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The Vial2Bag Advanced® 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.

The Vial2Bag Advanced® 20mm Admixture Device is a single-use, sterile, needle-less, nonpyrogenic, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is intended to be used with standard drug vials with a 20mm closure and an elastomeric stopper. The Vial2Bag Advanced® 20mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set.

The provided text describes a medical device, the Vial2Bag Advanced® 20mm Admixture Device, and its comparison to a predicate device for substantial equivalence. It is not an AI/ML device, therefore, many of the requested fields are not applicable.

Here's an analysis based on the information provided:

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

The document outlines performance testing, but the explicit acceptance criteria are not tabulated with specific performance results. Instead, it states that testing was conducted to ensure the device "met the applicable design and performance requirements." For some tests, it mentions the basis for acceptance criteria or sample size, but not the actual criteria set.

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

• Sample Size for Fragmentation Test: "sample size based on EN ISO 7864, Annex B, Section B.4." (Specific number not provided, but the standard is cited.)
• Sample Size for other tests: Not explicitly stated.
• Data Provenance: The tests are in-house, suggesting they were conducted by the manufacturer, West Pharma. Services IL, Ltd., in Ra'anana, Israel. There is no mention of retrospective or prospective data in the context of performance testing on the device itself.

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

This is not applicable as the device is a physical medical device (fluid transfer device) and not an AI/ML diagnostic or predictive tool that requires expert-established ground truth on a test set. The performance testing is based on engineering and material standards.

4. Adjudication method for the test set:

Not applicable for a physical device's performance testing. The outcomes of the tests are objective measurements against established standards or in-house criteria.

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 conducted or is relevant.

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:

The performance criteria are established through:

• In-house test methods (presumably based on engineering principles and intended function).
• International standards (e.g., EN ISO 8536-2 for Fragmentation, ISO 10993-1 for Biocompatibility).
• Comparison to a predicate device to demonstrate "substantial equivalence."

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable.

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Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist seff-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

The proposed device, NovaGuard SA Pro Safety System, is a non-sterile, single use anti needlestick accessory for pre-filled ISO standard glass syringes that are 1ml long with a max needle length of 5/8". The NovaGuard SA Pro Safety System consist of three components, syringe holder, sleeve and spring. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the injection, the needle is then covered by the sleeve protecting the user from potential sharps needle stick injury. There is a visual, tactile and audible recognition that the device safety feature has activated.

The provided document describes the NovaGuard SA Pro Safety System, an accessory for pre-filled syringes designed to prevent needlestick injuries. The submission is a 510(k) premarket notification, which means the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All testing met the required acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test. It only identifies the types of performance tests conducted and confirms they were measured against "internal performance standards."

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

The document does not specify the sample size for any of the performance tests.
The data provenance is not explicitly stated, but based on the context of a 510(k) submission from West Pharmaceutical Services, Inc., an American company, the testing would likely have been conducted in the United States (or by a contracted lab) and would be prospective (i.e., conducted specifically for this submission).

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

This type of study does not involve experts establishing ground truth in the traditional sense (e.g., diagnosing medical conditions). The ground truth for performance testing of a mechanical device like this is determined by engineering specifications and objective measurements against predefined internal standards for force, impact resistance, and functionality. Therefore, this information is not applicable.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective mechanical/performance evaluations, not subjective assessments requiring 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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is a factor. The NovaGuard SA Pro Safety System is a mechanical safety device. The document explicitly states: "The proposed device, NovaGuard SA Pro Safety System, modifications did not affect the device design impacting activation of the safety prevention feature therefore based upon their risk analysis a simulated use study was deemed not necessary." This indicates that even a human factors or simulated use study was considered unnecessary due to the nature of the modifications.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on engineering specifications and internal performance standards for mechanical integrity and functionality, rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic medical devices.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this mechanical device. This concept applies to machine learning algorithms.

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

Not Applicable. As there is no training set, there is no ground truth for it.

In summary:

The document describes performance testing for a mechanical safety device, the NovaGuard SA Pro Safety System, which focuses on demonstrating its functional safety and mechanical integrity. The relevant "acceptance criteria" are the internal performance standards against which the device was tested, and the "study" is a series of bench tests. The submission argues for substantial equivalence based on these tests and the minor nature of the design modifications compared to the predicate device. Notably, no clinical or simulated use studies were deemed necessary for this 510(k) clearance due to the nature of the device and its modifications.

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The Intradermal Adapter is an accessary to a 1ml, ½ inch fixed-needle allergy syringe indicated for use on patients ranging from children 2 year to adults, as a guide for performing intradermal injections.

