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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 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.

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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.

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Disposable Blood Lancet is used for capillary blood collection.

Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood collection. 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 text describes the regulatory clearance of a medical device, the "Disposable Blood Lancet," and details its non-clinical testing for substantial equivalence to a predicate device. It does not involve AI or algorithms, and therefore, the requested information regarding AI-specific criteria, such as MRMC studies, training/test set details, and expert adjudication, is not applicable.

Here's an analysis based on the information provided regarding the non-AI device:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly derived from the non-clinical tests performed to demonstrate substantial equivalence to the predicate device. The "reported device performance" is the result of these tests.

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

The document does not specify the exact sample sizes used for each non-clinical performance test. It only states that "bench testing performed verifies that the performance of the proposed device is substantially equivalent." For biocompatibility, it states "biocompatibility evaluations were conducted." The provenance of the data is from non-clinical lab testing conducted by the manufacturer, SteriLance Medical (Suzhou) Inc., likely in China. The nature of these tests is retrospective in the context of the 510(k) submission, as they were completed prior to the review.

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

This question is not applicable as the device is a physical medical device, not an AI/algorithm-driven one. Ground truth is established through standardized laboratory testing and measurement procedures defined by the relevant ISO and ASTM standards. Experts in laboratory testing and quality assurance would perform and evaluate these tests, but their qualifications are not detailed beyond their adherence to the standards.

4. Adjudication method for the test set

This question is not applicable for a non-AI physical device. The testing described involves objective measurements and standardized biological evaluations.

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 question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve AI assistance or human readers in an interpretive capacity.

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

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not contain an algorithm.

7. The type of ground truth used

For the performance tests (e.g., appearance, dimensions, sharpness, binding strength, etc.), the "ground truth" is established by engineering specifications, design requirements, and applicable international standards (e.g., ISO 9626 for needle size). For biocompatibility, the ground truth is established by standardized biological evaluation methods and criteria outlined in ISO 10993 series.

8. The sample size for the training set

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve an AI training set.

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

This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve an AI training set.

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Lancing device is used with disposable blood lancet to obtain capillary blood samples.

Lancing device is used with disposable blood lancet to obtain capillary blood samples. It has multiple penetration depth levels, normally 6 or 9. Lancing device is for single patient use only.

This document describes the FDA 510(k) clearance for a lancing device (K221970). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that proves the device meets specific acceptance criteria in the context of an AI/ML-based medical device (which this lancing device is not).

Therefore, many of the requested elements for an AI/ML device study (like MRMC studies, effect sizes of AI assistance, expert adjudication for ground truth of an AI model, or sample sizes for training sets) are not applicable to this submission.

However, I can extract the relevant information regarding the performance data provided for this specific medical device (a lancing device) and present it in a similar structured format, adapting the questions where necessary.

Device: Lancing device (SteriLance Medical (Suzhou) Inc.)
FDA 510(k) Number: K221970
Predicate Device: ACON Laboratories, Inc., On call® Lancing device (K113332)

1. Acceptance Criteria and Reported Device Performance

For this medical device (a lancing device), the "acceptance criteria" are implied by the non-clinical bench testing conducted to demonstrate substantial equivalence to the predicate device. The performance data is reported as successful completion of these tests.

Note on Puncture Depth: The specific depth values for each gear setting (e.g., LDE model: 1-gear 0.60±0.30mm, 2-gear 0.90±0.30mm, etc.) serve as the specific functional performance criteria for this device, and the testing verified that these were met.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact number of units or repetitions for each non-clinical bench test (e.g., how many lancing devices were tested for bounce performance, or how many punctures were performed). It only lists the types of tests conducted.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This type of data typically comes from in-house lab testing, not patient data in the sense of AI/ML models.

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

• Applicability: Not applicable in the context of this device and testing. "Ground truth" in this context refers to engineering specifications, physical measurements, and standard biocompatibility test results, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

• Applicability: Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Test results are based on objective measurement or established lab protocols (e.g., passing ISO 10993 tests).

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

• Applicability: Not applicable. This is a physical medical device (lancing device), not an AI/ML-based diagnostic or assistive technology for human readers.

6. Standalone (Algorithm Only) Performance

• Applicability: Not applicable. This device does not contain an algorithm in the sense of AI/ML. Its performance is determined by its mechanical and material properties.

7. Type of Ground Truth Used

• Ground Truth: For biocompatibility, the ground truth is established by adherence to the FDA guidance on ISO 10993-1 and the results of standardized biological tests (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity).
• For non-clinical bench testing, the ground truth is the device's design specifications for dimensions, performance characteristics (e.g., puncture depth tolerance), and comparison to the known performance of the predicate device.

8. Sample Size for the Training Set

• Applicability: Not applicable. This device is not an AI/ML model, so there is no "training set" in the computational sense. The device is manufactured based on design specifications and then tested.

