(135 days)
The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
On the Go Sharps Container is designed as a single use device that holds a single contaminated sharp. The contaminated sharp is placed into the container and immediately locked using the Safe-Lock Lid. Once closed the device can not be opened thereby minimizing the risk of contamination.
This regulatory filing describes a medical device, not an AI/ML powered device, therefore the requested information for acceptance criteria and study that proves the device meets the acceptance criteria is not applicable in the context of AI/ML performance. The filing does not contain the specific information requested regarding AI/ML models or studies.
However, based on the provided text for the "On the Go Sharps Transport and Disposal with Safe-Lock™" device, here's an interpretation of the performance characteristics and the supporting study, framed to answer as much as possible from your request, acknowledging the non-AI nature:
Acceptance Criteria and Study for On the Go Sharps Transport and Disposal with Safe-Lock™ (Non-AI Device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ease of Use for General Public | Simulated use studies confirmed that people with different educational backgrounds can successfully use the On The Go Sharps Container in accordance with instructions provided. |
| Tamper-Proof After Locking | Once locked, the device cannot be opened. The contaminated sharp does not penetrate the plastic. |
| Protection Against Needle Penetration | The contaminated sharp does not penetrate the plastic, thereby providing a safe method for transporting contaminated sharps to a site for disposal. |
| Containment of Contaminated Sharps | Provides a safe method for transporting contaminated sharps to a site for disposal. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated. The description mentions "people with different educational background," implying a diverse user group for the simulated use study, but no specific number of participants is provided.
- Data Provenance: The study was a "simulated use study." The location or country of origin is not specified, but given the US FDA filing, it's reasonable to infer a US context, though this is not explicitly stated. The study was likely prospective in nature, as it involved actively testing the device with users.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This concept is not applicable here as the device is not AI-powered and thus does not rely on "ground truth" derived from expert interpretation in the way an AI model would. The "ground truth" for this device's performance would be direct observation of its physical characteristics (e.g., whether it locks, whether a sharp penetrates it) and user behavior. No experts were used to establish "ground truth" in the AI sense.
4. Adjudication Method for the Test Set
- Not applicable in the context of an AI study. The "simulated use study" would likely involve direct observation of participants' ability to use the device and direct testing of the device's physical properties. There would be no "adjudication method" in the sense of reconciling disagreements between multiple human readers or experts for an AI model.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI system on human reader performance, which is not relevant for this non-AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm study was not done. This device is a physical product and does not involve an algorithm.
7. Type of Ground Truth Used
- For this physical device, the "ground truth" is established through direct observation and empirical testing of the device's physical properties and functionalities. For instance:
- Whether the device locks once closed.
- Whether a contaminated sharp penetrates the plastic.
- Whether users can follow instructions to correctly operate the device.
- This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to AI models.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML 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 a non-AI device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).