The Intradermal Adapter consists of a single injection molded part manufactured from a medical grade polycarbonate. The Intradermal Adapter is a piston syringe accessory which is designed for use with 1mL allergy syringes with ½ inch (27g), (28g), (29g) needles, which are commonly used for intradermal injections given with a traditional Mantoux technique. The Intradermal Adapter has been designed to snap fit on to the end of the syringe forming an injection guide to control the depth and angle of needle insertion exposing only the minimal needle length required to perform a successful intradermal injection. The Intradermal Adapter is provided sterile in an individually packaged configuration.

The provided text describes the 510(k) premarket notification for the "Intradermal Adapter" device. Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific performance metrics and their corresponding reported values. Instead, it describes a qualitative acceptance based on the device's ability to maintain a controlled injection depth, similar to its predicate device, and the intended expansion of its indications for use.

The "Performance Testing" section states:

"Results of performance testing demonstrated that the Intradermal Adapter, when used as an accessory to the piston syringe, can be indicated for administering intradermal injections to the indicated patient population."

And regarding injection depth:

"...the peer reviewed studies presented in this submission confirm through the acquisition of data from 485 pediatric patients, that the controlled design of the ID Adapter prevents an injection depth to greater than 0.75mm which is well within the epidermis + dermis layer necessary for successful intradermal injection in a pediatric patient age group."

Based on this, we can infer the primary acceptance criterion and reported performance:

Study Details:

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

   • Sample Size: 485 pediatric patients.
   • Data Provenance: The data was acquired from "peer reviewed journal articles," indicating that the data is retrospective and originates from clinical research studies likely conducted in various countries/institutions depending on the journal articles cited. The document does not specify a single country of origin but refers to "medical literature obtained through peer reviewed journal articles."

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

   • The document does not specify the number of experts or their qualifications for establishing ground truth for the test set from the peer-reviewed studies. It references "peer reviewed journal articles" which implies expert validation inherent in the peer-review process, but not specifically for defining ground truth for this device's submission.

3. Adjudication Method for the Test Set:

   • The document does not mention a specific adjudication method like 2+1 or 3+1. The data was "acquired from medical literature" which would have established its own ground truth and validation methods within those original studies.

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 performed as described in this document. The study described focuses on device performance validation and comparison to Mantoux technique, not on human reader improvement with AI assistance.

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

   • This device is a physical medical device (an adapter for a syringe), not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance is not applicable and was not done.

6. The Type of Ground Truth Used:

   • The ground truth for the injection depth was established through the "controlled design of the ID Adapter" and confirmed by clinical data from peer-reviewed studies demonstrating a consistent injection depth "well within the epidermis + dermis layer necessary for successful intradermal injection." This combines design specifications with clinical outcomes (successful intradermal injection).

7. The Sample Size for the Training Set:

   • This document describes safety and performance testing for a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" as understood in machine learning is not applicable here. The device's design and engineering principles, informed by prior knowledge and the predicate device, serve a similar function as a "training" phase for an algorithm.

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

   • As stated above, the concept of a "training set" is not applicable. The device's design and functionality are based on principles established through prior engineering knowledge, the predicate device (K123588), and understanding of anatomical requirements for intradermal injections. The "ground truth" for its design and desired performance would have been established through biomechanical principles, anatomical knowledge, and validated clinical requirements for successful intradermal delivery.

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The Intradermal Adapter is an accessory to a 1 ml, ½ inch fixed-needle allergy syringe indicated for use as a guide for performing intradermal injections.

The Intradermal Adapter consists of a single injection molded part manufactured from a medical grade polycarbonate. The Intradermal Adapter is a piston syringe accessory which is designed for use with 1ml allergy syringes with ½ inch (27g), (28g), (29g) needles, which are commonly used for intradermal injections given with a traditional Mantoux technique.

The Intradermal Adapter has been designed to snap-fit on to the end of the syringe forming an injection guide to control the depth and angle of needle insertion exposing only the minimal needle length required to perform a successful intradermal injection. The Intradermal Adapter is provided sterile in an individually packaged configuration.

The provided text describes the West Intradermal Adapter, a medical device, and its 510(k) submission. However, it does not contain specific acceptance criteria or detailed study results that would allow for a table of acceptance criteria and reported device performance. The information is high-level and broadly states that performance testing was conducted.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study for West Intradermal Adapter

The provided 510(k) summary for the West Intradermal Adapter (K123588) broadly states that "Performance testing including bench, animal and simulated use was conducted to assess the safety and effectiveness of the Intradermal Adapter for the stated indications for use." It concludes that "Results of performance testing demonstrated that the Intradermal Adapter used as an accessory to the piston syringe is safe and effective in administering intradermal injections."

