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The UltiCare Disposable Pen Needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

The UltiCare Disposable Pen Needles are sterile, single-use, Type A, hypodermic single lumen needles designed for use with insulin pen injector devices. The UltiCare Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare Disposable Pen Needles are non-toxic and non-pyrogenic, and are available in a variety of needle sizes (29 gauge to 32 gauge) and lengths (3/16" to 1/2").

The provided document describes the UltiMed UltiCare Disposable Pen Needles and their substantial equivalence to predicate devices, rather than an AI device. As such, the typical acceptance criteria and study designs for AI/ML devices, such as those related to effect size for human readers with AI assistance, standalone algorithm performance, or training set details, are not applicable.

The acceptance criteria for the UltiMed UltiCare Disposable Pen Needles are based on meeting established voluntary standards and FDA guidance for medical devices of this type, demonstrating substantial equivalence to predicate devices. The study conducted to prove the device meets these criteria is primarily non-clinical performance testing and biocompatibility testing.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of an AI/ML algorithm. For the non-clinical performance testing of the pen needles, the sample sizes for the various tests (e.g., those detailed in ISO standards) are not explicitly stated. This would typically be defined within the test protocols for each specific standard. The data provenance is implied to be from laboratory testing conducted by UltiMed Inc.

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 an AI/ML context is not relevant for this device. The "ground truth" for the device's performance is determined by its physical and material properties meeting the specifications of the referenced ISO standards.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth from multiple expert opinions, neither of which is described for this 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, as this is not an AI device.

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

Not applicable, as this is not an AI device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective measurements and adherence to established voluntary international and national standards. For example, for mechanical properties, there would be measurable criteria outlined in ISO 7864; for biocompatibility, the results of tests outlined in ISO 10993-1 would form the ground truth; for sterilization, the validation to ISO 11135.

8. The sample size for the training set

Not applicable, as this is not an AI device and therefore has no "training set."

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

Not applicable, as this is not an AI device and therefore has no "training set."

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UltiMed UltiCare Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety shield aids in the prevention of needle stick injuries.

The UltiMed UltiCare Safety Syringe is a standard piston type syringe with permanently attached (uni-body) needle and protective shield. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, plunger rod with gasket, permanently attached hypodermic single lumen needle, needle cap, and protective shield. The UltiMed UltiCare Safety Syringes are non-toxic and nonpyrogenic, and will be available in a variety of combinations of syringe sizes (0.5 to 3.0 ml (cc)), needle sizes (27 to 21 gauge), and needle lengths (5/16" to 1½''). The protective shield is made of clear plastic and is furnished in a retracted position with the needle cap over the needle. When the needle cap is removed, medication can be drawn and injected in the conventional manner. After the injection, the protective shield is engaged by sliding it away from the finger grip to an extended position over the needle and then applying a turning or rotating motion to lock the shield in place.

Here's a breakdown of the acceptance criteria and study information for the UltiMed UltiCare Safety Syringe, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the UltiMed UltiCare Safety Syringe and states its substantial equivalence to a predicate device. Instead of specific performance metrics with numerical targets, the acceptance criteria are defined by compliance with a set of international ISO standards. The "reported device performance" is the statement of this compliance.

Table of Acceptance Criteria and Reported Device Performance

Study Information

The provided text describes the submission for a 510(k) premarket notification, which focuses on demonstrating "substantial equivalence" rather than a traditional clinical study with a test set and ground truth in the context of diagnostic AI.

Here's the information regarding the "study" (or rather, the evidence presented for substantial equivalence):

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

   • The document does not specify a "test set" in the sense of a dataset for evaluating an AI algorithm.
   • It mentions a "simulated clinical use study," but no details regarding its sample size, design, or data provenance (e.g., country of origin, retrospective/prospective) are provided. It's likely this refers to a benchtop or usability study for the physical device.

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

   • This concept is not applicable to the information provided. There is no "ground truth" establishment by experts for a test set in the context of an AI or diagnostic device being evaluated. The evaluation is primarily against engineering standards and comparison to a predicate device.

3. Adjudication Method for the Test Set:

   • Not applicable, as there is no "test set" in the context of an AI algorithm with expert adjudication.

