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Lancet is intended to be used to obtain capillary blood sample for self-monitoring of blood glucose.

Lancing Device is used with lancets to draw a capillary blood sample for testing, utilizing small amounts of blood. The Lancing Device is intended for use by a single patient and should not be shared.

Lance Device have two parts, lancet and lancing device. Lancet is composed of a lancet body, a needle and a protective cap. Lancing device is mainly composed of depth adjustment tip, cap, release button, shield, rear sliding barrel and an ejector. The cover consists of inner cover, cap inner core, rear sliding barrel, inner core, buckle ring and two springs, with 12 depth adjustment gears.

The lancet is provided as sterile state and have four model: Model BYY3, Model BYY4, Model BYB and Model BYC. The lancet body of Model BYY3 and Model BYY4 is circular, and the lancet body of Model BYB and Model BYC is flat. The lancing device is provided as non-sterile state and a reusable medical device for use only on a single patient and have four model: Model CX11B1, Model CX11B2, Model CX11C1 and Model CX11C2. Model CX11 Lancing device is divided into CX11B (threaded connection) and CX11C (buckle connection) according to the different connection structures of the cap and body of the lancing device. Model CX11B is divided into CX11B1 (suitable for round lancet) and CX11B2 (suitable for flat lancet) according to the different structure of the lancet. Model CX11C is divided into CX11C1(suitable for round lancet) and CX11C2(suitable for flat lancet) according to the different structures of the lancet.

The lancet is sterilized by Gamma ray and for single use,the shelf life is 5 years. The lancing device is provided as non-sterile state,for use only on a single patient. The useful life is 5 years or 6000 times.

This document primarily outlines the premarket notification (510(k)) for a Lancing System, focusing on demonstrating its substantial equivalence to a predicate device based on bench testing and biocompatibility assessments. It does not present a study with specific acceptance criteria and reported performance data for a standalone or human-in-the-loop AI/ML device.

The document describes a medical device (Lancing System) used for obtaining capillary blood samples, not an AI/ML-driven diagnostic or assistive system. Therefore, the questions related to AI/ML specific performance, such as MRMC studies, standalone algorithm performance, expert ground truth establishment for test sets, and training set details, are not applicable to the information provided in this 510(k) summary.

The "Performance testing summary" section (8.0 onwards) details bench testing and biocompatibility testing conducted to demonstrate the safety and effectiveness of the physical Lancing System, but these are not related to AI/ML performance.

To address the prompt as much as possible given the provided text, I will describe the performance testing as presented for this physical medical device, acknowledging that it does not fit the AI/ML framework implied by many of the prompt's questions.

Acceptance Criteria and Study for the Lancing System (Physical Device)

This 510(k) submission for the Lancing System primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments, rather than evaluating an AI/ML-driven system. Therefore, the concepts of "acceptance criteria" and "reported device performance" are discussed in the context of the physical device's mechanical and biological properties, not AI/ML precision, recall, or reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical medical device, specific numerical acceptance criteria and precise reported performance values are typically detailed in the full test reports, which are summarized here. The summary provides a list of tests conducted and a general statement that the device meets requirements or the tests show "well" performance.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify exact sample sizes for each bench test. For physical device testing, sample sizes are typically determined by relevant ISO standards (e.g., for sterility, dimensions, mechanical function) and internal quality control procedures.
• Data Provenance: The document does not explicitly state the country of origin for the data collection, but the manufacturing company is "Ningbo Medsun Medical Co., Ltd." in "Ningbo, P.R.China," implying that the testing was likely conducted in China or by labs contracted within the region. The tests are presented as being conducted in support of the 510(k) submission, implying a prospective testing approach designed for regulatory clearance.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This pertains to AI/ML ground truth establishment. For a physical medical device, "ground truth" refers to the objective measurement against established standards (e.g., dimension measurements, force measurements, sterility cultures) rather than subjective expert consensus on image interpretation. Expert involvement would be in defining the standards, designing the tests, and interpreting the raw data, but not in establishing a "ground truth" derived from human interpretation.

4. Adjudication Method for the Test Set

• Not Applicable: This pertains to AI/ML test set ground truth. For physical device performance, adjudication is typically through statistical analysis of quantitative measurements against pre-defined acceptance limits, or pass/fail criteria for qualitative tests, not through expert consensus adjudication.

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

• Not Applicable: This concept is relevant for AI/ML systems that directly assist human readers (e.g., radiologists interpreting images). This submission is for a physical medical device (lancing system) and does not involve AI assistance for human tasks that would necessitate an MRMC study.

