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The device is designed for obtaining capillary blood sample.

The SafetiCET Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a needle encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use.

The provided text describes the SafetiCET Safety Lancet and its substantial equivalence to a predicate device (VeriFine Safety Lancet) based on performance testing. However, it does not provide specific acceptance criteria values or detailed study results that prove the device meets these criteria in a quantitative sense for each test. Instead, it lists the types of performance tests conducted and generally states that the device's performance is comparable to the predicate or meets requirements.

Here's a breakdown of the requested information based on the provided text, with notes on what is not available:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The SafetiCET Safety Lancet is a single-use blood lancet designed to obtain capillary blood samples. Its substantial equivalence to the predicate device (VeriFine Safety Lancet, K221368) is asserted based on similarities in intended use, indications for use, sterilization methods, and performance characteristics.

The testing conducted aimed to confirm the safety and effectiveness of the device by evaluating various physical and mechanical properties relevant to its function and specified safety features. While specific numerical acceptance criteria for each test are not explicitly stated, the summary implies that the results of these tests were found to be acceptable and comparable to the predicate device's performance.

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

Note: The document only lists the types of tests and generally states that the device's performance is comparable to or meets the requirements, rather than providing specific numerical acceptance thresholds or detailed performance metrics. For example, for "Penetration depth test," it says "results...are in the same range," but doesn't provide the range itself or the specific measurements.

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

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: Not specified. It can be inferred that the testing was performed by NSP Tech Pte Ltd, based in Singapore, but details about the origin of test data (e.g., country, retrospective/prospective) are not provided.

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 performance tests described are mechanical and physical property tests of the medical device itself, not diagnostic performance tests requiring expert interpretation or ground truth establishment by clinical experts.

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

Not applicable, as this refers to clinical evaluation requiring adjudication (e.g., in cases of disagreement among expert readers). The tests described are objective, physical, and mechanical performance evaluations of the device.

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 device is a blood lancet, a mechanical instrument, not an AI-powered diagnostic tool.

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

Not applicable. This device is a blood lancet, a mechanical instrument, not an AI algorithm.

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

Not applicable in the clinical sense. For the physical and mechanical tests, the "ground truth" would be established by objective measurements against predefined engineering specifications and relevant ISO standards (e.g., ISO 11137-1:2006 for sterility, ISO 10993 series for biocompatibility).

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, not a machine learning model that requires a training set.

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

Not applicable.

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The device is used to obtain capillary blood samples from the heel of newborn and neonatal infants in the healthcare setting by qualified healthcare providers.

The SafetiHeel Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a blade encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use. The SafetiHeel Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means. The SafetiHeel device is marketed under model numbers SH-065, SH-100 and SH-150. The device is also marketed under trade names such as MediHeel and Novaplus in the USA market. The models for the MediHeel include model number 1003, 1004, 1005 and 1006. For the Novaplus device, the model numbers are 10041 and 10051.

The document provided describes the SafetiHeel, MediHeel, and Novaplus blood lancets, which are intended for obtaining capillary blood samples from the heel of newborn and neonatal infants. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the "Predicate Device (specification)" column, and the reported device performance is indicated in the "SafetiHeel performance," "MediHeel performance," and "Novaplus performance" columns.

SafetiHeel Device Performance

MediHeel Device Performance

Novaplus Device Performance

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

The document does not specify the exact sample size for the test set beyond stating that "The samples of all the models tested show..." for the Blade Retraction Test, and presenting ranges for Cutting Depth and Trigger Force. This implies that multiple units were tested for each model.

Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests described (physical performance tests on the devices themselves), it is highly likely these were prospective laboratory or engineering tests conducted on manufactured devices, rather than clinical studies involving human patients or existing datasets.

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

This information is not applicable to the type of performance testing described. The "ground truth" for these physical performance tests (cutting depth, trigger force, blade retraction) is established by direct measurement against known engineering specifications, not by expert interpretation.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies when establishing ground truth for diagnostic decisions. The tests here are physical measurements of device 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. The device is a physical blood lancet, not an AI-powered diagnostic or assistance tool that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical blood lancet, not an algorithm.

7. The type of ground truth used

The ground truth for these performance tests is based on engineering specifications and direct physical measurements. Specifically:

• Cutting Depth: Measured depth of blade protrusion.
• Trigger Force: Measured force required to activate the blade.
• Blade Retraction: Visual and/or mechanical confirmation of the blade returning into the housing.
• Sterility: Adherence to established sterility assurance levels (SAL) based on ISO standards.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an algorithm that requires a training set.

