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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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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.

Sterile safety lancet consists of outer shell, middle sleeve, needle holder, spring, upper shell, back cover, small cover, needle. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use and single person use only. The shelf-life of the product is 5 years. The device is for medical professionals and lay person use as an OTC use.

This document is a 510(k) Summary for a medical device called "MedtFine Safety Lancet". It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the provided text for acceptance criteria and the study proving the device meets them:

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

The document provides a "Characters comparison" table (Table 2) that includes performance parameters for both the proposed "MedtFine Safety Lancet" and the predicate device "Safety Lancet (K220370)". This table effectively serves as a comparison against acceptance criteria. The acceptance criterion for each performance characteristic is generally implied to be "same" or within the range of the predicate device, or "meet requirements."

8. The sample size for the training set

This information is not applicable. The MedtFine Safety Lancet is a mechanical medical device, not an AI/ML-based device that requires a "training set." Its design and manufacturing are based on engineering principles and material science, not data-driven learning.

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

This information is not applicable for the reasons stated above (not an AI/ML device). The design and development process for such a device relies on established engineering specifications, material selection, and manufacturing processes, which are then validated through the performance and biocompatibility testing outlined.

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Safety lancet is intended for capillary blood sampling.

The Medifun Safety Lancet (MSL1 series) is designed to obtain capillary blood samples from the fingertip. The intended users include healthcare personnel, patients, and lay persons. According to the needle and color differences, the safety lancets have 6 models : MSL1-30, MSL1-28, MSL1-26, MSL1-23, MSL1-21, and MSL1-18. The safety lancets consist of the needle seat, main body, release platform, spring, and protective 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 lancets contain a safety feature. After use, the puncture mechanism retracts, rendering it unusable for a second time.

The provided text is a 510(k) summary for the Medifun Safety Lancet (MSL1 series). It details the device's characteristics, its comparison to a predicate device, and the performance data that supports its substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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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

• In Vitro Cytotoxicity: No Cytotoxicity (ISO 10993-5: 2009)
• Skin Sensitization: No Skin sensitization (ISO 10993-10: 2010)
• Intracutaneous Reactivity: No irritation (ISO 10993-10: 2010)
• Acute Systemic Toxicity: No Acute Systemic Toxicity (ISO 10993-11: 2017)
• Pyrogenicity: No thermogenic reaction (ISO 10993-11: 2017) |
  | Sterilization Method & SAL | Sterilized by Radiation, SAL = 10^-6. Same as predicate. |
  | Shelf-life | 5 years. Same as predicate. |
  | Reuse Durability | Single use. Same as predicate. |
  | Label/Labeling | Complied with 21 CFR part 801. Same as predicate. |

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 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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