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The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.

The SurgiLance® Safety Lancet is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be ergonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types. The SurgiLance® Safety Lancet comes in seven (7) models: two low flow, two medium flow, and three high flows. The seven models are differentiated by their casing color. SurgiLance® Safety Lancets are safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently pushes the lancet down against the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use. SurgiLance Safety Lancets are provided sterile and are single patient use only. They are sterilized using irradiation (R) sterilization method.

This document is a 510(k) summary for the SurgiLance® Safety Lancet. It does not describe an AI/ML device, therefore, the requested information elements related to AI/ML device testing are not applicable.

The document indicates that the device is a puncture device used to obtain micro blood samples and has a sharps prevention feature. The 510(k) submission establishes substantial equivalence to a primary predicate device (MediPurpose SurgiLance® Safety Lancet, K101145) and an additional predicate device (BD Autolancet [Microtainer® Lancet], K822209), stating that the proposed device did not change technological characteristics or material specifications from the primary predicate.

Here's the information that can be extracted relevant to acceptance criteria and device performance:

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

The document broadly states that the device was tested to meet performance and safety requirements. However, it does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it states that testing was "completed to demonstrate that the known biocompatible materials maintained compliance through manufacturing and sterilization" and lists the types of tests performed.

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

The document does not specify the sample sizes used for performance and safety testing. It also does not mention data provenance (e.g., country of origin, retrospective/prospective). This is common for this type of device where performance is typically evaluated through laboratory testing rather than clinical data from human subjects.

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

Not applicable. This device is a physical medical device, and its performance and safety are assessed through engineering and laboratory testing against established standards and predicate devices, not by expert interpretation of patient data to establish "ground truth."

4. Adjudication method for the test set:

Not applicable. This is not an AI/ML device or a device requiring expert adjudication of results.

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 device, and no MRMC study was performed.

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

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

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

Not applicable in the context of typical AI/ML ground truth. For this device, "ground truth" would be defined by engineering specifications, material properties, and functionality benchmarks established in industry standards and by predicate device performance. For instance, penetration depth would be measured directly, or sharps retraction would be visually confirmed as per design.

8. The sample size for the training set:

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

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

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

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The babyLance® is an incision device to obtain a blood sample from the heel of newborn and preemie infants. The babyLance® has a sharps prevention feature to protect the user from a sharps injury.

The MediPurpose babyLance® Heel Incision Device is designed to be a one handed automated incision device for use in heel sticks of newborn and neonatal infants (also called preemie infants). A heel stick is a procedure in which a newborn baby's heel is pricked for blood collection for use in newborn screening tests. The outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. The user breaks off the trigger lock from the device, the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision. Once the blade has been triggered, the blade is automatically retracted within the housing. The device is discarded in a sharps container after use.

The babyLance® comes in two models, preemie and newborn. The preemie model is to be used on pre term neonates, while the newborn model is for full term neonates. The two models are differentiated by color.

The provided text describes a Special 510(k) submission for the MediPurpose babyLance® Heel Incision Device. This type of submission is typically used for modifications to a legally marketed device that do not significantly alter its safety or effectiveness. The information focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria as would be common for novel AI/ML devices or higher-risk devices.

Therefore, the document does not present a table of acceptance criteria with reported device performance in the manner you specified for AI/ML or diagnostic devices. Instead, it details why the modified device is substantially equivalent to its predicate.

Here's an analysis based on the information provided, addressing your points where possible:

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

The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or AUC that would be typical for an AI/ML device. For this device (a manual surgical instrument), the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, focusing on maintaining or improving safety and effectiveness.

The document states:

• "Testing results support the determination of substantial equivalence with the results demonstrating that the babyLance® Heel Incision Device (Version 2, proposed device) has equivalent or in some cases improved results than the first version of the babyLance Heel Incision Device (predicate device)."

The "performance" is described qualitatively as:

• "same basic technology characteristics"
• "retains the sharps injury prevention features"
• "intended for piercing the heel skin of a preemie or newborn, as the predicate device"
• "indications for use are the same"
• "materials are the same except as noted under differences"
• "blades using the same medical grade stainless steel"
• "housings made of the same plastics"
• "redesigned with a flat surface against the heel for better stability"
• "trigger activation was modified with the addition of a spring to prevent the possibility of variable incisions"
• "added non patient contacting spring is medical grade stainless steel"
• "trigger plastic was changed to Nylon"
• "All the materials are known biocompatible materials"

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

The document mentions "product drop tests, cut profiles with comparisons to the predicate device, and simulated use." However, it does not specify the sample size for these tests or the data provenance (e.g., number of devices tested, number of simulated uses, origin of data).

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 type of testing performed (mechanical and simulated use) for a lancet typically does not involve human expert adjudication in the same way an AI/ML diagnostic device would.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. The testing described (drop tests, cut profiles, simulated use) does not involve human readers or a consensus process.

