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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.

N/A

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Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Safety Lancet could be divided into Model XA Pro and Model ZF.Each model has sharps protection features that it can reduce the occurrence of accidental needle sticks. The device is sterilized by Co-60 or e-beam gamma ray and for single use.The shelf life is 5 years. Model XA Pro has four versions according to the different three penetration depths, version XA1 Pro,version XA3 Pro,version XA5 Pro and version XA11 Pro. Model ZF also has four versions according to the different need type and material of slider, version ZF1,version ZF2,version ZF1 Blade and version ZF2 Blade.

Model XA Pro is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.There is an integrated automatic inactivation system to prevent lancet reuse. When the back cover is pressed down, it drives the rear spring to compress downwards. The back cover support legs are flush with the inclined surface of the protruding line head of the housing. The needle is rotated and slided downwards under the force of the rear spring until it is disengaged from the inclined surface and fired forward for blood sampling, while compressing the front spring. The needle will be retracted automatically back into the housing after the puncture due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.

Model ZF lancet is composed of spring, three-facet needle or blade, housing, and slider. The needle body with needle or blade is concealed within housing/slider. The lancets of different specifications are in different colors. There is an integrated automatic inactivation system to prevent lancet reuse. The spring is fixed at the bottom of the housing, and when the slider is pressed down, which drives the spring to compress downwards.The two locking points(blocked the needle) on the slider will be opened along the slope of the housing, the needle will be released to fire under the force of the spring for blood sampling. After the puncture is completed, the spring retracts to a relaxed state and synchronously pulls the needle body back into the housing. Therefore, the device cannot be re-used.

The provided document is a 510(k) summary for a "Safety Lancet" (K242627). It details the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device (K222090).

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 individual test within the "Performance Test" section. It broadly states that "All non-clinical bench testing performed on the subject device is to demonstrate the substantial equivalence to the predicate devices."

For the "Performance of Clinical Simulated Use Testing for Sharps Injury Protection," it states: "Select the most widely sold in the market of each model as typical product for study." This suggests a limited sample size focused on representative models, but the exact number isn't provided.

The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective. Given the manufacturer is Ningbo Medsun Medical Co., Ltd. in China, it's highly likely the testing was conducted in China. The "non-clinical bench testing" and "clinical simulated use testing" imply a prospective testing approach dedicated to this submission.

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

The document does not involve expert-established ground truth in the traditional sense for diagnostic AI/software. The testing described is for a physical medical device (safety lancet) and focuses on engineering and performance criteria. The "ground truth" for the performance tests would be objective measurements and observations against pre-defined engineering and safety standards. No human expert consensus for a diagnostic outcome is relevant here.

4. Adjudication method for the test set

Not applicable. This is not a diagnostic study requiring human adjudication for interpretation. The performance tests involve objective physical and chemical measurements.

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 is a submission for a physical medical device (safety lancet), not an AI-powered diagnostic tool, and therefore an MRMC study is not relevant.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

The ground truth used for these tests are the pre-defined technical specifications, engineering requirements, and safety standards (e.g., ISO 23908:2011, ISO 10993 series, and 21 CFR 801). The "Passed" results indicate that the device met these objective criteria.

8. The sample size for the training set

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

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

Not applicable. There is no training set for a physical safety lancet.

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Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years. Product Structure of the Safety Lancet are summarized in the table below: Model XY is composed of a protective cap, slider, front spring, housing, needle body with a tri-bevel edge needle or blade, a rear spring, and a back cover. The needle body is hidden inside the housing/slider, and the housing is color-coded for different versions. Model XH is composed of a protective cap, front spring, housing, needle body, rear spring, and back cover. Model XA is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions. There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.

The provided text describes a 510(k) submission for a Safety Lancet, demonstrating its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, detailed study results, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, or MRMC study information that you requested.

The document states that the device meets certain performance criteria through "non-clinical bench testing" and adherence to ISO standards, but it only lists the types of tests performed, not the quantitative acceptance criteria or the specific results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Details: The document only states that these tests were "verified" or "meet requirements." It does not provide specific quantitative acceptance criteria for each test (e.g., what is the acceptable range for penetrating force, or the specific dimensions) nor does it provide the numerical results for the device's performance against these criteria. It simply generally affirms that the design was "verified."

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

• Sample Size for Test Set: Not specified. The document only mentions "non-clinical bench testing."
• Data Provenance: Not specified. It's implied this testing was conducted by the manufacturer, Ningbo Medsun Medical Co., Ltd., in China, as part of their design control process. The data is likely retrospective in the sense that it was collected during product development/verification prior to this submission.

