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The InviroStripe Standard Luer Lock Syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.

The InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body. The piston syringe is a plastic disposable htpodermic syringe made of the following components: - 1 -Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle. - 2 Plunger - The plunger is used to aspirate and inject fluids into and out of the syringe. - 3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger. - 4 Cap - Covers the cannula/needle until the syringe is to be used. The InviroStripe Luer Lock Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a Blister Pack. One Hundred syringes without needles are packaged in a Dispenser Box. Each Blister Pack, Dispenser Box and Case are labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

The Inviro Medical Luer Lock Syringe (InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock syringes) is a Piston Syringe used to inject medicines and vaccines into, or withdraw fluids from, the body.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission indicates compliance with several international and national standards. The acceptance criteria essentially are successful adherence to the requirements outlined in these standards. The device's reported performance is its claim of successful compliance.

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

The 510(k) summary does not specify the exact sample sizes used for the performance tests conducted under the listed ISO/ANSI standards. It simply states that "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." These standards themselves often outline appropriate sample sizes for various tests.

• Data Provenance: The document does not explicitly state the country of origin of the data. Given the "Submitter Information" indicates Inviro Medical, Inc. is located in Lawrenceville, GA, USA, it is highly probable that the testing, and thus the data, originated in the United States or was conducted on devices manufactured for the U.S. market. The study appears to be retrospective in the sense that the results of the performance testing are being presented to demonstrate compliance for regulatory approval.

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

For this type of device (piston syringes), "ground truth" is not established by human experts in the sense of clinical diagnoses or image interpretations. Instead, the "ground truth" is determined by the objective and quantifiable pass/fail criteria defined within the specified international and national standards (ISO, ANSI/AAMI).

• Number of Experts: Not applicable in the context of human interpretation.
• Qualifications of Experts: Not applicable. The "experts" are the standards themselves and the engineers/technicians who perform the tests according to those standards.

4. Adjudication Method for the Test Set

Not applicable. The performance tests against established standards have objective pass/fail criteria, meaning there is no need for subjective adjudication by multiple experts. The outcome is determined by whether the device's measured properties fall within the specified limits of the standard.

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

No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the goal is to assess the impact of an AI algorithm on human performance. The Inviro Medical Luer Lock Syringe is a physical medical device, not a diagnostic AI system, so an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The compliance testing against ISO and ANSI/AAMI standards represents a "standalone" evaluation of the device's physical properties and performance characteristics. This evaluation does not involve a human-in-the-loop scenario, as the device itself is being tested to ensure it meets predefined technical specifications. There is no "algorithm" in the typical AI sense to be evaluated.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on objective, quantifiable specifications and pass/fail criteria defined in recognized international and national standards (e.g., ISO 594-1, ISO 7886-1). This is a form of engineering/performance standard compliance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this device.

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The InviroSnap 50 and 100 unit Insulin Safety Syringe is used to inject insulin into the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.

The Inviro Medical InviroSnap 50 and 100 unit Insulin Safety Syringe is used to inject insulin into the body. The InviroSnap Insulin Safety Syringe is designed to aid in the prevention of needle stick injuries.

The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components:

• Barrel
• Plunger
• O-Ring
• Stopper
• Hub Assembly
• Cannula
• Locking Ring
• Cap

After use, the health care professional fully depresses the plunger to engage the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container.

The InviroSnap insulin Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack.

Here's a summary of the acceptance criteria and study information based on the provided text, structured according to your request:

Acceptance Criteria and Device Performance

Study that Proves the Device Meets the Acceptance Criteria:

A "Special 510(k)" submission was made, indicating that the device is substantially equivalent to a previously cleared predicate device. Performance testing was conducted to demonstrate compliance with the applicable sections of the three voluntary international standards listed above. The document concludes that "The InviroSnap 50 and 100 unit Insulin Safety Syringes are substantially equivalent to the InviroSnap 100 unit Insulin Safety Syringe in indications for use and technological characteristics."