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

This is not applicable as the device is a manual surgical instrument (lancet), not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used

For this device, "ground truth" would relate to the physical performance and safety characteristics. The document implies the "ground truth" was established by engineering tests and evaluation of material properties:

• "product drop tests"
• "cut profiles with comparisons to the predicate device"
• "simulated use"
• Evaluation against "FDA's guidance document" for sharps prevention.
• Confirmation that "All the materials are known biocompatible materials."

8. The sample size for the training set

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

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

This is not applicable (see point 8).

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The MediPlus-Foam™ AG, MediPlus-ComfortFoam™ AG, and MediPlus-SuperFoam™ AG Dressings are indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:

• Ulcers (venous, arterial, diabetic) .
• Pressure Sores ●
• . Donor Sites
• Surgical Incisions .
• Surgical Excisions .
• . Burns (1st and 2nd degree)

The MediPlus-Foam™ AG Dressings product line is a multi-layered, sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth elastic and breathable PU foam sandwiched in between a breathable PU film and a silver net layer acting as an ... antimicrobial barrier. The product line is available in different sizes. The MediPlus-SuperFoam™ AG Dressings product line has slightly thicker PU foam and is easier to bend for covering wound areas such as elbows or heels.

The MediPlus-ComfortFoam™ AG Dressings is a multi-layered, sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth elastic and breathable PU foam sandwiched in between a breathable PU film coated with acrylic adhesive and extends to act as a border adhesive film to allow application without need for secondary dressing or fixation bandage. The silver net layer acts as an antimicrobial barrier. MediPlus-ComfortFoam AG is useful for body sites where applying a secondary dressing or fixation bandage is not practicable or not desired by the user.

MediPlus-Foam AG, MediPlus-ComfortFoamAG, andMediPlus-SuperEoam AG Dressingsare used as an antimicrobial barrier for partial and full-thickness wounds such as builts, donor sites and graft recipient sites that are judged to be at risk from infection. The product features include: managing moisture level in the wound environment, controlled silver release, and the product mesh facilitates the passage of fluids/exudates through the dressing into the PU foam for adsorption. The dressings can remain on the wound for five to seven (5-7) days dependent on the amount of wound exudates.

The provided text describes a 510(k) premarket notification for "MediPlus-Foam™ AG Dressings," a type of silver-containing wound dressing. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria for AI or diagnostic purposes.

Therefore, the provided text does not contain the information required to answer your request about acceptance criteria and a study proving a device meets those criteria, especially in the context of AI/diagnostic device performance. The document is for a traditional medical device (wound dressing) and its approval is based on equivalence to existing products, supported by biocompatibility and antimicrobial effectiveness testing, not a comparative effectiveness study involving human readers or standalone AI performance.

To directly address your numbered points based only on the provided text, the answer is that this information is Not Applicable or Not Provided for an AI/diagnostic device.

However, I can extract information relevant to the type of device and the regulatory process described:

Device Type: Medical Device (Wound Dressing), specifically Silver Containing Wound Dressing. Product Code: FRO.

Regulatory Pathway: Traditional 510(k), seeking to demonstrate Substantial Equivalence to a predicate device (Smith & Nephew Inc., Allevyn Ag Dressings, 510(k) # K063835).

Here's a breakdown of why each of your requested points cannot be answered from the provided text in the context of AI/diagnostic device performance:

1. A table of acceptance criteria and the reported device performance: Not Applicable/Provided. This document does not establish performance criteria in terms of sensitivity, specificity, accuracy, or similar metrics for an AI or diagnostic device. Performance is framed as demonstrating comparable attributes (technology, materials, intended use) and passing standard tests for biocompatibility and antimicrobial effectiveness for a physical wound dressing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not Applicable/Provided. The document refers to "testing requirements of the recognized biocompatibility standard" and "antimicrobial effectiveness" but does not detail the specific sample sizes, data provenance, or study design typical for an AI performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable/Provided. Ground truth establishment by experts is not relevant for the type of testing (biocompatibility, antimicrobial effectiveness) described for this physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable/Provided. Adjudication methods are not relevant for the 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: Not Applicable/Provided. This is a physical wound dressing; it does not involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Applicable/Provided. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not Applicable/Provided. Ground truth as defined for AI/diagnostic studies is not relevant. The "truth" for this device relates to meeting established safety and performance standards for wound dressings (e.g., non-toxic, effectively manages exudate, releases silver as intended).
8. The sample size for the training set: Not Applicable/Provided. There is no AI training set for this device.
9. How the ground truth for the training set was established: Not Applicable/Provided. There is no AI training set for this device.

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

The MediPurpose SurgiLance® Safety Lancets is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Point-of-Care (POC) tests currently using micro-sample quantities of whole blood include glucose, cholesterol, HIV, Hepatitis, A1C, Allergies, Lactate, HgB, H.Pvlori. Creatinine, Mono, PT, D-Dimer, Anemia, Thyroid, Triglycerides, Ketones, Prostate, IgE. Chagas and more. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be ergonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types.

