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Unistik® ShieldLock: The Unistik ShieldLock Blood Collection Set is a sterile, multi-sample, single-use "butterfly" style blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients into blood collection tubes or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe.

Unistik® VacuFlip: The Unistik VacuFlip Safety Blood Collection Needle is intended to be used by healthcare professionals with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Unistik® ShieldLock is a sterile, single use, multi-sample blood collection set for use by healthcare professionals to obtain venous blood specimens from patients when used in conjunction with blood collection tubes or syringes. The Unistik Shield Lock is a 'butterfly needle' with wings, the color of the wings is unique for each needle gauge to assist with identification. The Unistik ShieldLock is designed for prescription use only and is to be used only by healthcare professionals for patients who are required to have venous blood specimens collected.

The Unistik® VacuFlip is a sterile, single use, multi-sample blood collection vacuum needle for use by healthcare professionals to obtain venous blood specimens from patients when used in conjunction with blood collection tubes or syringes. The Unistik VacuFlip is a 'vacuum needle' and is designed with a user activated integral sharps injury prevention feature, the safety shield, which can be activated after the needle is removed from the vein to help prevent needlestick injuries. The safety shield features a textured surface to help improve grip during activation. An audible click signals that the safety shield is activated and is locked in place, covering the needle, and preventing reuse. The color of the safety shield is unique for each needle gauge to assist with identification. The Unistik VacuFlip is designed for prescription use only and is to be used only by healthcare professionals for patients who are required to have venous blood specimens collected.

This FDA 510(k) summary describes the acceptance criteria and study results for two medical devices: Unistik® ShieldLock Blood Collection Set and Unistik® VacuFlip Safety Blood Collection Needle.

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 explicitly states that "Design verification testing has been performed on the Unistik® ShieldLock and Unistik VacuFlip lancets to demonstrate that the devices operate safely and effectively. Testing has been conducted to evaluate the performance of the devices against defined acceptance criteria." The tables show a comprehensive list of bench tests and corresponding ISO/ASTM standards.

• Sample Size for Test Set: The document does not specify the exact sample size for each individual test. It generally states that "samples" were tested. However, the mention of "samples that were accelerated aged to the 5 year shelf life" for Unistik® ShieldLock's shelf life confirmation implies multiple units were subjected to these tests. Given the nature of medical device testing for regulatory submission, these samples would have been representative of the production.
• Data Provenance (Country of Origin and Retrospective/Prospective): The data provenance is not explicitly stated in terms of country of origin. The submitting company, Owen Mumford Ltd, is located in the United Kingdom. The testing appears to be prospective as it's verification testing for a new device submission.

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

This section is not applicable. The studies described are bench testing (laboratory-based performance and safety evaluations against recognized industry standards and internal specifications) and biocompatibility testing. These types of studies do not involve human expert interpretation of results to establish a "ground truth" in the way clinical studies or AI diagnostic studies do. The "ground truth" is typically defined by the objective metrics and criteria within the specified standards.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human observers or readers to resolve discrepancies in diagnoses or assessments, which is not the nature of the bench and biocompatibility testing performed here.

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 MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device." These devices are blood collection devices and do not involve AI assistance or diagnostic interpretation by human readers.

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

No standalone algorithm (AI) performance study was done. These are physical medical devices (blood collection sets and needles), not AI algorithms.

7. The type of ground truth used

The "ground truth" for the performance criteria is established by the requirements and specifications within the referenced international and national standards (ISO, ASTM, USP), as well as the manufacturer's own validated specifications. For example, for "Fluid Leakage Test," the ground truth is "Meets specification" based on the criteria outlined in ISO 80369-7:2016. For biocompatibility, the ground truth is adherence to the requirements of the ISO 10993 series and FDA guidance.

8. The sample size for the training set

This section is not applicable. There is no AI component mentioned in the device description or testing. Therefore, there is no "training set."

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

This section is not applicable, as there is no training set.

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Unistik® Heelstik: The Unistik® Heelstik heel incision safety lancets are single use devices used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers. Unistik® TinyTouch: The Unistik® TinyTouch heel incision safety lancets are single used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.

The submission devices are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. The devices automatically self-disable after a single use, thus preventing any hazards of re-use. The submission devices are intended for use by healthcare professionals only, for performing heel incisions on newborns, preemies, and toddlers to obtain capillary blood specimens for IVD assays. The product is intended for prescription (Rx) only use.