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

This information is not applicable. As stated above, there is no training set for this type of device.

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The Bevel Up Holder is used for the collection of blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. The device is to be used by trained healthcare professional only.

The Bevel Up Holder device is a single use and non-invasive device to be used in venipuncture procedures for the collection of blood specimens. It is to be used as a Tube Holder with blood collection tubes such as the Becton Dickinson Vacutainer® blood collection tube. The Bevel Up Holder device is also used with blood collection needles and blood collection sets such as the Becton Dickinson Eclipse Needle set, Becton Dickinson Vacutainer Multi Sample and Becton Dickinson Safety Lok Blood Collection Set for the collection of blood specimen into the blood collection tubes. The Bevel Up Holder is to be used by trained healthcare professional only and is intended for prescription use.

The Bevel Up Holder has a clear plastic holder body with an opening on one end for the insertion of blood collection tube and an interface device connecting feature on the other end for venous access device for connecting to blood collection needle and blood collection set.

The connecting end of the venous access device of the Bevel Up Holder (BUH) device allows the adjusting of the position of the venous access device with rotating it.

The provided document, a 510(k) premarket notification for the "Bevel Up Holder," details various tests and their outcomes. However, it does not delineate specific numerical acceptance criteria for each test nor present the reported performance values in a direct comparative table as requested. Instead, it generally states that the device "met the acceptance criteria" or "shows no permanent change."

Here's an attempt to answer the questions based on the available information:

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)

• Sample Size: For the simulated blood collection test, 20 sets of the subject device (Bevel Up Holder) and interface device were used. For the deformation test, the sample size is not explicitly stated but implies testing of "the device." The same applies to the insertion and evacuation force test, connectivity test, and shelf life test. Biocompatibility was leveraged from another device.
• Data Provenance: The document does not specify the country of origin where the tests were conducted or if the data was retrospective or prospective. Given the applicant is from Singapore, it's plausible the testing occurred there, but this is not confirmed.

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)

This is not applicable as the device is a blood specimen collection tube holder, not an AI or diagnostic device that requires expert ground truth establishment in the traditional medical imaging sense. The testing focuses on physical and functional performance, not diagnostic accuracy.

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

This is not applicable for the same reasons as above. No diagnostic interpretations or clinical assessments requiring adjudication were performed.

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. The device is a physical medical instrument, not an AI-powered diagnostic tool.

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

This is not applicable. The device is a physical medical instrument, not an algorithm. Performance tests evaluate the device's physical and functional properties.

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

The concept of "ground truth" as typically used for AI or diagnostic devices does not directly apply to this product. The "truth" for this device's performance is established by:

• Physical measurements (e.g., outer diameter in the deformation test, force in insertion/evacuation test).
• Visual inspection (e.g., fit, leakage, function in simulated blood collection and connectivity tests).
• Standardized test methods (e.g., ASTM, ISO standards).
• Leveraging prior biocompatibility data for a similar device.

8. The sample size for the training set

This is not applicable as the device is a physical product and does not involve AI or machine learning that requires a "training set."

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

This is not applicable for the reasons stated above.

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The Blood Collection Accessory (BUCA) is a single use, sterile and non invasive device used for connecting to venous access device for the collection of blood specimens.

The Blood Collection Accessory (BUCA) is a single use device comprising of a holder made from polypropylene plastic with a male luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder.

The Blood Collection Accessory (BUCA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Collection Accessory (BUCA) also house the sample collection tube and protects the user or healthcare personnel from direct contact with blood specimen. The Adapter connected to the blood collection device for the blood transfer. The sample collection tube is inserted from the far end of the holder where the opening is located. This transfer is conducted until the required amount of blood is completed. The sample collection tube is then evacuated from the Blood Collection Accessory (BUCA) by pulling it away from the latter.

The provided text describes the acceptance criteria and the study conducted for the Blood Collection Accessory (BUCA) device to demonstrate substantial equivalence to a predicate device, the Vacutainer® Brand Multiple Sample Luer Adapter.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the device "passed predetermined acceptance criteria" for various tests, but it does not explicitly list the numerical acceptance criteria for each test. Instead, it states that the tests demonstrated substantial equivalence.

