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The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature.

The Disposable Safety Lancets consists 7 parts, include a lancet cap, body, slide, lancet, tip cover, spring and bottom. The models of the Disposable Safety Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. The Disposable Safety Lancets is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The device contains a sharp injury protection feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. Used Gamma sterilization, and are products for single use.

The provided document describes a 510(k) premarket notification for "Disposable Safety Lancets" by Suzhou Kyuan Medical Apparatus Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of AI performance. Therefore, many of the requested details related to an AI-driven device's acceptance criteria and study proving its performance (e.g., MRMC studies, training set details, expert ground truth) are not applicable to this submission.

However, the document does contain information about performance testing for the mechanical and biological aspects of the lancet. I will extract the relevant information for the acceptance criteria and performance of the device itself (the lancet), not a hypothetical AI component, as well as indicating where information is not present or not applicable based on the nature of the submission.

Acceptance Criteria and Device Performance (Non-AI Device)

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing:

Sterilization and Shelf Life Testing:

• Irradiation sterilization validation: Per ISO 11173-1 and ISO 11173-3 (Pass, implied by conclusion of substantial equivalence).
• Pyrogen testing: Per USP (Pass, as listed in biocompatibility).
• Simulated shipping: Per ASTM D4169 (Pass, implied by conclusion of substantial equivalence).
• Shelf life: 5 years determined based on stability study which includes ageing test (Pass, implied by conclusion of substantial equivalence).

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

The document does not specify the exact sample sizes (number of units tested) for each of the performance or biocompatibility tests. It broadly states "The following performance data were provided in support of the substantial equivalence determination." This is common for 510(k) summaries where detailed protocols and raw data are part of the full submission but not typically presented in this summary format.

Data Provenance: Not explicitly stated beyond "non-clinical testing." It's generally assumed these tests were conducted at the manufacturer's or contracted labs (often in China, given the manufacturer's location in Suzhou, P.R.China) as part of their quality system requirements. These are laboratory tests of device properties, not clinical data from patients.

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

This is not applicable as this is a submission for a physical medical device (lancet), not an AI device that requires expert-established ground truth for image or data interpretation. The "ground truth" for the lancet specifications is based on physical measurements, mechanical properties testing, and standardized biological/chemical tests performed in a lab setting, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no human interpretation or subjective assessment that would require an adjudication method for this type of device testing.

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

This is not applicable. This is not an AI-assisted device.

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

This is not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on pre-defined engineering specifications, material properties, and standardized biological safety endpoints (e.g., a penetration force

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The product is intended to be used in a hospital or at home to obtain capillary blood samples from the fingertip for tests using small amounts of blood. The lancet is intended to be assembled with a lancing device, such that once the lancing device is launched, the needle of the lancet can prick the skin.

The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 18G; 21G; 23G; 26G; 28G; 30G; 32G; 33G. Disposable Blood Lancets are used to collect blood samples for hospital clinic test. It is sterilized by Irradiation and is a single-use product.

The provided document (K220387 510(k) summary for Disposable Blood Lancets) details acceptance criteria and the results of a study to demonstrate substantial equivalence to a predicate device, rather than a study proving significant improvement over human readers or standalone performance. The document focuses on performance testing against defined specifications for the device itself.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

In addition to these direct performance tests, biocompatibility, sterilization validation, and shelf life testing were also performed, with implied "Pass" results for substantial equivalence:

Biocompatibility Testing (Evaluated in accordance with ISO 10993-1:2018):

• Cytotoxic test (ISO 10993-5:2009)
• Skin sensitization test (ISO 10993-10:2010)
• Intracutaneous test (ISO 10993-10:2010)
• Acute systemic toxicity test (ISO 10993-11:2017)
• Hemolysis test (ISO 10993-4:2017)
• Pyrogen Test (USP )

Sterilization and Shelf Life Testing:

• Irradiation sterilization validation per ISO 11173-1 and ISO 11173-3.
• Pyrogen testing per USP .
• Simulated shipping per ASTM D4169.
• Stability study (including aging test) for a 5-year shelf life.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many lancets were tested for sharpness or appearance). It only reports "Pass" for each criterion.

The data provenance is from non-clinical testing performed by the manufacturer, Suzhou Kyuan Medical Apparatus Co., Ltd., in China. The study is a retrospective evaluation of the device's adherence to established performance and safety standards, typical for a 510(k) submission.

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

This type of information is not applicable to the provided document. The "ground truth" for this device's performance is based on objective, quantifiable engineering and biological test standards (e.g., penetration force of 1.00N, bioburden

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