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

• Number of Experts: Not applicable. This is a non-clinical device (Safety Lancet), not an AI/software device that typically requires expert-established ground truth for performance evaluation in a clinical context. The "ground truth" here is adherence to engineering specifications and international standards.
• Qualifications of Experts: N/A for the reasons above.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This is a non-clinical device. The verification is based on objective measurements against defined specifications and standards, not subjective expert judgment.

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

• MRMC Study: No. This is a physical medical device (Safety Lancet), not an AI-powered diagnostic or assistive tool.

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

• Standalone Performance: Not applicable. This device does not involve an algorithm.

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

• Type of Ground Truth: The "ground truth" for this device's performance primarily relies on engineering specifications, direct physical measurements, and adherence to established international standards (e.g., ISO 9626, ISO 7864, ISO 10993 series).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable. No training set is used.

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

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Safety Lancet (Model XXXV).

The document is a 510(k) summary for a medical device called "Safety Lancet (Model XXXV)" submitted to the FDA. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a predicate device already legally marketed in the US. This type of submission generally relies on non-clinical testing rather than extensive clinical trials for devices like lancets.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Bench Testing: The document does not specify a separate "test set" sample size for the core performance criteria (launch, puncture force, lubricant, disposable, safety feature) beyond indicating that these tests were performed and met requirements.
   • Biocompatibility Testing: Not specified for individual tests.
   • Simulated Clinical Use Study: 300 device samples were used.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission from a Chinese manufacturer (Tianjin Huahong Technology Co., Ltd.) to the US FDA, the testing was likely conducted in accordance with international standards to satisfy US regulatory requirements.

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

   • This information is not provided. For device performance testing of this nature (bench tests for physical characteristics and biocompatibility), "experts" in the sense of clinical decision-makers establishing ground truth for disease states are typically not involved. The "ground truth" is established by predefined engineering specifications, regulatory standards (e.g., ISO, FDA guidance), and objective measurements.

3. Adjudication Method for the Test Set:

   • Not applicable as the testing involves objective measurements against pre-defined engineering and regulatory standards rather than subjective human interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-assisted diagnostic devices where human readers provide interpretations. This device is a simple mechanical blood sampling device.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device is a mechanical medical device, not an algorithm or AI product.

6. Type of Ground Truth Used:

   • Bench Testing: Engineering specifications, objective measurements, and compliance with general safety and performance requirements (e.g., smooth operation, proper safety mechanism function).
   • Biocompatibility Testing: Results of standardized in-vitro and in-vivo tests according to ISO 10993 series standards, demonstrating absence of cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity.
   • Simulated Clinical Use: Pre-established criteria defined by FDA Guidance and ISO 23908 for evaluating the safety mechanism of sharps injury prevention features.

7. Sample Size for the Training Set:

   • Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the same reason as above.

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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.
According to surface difference or structure, the Safety lancets have 7 models: XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.
XXIX, XXX model have sub model according to surface difference.
For Model XXVIII and XXX, the safety lancets consist of needle core, button, housing and spring. For Model XXIX, the safety lancets consist of needle core, button, housing, spring, and Depth adjuster ring. For Model XXXI, the safety lancets consist of needle core, top cover, bottom and spring. For Model XXXII, the safety lancets consist of needle core, top cover, bottom, small lid and spring. For Model XXXIII, the safety lancets consist of needle core, button, housing, inner sleeve and spring. And for Model XXXIV, the safety lancets consist of needle core, button, housing, bottom, 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.

This document is a 510(k) summary for a medical device called "Safety Lancet," and it does not contain information about an AI/ML powered device. The information provided is for a physical medical device (safety lancets) used for capillary blood sampling. Therefore, many of the requested fields related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, training set details, and expert ground truth establishment for AI) are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this physical device.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Simulated Clinical Use Study: 300 device samples each for the Safety Lancet (various models).
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective/prospective). This was a bench test and simulated use study, not a human data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for this physical device was based on objective physical measurements and established biological safety standards from ISO 10993 and FDA guidance, not expert interpretation of data.

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

Not applicable. This was a non-clinical bench and simulated use study, not a study requiring adjudication of expert opinions.

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 is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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

For bench testing: Objective physical measurements and adherence to functional specifications.
For biocompatibility testing: Laboratory results following ISO 10993 standards.
For simulated clinical use: Evaluation of the safety mechanism against pre-established criteria defined by FDA Guidance (Medical Device with Sharps Injury Prevention Feature) and ISO 23908.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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The safety lancet is intended for capillary blood sampling.

