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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

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.

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The Timex AccuCurve ™ Talking 30 Second Thermometer is an electronic thermometer to measure patient body temperature orally. Timex AccuCurve ™ Talking 30 Second Thermometer is intended for professional and over-the-counter use.

Electronic Thermometer

The provided text is a 510(k) summary for the Timex AccuCurve™ Talking 30 Second Thermometer. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data that would demonstrate the device explicitly meets those criteria.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states these are "Performance Characteristics" but does not explicitly label them as "acceptance criteria" nor does it provide a study report detailing how the device's performance was measured against these characteristics. It only lists what the device is designed to do.

2. Sample size used for the test set and the data provenance

• Sample size: Not mentioned.
• Data provenance: Not mentioned. The document only references substantial equivalence to another device and lists performance characteristics, not actual test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. The device is a thermometer, and its accuracy would typically be verified against known temperature standards or highly accurate reference thermometers, not expert opinions.

4. Adjudication method for the test set

• Not applicable and not provided, as ground truth is not established by expert consensus for this type of device.

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 device is an electronic thermometer, not an AI-assisted diagnostic tool that requires human reader studies.

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

• Not explicitly stated, but the "Performance Characteristics" section describes the device's inherent capabilities, which implies standalone performance. However, there is no detailed study report provided.

7. The type of ground truth used

• The document implies that the ground truth for evaluating temperature accuracy would be a known temperature standard or a highly accurate reference thermometer. This is inferred from the nature of the device (a thermometer) and the specified accuracy (±0.2°F). However, the document does not explicitly state the methodology for establishing ground truth during testing.

8. The sample size for the training set

• Not applicable. This device is a traditional electronic thermometer, not a machine learning or AI-based device that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

Overall Conclusion based on the provided text:

The 510(k) summary provided describes the device's intended performance characteristics and asserts its substantial equivalence to a predicate device. However, it does not include the detailed study reports or data that would explicitly demonstrate how these characteristics were tested and met in a formal study. The FDA's letter simply acknowledges the 510(k) submission and determines substantial equivalence based on the information provided by the applicant, but it does not reproduce the full study details within this summary document. For a complete understanding of how these performance criteria were met, one would typically need to review the full 510(k) submission, which contains the detailed testing information.

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The Timex ACCU-CURVE and Traditional Digital Oral Thermometers are electronic thermometers to measure patient temperature orally. Targeted users include professional and over-the-counter users.

Timex ACCU-CURVE Digital Oral Thermometer, Timex Oral Digital Thermometer

The provided document is a 510(k) clearance letter for the Timex ACCU-CURVE Digital Oral Thermometer and Timex Oral Digital Thermometer. It confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain information regarding detailed acceptance criteria or a study proving that the device meets specific performance criteria. The letter acknowledges a "Section 510(k) premarket notification" which would typically include such study information, but the study details themselves are not present in the provided text.

Therefore, I cannot extract the requested information from this document. To fulfill your request, I would need access to the actual 510(k) submission document that details the performance studies conducted for these thermometers.

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