This document describes the performance testing conducted for the Unistik® TinyTouch and Unistik® Heelstik sterile single-use heel incision safety lancets.

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) summary for a medical device that appears to be a blood lancet, the "acceptance criteria" are implied to be established specifications and standards for similar devices, ensuring safety and effectiveness. The reported device performance is consistently listed as "Meets acceptance criteria/ Pass" for all tests. Specific numerical acceptance criteria are not provided in this summary.

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

The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of devices tested for button actuation force). However, it indicates that "Design verification testing... has been carried out to evaluate the performance of the devices against defined acceptance criteria." The tests appear to be laboratory-based bench evaluations.

The data provenance is not explicitly stated in terms of country of origin, but Owen Mumford Ltd is based in the United Kingdom. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

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

For bench testing of a physical medical device like a lancet, the "ground truth" is typically established by engineering specifications, validated test methods, and compliance with recognized standards. This generally does not involve expert consensus in the same way as, for example, image interpretation. The testing would have been performed by qualified technicians and engineers following established protocols. The document does not specify human experts for establishing ground truth for these types of tests.

4. Adjudication Method for the Test Set

Not applicable for this type of bench testing. The results are objective measurements against predefined engineering specifications and pass/fail criteria.

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

No. This is a 510(k) submission for a blood lancet, not an AI or imaging device that would typically undergo an MRMC study.

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

Yes, in a sense. The performance data presented refers to the standalone performance of the physical devices themselves through various bench tests (e.g., incision profile, button actuation force, drop test). There is no "algorithm" in the context of an AI device.

7. The Type of Ground Truth Used

The ground truth for the performance tests is based on engineering specifications, predefined acceptance criteria, and compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization). For example, "incision profile - depth of cut" would have a specific numerical range as an acceptance criterion.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a training set.

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

Not applicable, as there is no training set.

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The intended user is any patient that needs to obtain capillary samples at home/clinical environment. Unistik Pro is a single-use lancet used to obtain a capillary blood sample.

The Unistik® Pro is a sterile single-use safety lancet, a hand-held disposable device intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® Pro sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.q., for blood glucose monitoring in patients with diabetes,

The Unistik® Pro safety lancets are available in 3 different variants, each with a different needle gauge (21G, 25G and 28G with penetration depths of 2.0mm, 1.6mm and 1.2mm respectively) as required by the patient.

The Unistik® Pro sterile single-use safety lancets are designed for prescription and over-thecounter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the finqertip, in order for caregivers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime.

The Unistik® Pro sterile single-use safety lancets feature integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.

The provided text describes the 510(k) summary for the Unistik® Pro, a single-use lancet. While it outlines various performance tests and acceptance criteria for mechanical and material properties, it does not contain information related to an AI/ML-driven medical device, nor does it discuss clinical studies with human readers or image analysis for establishing ground truth. The device is a physical blood lancet, not a diagnostic imaging or AI product.

Therefore, many of the requested criteria for describing an AI/ML device's acceptance criteria and study are not applicable to this document. The document primarily focuses on non-clinical performance data for a physical medical device.

However, based on the non-clinical performance data provided for this physical device, here's an attempt to answer the relevant questions to the best of my ability from the given text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for each test. It only states that "Design verification testing... has been carried out" and "All additional performance tests met the acceptance criteria." The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned beyond acknowledging that some prior documentation might reference "Artaplast" or other names for the device. These are bench tests, not clinical data sets.

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. The ground truth for these physical tests is established through objective measurements against predefined specifications, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies with human readers, not for physical device performance tests.

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 physical medical device (lancet), not an AI-driven diagnostic tool. No human reader studies with AI assistance were conducted or are 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, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of "ground truth" for these performance tests is based on pre-defined engineering and safety specifications for the physical properties of the lancet (e.g., precise needle penetration depth, force required for activation, effectiveness of sharps protection).

8. The sample size for the training set
Not applicable. The document describes 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
Not applicable, as there is no training set for an AI/ML algorithm.

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Freestyle Lancing Device II: Use with compatible lancets for capillary blood sampling.

Autolet: Use with compatible lancets for capillary blood sampling.