However, the document does not specify the acceptance criteria themselves, nor does it provide a detailed breakdown of the reported device performance against such criteria. Therefore, a table explicitly outlining acceptance criteria and reported performance cannot be constructed from the given text.

Below is a breakdown of the other requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Not provided in the document. The 510(k) summary states that performance testing (bench, animal, simulated use) was conducted and demonstrated safety and effectiveness, but it does not list specific quantitative or qualitative acceptance criteria, nor the detailed results achieved.

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

   • Test Set Sample Size: Not specified in the document.
   • Data Provenance: The general categories of testing mentioned are "bench, animal and simulated use." The country of origin and whether the data was retrospective or prospective are not specified.

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. Given the nature of a medical device accessory for injections, 'ground truth' in the AI/ML sense (e.g., expert consensus on image interpretation) is generally not applicable to this type of device submission. Performance testing for such devices typically involves assessing physical and functional attributes, not diagnostic accuracy requiring expert image review.

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

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., radiology reads) to establish ground truth or resolve discrepancies. For a physical medical device like an intradermal adapter, performance is usually evaluated against objective metrics (e.g., depth of penetration, stability, material integrity), not through human adjudication of interpretations.

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 study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers are interpreting data with or without AI assistance. The West Intradermal Adapter is a physical accessory, not an AI diagnostic tool, so an MRMC study is not applicable.

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

   • Not applicable. The device is a physical accessory, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.

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

   • For a physical medical device, "ground truth" would be established through objective measurements and observations during bench testing (e.g., dimensional accuracy, material strength, leakage tests) and through direct assessment of injection performance in animal or simulated use models (e.g., successful intradermal bleb formation, correct depth of injection). The document broadly mentions "bench, animal and simulated use" but does not detail the specific performance metrics or how "ground truth" for those metrics was established.

8. The sample size for the training set:

   • Not applicable/Not provided. The device is a physical accessory, not an AI/ML model, so there is no "training set."

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

   • Not applicable. As there is no training set for a physical accessory device, the establishment of its ground truth is not relevant in this context.

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The primary function of the NOVAguard™ Safety Needle is for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin. The needle stick prevention feature helps prevent accidental needle sticks by shielding the needle after use.

NOV Aguard™ is a sharps injury protection device with a passively activated safety shield. The NOV Aguard™ product has a female luer connector, compatible with a luer-lock syringe, on one side and a stainless steel cannula on the other. A shield is mounted around the cannula. This product is packaged in a rigid container sealed by a Tyvek lid to facilitate sterilization. The product is removed from the package and connected to a luer-lock syringe simultaneously; this is accomplished when attaching the syringe, turning it in a clockwise direction. During this process, the shield is automatically moved to a position where the cannula tip is exposed so that the user can easily see it. An injection is given using the standard common technique. Inserting the cannula into the patient displaces the shield causing the shield legs to move apart and act like a spring. Upon removal, the spring force of the shield legs forces the shield over the tip of the cannula into a locked position.

The NOV Aguard™ Safety Needle is an assembly of three components. A cannula, a hub and a safety shield.

The provided text describes a 510(k) submission for the NOVAguard™ Safety Needle, asserting its substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria. Therefore, the information requested in the prompt based on "acceptance criteria" and a "study that proves the device meets the acceptance criteria" is largely not present in the provided document.

Here's an analysis based on the information available and what is not present:

Missing Information:
The document does not provide:

• A table of specific acceptance criteria (e.g., minimum performance thresholds for parameters like activation force, shield engagement time, etc.).
• Reported device performance against such specific criteria.
• Details of a standalone study specifically designed to prove acceptance criteria (e.g., a performance study with a test set, ground truth, expert readers, etc.). This document focuses on demonstrating substantial equivalence to already approved predicate devices.
• Sample sizes for a test or training set in the context of performance evaluation.
• Data provenance for such tests.
• Citations of experts, their qualifications, or adjudication methods for establishing ground truth for performance.
• Information about a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Information on how ground truth for training or test sets was established.

Information that can be inferred or is partially present:

The document asserts the device's safety and effectiveness implicitly through its comparison to predicate devices, and through general quality control measures.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The "acceptance criteria" here are inferred from the claims of the 510(k) submission regarding its similarity to predicate devices and general regulatory compliance rather than explicit metrics from a performance study.

