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The safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample. Model XXXV, the safety lancets consist of needle core, button, housing and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Safety Lancet (Model XXXV).

The document is a 510(k) summary for a medical device called "Safety Lancet (Model XXXV)" submitted to the FDA. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a predicate device already legally marketed in the US. This type of submission generally relies on non-clinical testing rather than extensive clinical trials for devices like lancets.

Acceptance Criteria and Reported Device Performance

• In Vitro Cytotoxicity: No Cytotoxicity (ISO 10993-5: 2009)
• Skin Sensitization: No Skin sensitization (ISO 10993-10: 2010)
• Intracutaneous Reactivity: No irritation (ISO 10993-10: 2010)
• Acute Systemic Toxicity: No Acute Systemic Toxicity (ISO 10993-11: 2017)
• Pyrogenicity: No thermogenic reaction (ISO 10993-11: 2017) |
  | Sterilization Method & SAL | Sterilized by Radiation, SAL = 10^-6. Same as predicate. |
  | Shelf-life | 5 years. Same as predicate. |
  | Reuse Durability | Single use. Same as predicate. |
  | Label/Labeling | Complied with 21 CFR part 801. Same as predicate. |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Bench Testing: The document does not specify a separate "test set" sample size for the core performance criteria (launch, puncture force, lubricant, disposable, safety feature) beyond indicating that these tests were performed and met requirements.
   • Biocompatibility Testing: Not specified for individual tests.
   • Simulated Clinical Use Study: 300 device samples were used.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission from a Chinese manufacturer (Tianjin Huahong Technology Co., Ltd.) to the US FDA, the testing was likely conducted in accordance with international standards to satisfy US regulatory requirements.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

   • This information is not provided. For device performance testing of this nature (bench tests for physical characteristics and biocompatibility), "experts" in the sense of clinical decision-makers establishing ground truth for disease states are typically not involved. The "ground truth" is established by predefined engineering specifications, regulatory standards (e.g., ISO, FDA guidance), and objective measurements.

3. Adjudication Method for the Test Set:

   • Not applicable as the testing involves objective measurements against pre-defined engineering and regulatory standards rather than subjective human interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-assisted diagnostic devices where human readers provide interpretations. This device is a simple mechanical blood sampling device.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device is a mechanical medical device, not an algorithm or AI product.

6. Type of Ground Truth Used:

   • Bench Testing: Engineering specifications, objective measurements, and compliance with general safety and performance requirements (e.g., smooth operation, proper safety mechanism function).
   • Biocompatibility Testing: Results of standardized in-vitro and in-vivo tests according to ISO 10993 series standards, demonstrating absence of cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity.
   • Simulated Clinical Use: Pre-established criteria defined by FDA Guidance and ISO 23908 for evaluating the safety mechanism of sharps injury prevention features.

7. Sample Size for the Training Set:

   • Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the same reason as above.

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