Autolet Lite: Use with compatible lancets for capillary blood sampling.

Unilet Lancets: Use with compatible lancing device for capillary blood sampling.

The FS & A Device is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The ADC Freestyle Lancing Device II variant is sold for use with ADC 'Freestyle' single-use lancets; these are not included in this submission. The OM Autolet variant is sold for use with Unilet Lancets and as 'universally compatible with most lancets'. The lancets are disposed of after each use and the device is maintained by using isopropyl alcohol or soap to wipe the outside of the device. The FS & A Device is for use only on a single patient.

The Autolet Lite is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The device was designed for use as a system with Unilet Lancets (and as 'universally compatible with most lancets') which are included in this 510(k) The Unilet Lancets feature 3 lancet gauges, 3 with labelling "Unilet Lancets" and the same 3 lancet gauges labelled "Unilet ComforTouch Lancets". These lancets have different gauge sizes and styling but are functionally identical and for the purpose of this 510(k), all references to "Unilet Lancets" can be considered to apply to Unilet Lancets and Unilet ComforTouch Lancets.

The provided text describes a 510(k) premarket notification for Owen Mumford Ltd.'s Freestyle Lancing Device II, Autolet, Autolet Lite, and Unilet Lancets. The goal of the submission is to demonstrate substantial equivalence to a predicate device, the Accu-Chek Softclix Blood Lancing System (K214022).

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study proving the device meets them:

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

The document states: "Design verification testing of the FS & A has been carried out to evaluate the performance of the devices against defined acceptance criteria." and "The objective of the design verification testing conducted was to verify that the submission devices met the pre-determined specifications, to support the conclusion that they are fit for purpose and are considered safe and effective for the intended use."

However, the specific "acceptance criteria" (e.g., numerical targets for depth of penetration accuracy, load/fire mechanism reliability) are not explicitly listed in a detailed table or described quantitatively for each test. The table below summarizes the general acceptance and reported performance.

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

The document does not specify the sample sizes used for the "design verification testing" for the specific tests (e.g., how many devices were tested for mechanical performance, how many samples for biocompatibility).

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond the fact that the testing was carried out as part of the design verification internally by Owen Mumford Ltd. (UK-based company). The Toxicologist for biocompatibility assessment was from Medwise International Consultancy Limited, York, UK.

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 as the document describes technical performance testing and biocompatibility assessments, not a diagnostic device involving expert interpretation or "ground truth" establishment in a clinical sense. For biocompatibility, an "Expert toxicological review" was conducted by a toxicologist from Medwise International Consultancy Limited, York, UK. Their specific qualifications (e.g., years of experience) are not detailed.

4. Adjudication method for the test set

This information is not applicable for the type of technical and biocompatibility testing described.

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 information is not applicable. The submission is for lancing devices and lancets, which are mechanical devices for capillary blood sampling, not AI-powered diagnostic tools requiring MRMC studies.

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

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For the technical performance tests, the "ground truth" or reference was the pre-determined specifications and design input IDs for the devices. For biocompatibility, the ground truth was established against ISO 10993-1:2009 and ISO 10993-5:2009 standards and an expert toxicological review. For sterilization, it was against ISO 11137 standards.

8. The sample size for the training set

This information is not applicable as the submission is for a physical medical device (lancing devices and lancets), not a machine learning or AI model that requires a training set.

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

This information is not applicable as there is no training set for a physical medical device.

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The Unistik® Touch is a puncture device to obtain micro blood samples. Unistik Touch has a sharps prevention feature to protect the user from a needlestick injury.

The Unistik® Touch contact-activated safety lancets are hand-held disposable devices intended for performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism. Unistik® Touch safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes. The Unistik® Touch contact-activated safety lancets are available in five different variants of needle gauge as follows: Needle gauge 16G, Penetration Depth 2.0 mm Needle gauge 21G, Penetration Depth 2.0 mm Needle gauge 23G, Penetration Depth 2.0 mm Needle gauge 28G, Penetration Depth 1.8 mm Needle gauge 30G, Penetration Depth 1.5 mm The Unistik® Touch contact-activated safety lancets are intended for prescription and over-the-counter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for caregivers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female. right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime. Unistik® Touch contact-activated safety lancets are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the devices automatically self-disable after a single use, thus preventing any hazards of re-use. The Unistik® Touch contact-activated safety lancets achieve their intended purpose of performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded. The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.

