Search Results

The disposable safety lancet is used for capillary blood collection. The device has an integral sharps injury prevention feature.

The Disposable Safety Lancets produced is sterile, single use, spring loaded lancets designed for capillary blood sampling. The device intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use. The device is intended to be used by professionals and lay person.

The provided FDA 510(k) summary for the Disposable Safety Lancet by SteriLance Medical (Suzhou) Inc. does not contain the acceptance criteria and study details as requested. This document primarily outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device, rather than detailing a specific performance study against defined acceptance criteria.

The sections for "Performance Data" and "Non-clinical data" briefly mention various tests conducted (Biocompatibility, Appearance, Dimensions, Needle characteristics, Safety), but they do not provide specific acceptance criteria, reported performance values, or any of the detailed study parameters requested in the prompt (e.g., sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information).

Therefore, I cannot populate the requested information from the provided text. The document states that "Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device," but it does not elaborate on the specific results of these tests in the format requested.

Ask a specific question about this device

The product is used to obtain capillary blood samples from fingertip in a home. The device contains a sharp injury protection feature.

The Disposable Safety Lancets consists 7 parts, include a trigger, plastic handle, out shell, back cover, spring, protective cap and needle. The models of the Disposable Safety Lancets are 21G; 23G; 26G; 28G; 30G. The product is used to obtain capillary blood samples from fingertip in a hospital or at home. The device contains a sharp injury feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. And once activated, the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. Used Gamma sterilization, and are products for single use.

The provided text describes the 510(k) summary for a medical device (Disposable Safety Lancets) and focuses on demonstrating substantial equivalence to a predicate device, rather than the acceptance criteria and study data for an AI/algorithm-driven device.

Therefore, most of the requested information regarding AI/algorithm performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) cannot be extracted from this document, as it pertains to a physical medical device (blood lancet) and not an AI-powered diagnostic or assistive tool.

However, I can extract the acceptance criteria and performance results for the physical device's non-clinical testing.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Testing for a Physical Device)

Information that cannot be extracted from the provided text (as it's not relevant to this type of device submission):

• Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI models.
• The sample size for the training set (for AI models).
• How the ground truth for the training set was established (for AI models).

Ask a specific question about this device

The Disposable Safety Lancet is intended for capillary blood sampling.

The Disposable Safety Lancet is intended for capillary blood sampling. The Disposable Safety Lancet include eleven models as IV, V, W2, M3, M3 PLUS, M4, M5, M5 MINI, M6, M7, E1. The models include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G. Disposable Safety Lancet are spring-loaded lancet. Disposable Safety Lancet are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle.

The provided document is a 510(k) summary for a medical device called "Disposable Safety Lancet". It describes the device, its intended use, and argues for its substantial equivalence to a predicate device based on non-clinical tests.

However, the document does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in a way that typically applies to AI/ML medical devices.

Specifically, it lacks the following information that you requested:

• A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria (e.g., sensitivity, specificity, accuracy) for diagnosis or detection, nor does it present results against such criteria. The "performance" mentioned is in the context of mechanical and biocompatibility testing.
• Sample size used for the test set and the data provenance: No test set (in the context of clinical data for AI/ML) is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to clinical assessment is discussed.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there's no clinical test set mentioned.
• 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: The device is a physical medical lancet, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a physical lancet in this context.
• The sample size for the training set: Not applicable for a physical lancet.
• How the ground truth for the training set was established: Not applicable for a physical lancet.

The "studies" mentioned in the document are non-clinical bench tests and biocompatibility evaluations, not clinical performance studies involving a test set, ground truth acquisition, or expert readers.

Here's a summary of the non-clinical tests that were performed and their conclusions:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set Sample Size: Not applicable. The document refers to non-clinical bench tests and biological evaluations, not a clinical test set with patient data for performance evaluation.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for clinical diagnostic purposes or AI model validation is not relevant for this type of device and study.

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

• Not applicable.

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:

• No. This is a physical medical device (lancet), not an AI/ML diagnostic or assistive device.

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

• No. This is a physical medical device.

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

• Not applicable in the context of AI/ML evaluation. The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., cell viability for cytotoxicity, physical measurements for mechanical tests).

8. The sample size for the training set:

• Not applicable. This is a physical medical device.

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

• Not applicable.

Ask a specific question about this device

The disposable safety lancet is used to obtain capillary blood samples. The device has an integral sharps injury prevention feature

The disposable safety lancet is sterile, single use, spring loaded and designed to draw a capillary blood sample. The device is mainly comprised of a single use needle/blade attached to a needle core by injection molding and then assembled with spring, press button, depth adjusting ring (optional) and shell parts, which also forming an integral sharps injury prevention feature. The device is used to puncture the skin to obtain a drop of blood for testing purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

Flex 3 model is the only adjustable lancet, and all other models (Press, Press Plus, Press2, Press2 Plus, Lite3) are provided at various single depths.

The device is intended to be used by professionals and individuals.

The provided text describes a 510(k) premarket notification for a medical device called "Disposable Safety Lancet". It does not describe an AI/ML device or its acceptance criteria and study. Therefore, I cannot generate the requested information based on the provided text.

Here's why the request cannot be fulfilled:

• No AI/ML Device: The document is about a "Disposable Safety Lancet," a physical medical device used for drawing capillary blood samples. It does not mention any artificial intelligence or machine learning components.
• No Acceptance Criteria for AI/ML: Since it's not an AI/ML device, there are no acceptance criteria related to its performance in tasks like image interpretation, prediction, or classification. The document outlines bench testing for physical characteristics (e.g., appearance, dimensions, needle sharpness, safety).
• No "Ground Truth," "Experts," or "Training Set": These terms are specific to the evaluation of AI/ML models. A physical medical device does not have a "ground truth" in the same sense, nor does it require experts to establish a ground truth or a training set for an algorithm.

If you intended to provide a different document describing an AI/ML medical device, please provide that text.

Ask a specific question about this device

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 <151> (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 <= 1.00N, sterility, no cytotoxicity). These are objective measurements and test results, not subjective expert consensus or clinical outcomes data in a broad sense.

8. The sample size for the training set

This is not applicable. This is not an AI device and does not involve a training set.

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

This is not applicable. This is not an AI device and does not involve a training set.

Ask a specific question about this device