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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.

The intended users include Healthcare personnel, patients and lay persons.

Model XXXVII, the safety lancets consist of needle core, button, housing, ring 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.

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droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users for capillary blood sampling.

droplet® personal lancet is made of steel needle placed inside the plastic body lancet with plastic protective cap.

The lancet remains sterile until the cap is removed. There are two versions of droplet® personal lancets which differ in the needle diameter: 28G and 30G. These two versions differ in lancet body color. The version 28G is available in pink and blue colors, and version 30G is available in violet version.

The provided FDA 510(k) Clearance Letter for droplet® personal lancets outlines the device's technical characteristics and studies performed. However, it does not contain detailed acceptance criteria tables, specific performance metrics, sample sizes, or information typically associated with AI/software-based medical devices (such as clinical study design, ground truth establishment, expert adjudication, or MRMC studies).

The document states: "Clinical data is not required." and focuses on non-clinical performance data for physical device characteristics and compatibility.

Therefore, the following response is based solely on the information available in the provided text, and will highlight what is present while explicitly stating what information is not provided as per the request.

Acceptance Criteria and Study Proving Device Meets Criteria for droplet® personal lancets

The droplet® personal lancets are mechanical medical devices (blood lancets) and as such, the acceptance criteria and study data relate to physical and functional attributes rather than diagnostic or analytical performance metrics typical of AI/software devices. The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of tests performed and states that "All tests were passed and met the predefined acceptance criteria." However, it does not provide a specific table of these "predefined acceptance criteria" or the quantitative reported performance values. It lists the categories of tests conducted.

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

The document does not specify the sample sizes used for any of the non-clinical performance tests.

• Data Provenance: The tests were conducted internally by HTL-Strefa S.A.'s quality control and presumably in their home country (Poland), as indicated by the company's address. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided. The droplet® personal lancets are physical medical devices, and their performance evaluation relies on engineering, material science, and functional testing, not expert interpretation of outputs like in AI/imaging devices. Ground truth for properties like sharpness or needle protrusion would be established via metrology and physical testing methods, not human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing consensus ground truth in clinical evaluations, particularly for subjective assessments or borderline cases, which is not relevant to the described non-clinical testing of a lancet.

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

A MRMC study was not conducted and is not applicable. This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks, typically within imaging or pathology. The droplet® personal lancets are standalone devices used for blood sampling, not for diagnostic interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm was not conducted and is not applicable. This device does not involve an algorithm. The reported non-clinical performance data represents the "standalone" performance of the physical device on its own against specified criteria.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be based on:

• Manufacturer's Predefined Product Specifications: For physical attributes like color, aesthetics, needle presence, orientation, sharpness, and length.
• Engineering/Functional Test Standards: For compatibility with lancing devices (e.g., proper fit, function, retraction).
• International Standards: For biocompatibility (ISO 10993-1) and sterilization (SAL).
• Simulated Environmental Conditions: For transport tests.

It is not based on expert consensus, pathology, or outcomes data in a clinical diagnostic sense.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product and does not involve AI/machine learning, therefore, there is no "training set."

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

This information is not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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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.

The intended users include Healthcare personnel, patients and lay persons.

Model XXXVI, the safety lancets consist of needle core, button, housing, protective cap 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.

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Disposable Blood Lancet is used for capillary blood sampling.

Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood sampling. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use. The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.

The provided document is a 510(k) summary for the SteriLance Medical (Suzhou) Inc. Disposable Blood Lancet. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

The document discusses:

• Regulatory classification: Class II, product code QRK/QRL (Blood Lancets)
• Device description: Single-use, sterile device for capillary blood sampling.
• Comparison to predicate device: Highlights similarities in intended use, sterilization, gauges, components, and materials, with a noted difference in exposed needle length for one model.
• Performance data: Mentions biocompatibility testing (cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity) and non-clinical bench testing (appearance, dimensions, sharpness, binding strength, double needles, empty needle, reverse needle, and compatibility with lancing device).

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them for an AI/ML perspective as this document describes a physical medical device (blood lancet) and not an AI/ML-driven device.

If you have a document pertaining to an AI/ML medical device, please provide it, and I will be happy to extract the relevant information.

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Heel Incision Safety Lancet is intended for capillary blood sampling from the heel of newborns, preemies and toddlers.

Heel Incision Safety Lancet is comprised of Outer cover, Press carrier and Blade holder (include the blade). The press carrier provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired after press the press carrier. The blade holder is to protect the blade from triggering before use and form a sterile barrier to maintain the blade sterile. The device was sterilized by Radiation.