The Unistik® Touch Single-Use Safety Lancets were evaluated through a series of non-clinical performance studies, primarily bench testing and a simulated clinical use study.

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

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

• Simulated Clinical Use Study: 500 device samples were used.
• Data Provenance: The document does not specify the country of origin of the data, nor whether it was retrospective or prospective, beyond stating it was a "simulated clinical use study."

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

• This information is not provided in the document. The studies described are non-clinical, primarily bench testing, and a simulated clinical use study. The performance criteria are objective measurements against established standards (e.g., ISO, FDA guidance).

4. Adjudication method for the test set:

• This information is not applicable and not provided. The studies involved objective measurements against predefined acceptance criteria rather than subjective expert 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 blood lancet, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's inherent functional performance without human interaction regarding its analytical functions (e.g., accurate puncture depth, safety mechanism activation). This was assessed through the various bench tests.

7. The type of ground truth used:

• The ground truth for the bench testing was based on objective, verifiable measurements and physical characteristics outlined in the acceptance criteria (e.g., freedom from burrs, adherence to dimensions, pH values, metal content, puncture depth measurements, force to activate safety features).
• For the simulated clinical use study, the ground truth was based on demonstrating that the device "met the pre-established criteria" for its safety mechanism, as evaluated against FDA Guidance and ISO 23908.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.

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

• Not applicable. As noted above, this is a physical medical device and does not involve a training set for an AI/ML algorithm.

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The single-use safety lancets are hand-held disposable devices intended to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are hand-held disposable devices intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes.

The Unistik® 3 safety lancets are available in five different variants, each with a different needle gauge (18G, 21G, 23G, 28G, 30G) to facilitate appropriate blood flow rates from the skin puncture. There are two high flow variants (18G, 21G) one medium flow variant (23G) and two low flow variants (28G, 30G). The Unistik® 3 Value devices are identical to the equivalent gauge of Unistik® 3 devices, except for the colour of the plastic body housings. The Unistik® 3 Value devices all have a vanilla body housing colour, whereas the Unistik® 3 devices have a different colour for each gauge.

The Abbott SF sterile single-use safety lancets are available in a single configuration only (28G needle).

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are designed for prescription and over-the-counter use and to be used by self-testing patients, caregivers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for care-givers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are sterile single-use devices with integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are used by first twisting off the end cap, the needle tip is then exposed but remains safely shielded within the device housing. The user then presses the end face of the device against the sampling site, then activates the device by pressing the release button on the side of the lancet needle is then automatically propelled forward by the internal pre-loaded spring to lance the skin and also automatically retracted by the spring back inside the device housing, where it is then automatically locked to prevent re-use. After firing, the locked position of the needle tip inside the device ensures that it remains safely shielded, and the device can be safely disposed of into an appropriate sharps receptacle.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets consist of a stainless steel lancet needle moulded into a plastic lancet holder component. which in turn is assembled into a moulded plastic outer housing with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded.

The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.

The provided text describes a 510(k) premarket notification for a medical device (Unistik® 3, Unistik® 3 Value, and Abbott SF sterile single-use safety lancets), not an AI/ML powered device. As such, information regarding AI/ML specific criteria like MRMC studies, standalone algorithm performance, number of experts for ground truth, or training set details are not applicable and are not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device through bench testing and compliance with relevant standards for a traditional medical device (blood lancets).

Below is the information regarding the acceptance criteria and study as presented in the document for the non-AI medical device.

1. Table of acceptance criteria and the reported device performance

Additionally, the document states: "All additional performance tests met the acceptance criteria."

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

The document does not specify the exact sample sizes used for each of the bench tests mentioned. The "data provenance" (e.g., country of origin of the data, retrospective or prospective) is also not explicitly stated, but the tests were conducted as part of the design verification for the devices by the manufacturer, Owen Mumford Ltd (United Kingdom). These would be considered prospective design verification tests.

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 (lancet), not an AI/ML diagnostic system requiring expert-established ground truth for a test set. The acceptance criteria are based on internal test specifications and engineering requirements.

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

This question is not applicable for a physical medical device where performance is evaluated through objective bench tests against technical 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 question is not applicable as the device is a physical medical device (lancet) and does not involve AI or human readers for diagnostic interpretation.