The safety lancet consists of needle core, protective cap, plug, trigger, spring, outer case and end cap. 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. The safety lancet is intended for capillary blood sampling. The device was designed to minimize the risk from accidental needle sticks with a used needle by application of a sharp injury prevention feature. The needle tip back into the safety lancet body automatically after launch and cannot be reused. The safety lancet can be disposed safely.

This document is a 510(k) summary for a "Safety Lancet" (K223208). It aims to demonstrate substantial equivalence to a predicate device (Tianjin Huahong Safety Lancet – K220370).

Here's an analysis of the acceptance criteria and study information provided and what's missing, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a single table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might expect for a diagnostic or AI device. Instead, it discusses various performance tests and compliance with standards. The "acceptance criteria" are implied by the standards and internal requirements, and "reported device performance" is summarized as meeting these requirements.

Here's a best effort to extract and present this information based on the provided text, recognizing that specific numerical results or direct comparisons to predicate device values (beyond "same" or "similar") are often not included in 510(k) summaries unless there's a significant difference to justify.

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

• Test Set Description: The document refers to "non-clinical testing results" primarily for physical performance, sterility, shelf-life, and biocompatibility. Additionally, a "simulated clinical use study" was conducted.
• Sample Size for Simulated Clinical Use Study: 500 device samples.
• Data Provenance for Simulated Clinical Use Study: Not explicitly stated, but it's a "simulated clinical use study," implying it wasn't conducted on actual patients. The company is based in China, so it's likely conducted there. It is a prospective study in the sense that the testing was performed on new samples according to a protocol.
• Other Testing Sample Sizes: For other physical, sterility, and biocompatibility tests, specific sample sizes are not provided in this summary, but implied by adherence to the referenced ISO and ASTM standards.

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

This information is not provided in the document. For a medical device like a safety lancet, "ground truth" (as typically thought of in AI/diagnostic studies) isn't directly applicable in the same way. The "truth" is established by adherence to engineering standards and safety requirements (e.g., "is the needle exposed after drop test?"). The "experts" would be the engineers, quality control personnel, and lab technicians conducting the tests and interpreting results against the objective standards. Their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (physical, sterility, biocompatibility), results are typically objective measurements against a standard, rather than subjective interpretations requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a mechanical safety lancet and does not involve AI or "human readers" in the context of interpretation of diagnostic images or data.

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

No, a standalone algorithm performance study was not done. This device is a mechanical safety lancet and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Adherence to recognized international and national standards: ISO standards (e.g., for needle tubing, sterility, biocompatibility), ASTM standards (e.g., for packaging), and USP standards (e.g., for sterility, endotoxins).
• Manufacturer's internal requirements: For specific features like cap removal force (3-9 N).
• FDA Guidance Documents: Particularly for sharps injury prevention features.
• Objective measurements and observations: Such as force measurements, visual inspections after drop tests, biological test results (e.g., "no cytotoxicity").

Essentially, the ground truth is defined by the fulfillment of these established safety and performance benchmarks.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device 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 information is not applicable and therefore not provided. As above, there is no "training set" for a physical medical device.

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Safety-Lancets with safety feature are used for single use capillary blood sampling.

The Safety Lancet consists of the following components: colorless plastic body, needle holder with needle or blade shaped lancing device, protective cap, carrier device, two springs, and the release button. The release button, the needle holder, and the protective cap are colored according to the variant available. The lancets are offered with different needle or blade shaped lancing devices, different sharpening and penetration depths, and accordingly in different colors. The lancets contain a safety feature. After puncture the needle retracts automatically into the housing to prevent sharps injuries.

The provided text describes the 510(k) submission for a Safety Lancet, and while it covers non-clinical testing, it does not include information about a study that assesses AI performance. The document focuses on the substantial equivalence of the new Safety Lancet to a predicate device, primarily through bench tests verifying physical and functional aspects.

Therefore, I cannot extract the detailed information requested regarding AI acceptance criteria and study performance from this document. The questions about AI performance, test set characteristics, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable to this Safety Lancet submission.

The document describes non-clinical testing for a medical device (a lancet), not a software or AI-driven diagnostic tool.

However, I can provide the acceptance criteria and reported device performance from the provided text as it relates to the physical device:

1. A table of acceptance criteria and the reported device performance (for the physical device):

Since the provided document is a 510(k) clearance for a physical medical device (Safety Lancet) and not an AI/software product, the following points are not applicable and cannot be answered from the provided text:

2. Sample sized used for the test set and 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
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years.

The provided document is a 510(k) summary for the "Safety Lancet" device, which makes an equivalence claim to previously cleared predicate devices. Since this is an equivalence claim, the studies described are primarily non-clinical bench testing to demonstrate that the subject device performs as safely and effectively as the predicate devices. It does not contain information about clinical studies with human participants.