Additional Study Information:

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

   • The document mentions "Performance testing" but does not specify the sample size used for these tests.
   • No information about data provenance (e.g., country of origin) is provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The device is a physical medical device (syringe), and ground truth is established through engineering and performance testing against international standards, not through expert human interpretation of data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for performance testing of a syringe against engineering standards.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI algorithm for diagnostic imaging but a physical safety syringe.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical safety syringe, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is defined by its ability to meet the specifications and performance requirements outlined in the international standards (ISO 8537:1991, ISO 7886-4:2006, ISO 11135:2007). This is a form of engineering and performance standard compliance.

7. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is a physical device, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable, for the same reason as above.

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The InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.

The Inviro Medical InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. The InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries. The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components: Barrel, Plunger, O-Ring, Stopper, Luer Assembly, Cannula, Locking Ring, Cap. After use, the health care professional fully depresses the plunger to engage the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container. The InviroSnap Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack.

The provided text describes the regulatory clearance for the InviroSnap Safety Syringe (K092430). The submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria tied to human or algorithm performance metrics. Therefore, a direct answer to some of the requested points, such as "number of experts used to establish ground truth" or "effect size of human readers with AI," is not applicable as these types of studies were not performed for this 510(k) submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against recognized international standards. The acceptance criteria are implicitly defined by compliance with these standards, not by specific numerical thresholds for, for example, diagnostic accuracy or clinical outcomes.

2. Sample Size for Test Set and Data Provenance

The provided text does not specify a "test set" in the context of clinical data for performance evaluation. The performance testing was based on compliance with international standards, likely involving engineering tests, material evaluations, and sterilization validation, not patient-specific data. Therefore, details like "country of origin" or "retrospective/prospective" are not applicable.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this type of device (a safety syringe) is established through engineering and materials testing to meet specified performance standards and safety features, not through expert consensus on medical images or clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in this submission.

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

No. An MRMC study is typically performed for diagnostic devices or AI algorithms that analyze clinical data and require human interpretation. This device is a physical medical device (safety syringe); therefore, an MRMC study was not conducted. The submission does not mention AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical safety syringe, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance, as demonstrated in the 510(k) submission, is compliance with established international performance and safety standards (ISO standards). This involves demonstrating that the device physically functions as intended (e.g., proper luer lock, needle retraction, sterilization efficacy) through laboratory and engineering tests, rather than clinical outcomes or expert diagnoses.

8. Sample Size for the Training Set

Not applicable. There was no "training set" in the context of machine learning or clinical data analysis for this device. The development and testing of a physical medical device do not typically involve this concept.

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

Not applicable. As there was no training set, this information is not relevant.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The study proving the InviroSnap Safety Syringe meets acceptance criteria was a series of non-clinical performance tests demonstrating compliance with relevant voluntary international standards. The 510(k) submission states: "Performance testing consisted of compliance to the applicable sections of the following voluntary standards: ISO 594-1:1986, ISO 594-2:1986, ISO 7886-1:1993, ISO 7886-4:2006, and ISO 11135:2007."

The rationale for regulatory clearance (510(k)) was based on the demonstration of substantial equivalence to a predicate device (InviroSnap 1, 3, 5 and 10 ml Safety Syringe, K032780). The submitter asserted that "Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness." This means that the device was shown to perform comparably to an already legally marketed device and pass the stipulated engineering and sterilization standards. No clinical studies with human participants were required or conducted as part of this specific 510(k) submission to prove the device's safety or effectiveness beyond its equivalence and compliance with standards.

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The InviroBlunt and InviroBlunt w/EZ Wings Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.

The InviroBlunt/InviroBlunt Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites. The family of InviroBlunt Plastic Cannulas are 18 gauge stainless steel blunt cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. The InviroBlunt Cannulas are used in conjunction with a syringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.

Here's an analysis of the provided text regarding the InviroBlunt/InviroBlunt w/EZ Wings Cannula, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device (K083851). It focuses on demonstrating substantial equivalence to a predicate device, not on presenting a comprehensive study of device performance to specific clinical acceptance criteria in the way a novel AI algorithm might. Therefore, many of the requested data points (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not present in this type of FDA submission summary for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify the sample size for any "test set" in the context of clinical or performance studies. For a physical device like a cannula, "test set" would typically refer to a number of units tested. The information provided is a summary of non-clinical tests.