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 medical device (lancet) and does not involve an algorithm.

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

For the bench tests, the "ground truth" or reference against which the device performance was measured were the internal test specifications. These specifications define the expected performance parameters (e.g., integrity, firing protocol, cap removal torque, needle penetration depth, environmental resilience, drop test). Biocompatibility was assessed against ISO 10993-1, and sterility against ISO 11137 with a Sterility Assurance Level (SAL) of 10^-6.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device (lancet) and does not involve a "training set" in the AI/ML context.

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

This question is not applicable as the device is a physical medical device (lancet) and does not involve a "training set" or "ground truth" for training purposes.

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The Unifine SafeControl™ range of pen needles are intended for use with multi-dose injection devices for the subcutaneous injection of FDA approved drugs, including insulin.

The Unifine SafeControl™ safety pen needle is a sterile, single-use, disposable device intended for use with multi-dose Injector devices for the subcutaneous injection of FDA approved drugs, including insulin. The device is designed for prescription and overthe-counter use and to be used by self-administering patients, caregivers and healthcare professionals. The safety pen needle is currently available in 30-gauge size with 5mm and 8mm lengths.

The pen needle assembly consists of a cannula attached to a needle carrier assembled into a plastic moulded needle hub and safety guard, a primary container that houses the entire assembly and a sterility seal that covers the assembly inside the primary container. The entire device is packaged and labelled as a sterile singleuse device.

The purpose of this Special 510(k) Premarket Notification is to increase the range of Unifine SafeControl™ safety pen needle devices to include qauge sizes of 31G and 32G in 4, 5, 6, and 8mm lengths.

This document is a 510(k) premarket notification for a medical device (Unifine SafeControl™ pen needles) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for an AI/ML-based medical device.

Therefore, many of the requested criteria (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone AI performance, ground truth establishment) are not applicable or not present in this type of submission. This document describes a traditional medical device (hypodermic needle) where performance is assessed through bench testing against established industry standards.

Here's an analysis based on the provided text, highlighting what is present and what is not:

Device Name: Unifine SafeControl™ (Pen Needle)
Regulation Number: 21 CFR 880.5570 (Hypodermic Single Lumen Needle)
Regulatory Class: Class II
Product Code: FMI

Purpose of the 510(k): To introduce additional needle lengths and gauge sizes (31G and 32G in 4, 5, 6, and 8mm lengths) to an already cleared predicate device (Unifine SafeControl™) approved under K173881. The submission aims to demonstrate that these new variations do not impact safety and effectiveness.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Meets standard" result for each test listed, indicating compliance with the specified ISO standards or protocols from the predicate device.

Study Details (Focusing on the Provided Document)

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

   • Sample Size: Not explicitly stated in the provided text. The document refers to "bench testing" but does not detail the number of units tested for each criterion.
   • Data Provenance: The manufacturer, Owen Mumford Ltd, is located in Woodstock, Oxfordshire, United Kingdom. The testing would presumably have been conducted there or by a contracted lab. The data is retrospective, as it's part of a premarket submission.

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

   • Not Applicable. This is a hardware medical device; ground truth is established through physical measurements and adherence to engineering standards, not through expert consensus on diagnostic interpretations.

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

   • Not Applicable. This is not a study requiring human adjudication of results in the traditional sense, as it involves physical bench testing.

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:

   • Not Applicable. This device is a pen needle, not an AI-assisted diagnostic tool.

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

   • Not Applicable. This device is a physical product, not an algorithm.

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

   • Engineering/Performance Standards: The "ground truth" for the device's performance is compliance with established international standards (e.g., ISO 11608-2:2012) and internal protocols validated with the predicate device (K173881). These standards define acceptable physical properties and functionalities for hypodermic needles.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set.

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

   • Not Applicable. This is not an AI/ML device.