The SurgiLance® Safety Lancet is safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently push the lancet down against the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use.

The SurgiLance® Safety Lancet comes in six models: two low flow, one medium flow, one medium-high flow, and two high flows. The six models are differentiated by their casing color.

The provided text describes the MediPurpose SurgiLance® Safety Lancet, a device designed to obtain micro blood samples while incorporating a sharps prevention feature. However, it does not include information about specific acceptance criteria or a study proving that the device meets those criteria.

The information primarily focuses on:

• Device Description: What the device is, its purpose (pricking a patient's finger for micro-sample blood draws for various diagnostic assays), its target users, and its functionality (safely retracted and concealed needle/blade, rendered inoperative after use). It also mentions different models based on depth of penetration and blood flow.
• Intended Use: "A puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury."
• Similarities and Differences to Predicate Devices: Discusses technological characteristics, materials (medical grade stainless steel for needles/blades, plastics for housing), and biocompatibility.
• Conclusion: States that the device has the "same principles of operation, intended use, and technological characteristics as the predicate devices." It also explicitly mentions that "The sharps prevention feature was fully tested to the FDA's guidance document as demonstrated in the performance testing."

Missing Information:
The document mentions performance testing for the sharps prevention feature but does not provide any details about:

• Specific acceptance criteria (e.g., success rate of sharps prevention, penetration depth accuracy, blood volume obtained, usability metrics).
• The actual results of the "performance testing."
• Study design details (sample size, data provenance, expert involvement, adjudication, standalone vs. MRMC, ground truth type, training set details).

Based on the provided text, I cannot complete the table or answer the specific questions related to acceptance criteria and study details. The document confirms that testing occurred for the sharps prevention feature, but the results and methodologies are not described.

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The babyLance™ is an incision device to obtain a blood sample from the heel of newborn and preemie infants. The babyLance™ has a sharps prevention feature to protect the user from a sharps injury.

The MediPurpose babyLance™ Heel Incision Device is designed to be a one handed automated incision device for use in heel sticks of newborn and neonatal infants (also called preemie infants). A heel stick is a procedure in which a newborn baby's heel is pricked for blood collection for use in newborn screening tests. The outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. There are three integrated components to the sharps prevention feature: a) a locking mechanism to prevent accidental activation of the device because the user breaks off the trigger locking mechanism from the device, b) once the locking mechanism has been removed, the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision, c) once the blade has been triggered, the device is immediately removed from the infant's foot which retracts the blade. The device is discarded in a sharps container after use.

The babyLance™ comes in two models, preemie and newborn. The preemie model is to be used on pre term neonates, while the newborn model is for full term neonates. The two models are differentiated by color.

The provided text describes the MediPurpose babyLance™ Heel Incision Device and its 510(k) submission (K101417). However, it does not contain a detailed study report with specific acceptance criteria that are quantitatively measured against device performance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed numerical results against predefined acceptance criteria.

Based on the information provided, here's what can be extracted and what is not available:

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)

This information is not provided in the given text. General "testing was completed" is mentioned, but details on sample size, data provenance, or study design (retrospective/prospective) are absent.

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 information is not provided in the given text. The relevant "testing" involved product drop tests, cut profiles, and simulated use, which are likely engineering/performance tests rather than requiring clinical expert-established ground truth in the way a diagnostic device would.

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

This information is not provided in the given text.

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

An MRMC comparative effectiveness study is not applicable to this device. The babyLance™ is a mechanical incision device, not a diagnostic device that involves human readers or AI assistance in interpreting results.

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

A standalone performance study in the context of an algorithm is not applicable here. This is a mechanical device.

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

The "ground truth" for the performance tests mentioned would likely be established by:

• Engineering specifications and standards: For product drop tests and sharps prevention feature functionality.
• Comparison to predicate device: For "cut profiles" and overall substantial equivalence.
• Simulated use protocols: To evaluate the device's function in a controlled environment.

There isn't a "ground truth" in the clinical diagnostic sense (like pathology or expert consensus) described for this device's performance evaluation in the provided summary.

8. The sample size for the training set

This information is not provided and is not applicable as this is a mechanical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not provided and is not applicable as this is a mechanical device, not an AI or machine learning algorithm.

Summary of missing information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing quantitative acceptance criteria and the comprehensive results of a standalone performance study. Much of the requested information (sample sizes, expert qualifications, adjudication methods, ground truth establishment for clinical endpoints, MRMC studies, training sets) is related to diagnostic devices or AI algorithms and is therefore not present or not applicable to this mechanical medical device based on the provided text. The document refers to "performance testing reports... contained in the 510(k) documentation (Section C)," which would likely contain the detailed information lacking in this summary.

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