• Sample Size: Not specified.
• Data Provenance: The tests described are non-clinical performance requirements, likely conducted internally by the manufacturer (Inviro Medical) in a controlled laboratory environment. No country of origin for clinical data is provided as no clinical data is referenced in this summary.

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

Not applicable. The "ground truth" for the performance criteria listed (e.g., smooth surface, dimensional accuracy, force requirements) would be established by engineering specifications and objective measurements, not by expert medical opinion in the way clinical ground truth is established for diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance criteria are based on objective, non-clinical engineering and performance metrics, not on human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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 (cannula), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to readers or AI assistance is irrelevant.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria are:

• Engineering Specifications: Dimensional requirements, force measurements (Cap Pull off, penetration, bending, tip breaking), flow rate.
• Visual Inspection Criteria: Smoothness, absence of contamination/defects/flash/burrs, invisible lubricant, correct color.
• Pressure Resistance Standards: Ability to withstand 330 kPa for 30 seconds without leakage.

8. The Sample Size for the Training Set

Not applicable. This is for a physical device, not an AI algorithm, so there is no "training set."

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

Not applicable. There is no training set for a physical device.

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The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicine or vaccines into, or withdraw fluids from, the body.

The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.

The piston syringe is a plastic disposable htpodermic syringe made of the following components:

• 1 Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
• 2 Plunger - The plunger is used to aspirate and inject fluids into and out of the syringe.
• 3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger.
• 4 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
• 5 Cap - Covers the cannula/needle until the syringe is to be used.

The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a tray pack. Twenty five syringes without needles are packaged in a tray and sealed with a tyvek Lid. Each tray pack and case is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

This is an analysis of a 510(k) premarket notification for a medical device, specifically hypodermic syringes. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against acceptance criteria in the way a diagnostic AI device would.

Therefore, the requested information elements related to AI performance, ground truth, expert consensus, and sample sizes for training/test sets are not applicable to this document. This submission is for a physical medical device (syringes), not a diagnostic algorithm.

However, I can extract the acceptance criteria based on voluntary standards and the reported device performance as stated.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, the "acceptance criteria" are compliance with established international and national standards for medical devices, and the "reported device performance" is the claim of compliance to these standards.

The study proving the device meets these criteria is referred to as "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." The conclusion of the submission is that the device is "substantially equivalent" to its predicate based on these tests and technological characteristics.

Non-Applicable Information for this Device (Hypodermic Syringes)

The following points are not applicable to the provided 510(k) summary for the InviroStripe hypodermic syringes, as this is a physical medical device and not an AI/diagnostic algorithm:

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing for physical devices typically involves engineering tests, material testing, and sterilization validation, not data sets in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI is not relevant here. Device performance is assessed against technical specifications and standard requirements.
4. Adjudication method for the test set: Not applicable. Adjudication relates to expert human review of data, which is not part of physical device testing.
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 for AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a physical syringe. The "ground truth" for this device's performance would be its adherence to the physical and functional specifications defined by the voluntary standards.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable. There is no AI model to train.

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The InviroLink and InviroLink w/EZ Wings Plastic Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.

The InviroLink/InviroTip Plastic Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites.

The family of InviroLink Plastic Cannulas are 18 gauge equivalent plastic cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. Following is a list of the InviroLink Plastic Cannulas:

1. InviroLink, Model # 130001
2. InviroLink with EZ wings, Model # 130501

The InviroLink Plastic Cannulas are used in conjunction with a syringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.