• Flow Rate: Time taken to fill a 3.0 ml blood collection Test tube with liquid of viscosity similar to blood.
• Leakage: Maximum number of insertion/evacuation rounds before leakage.
• Evacuation Force: Force to insert/evacuate a blood collection tube.
• Holding Strength of Needle to Adapter: Force to dislodge needle.
• Holding Strength of Sleeve to Adapter: Force to dislodge sleeve.
• Deformation Test: Permanent change in outer diameter after 5 kg force for 5 minutes. |
  | Sterilization | Achieved a Sterility Assurance Level (SAL) of 10^-6 as per ISO 11135-1:2014. |
  | Shelf Life | 1 year (The predicate device had 3 years; Non-Clinical Performance Testing was conducted to demonstrate SE for 1 year). |

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

The document does not explicitly state the sample sizes (number of devices tested) for the performance and biocompatibility tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable. This device is a physical blood collection accessory, and the "ground truth" for its performance is established through objective physical and chemical testing, not through expert consensus on interpretation.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading), not for the direct measurement of physical device properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is not relevant for this type of device, which is evaluated based on its physical and biological performance characteristics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical device, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that it is measured directly without human interpretive involvement in the outcome.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on objective measurements and adherence to international standards and benchmarks against a predicate device. For example:

• Biocompatibility: Adherence to ISO 10993 series and FDA guidance.
• Luer Lok Adapter: Conformance to ISO 80369-7:2016 and ISO 80369-20:2015.
• Performance Testing (Flow Rate, Leakage, Holding Strength, Deformation): Direct physical measurements and comparison to the predicate device's performance benchmarks.
• Sterilization: Achievement of a specific Sterility Assurance Level (SAL) according to ISO 11135-1:2014.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, 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 this device.

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The Blood Transfer Accessory is a sterile non invasive device for use in venous blood collection procedures in combination with blood collection devices with a male luer feature.

The Blood Transfer Accessory (BTA) is a single use device comprising of a holder made from polypropylene plastic with a female luer feature. A stainless-steel needle covered with a rubber sleeve is attached to the inside of the holder.

The Blood Transfer Accessory (BTA) has a Holder that encases the Needle preventing any needle stick issue with user. The Holder of the Blood Transfer Accessory (BTA) also house the sample collection tube and protects the user or healthcare personnel from direct contact with blood specimen. The Adapter connected to the blood collection device for the blood transfer. The sample collection tube is inserted from the far end of the holder where the opening is located. This transfer is conducted until the required amount of blood is completed. The sample collection tube is then evacuated from the Blood Transfer Accessory (BTA) by pulling away.

The provided text describes the regulatory clearance of a medical device, the Blood Transfer Accessory (BTA), by the FDA. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and performance studies in the context of an AI/human-in-the-loop system. The document focuses on the substantial equivalence of the BTA to a predicate device, primarily through biocompatibility and performance testing of the physical device, not an AI algorithm.

Specifically, the document discusses:

• Acceptance Criteria for the physical device: Things like sterility assurance level, material biocompatibility (ISO 10993 series), and physical performance (flow rate, leakage, holding strength, deformation).
• Studies conducted: Biocompatibility testing and performance testing against international standards (e.g., ISO 80369-7:2016) and benchmarking against the predicate device.

Missing Information:
The document does not include:

• A table of acceptance criteria for an AI system or its reported performance.
• Sample sizes for test sets in an AI context.
• Information on data provenance (country, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for ground truth in an AI context.
• Any mention of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance or human-in-the-loop studies for an AI system.
• The type of ground truth used for an AI system (expert consensus, pathology, etc.).
• Sample size for a training set or how ground truth was established for a training set (as this is not an AI device).

Therefore, I can only provide information based on the physical device's characteristics and its equivalence to a predicate, not for an AI component.

Based on the provided text, here's what can be extracted and what remains unknown regarding acceptance criteria and device performance:

Acceptance Criteria and Device Performance (for the physical Blood Transfer Accessory):

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vacutainer® Brand Multiple Sample Luer Adapter) based on material, function, and performance tests for the physical device. It does not describe an AI component.

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

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

• Sample Size: Not specified in the document for any of the performance or biocompatibility tests.
• Data Provenance: Not applicable as this is a physical device testing, not a data-driven AI model. The manufacturing applicant is NSP Tech Pte Ltd, Singapore.

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

• Not applicable. Ground truth for a physical medical device typically comes from laboratory testing against established standards and engineering specifications, often involving engineers and lab technicians, not clinical experts for "ground truth" in the AI sense.

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

• Not applicable. This concept applies to human reader studies, not physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• For physical device performance: Established international standards (e.g., ISO 80369-7:2016, ISO 11135-1:2014) and benchmarking against a legally marketed predicate device's measured performance characteristics.
• Not applicable for AI-related ground truth types like expert consensus, pathology, or outcomes data, as this is not an AI device.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. This is not an AI device.

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