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The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.

The Atrion Medical QL® Locking Syringe Device consists of a plastic syringe with a screw-type plunger and a locking mechanism.

The provided text is a 510(k) summary for the Atrion Medical QL® Locking Syringe Device. It describes the device, its intended use, and states that it has been found substantially equivalent to predicate devices. However, the document does not contain specific acceptance criteria, a detailed study report comparing the device to these criteria, or any information related to AI/ML device performance metrics.

Therefore, I cannot fulfill most of the requested information points, as they pertain to performance testing and evaluation metrics typically associated with AI/ML devices or more extensive clinical or bench testing beyond what is summarized here.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot provide. The document states "The materials of the device which contact the solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use." However, it does not specify what the acceptance criteria were (e.g., specific thresholds for extractables, biocompatibility, etc.) nor does it report detailed performance results against those criteria.

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

• Cannot provide. The document mentions "results of these studies" but gives no details on sample sizes or data provenance for any testing conducted.

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

• Not applicable / Cannot provide. This information is relevant for studies involving human interpretation (e.g., medical imaging devices evaluated by radiologists). The Atrion Medical QL® Locking Syringe Device is a mechanical device, and its testing would not involve "experts establishing ground truth" in this context.

4. Adjudication method for the test set

• Not applicable / Cannot provide. See point 3.

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. This is a mechanical device, not an AI/ML diagnostic tool. An MRMC study is not 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 algorithm.

7. The type of ground truth used

• Cannot provide specific details. The document states testing used "USP guidelines." For a mechanical medical device, "ground truth" would typically refer to validated measurement standards or established performance benchmarks defined by those USP guidelines (e.g., material compliance, dimensional accuracy, leak integrity, pressure handling, etc.). However, these specific ground truths are not detailed in the summary.

8. The sample size for the training set

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

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

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

Summary:
The document emphasizes "substantial equivalence" to predicate devices (Atrion Medical Products, Inc. QL® Inflation Device, K032840, and Merit Medical Systems, Inc. Viceroy™ Inflation device, K040138) rather than presenting a detailed performance study against specific acceptance criteria. The only testing mentioned is related to materials conforming to USP guidelines for safety for intended use, without providing specifics on methodology or results.

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The NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various clinical procedures as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.

The NeedleVISE™ Large-Bore Sharps Securing Device is a single patient procedure use, disposable device used for securing needles. The healthcare professional using only one hand can render the sharps harmless. The purpose of the NeedleVISE™ Large-Bore Sharps Securing Device is to provide a means to make contaminated sharps immediately unavailable for all instances in which introduction of contaminated sharps containers is not acceptable.

The provided text describes a 510(k) submission for the Atrion NeedleVISE™ Large-Bore Sharps Securing Device, focusing on establishing substantial equivalence to a predicate device. The information primarily concerns mechanical testing and an ease-of-use field trial rather than a complex AI-driven diagnostic or analytical device. As such, many of the requested criteria related to AI performance, expert review, and ground truth establishment for AI models are not directly applicable or explicitly stated in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "field trials designed to assess ease of use" and "Summary of Testing" for mechanical properties. However, it does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided. The "field trials" would likely have involved healthcare professionals, but their number, specific qualifications, or their role in establishing "ground truth" (beyond assessing ease of use) are not detailed. For mechanical tests, the ground truth would be objectively measured physical properties, not expert opinion.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of the device (a mechanical sharps securing device), adjudication methods commonly used for subjective diagnostic images are not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

An MRMC study was not done as this is a mechanical medical device, not an AI-assisted diagnostic tool. Therefore, there is no information about the effect size of human readers improving with AI assistance.

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

A standalone algorithm performance study was not done as this device is a mechanical product and does not involve any AI algorithms.

7. The Type of Ground Truth Used

For the mechanical tests (impact, puncture resistance, pull-out force), the ground truth would be objective physical measurements obtained through standardized testing procedures.

For the ease-of-use evaluation, the ground truth would be based on observational data and feedback from healthcare professionals during the field trials, likely assessing factors like intuitive design, efficient operation, and secure needle retention.

This is not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable as there is no mention of a training set for an AI model.

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

This question is not applicable as there is no mention of a training set for an AI model.

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The Atrion Epidural Anesthesia Kit is intended for use in the administration of anesthetic agents into the epidural space. It is recommended that the epidural catheter be removed or replaced every 72 hours.

The NeedleVISE™ sharps securing system is intended for use in sterile anesthesiology procedure trays as a sharps securing device for the contaminated specialized needles that do not have integral engineered sharps safety devices.