Summary of what is covered by the document:

• Device Description: Detailed description of the pen needle, its components, and the new larger range of gauge sizes and lengths being introduced.
• Predicate Comparison: Explicit table comparing the new device characteristics to the predicate device, highlighting that the essential characteristics are unchanged except for needle dimensions.
• Performance Bench Testing: A table outlining specific non-clinical bench tests performed (e.g., Visual Inspection, Needle Retention, Flow Rate, Aging).
• Standard Compliance: Indication that the tests were conducted according to ISO standards or established protocols, and that the device "Meets standard."
• Biocompatibility: Stated that existing biocompatibility reports from the predicate device are still valid as materials have not changed.
• Sterilization: Confirmed that sterilization methods comply with ISO 11137 and achieve a SAL of 10-6.

In conclusion, this 510(k) submission successfully demonstrates substantial equivalence for the modified pen needle by showing that the new needle lengths and gauges still meet the same performance standards as the predicate device through bench testing. The requested elements related to AI/ML or complex clinical study design are not relevant to this type of medical device submission.

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The Unifine SafeControl™ range of pen needles are intended for use with multi-dose injection devices for the subcutaneous injection of FDA approved drugs, including insulin.

The Unifine SafeControl™ safety pen needle is a sterile, single-use, disposable device intended for use with multi-dose Injector devices for the subcutaneous injection of FDA approved drugs, including insulin. The device is designed for prescription and over-the-counter use and to be used by self-administering patients, care-givers and healthcare professionals. The safety pen needle is a 30-gauge needle available in sizes between 5mm and 8mm lengths. The pen needle assembly consists of a cannula attached to a needle carrier assembled into a plastic moulded needle hub and safety guard, a primary container that houses the entire assembly and a sterility seal that covers the assembly inside the primary container. The entire device is packaged and labeled as a sterile single-use device.

This document is a 510(k) Premarket Notification for the Unifine SafeControl™ safety pen needle. It describes the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Meets standard" for each test listed, implying compliance with the specified ISO or ASTM standards. The reported device performance uniformly states "Meets standard" for all listed tests.

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

The document does not explicitly state the specific sample sizes used for each of the bench tests. It mentions that "Written protocols specified the scope, objectives, specifications, test equipment, test methods and acceptance criteria," which would typically include sample sizes, but these details are not provided in the summary.

The data provenance is not explicitly stated as retrospective or prospective clinical data. Given that it's a 510(k) summary focusing on bench testing, the data is primarily from non-clinical performance testing conducted by the manufacturer, Owen Mumford Ltd., which is based in the United Kingdom.

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

This information is not applicable to this submission. The "ground truth" for these tests relates to meeting objective engineering and material standards (e.g., specific force measurements, flow rates, sterility assurance levels), not a clinical diagnosis or interpretation by human experts.

For biocompatibility, it states that "Full device evaluation includes a review of all the materials, consumables, manufacturing processes and environments by an expert toxicologist." The number of toxicologists and their specific qualifications are not provided, but the expert's role here is to review and ensure compliance with biocompatibility standards based on material properties and testing results, not to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective bench tests based on measurable physical properties and adherence to established standards, not subjective assessments requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic devices where human readers' performance is compared with and without AI assistance. The Unifine SafeControl™ is a physical medical device (pen needle) and its effectiveness is determined by its physical and material properties, not through AI-assisted human interpretation.

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

No, a standalone algorithm-only performance study was not done. This concept is relevant for AI/ML-driven diagnostic software. The Unifine SafeControl™ is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through compliance with recognized industry standards and specifications. This includes:

• Engineering specifications: For physical properties like torque, force, flow rate, needle retention, etc. (e.g., ISO 11608-2, ISO 11608-5).
• Material and safety standards: For sterility assurance and biocompatibility (e.g., ISO 11607-1, ASTM F1980-16, ISO 10993 series, ISO 11137).
• Sharps safety guidelines: For the safety feature (e.g., ISO 23908:2011 & FDA Guidance).

Essentially, the ground truth is that the device performs as expected and safely according to these predefined, objective standards.

8. The Sample Size for the Training Set

There is no training set as this is a physical medical device (a pen needle) and not an AI/ML algorithm that requires training data.

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

Since there is no training set mentioned, this question is not applicable.

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The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.

Unifine® Pentips® and Unifine® Pentips® Plus are sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. The pen needles are used by consumers, caregivers, and healthcare professionals. They are available in a variety of lengths (4mm, 5mm, 6mm, 8mm and12mm) and gauges (29G, 31G and 32G).

The pen needle assembly consists of a double-ended cannula, a needle hub, a needle shield, primary container and sterility seal that covers the assembly inside the primary container.

