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The intended use of the Gettig Universal Vial Access Pin is to pierce the diaphragm of single or multi dose vials to inject or withdraw fluids without the use of a needle. The Gettig Universal Vial Access Pin is indicated for use with standard medication vials.

The Gettig Universal Vial Access Pin is a plastic "needle" used to pierce the diaphragm of single and multi dose vials for the injection or withdrawal of fluids. It consists of a single molded piece containing a luer hub for attachment to a disposable piston syringe and plastic "needle" for piercing the diaphragm. There is also a polypropylene cover for the "needle" portion.

The provided document is a 510(k) summary for the Gettig Universal Vial Access Pin, a medical device. It does not describe a study involving an AI or algorithm or human readers for diagnostic purposes. Instead, it describes a non-clinical study to demonstrate substantial equivalence to predicate devices based on engineering standards.

Therefore, many of the requested categories (e.g., AI performance, reader studies, training sets, ground truth for AI) are not applicable to this document.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance metrics in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by compliance with specific ISO standards demonstrating the safety and functionality of the physical device. The reported performance is that the device met these standards and was found substantially equivalent to predicate devices.

Study Details (Non-Clinical / Substantial Equivalence)

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

   • Sample Size: Not explicitly stated as a number of "samples" in the traditional sense of a clinical trial or AI dataset. The testing was conducted on the Gettig Universal Vial Access Pin and the predicate devices according to the listed ISO standards. The standards themselves define the number of units or tests required for compliance.
   • Data Provenance: Not applicable in the sense of country of origin for patient data. This was a non-clinical engineering/physical testing study.

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

   • Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here. This study assessed the physical characteristics and performance of a medical instrument against engineering standards. The "ground truth" is adherence to the technical specifications defined by the ISO standards. The "experts" involved would be the engineers and technicians conducting the tests and interpreting the results against the standards.

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

   • Not Applicable. Adjudication methods like 2+1 are used in clinical studies with human readers or AI outputs. This was a non-clinical, standards-based engineering test.

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 is a physical medical device (vial access pin), not a diagnostic AI. No MRMC study was conducted.

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

   • Not Applicable. This is a physical medical device; there is no algorithm involved.

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

   • Technical Compliance to ISO Standards: The "ground truth" for this substantial equivalence determination was the compliance of the device's physical properties and functionality with established international engineering standards (ISO 7886-1, ISO 594-1, ISO 594-2, ISO 8536-4). The predicate devices also serve as a benchmark for comparison within these standards.

7. The sample size for the training set:

   • Not Applicable. This is a hardware device. There is no AI or algorithm with a training set.

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

   • Not Applicable. There is no training set mentioned in this documentation.

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The intended use of the Amersham Health Needle Guard is to withdraw medications from a vial or ampule and to inject these medications subcutaneously, intramuscularly, intravenously, or via I.V. access ports. This device may aid in the prevention of needlestick injury.

The Amersham Health Needle Guard is a sterile, single use hypodermic needle designed to be used in conjunction with a disposable 3ml synnge. The device consists of six basic constituents, a Stainless Steel needle bonded to a Nylon hub, a Polypropylene cannula cover, a Nylon Luer attachment connected to a Polysulfone Luer hub used to connect to a syringe, and a PETG Protective sleeve. Once the Amersham Health Needle Guard is attached to a syringe, the cannula cover is removed, exposing the needle. In this condition the needle can be inserted into a vial or ampule to withdraw medication into the syringe or to administer the medication through injection. Once the needle is withdrawn from the patient, the sleeve is pushed forward to the locked safety position for disposal. The sharps safety feature is an active safety feature

The provided text describes the Amersham Health Needle Guard and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) nor detailed results of a study proving the device meets such criteria. The study mentioned is primarily "simulated use testing" to assess the safety feature.

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.

Here's the breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document generally states that the device "meets our specifications for hypodermic needles" and that "there were no unexpected risks in use of this device." However, specific numerical acceptance criteria for the safety feature's effectiveness (e.g., "X% reduction in needlestick injuries") are not provided.