4. 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, as this is a physical medical device (syringe) and not an AI or diagnostic imaging system that would typically undergo such a study.

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

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

6. The Type of Ground Truth Used:

   • The primary "ground truth" here is compliance with established international standards (ISO standards) for mechanical performance, sterility, biocompatibility, and packaging of hypodermic syringes and needles. The other aspect of "ground truth" is that the predicate device (Sherwood Medical Co. Monoject Safety Syringe) is legally marketed and accepted as safe and effective.

7. The Sample Size for the Training Set:

   • Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

   • Not applicable, as there is no training set.

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The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin pen needles in the home. After use the used pen needle can be placed back into the container for safe storage and eventual disposal according to local regulations.

The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container contains 100 insulin pen needles. Pen needles can be removed from the dispenser as needed, and used pen needles can be removed and deposited back into the top of the container for safe storage. When all 100 pen needles have been used and discarded into the container, the container is disposed according to local regulations. The disposable pen needles and UltiGuard container are intended for single use only.

The UltiGuard™ Home Insulin Pen Needle Dispenser and Sharps Container is a Class II medical device (product code MMK) intended for home use to transport, store, and dispense insulin pen needles, and to safely store used pen needles for eventual disposal. The device's acceptance criteria and the study proving it meets these criteria are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided 510(k) summary does not specify a sample size for any test set nor does it provide details on data provenance (e.g., country of origin or whether data was retrospective or prospective). The evaluation is based on compliance with established standards and comparison to a predicate device.

3. Number and Qualifications of Experts for Ground Truth

The summary does not mention the use of experts to establish ground truth for a test set. The assessment is based on compliance with engineering standards and substantial equivalence, not clinical performance requiring expert interpretation.

4. Adjudication Method

No adjudication method is mentioned as there was no test set requiring expert review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or mentioned in the provided text. The device is a physical container and dispenser, not an AI or imaging diagnostic tool that would typically involve a multi-reader multi-case study.

6. Standalone Performance Study

A standalone performance evaluation was done in the sense that the device was tested against specific engineering standards (BS 7320 and ASTM F2132). The conclusion of the submission relies on the device's ability to meet these published standards, demonstrating its physical and material performance characteristics relevant to its function as a sharps container and dispenser.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on compliance with recognized engineering standards (BS 7320 and ASTM F2132) and detailed descriptive data demonstrating its technical characteristics and intended use are substantially equivalent to a legally marketed predicate device. This is a non-clinical assessment.

8. Sample Size for Training Set

The concept of a "training set" is not applicable here as the device is a physical product and not an AI or machine learning algorithm.

9. How Ground Truth for Training Set Was Established

Similarly, the establishment of ground truth for a training set is not applicable given the nature of the device and the substantial equivalence pathway used for its clearance.

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The Insulin Syringes (0.3 to 1.0 cc) are intended for subcutaneous injection of U-100 insulin.

The UltiCare disposable syringes and needles (0.3 to 3.0 cc) are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceur icul directly to the patient. As an alternative use the product will allow administration of the pharmacenty to to the patient via an intravenous port, heparin lock, or saline lock.

The UltiCare Disposable Syringes and Needles and Insulin Syringes are standard piston type syringes with permanently attached (unibody) needles. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, a plunger rod, and a hypodermic single lumen needle. The UltiCare Disposable Syringes and Insulin Syringes are non-toxic and non-pyrogenic, and are available in a variety of combinations of syringe sizes (0.3 to 3.0 cc (ml)), needle sizes (31 to 22 gauge), and needle lengths (5/16" to 1.5").

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the way typically found for AI/ML-based medical devices or diagnostic tools. The document is a 510(k) summary for a traditional medical device (syringes and needles), which focuses on "substantial equivalence" to predicate devices rather than novel performance metrics and validation studies common for AI.

Therefore, I cannot populate the requested table and answer the questions related to AI/ML device performance validation. The document describes the device, its intended use, and lists predicate devices, but it does not include data on acceptance criteria, a test set, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an algorithm.