The hub has internal threads, which allows the pen needle to be screwed onto a pen injector device. The Non Patient (NP) end of the cannula (inside the hub) penetrates the rubber septum of the cartridge in the pen injector device. The Patient end and NP end of the cannula are lubricated using a silicone based lubricant to aid in injection and penetration into the rubber septum. The inner needle shield is injection molded and assembled over the Patient end of the needle to protect the needle from damage and accidental needle-sticks. The pen needle assembly is then inserted into an iniection molded outer container and sealed with a protective peel-away label to ensure a sterility barrier and tamper evidence. The outer container can be used to remove the hub with cannula from the pen injector device after the injection is completed. The peel-away label is pre-printed with information, which includes the lot number, expiry date, and size (length) and gauge of the needle. The individual needle assemblies are then packaged in bags and/or cartons, and placed into shippers with appropriate labeling. The shipper cases are then placed on pallets for sterilization.

Unifine Pentips Plus pen needles differ from Unifine Pentips pen needles because the primary container consists of two 'chamber contains a new, unused pen needle and the second chamber is empty. The empty chamber serves as a built-in pen needle remover, and may prevent accidental needlesticks. Users can insert their used needle into the chamber, then unscrew from the injection pen. The primary container is designed to hold the used pen needle until it can be disposed of in a suitable sharps container. The actual pen needle is identical between Unifine Pentips and Unifine Pentips Plus in both the physical appearance and functionality.

This document is a 510(k) Premarket Notification for medical devices, specifically pen needles. It is not a study proving an AI/ML medical device meets acceptance criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies, cannot be extracted from this document.

This document focuses on demonstrating substantial equivalence of the Unifine® Pentips® and Unifine® Pentips® Plus pen needles to legally marketed predicate devices, primarily K973899 (Unifine® Pentips®). This is a regulatory pathway for Class II medical devices in the US, where the manufacturer needs to show that their new device is as safe and effective as an already cleared device.

Here's what can be extracted based on the provided text, and where the requested information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these pen needles are primarily defined by adherence to ISO standards and internal performance tests. The document states that the devices meet these standards/criteria.

Note: The document states "The devices comply with the acceptance criteria established based on the specifications of the devices" for internal tests, but does not provide the specific numerical criteria for these tests.

Regarding the study that proves the device meets acceptance criteria (for an AI/ML context):

This document describes a regulatory submission for a physical medical device (pen needles), not an AI/ML software device. Therefore, the concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication," and "MRMC studies" as they apply to AI/ML performance evaluation are not relevant here. The "study" described is a series of non-clinical performance (bench) tests and biocompatibility tests to demonstrate substantial equivalence to existing devices.

Here's why the specific questions are not applicable or cannot be answered from this document:

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

• Not Applicable in AI/ML context: This is a physical device. "Test set" refers to samples tested during bench testing.
• Sample Size: The document does not specify the number of pen needles tested for each performance test. It only states that the tests were performed and results "meet standard" or "meet acceptance criteria."
• Data Provenance: Not applicable in the AI/ML sense. Data is from laboratory bench testing of manufactured pen needles. The manufacturing locations mentioned are the UK (Owen Mumford) and Italy (Artsana S.p.A.).

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

• Not Applicable: There is no "ground truth" in the AI/ML sense (e.g., expert-annotated images) for a physical device like a pen needle. The "ground truth" is defined by the objective physical and mechanical properties measured against established ISO standards and internal specifications. Bench testing is typically performed by trained technicians.

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

• Not Applicable: No expert adjudication process as would be used for clinical image interpretation or AI model validation. Bench tests have objective, measurable outcomes.

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 type of study (MRMC, human readers, AI assistance) is for clinical decision support or diagnostic AI devices. This document is for a mechanical device.

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

• Not Applicable: This is not an algorithm or software device.

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

• Not Applicable in AI/ML context: The "ground truth" for these pen needles is defined by objective physical and mechanical measurements against established ISO standards (e.g., dimensions, flow rate, bond strength) and internal engineering specifications. Biocompatibility is assessed through standardized biological tests.

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: As above, no training set or AI/ML ground truth. The "ground truth" for manufacturing and quality control of pen needles is based on engineering specifications and adherence to international standards for medical devices.

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