6. Standalone (Algorithm Only) Performance

• Not Applicable: This applies to AI/ML algorithms. The Lancing System is a physical device, and there is no standalone algorithm performance to evaluate.

7. Type of Ground Truth Used

• Objective Measurements/Standards: For this physical device, the "ground truth" is established by:
  • Referenced ISO Standards: The document repeatedly mentions adherence to ISO standards (e.g., ISO 10993 series for biocompatibility, ISO 23908:2011 for sharps injury protection, ISO 9626:2016 for needle gauges). These standards define the acceptable performance characteristics and test methods.
  • Engineering Specifications: Device dimensions, puncture force, and mechanical functions are measured against design specifications.
  • Laboratory Assay Results: Biocompatibility tests yield objective results (e.g., cell viability, presence of pyrogens) against established acceptable ranges.
  • Qualitative Assessments: Appearance and functional tests are performed against defined visual and operational criteria.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

• Not Applicable: As there is no AI/ML training set, this question is not relevant.

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"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"

The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

"Sterile Lancet for Single Use" is a single use device indicated for capillary blood sampling. It can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.

"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"

"Sterile Lancet for Single Use" is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals in hospital settings or patients at home.

"Sterile Lancet for Single Use" is a disposable blood lancet intended for a single use that is comprised of a cap, a single use blade attached to a solid, non-reusable base, and it is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The needle is protected with a cap before use. The steel needle is made of stainless steel SUS304. The needle cap and needle base are made of polyethylene plastic, and are injection molded. The Sterile Lancet for Single Use is sterilized by gamma irradiation.

"Sterile Lancet for Single Use" can be used alone in either home or healthcare settings, or be used together with "Lancing Device" in home settings.

Based on different design and shape, there are three different types of "Sterile Lancet for Single Use", and also can accommodate different needle gauges.

"Lancing Device" is a multiple use, sterile, medical devices designed to be used in collecting the blood sample. The products can be used by patients and lay persons. Thev are not intended for healthcare workers because the device can not be used among different patients.

Lancing Device is a multiple use capillary blood lancet intended for use on a single patient. Before each use, a single use lancet is attached to the reusable case, and when launched, is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

After use, the single use blade ("Sterile Lancet for Single Use") is disposed of, and the lancing device is cleaned and disinfected, ready for the next use.

The lancing device has five adjustable gears (marked 1 to 5) that allow for different puncture depth.

Lancing Device is made of a needle base, spring, a launching part, return spring, launch button, a casing, and a cap. The needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components.

The provided document is a 510(k) summary for a medical device (lancing system) seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and performance data.

However, the request asks for details related to a study proving the device meets acceptance criteria specific to AI/Machine Learning models, including expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training and test sets.

The provided document does not contain any information about an AI/Machine Learning model. The device described is a physical lancing system for blood collection. Therefore, the requested information regarding AI/ML specific acceptance criteria and study designs (like MRMC, human-in-the-loop, or training/test set ground truth for AI) is not applicable to this submission.

The document discusses non-clinical performance testing (physical, chemical, mechanical properties, packaging integrity, sterilization validation) and biocompatibility testing, which are standard for physical medical devices. It explicitly states: "No clinical study is included in this submission." This further confirms the absence of any data related to AI/ML performance evaluation as specified in your prompt.

Therefore, I cannot populate the table or answer the specific questions about AI/ML model acceptance criteria and study design based on the provided text.

However, I can extract the information that is relevant to the device's acceptance testing as described in the document:

Acceptance Criteria and Device Performance (as per the provided 510(k) Summary for a Lancing System):

Since this is a physical medical device (lancing system) and not an AI/ML model, the "acceptance criteria" and "device performance" relate to physical, chemical, and mechanical properties, not AI metrics like sensitivity, specificity, or AUC. The document states "All tests were verified to meet acceptance criteria" without listing the specific numeric criteria or results for each test.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/ML specific questions (2-9), the document explicitly states information that makes them not applicable: "No clinical study is included in this submission." and the device is not an AI/ML product.

However, to address the prompt for completeness based on the absence of AI/ML, I will state "Not Applicable" for these points.

2. Sample sized used for the test set and the data provenance: Not Applicable (No AI/ML model, tests are bench testing on physical units)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (No AI/ML model; ground truth for physical device testing is based on engineering specifications and laboratory measurements)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable (No AI/ML model; testing is primarily objective bench 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: Not Applicable (No AI/ML model)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable (No AI/ML model)

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the physical device, ground truth for performance is established by engineering specifications, relevant ISO standards, and established laboratory measurement techniques.

8. The sample size for the training set: Not Applicable (No AI/ML model)

9. How the ground truth for the training set was established: Not Applicable (No AI/ML model)

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