Reported Device Performance:
The document states that "simulated use testing was conducted to determine the effectiveness of the safety feature mechanism in preventing accidental sharp object injuries" and that "based on the testing results and findings we have concluded that there were no unexpected risks in use of this device." No quantitative performance metrics (e.g., number of successful activations, percentage of avoided needlesticks during simulation) are reported.

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

• Sample Size for Test Set: Not specified in the provided text for the simulated use testing. The document mentions "simulated use testing was conducted" but does not give a number of trials, users, or instances.
• Data Provenance: The simulated use testing was conducted, implying it's prospective, but the location/country of origin is not specified.

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

• Number of Experts: Not applicable/Not specified. The "ground truth" for the simulated use testing appears to be the observation of the device's safety feature performing its intended function without unexpected risks, rather than an assessment requiring multiple human experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. Since there's no mention of multiple experts or subjective assessments, an adjudication method like 2+1 or 3+1 is not indicated.

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

• MRMC Study: No. This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a needle guard device.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm. Its "safety feature" is mechanical, not software-based in a way that would have standalone algorithmic performance.

7. Type of Ground Truth Used

• Type of Ground Truth: Observational assessment during "simulated use testing." The "effectiveness" and safety were determined by direct observation in a simulated environment, rather than expert consensus on complex images, pathology, or long-term outcomes data.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided documentation focuses on establishing substantial equivalence through non-clinical bench testing (compliance with ISO and ASTM standards) and a general "simulated use testing" for the safety feature. It lacks the quantitative performance metrics and study details typically associated with acceptance criteria for diagnostic or AI-powered devices.

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The Gettig Disposable Syringe, with or without a hypodermic single lumen needle, is intended to inject fluids into, or withdraw fluids from, the body. The syringe is designed for manual use.

The Gettig Disposable Syringe is a standard piston syringe. It consists of a calibrated hollow barrel and a moveable plunger. At one end of the barrel there is a male connector (nozzle) for the female connector (hub) of a hypodermic single lumen needle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Gettig Disposable Syringe:

Note: The provided document is a 510(k) summary for a medical device (syringe). For this type of device, the "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to predicate devices through compliance with established industry standards, rather than clinical efficacy studies often seen for diagnostic or therapeutic AI/ML devices. Therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, standalone performance with AI, etc.) is not applicable or not present in this type of submission.

Acceptance Criteria and Device Performance Study for Gettig Disposable Syringe (K022495)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample size (number of syringes) used for "standards testing." However, such testing typically involves a statistically relevant number of units to ensure product consistency and compliance.
• Data Provenance: The testing was conducted "on the Gettig Disposable Syringe and the predicate devices." This implies internal (manufacturer-sponsored) testing. The country of origin for the data is not explicitly stated, but since the submission is to the US FDA, the testing would generally adhere to international standards recognized by the FDA. The testing is prospective in the sense that it was performed on new devices manufactured for the purpose of demonstrating conformity to standards.

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

This information is not applicable to this type of device submission. The "ground truth" for a mechanical device like a syringe is its physical and functional compliance with established international standards (ISO standards). The "experts" involved would be the engineers and technicians performing the tests and comparing results against the standard's specifications.

4. Adjudication Method for the Test Set:

This information is not applicable. The "adjudication method" as described typically refers to a process of resolving discrepancies in expert interpretations, which is relevant for subjective assessments (e.g., medical image interpretation). For compliance testing against objective engineering standards, the results are typically pass/fail based on objective measurements against defined thresholds.

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. This submission is for a medical device (a syringe), not an AI/ML-driven diagnostic or therapeutic system. Therefore, no MRMC study or AI-related comparative effectiveness was performed or presented.

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

This is not applicable. This submission is for a medical device (a syringe), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is compliance with established international engineering standards (ISO 7886-1, ISO 594-1, ISO 594-2). These standards define objective criteria for syringe performance, such as leakage, force to operate plunger, Luer taper dimensions, etc.