Therefore, many of the requested fields related to clinical efficacy studies, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to the information provided in this 510(k) summary. These types of studies are typically conducted for new technologies or to demonstrate clinical efficacy, which is not the primary purpose of a 510(k) submission based on substantial equivalence.

Here's the information extracted from the document based on the request:

1. Table of acceptance criteria and the reported device performance:

The document lists performance tests conducted but does not explicitly state "acceptance criteria" and "reported device performance" in a direct side-by-side format with quantitative measures for each criterion. Instead, it states that the performance data were "provided in support of the substantial equivalence determination" and that "The test results show that the product had well sharps injury prevention feature." This implies that the device met the internal (or external standard-based) acceptance criteria for each test.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is typically provided in detailed test reports, not in a 510(k) summary. The document does not specify exact sample sizes for each bench test. The studies were non-clinical bench tests. The country of origin for the studies is not explicitly stated, but the manufacturer is Ningbo Medsun Medical Co., Ltd. in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this was a non-clinical bench study for a physical medical device (safety lancet), not an AI/software device requiring expert interpretation for ground truth.

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

Not applicable, as this was a non-clinical bench study.

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, as this was a non-clinical bench study for a physical medical device.

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

Not applicable, as this was a non-clinical bench study for a physical medical 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 established engineering standards (e.g., ISO, internal specifications) for mechanical function, material properties, sterility, and biocompatibility. For example, ISO 9626:2016 for needle dimensions or ISO 10993 series for biocompatibility.

8. The sample size for the training set

Not applicable, as this was a non-clinical bench study for a physical medical device, not an AI/software device that requires a training set.

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

Not applicable, as this was a non-clinical bench study for a physical medical device.

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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. According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference. For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid 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° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

The provided text describes the 510(k) summary for a Safety Lancet device, specifically K220370. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and simulated clinical use. It is a regulatory submission for a medical device rather than a report detailing a clinical trial or an AI/software as a medical device (SaMD) study. Therefore, many of the requested details, such as the use of AI, human reader studies, and sophisticated ground truth establishment, are not applicable to this type of device submission.

However, I can extract the relevant information from the provided text regarding acceptance criteria and the studies performed for this specific medical device.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

Here's a table summarizing the acceptance criteria and reported device performance based on the "Non-Clinical Testing" section:

Summary of Device Performance Study Information:

The provided document describes physical and biological tests for a medical device (Safety Lancet), not an AI/Software as a Medical Device (SaMD). Therefore, many of the questions related to AI performance, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI models are not applicable.

Here's the information that is extractable from the provided text:

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

   • Simulated Clinical Use: 500 device samples were used for the simulated clinical use study.
   • Non-Clinical Testing: The sample sizes for the individual bench tests (e.g., appearance, dimension, firmness) are not explicitly stated, but it's implied that sufficient samples were tested to "Meet the requirement."
   • Data Provenance: Not specified in terms of country of origin. The studies are described as "bench testing" and "simulated clinical use," implying lab-based testing rather than clinical patient data. The document is a 510(k) submission to the FDA, from a company in Tianjin, China.

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

   • Not applicable in the context of this device's testing. Ground truth for physical characteristics (e.g., dimensions, corrosion) is established by measurement against predefined specifications, not by expert consensus in this specific case.
   • For biocompatibility testing, compliance with ISO 10993 series standards is the "ground truth," evaluated by laboratory tests performed by qualified personnel, but not "experts" in the sense of radiologists.

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

   • Not applicable as this is not a study requiring adjudication of interpretations (e.g., imaging reads). The tests are objective measurements or categorical observations (e.g., "no burr," "no corrosion").

4. 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 (Safety Lancet), not an AI/software. Therefore, no MRMC study with human readers was conducted or is applicable.

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

   • Not applicable. This is not an algorithm or AI device. The testing described is for the physical performance and safety features of the lancet itself.

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

   • For Non-Clinical Testing (bench tests): The ground truth is based on engineering specifications, industry standards (e.g., ISO 9626 Annex A for pH, specific limits for extractable metals), and established physical or visual inspection criteria (e.g., "free of burr," "no dust," "no evidence of corrosion").
   • For Biocompatibility Testing: Ground truth is established by adherence to and passing results from tests specified in ISO 10993 series standards (e.g., "No Cytotoxicity," "No Skin Sensitization").
   • For Simulated Clinical Use: The ground truth is whether the device "met the pre-established criteria" for its safety mechanism, evaluated according to FDA Guidance and ISO 23908.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model that requires a training set.

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

   • Not applicable. As noted above, there is no AI training set for this device.

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