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The PLANCET blood lancet is a puncture device to obtain micro-litre capillary whole blood samples from finger tips or palm or alternate body sites. The PLANCET blood lancet is normally loaded in a spring-operated lancing device for rapid puncture of skin.

The PLANCET blood lancet is a needle device to be loaded in a spring operated lancing device for pricking a patient's finger or palm to draw a micro-litre sample of whole blood to perform in-vitro diagnostic (IVD) blood tests. The PLANCET has a needle that is encapsulated by a plastic material that forms a body and a cap. This plastic encapsulation ensures the needle's integrity and sterility till point of use. The needle is made of a high performance and bio-compatible plastic material. The procedure to use PLANCET is to pull off the cap and to load PLANCET into a spring operated lancing device. Once triggered, the PLANCET will be actuated and retracted rapidly to penetrate the skin and create a small wound for getting some capillary whole blood.

Here's an analysis of the PLANCET Blood Lancet's acceptance criteria and studies, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it describes performance deemed "comparable" to the predicate device.

2. Sample Sizes and Data Provenance

• Test Set (Focus Group Survey):

  • Sample Size: 18 people.
  • Data Provenance: Not explicitly stated, but it was a "focus group" and "blind study" involving actual use, implying prospective data collection in a controlled environment. The country of origin is not specified, but the manufacturer is based in Singapore, suggesting it might be local data.

• Test Set (Bench Tests):

  • Sample Size: Not explicitly stated for the "series of penetration tests." It mentions "PLANCET blood lancets" in plural, implying multiple devices were tested, but no specific number is given.
  • Data Provenance: Retrospective (bench testing/laboratory evaluation). Country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Focus Group Survey: No experts were directly used to establish ground truth in the traditional sense for pain level or blood volume. The participants themselves reported pain levels, and "sufficient blood" was likely determined by whether a glucose test could be successfully performed.
• Bench Tests: No experts were explicitly mentioned for the bench tests. The assessment of needle damage was likely based on objective inspection (e.g., under magnification).

4. Adjudication Method for the Test Set

• Focus Group Survey: Not applicable in the context of expert adjudication. The study was a "blind study" comparing the new device to a predicate device, with participants reporting on their experience.
• Bench Tests: No adjudication method described; assessment was objective inspection.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The focus group study involved human users comparing the device to a predicate, not human readers interpreting data with and without AI assistance. This device is a physical medical instrument (a lancet), not an AI-driven image analysis or diagnostic tool. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone (Algorithm Only) Performance

Not applicable. The PLANCET Blood Lancet is a physical device, not an algorithm.

7. Type of Ground Truth Used

• Focus Group Survey:
  • Pain Level: Subjective self-reporting by participants.
  • Blood Volume: Functional assessment – whether sufficient blood was obtained for a glucose test (implied clinical utility).
  • Needle Intactness: Visual inspection under magnification.
• Bench Tests: Objective physical assessment of needle integrity and penetration capability.

8. Sample Size for the Training Set

Not applicable. This device is a physical lancet, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device like this.

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