The SteriLance Medical (Suzhou) Inc. Heel Incision Safety Lancet (SteriHeel 2) underwent various performance tests to demonstrate substantial equivalence to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in quantitative terms for each test. Instead, it lists the types of tests performed to verify substantial equivalence. The reported device performance is that the device verifies or demonstrates performance characteristics and compliance.

2. Sample Size and Data Provenance

The document does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "bench testing performed" for non-clinical data and "biocompatibility evaluation" without detailing the number of units tested.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. The device is a medical lancet, not an AI or diagnostic imaging device that requires expert review for establishing ground truth. The performance criteria are objective physical and biological properties.

4. Adjudication Method

This information is not applicable, as no expert adjudication was involved in establishing ground truth for the physical and biological performance tests of a medical lancet.

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

No MRMC comparative effectiveness study was mentioned or performed, as this device is a physical medical instrument, not a diagnostic AI system requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study was mentioned or performed, as the device is a physical medical instrument and does not incorporate an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established through objective physical measurements, chemical analyses, and biological assays based on recognized international standards and bench testing methods. These include:

• Physical measurements (dimensions, hardness, surface roughness, sharpness)
• Functional tests (puncture function, safety, single-use, cutting depth/width)
• Biocompatibility tests (cytotoxicity, sensitization, systemic toxicity)
• Sterility validation.

8. Sample Size for the Training Set

No training set is referenced or relevant, as this is a physical medical device and not an AI or machine learning model.

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

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

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The ImPress is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

The LetsGetChecked ImPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressed against the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.

The provided FDA 510(k) summary for the LetsGetChecked ImPress blood lancing device (K242680) outlines several non-clinical performance studies conducted to demonstrate substantial equivalence to its predicate device (TAP Lancet, K223201). However, it does not include a table of acceptance criteria and reported device performance for the usability study, nor does it provide detailed information regarding the study design elements typically found for a study proving acceptance criteria.

The information provided primarily focuses on the device's technical characteristics and the types of non-clinical tests performed. It mentions usability testing but lacks specific performance metrics or acceptance criteria for that test.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given document. While it states that "Usability Testing was performed to verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device," it does not specify the quantitative or qualitative acceptance criteria for these aspects or the actual performance results against those criteria.

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

For the Usability Testing: The document does not specify the sample size used for this test. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is not provided for the usability testing or any other test. "Ground truth" in the context of usability would typically refer to expert evaluation of user performance or validated criteria for "good" usability.

4. Adjudication method for the test set

This information is not provided.

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

An MRMC study is relevant for diagnostic imaging devices where human readers interpret results, often with AI assistance. This device is a blood lancing device, not an imaging diagnostic tool. Therefore, an MRMC study was not performed, and this question is not applicable.

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

This question is also more relevant for AI/ML-driven diagnostic or assistive devices. As the LetsGetChecked ImPress is a mechanical blood lancing device, it does not involve algorithms or AI. Therefore, a standalone algorithm-only performance study was not performed, and this question is not applicable.

7. The type of ground truth used

For the usability testing, the "ground truth" would likely be defined by a set of pre-established usability goals and criteria, as the device is mechanical and its function is to produce blood samples. The document states the usability testing aimed to "verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device." This implies a combination of:

• Performance-based criteria: Successful production of blood samples.
• Qualitative user feedback: Ease of use and user satisfaction.
• Compliance with instructions: Verification of user comprehension.

However, the specific methods for establishing these "truths" (e.g., expert observation, direct measurement, user questionnaires with pre-defined success rates) are not detailed.

8. The sample size for the training set

This question is applicable to devices involving machine learning or AI. As the ImPress is a mechanical device, there is no training set in the context of AI/ML.

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

As there is no training set (see point 8), this question is not applicable.

Summary of what is available and what is missing:

The document lists several non-clinical studies conducted (Shelf-life, Transport, Biocompatibility, Usability, Accidental Drop) and states their purpose (confirm specifications, intended use, substantial equivalence). For the Usability Testing, it broadly describes the goals (user comprehension, ability to produce samples, ease of use, satisfaction). However, it lacks the specific quantitative or qualitative acceptance criteria and the detailed results of these tests, which would directly "prove" the device meets acceptance criteria. Furthermore, details regarding sample sizes, ground truth establishment, expert involvement, and adjudication methods for the usability study are not provided in this specific FDA letter and summary.

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