Here's why the information isn't available in the provided text:

• Device Type: The device is a traditional disposable syringe and needle, not an AI/ML-based diagnostic or imaging device. Its clearance hinges on demonstrating substantial equivalence to existing devices in terms of materials, design, and intended use, rather than demonstrating specific accuracy or performance metrics against a ground truth dataset.
• 510(k) Summary Nature: A 510(k) summary (especially for traditional devices) typically outlines the device description, intended use, predicate devices, and a comparison demonstrating substantial equivalence. It generally does not include extensive clinical study data with detailed performance metrics, especially not in the context of AI/ML validation.
• Lack of Performance Data: There are no sections discussing performance metrics like sensitivity, specificity, AUC, or a "reported device performance" that would align with acceptance criteria for a diagnostic algorithm. The "performance" for these devices would typically relate to sterility, material compatibility, and physical dimensions, which are not outlined in such a summary.

Therefore, I must state that the requested information cannot be extracted from the provided document.

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The UltiCare Disposable Syringe is used to draw a quantity of pharmaccutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.

The UltiCare 3 ml Disposable Syringe is a standard piston type hypodermic syringe, with a black colored protective needle cap. This device is a sterile, single-use, disposable piston svringe with permanently affixed hypodermic single lumen needle. This device is a sterile, single use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The UltiCare 3 ml Disposable Syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The UltiCare 3 ml Disposable Syringe is available in a 3.0 cc syringe capacity with a 22 GAUGE x 1½" hypodermic single lumen needle.

This document is a 510(k) summary for a disposable medical device (syringe), not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and compliance with established performance standards for syringes.

Here's the information that is extractable and relevant from the provided document, presented as closely as possible to the requested format:

Acceptance Criteria and Device Performance for UltiCare™ Disposable Syringe (3 ml/cc)

This 510(k) submission primarily relies on demonstrating substantial equivalence to two predicate devices and compliance with recognized international standards for syringes. The "acceptance criteria" are implicitly these standards, and the "reported device performance" is the claim of meeting these standards and being substantially equivalent.

1. Table of Acceptance Criteria and 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)

• Not Applicable. This submission is for a conventional medical device (syringe), not an AI/ML device. Performance is demonstrated through substantial equivalence to predicate devices and compliance with ISO standards, rather than through a clinical test set with specific sample sizes and data provenance as would be relevant for an AI/ML algorithm. Testing would have typically involved laboratory-based verification and validation of engineering design and manufacturing against the ISO standards. The document does not detail this testing (which is common for 510(k) summaries of such devices).

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. See point 2. Ground truth establishment by experts is not a concept applied to the evaluation of a disposable syringe in this context.

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

• Not Applicable. See point 2.

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 non-AI device.

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

• Not Applicable. This is a non-AI device.

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

• Not Applicable. For this device, "ground truth" equates to the physical and functional characteristics specified in the ISO standards (e.g., sterility, dimensional accuracy, material properties, fluid delivery pressure/flow) and the functionality of predicate devices. These are not established by expert consensus, pathology, or outcomes data in the way an AI algorithm's performance is evaluated.

8. The sample size for the training set

• Not Applicable. This is a non-AI device; there is no training set.

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

• Not Applicable. This is a non-AI device; there is no training set or associated ground truth establishment process.

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The product is a standard piston type hypodermic syringe. Such device will be used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use, and which the product will be specifically marketed for, the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.

The Ulti Care Low Dead Space syringe is substantially equivalent to the Becton Dicksnson MedSaver The syringe. The device is intended to minimize the consumption of expensive pharmacenticals by reducing the distance between the calibrated barrel of the syringe and the needle. The devise has a permanently attached needle that eliminates the tip and hub-of a normal needle/syringe combination. This results in less waste of pharmaceutical and greater efficiency. The intended device has the same technological characteristics as the presently marketed Becton Dickinson MedSaver using a manually operated piston type hypodemic syringe, injected molded plastic parts, a synthetic latex gasket and permanently attached stainless steel needle.

The provided text describes a 510(k) submission for the UltiCare Disposable Syringe. It focuses on establishing substantial equivalence to a predicate device (Becton Dickinson MedSaver™) and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document is a regulatory submission for market clearance, outlining the device's intended use, technological characteristics, and comparison to a legally marketed predicate. It does not detail specific performance studies or acceptance criteria beyond stating substantial equivalence.

Therefore, I cannot provide the requested information based on the given text.

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