceptance criteria and the reported device performance (based on the context of this physical device):
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (as stated in document) |
|---|---|
| ISO 8537:2007 (Sterile single-use syringes, with or without needle, for insulin) | "The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device." |
| USP (Particulate matter in injections) | "The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device." |
| ISO 10993-1, -4, -10, -11 & USP 39 (Biocompatibility) | "The performance tests demonstrated that SUNGSHIM® Sterile single-use Insulin Syringe is as safe, as effective and performs in a substantially equivalent manner to the predicate device." |
Regarding the other points, they are not applicable to this document as it pertains to a physical, non-AI medical device.
- Sample size used for the test set and the data provenance: Not applicable. Tests are physical/chemical/biological, not data-driven in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an insulin syringe is defined by engineering specifications and direct measurements against standards, not expert consensus on data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI sense. Ground truth is defined by specified physical/chemical/biological parameters in the standards.
- The sample size for the training set: Not applicable (no training set for a physical device).
- How the ground truth for the training set was established: Not applicable.
§ 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).