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

• Sample Size: Not specified for any performance testing. The submission relies on demonstrating substantial equivalence, not novel performance data from a specific test set.
• Data Provenance: Not applicable in the context of a performance study test set. The biocompatibility testing likely involved laboratory tests following international standards.

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

• Not applicable. The document does not describe a performance study involving expert assessment or ground truth establishment for a test set.

4. Adjudication method for the test set:

• Not applicable. No test set adjudication method is 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. This device is a physical medical device (safety needle), not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

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

• Not applicable. This is a physical device.

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

• For biocompatibility: Ground truth was established by adherence to FDA General Program Memorandum #G95-1 and ISO-10993 testing results.
• For manufacturing quality: Finished products are tested against "required release specifications." The specific criteria for these specifications are not detailed in the summary but would constitute the "ground truth" for manufacturing quality.
• For functional aspects (e.g., safety shield activation, luer-lock compatibility): Implied to be verified through engineering and functional testing, comparing favorably to predicate devices, though specific "ground truth" methodologies are not described.

8. The sample size for the training set:

• Not applicable. No "training set" in the context of a machine learning algorithm is mentioned.

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

• Not applicable.

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The Clip'n'Ject Reconstitution System is a single use device intended to transfer diluent into a vial containing a lyophilized drug, mix the diluent and the lyophilized drug, and transfer the reconstituted drug into a standard syringe. The Clip'n'Ject Reconstitution System may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physician to administer injections of prescribed medication.

Clip'n'Ject Reconstitution System is a single use device intended to transfer, mix and inject lyophilized drugs contained in vials. The Clip'n'Ject Reconstitution System shown in Figure 1 is comprised of a sliding joint and connector and is compatible with a BD Readyfill or comparable syringe(s). The syringe and needle would be legally authorized through its own clearance or customer NDA and is not intended to be cleared as part of this premarket notification. The needle is attached to the syringe by means of a standard luer connection. The sliding joint is placed onto a portion of the syringe. The syringe with the sliding joint and needle is inserted into the connector. The user attaches the Clip'n'Ject Reconstitution System to a vial by inserting the vial into the connector. The system is then activated by pressing down on the syringe. This advances the needle into the vial through the vial stopper. The user then attaches the plunger rod to the syringe. The contents of the syringe are then transferred into the vial. Mixing of the syringe contents and vial contents then occurs. After this is complete, the mixture is then drawn back into the syringe. The syringe with needle attached is then removed from the connector and sliding joint. The syringe can then be used for administration. This system is disposable and for single use only.

The provided text describes the "Clip'n'Ject Reconstitution System" and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving device performance against such criteria in the detail requested by the prompt.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a detailed performance study with acceptance criteria.

However, I can extract the information that is present concerning performance, testing, and regulatory compliance.

Here's a breakdown of what is available in the provided text:

Summary of Performance and Compliance Information from the Document:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria table or quantitative performance data (e.g., sensitivity, specificity, accuracy, error rates) is provided for the Clip'n'Ject Reconstitution System itself. The document states "A six (6) point comparison of technological characteristics... The devices were found to be substantially equivalent," indicating a qualitative comparison rather than a quantitative performance study with thresholds.

The document does list compliance with recognized consensus standards:

• ANSI/AAMI/ISO 11135-1995: Guideline for Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
• AAMI TIR 10:2000: Process Development and Performance Qualification for Ethylene Oxide Sterilization - Microbiological Aspects
• AAMI/ANSI/ISO: 10993-7:1995 ® 2001: Biological Evaluation of Medical Devices part 7: Ethylene Oxide Sterilization Residuals

However, these are standards for sterilization and biocompatibility, not for the functional performance (e.g., drug transfer efficiency, leak rates, mixing effectiveness) of the reconstitution system itself as would be presented in a performance study with defined acceptance criteria.

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. No performance study directly evaluating the Clip'n'Ject system against specific acceptance criteria is detailed. The comparison was for "technological characteristics."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment is described for a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is 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. This device is a medical device for drug reconstitution, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.

6. 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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described. The "Summary of Technological Characteristics" mentions a six-point comparison. For substantial equivalence, the "ground truth" implicitly refers to the characteristics and performance capabilities of the predicate devices.

8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.

In summary, the provided document is a regulatory submission for substantial equivalence (510(k)) and not a detailed clinical or performance study with defined acceptance criteria and results for the device's functional attributes. It focuses on comparing technological characteristics and compliance with general standards rather than specific performance metrics.

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