8. The Sample Size for the Training Set:

This is not applicable. This device is a traditional mechanical medical device, not an AI/ML system that requires a "training set."

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

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

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The intended use of the device is to inject medicaments subcutaneously, intramuscularly, or via I.V. access ports. This device is intended for all adult patient populations based upon the appropriate needle size selection by the physician or clinician, and is governed by the specific drug being administered. Any pediatric applications is at the discretion of the physician and governed by the specific drug being administered.

The Gettig Styrl-Ject® Delivery System is a sterile, single use hypodermic syringe cartridge device designed to be similar to current single use products. The device consists of two basic constituents - a previously filled glass carpule, and plastic syringe. The carpule features a plastic retainer with a frangible button. When ready to use, the carpule retainer button is snapped off, exposing the rubber diaphragm insert. Until, the button is snapped the carpule needle path remains sterile, thus eliminating the need for an alcohol swab. The plastic syringe is also sterile until ready for use via the plunger rod encapsulating the needle rear extension. After removal of the threaded plunger rod, the carpule is then inserted into the clear plastic syringe allowing the syringe needle rear extension to puncture the rubber diaphragm creating a path for medicament administration. Then the syringe plunger rod is engaged with the plunger and the cover (needle or luer) is removed, to allow aspiration and injection. The syringe can be configured for a variety of needle sizes for subcutaneous injection as well as for I.V. applications via butyl and needleless access ports.

The Gettig Styrl-Ject® Delivery System is a hypodermic syringe cartridge. The provided documents detail its design, intended use, and the non-clinical bench tests performed to demonstrate its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document lists various performance bench tests. However, it does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that the tests conform to the "same protocols and standards used for the evaluation of our standard syringe products." Without specific numerical targets from those standards, it's impossible to create a table with quantitative acceptance criteria.

The document lists the following performance bench tests and implies that the Gettig Styrl-Ject® Delivery System successfully met the standards for these tests, as the FDA cleared the device.

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

The document does not specify the sample sizes used for the various bench tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective. Given that these are bench tests for a medical device prior to market, they are inherently prospective in nature, being performed as part of the device's development and regulatory submission.

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

This information is not applicable to the provided documentation. The "ground truth" for a device like a hypodermic syringe is established through physical and mechanical testing against recognized standards and protocols, not through expert human assessment of subjective data (like in areas such as image analysis). The "experts" involved would be the engineers and technicians conducting the tests and interpreting the results against established engineering specifications. Their qualifications are not detailed.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human assessment where there's a need to resolve discrepancies in expert opinions (e.g., in reading medical images). For physical bench tests, the outcome is objective (e.g., a measurement, a pass/fail according to a tolerance), and thus, expert adjudication in that sense is not performed.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the AI's impact on human performance. The Gettig Styrl-Ject® Delivery System is a physical medical device, not a diagnostic one, so an MRMC study is not relevant.

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

Yes, in essence, standalone performance testing was done. The listed "Performance Bench Tests" are precisely this – tests of the device's inherent physical and mechanical properties and functionality, independent of human interaction during the testing phase (though human technicians conducted the tests). The device itself (not an algorithm) is the "standalone" entity being tested for its performance against defined benchmarks.

7. The Type of Ground Truth Used:

The ground truth used for these bench tests is based on established engineering specifications, industry standards, and recognized test protocols for hypodermic syringes and their components. This forms an objective "ground truth" against which the device's performance is measured. For example, a "Carpule Leak Test" would have specific criteria for what constitutes a leak according to a standard, and the test result would be compared to that.

8. The Sample Size for the Training Set:

This information is not applicable. The Gettig Styrl-Ject® Delivery System is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. Manufacturing process control and design iterations would involve testing different batches, but this is distinct from an AI training set.

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

This information is not applicable for the same reasons as point 8.

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