9. How Ground Truth for the Training Set Was Established

• Applicability: Not applicable. As there is no AI/ML training set, there is no corresponding ground truth establishment process required.

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Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

Heel Incision Safety Lancet is comprised of top upper cover, bottom cover, button, safety plug, slider, rod, holder, spring, blade. The spring provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired when the spring is under pressure. The safety plug is to protect the blade from triggering before use. Heel Incision Safety Lancet is single use, sterile medical devices designed to be used in collecting the blood sample. Heel Incision Safety Lancet is intended to be used by professionals. Heel Incision Safety Lancets are sterile and non-toxic. The product is intended for prescription (Rx) only.

The provided document is a 510(k) Premarket Notification for a medical device (Heel Incision Safety Lancet) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study proving a device meets acceptance criteria for an AI/ML-based medical device.

Therefore, many of the requested details regarding acceptance criteria, AI/ML study design, sample sizes, expert involvement, and ground truth establishment (especially for AI/ML models) are not applicable and not present in this document. This document describes a traditional medical device (a lancet) and its non-clinical performance testing.

However, I can extract the closest analogous information available from the document regarding acceptance criteria and performance for this non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

The document provides a "Summary of non-clinical testing" with "Items" (which can be interpreted as the performance characteristics for which acceptance was sought) and "Results" (the performance shown). While explicit "acceptance criteria" values (e.g., "must be > X N Force") are not always stated, the "Results" implicitly demonstrate acceptance where they state "No failures observed", "Meet the requirement", or "Compared with equivalent devices, there was no statistical difference."

Biocompatibility Testing:

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

• Test Set Sample Sizes: For key functional tests like "Safety self-locking," "Safety plug pullout," "Shooting performance," and "Accidental access to sharp once in safe mode," a test run of 500 devices was used, with "no failures observed." For other physical property and material tests, specific sample sizes are not explicitly stated, but are implied to be sufficient for meeting the standard/requirement (e.g., "All models have been tested within tolerances").
• Data Provenance: The tests are "bench testing" and "biocompatibility evaluations" conducted by the manufacturer, SteriLance Medical (Suzhou) Inc., based in Suzhou, Jiangsu, P.R.China. The data is prospective, generated specifically for this 510(k) submission.

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 not an AI/ML device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for this device's performance is established by direct measurement of physical properties (e.g., dimensions, forces) and standard laboratory tests (e.g., material analysis, sterility, biocompatibility).

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML ground truth establishment where human readers might disagree. For bench testing of a physical device, results are typically objective measurements or pass/fail outcomes against defined specifications.

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 as this is a physical medical device, not an AI/ML-based diagnostic or assistive technology. No MRMC study was performed.

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

This is not applicable as this is a physical medical device, not an AI/ML algorithm.

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

As explained, for this physical device, the "ground truth" for performance is established by:

• Direct physical measurements (e.g., dimensions, force values).
• Standardized analytical tests (e.g., material composition, sterility).
• Biocompatibility tests according to ISO standards.
• Pass/fail criteria based on safety and functional requirements.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.

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The Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

The proposed device, Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tubing, needle tip shield, needle base, needle base shield, sealing dialysis paper, glue and silicone oil. The needle base can be connected screwed onto the insulin pen.

The Pen Needle is offered in various gauge size and length.

The proposed device is available in radiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.

This document describes the non-clinical testing performed to demonstrate the substantial equivalence of the "Easy Drip Disposable Insulin Needle" to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each non-clinical test. However, it indicates that "nonclinical tests were conducted to verify that the proposed device met all design specifications" and that the "test results demonstrated that the proposed device complies with the following standards." The provenance of the data is not explicitly stated in terms of country of origin, nor is it classified as retrospective or prospective; these are laboratory bench tests.

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

Not applicable. These were non-clinical bench tests performed against established international standards (ISO, ASTM, USP). Expert consensus is not typically used to establish ground truth for these types of tests; rather, the ground truth is defined by the objective pass/fail criteria of the specified standards.

4. Adjudication method for the test set

Not applicable. As noted above, these were objective non-clinical bench tests against standardized criteria.

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. This document pertains to a medical device (insulin needle) and its non-clinical performance and biocompatibility, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth for the non-clinical tests was established by adherence to and compliance with relevant international and national standards, including:

• ISO 7864 (Sterile hypodermic needles for single use)
• ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)
• ISO 11608-2 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods)
• ISO 10993 series (Biological evaluation of medical devices, including parts 4, 5, 10, 11)
• ASTM F765 (Standard Practice for Assessment of Hemolytic Properties of Materials)
• USP Pyrogen Test
• USP Bacterial Endotoxins Test

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not a machine learning model, so there is no "training set."

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

Not applicable, for the same reason as above.

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