This looks like a 510(k) summary for a medical device called InviroLink/InviroLink w/EZ Wings Plastic Cannula.
The summary does not contain information about an AI/ML device, therefore, the following information is not available:

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
2. 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)
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
7. The sample size for the training set
8. How the ground truth for the training set was established

However, it does provide acceptance criteria and a summary of the nonclinical and clinical tests performed.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Study that Proves the Device Meets the Acceptance Criteria:

The document states: "The InviroLink/InviroLink w/EZ Wings Plastic Cannulas met the following product/performance requirements: A visual inspection of the device showed that the surface of the device was smooth and without oil contamination or extraneous matter or other defects. The lubricant on the cannula was invisible and the device was free of flash and burrs."

The study described is a series of nonclinical performance tests conducted by Inviro Medical. The details provided are a direct summary of the outcomes of these tests, confirming that the device achieved the established product/functional requirements. There is no specific study name or reference provided beyond this summary.

Breakdown of the Nonclinical Tests:

• Visual Inspection: This involved physical examination to ensure the device's surface quality (smoothness, absence of contaminants, defects, flash, burrs) and the visibility of lubricant.
• Color Check: Verification that the cannula and cap colors conformed to product specifications.
• Dimensional Testing: Measurement of all components of the InviroLink and InviroLink w/EZ Wings to ensure they met the specified dimensional requirements outlined in the part/assembly drawings.
• Functional Testing: This encompassed several specific tests:
  • Cap Pull off Force: Measuring the force required to remove the cap.
  • InviroLink/Syringe interface: Assessing the integrity and fit of the connection to the syringe.
  • Penetration: Evaluating the ease and effectiveness of penetrating rubber-stoppered vials or septums.
  • Bending: Testing the device's resistance to bending.
  • Tip breaking Forces: Determining the force at which the tip would break.
  • Flow rate: Measuring the rate at which fluids can be dispensed through the cannula.
• Interface Testing: This focused on the security and integrity of the critical connections:
  • Medicine Vial Stopper Interface: Testing the seal between the cannula and a medicine vial stopper.
  • Syringe Luer Lock Fitting Interface: Testing the seal between the cannula and the syringe luer lock.
  • Both interfaces were tested to withstand 330 kPa of pressure for 30 seconds without leakage.

The document presents the outcomes of these tests as conclusive proof that the device met all listed product/performance requirements. There's no mention of a traditional "study" in the sense of a published clinical trial or a detailed methodology report beyond this summary of successful outcomes.

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The InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.

The Inviro Medical InviroSnap Safety Syringe is used to inject medicines and vaccines into, or withdraw fluids from, the body. The InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.

The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components:

• l Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
• 2 Plunger - After using the syringe, the plunger is retracted and snapped off leaving the needle in the barrel of the syringe.
• 3 O-Ring - The O-ring minimizes the risk of leakage around the Adapter.
• Stopper The Stopper maintains the fluid in the barrel 4 between the Adapter and Plunger.
• Adapter The Adapter facilitates passage of the fluid 5 between the cannula and the barrel. In addition, the cannula/needle is bonded to the Adapter.
• 6 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
• 7 Cap - Covers the cannula/needle until the syringe is to be used.

After use, the health care professional fully depresses the plunger to engage the Adapter Needle assembly. Once the Adapter Needle Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container.

The InviroSnap Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

This 510(k) summary describes a special 510(k) submission for the InviroSnap Safety Syringe, which is an updated version of a previously cleared device. The submission primarily focuses on demonstrating substantial equivalence to the existing predicate device through compliance with recognized standards rather than extensive clinical studies.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance testing. The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond the general statement that "performance testing consisted of compliance to the applicable sections of the following voluntary standards." This suggests that the testing was likely conducted in a controlled lab environment and is not based on patient data.

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

Not applicable. This submission relies on engineering and device performance standards, not expert-adjudicated clinical data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as the testing is based on engineering standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical and functional equivalence of the device to standards, not human reader performance with or without AI assistance.

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

Not applicable. This device is a physical medical device (syringe), not an algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the specified voluntary international standards (ISO 594-1, ISO 594-2, ISO 7886-1, ISO 7886-3). These standards define the expected physical and functional characteristics for syringes.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device. The design and manufacturing process would adhere to an established quality system and engineering specifications, which are based on the requirements of the referenced ISO standards.

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