The Atrion Epidural Anesthesia Kit with NeedleVISE™ Sharps Securing System consists of components necessary for conducting repeated administration of anesthetic agents in the epidural space. The kit also contains the NeedleVISE™ sharps securing system which is a opidural opade, single patient procedure use, disposable device used for securing the specialized needles found in sterile anesthesiology procedural trays.

As provided to the user, the NeedleV/SE™ sharps securing system is retained in an upright position in the sterile procedure tray to allow for stability and one-hand insertion of sharps during a procedure. The healthcare professional using only one hand can render the sharps harmless while remaining with the patient in the sterile field. The purpose of the NeedleVISE™ sharps while rounsvitem is to provide a means to make engineered sharps control protection available within the sterile field, for all instances in which introduction of contaminated sharps containers is not acceptable.

The provided text is a 510(k) premarket notification for the Atrion Epidural Anesthesia Kit with NeedleVISE™ sharps securing system. It is a submission to the FDA for a medical device and therefore does not include acceptance criteria or a detailed study plan/results for AI-powered devices. The information provided is for a traditional medical device, not an AI/ML diagnostic tool.

Therefore, many of the requested fields cannot be extracted from the given text.

Here's an attempt to answer the questions based on the provided text, flagging where information is not available:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The term "field trials" suggests prospective data collection in a clinical setting, but no details are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The testing described focuses on mechanical properties and ease of use of a physical medical device, not diagnostic accuracy requiring expert ground truth.

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

This information is not applicable and not provided. The testing described focuses on mechanical properties and ease of use of a physical medical device, not diagnostic accuracy 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

This information is not applicable. The device is a physical epidural anesthesia kit with a sharps securing system, not an AI-powered diagnostic tool. No MRMC study was performed.

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

This information is not applicable. The device is a physical epidural anesthesia kit with a sharps securing system, not an AI-powered algorithm.

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

This information is not applicable. The testing described for the NeedleVISE™ sharps securing system involved mechanical property testing (impact, stability, puncture, leak resistance) and "field trials designed to assess ease of use." Ground truth in the sense of diagnostic accuracy is not relevant here. The "ground truth" would be the direct measurements of these mechanical properties and subjective user feedback on ease of use.

8. The sample size for the training set

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

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

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

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The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.

The provided text describes a 510(k) premarket notification for the "Atrion Medical QL® Inflation Device". It is a submission for a medical device, and as such, the concept of "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood in the context of clinical trials for diagnostic algorithms or AI models does not directly apply here.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for devices like this. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).

Here's an analysis based on the provided text, addressing the points you requested where applicable, and highlighting why some points are not relevant to this type of device and submission:

Analysis of Acceptance Criteria and Device Performance for Atrion Medical QL® Inflation Device (K032840)

1. Table of Acceptance Criteria and Reported Device Performance:

For a device like the Atrion Medical QL® Inflation Device, the "acceptance criteria" are primarily based on demonstrating that it performs equivalently to predicate devices in its fundamental functions and does not raise new questions of safety or effectiveness. The document states:

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

This information is not applicable to this type of 510(k) submission. The "test set" and "data provenance" as described in the context of AI/diagnostic algorithm validation (e.g., country of origin, retrospective/prospective) are not relevant here. This submission relies on engineering testing and comparison to predicate device specifications, rather than clinical data sets in that sense.

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

This information is not applicable. The "ground truth" for a device like an inflation device is based on objective engineering specifications (pressure, material safety, leak integrity, etc.) and its functional equivalence to predicate devices, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. This is not how the performance of an inflation device is evaluated.

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

This information is not applicable. MRMC studies are used to assess the impact of a diagnostic tool on human reader performance. The Atrion Medical QL® Inflation Device is a surgical accessory, not a diagnostic tool requiring such a study.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's safety and effectiveness determination is primarily based on:

• Engineering Specifications and Performance Testing: Demonstrating the device meets its functional requirements (e.g., pressure range, leak-free operation, material integrity).
• Predicate Device Equivalence: Showing that its design, materials, and intended use are substantially equivalent to previously cleared devices.
• Biocompatibility Testing: Ensuring materials in contact with body fluids are safe.

8. The sample size for the training set:

This information is not applicable. This is not an AI/ML device, so there is no "training set" in the computational sense. The design and testing are based on engineering principles and regulatory standards.

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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The syringe is intended for single use by healthcare professionals to dispense fluids to the body and monitor the pressure of those fluids.

The Atrion Medical QL™ Fluid Dispensing Syringe consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a connecting tube.

The provided documents discuss the Atrion Medical QL™ Fluid Dispensing Syringe, a medical device. There is no information in these documents about any AI/ML components or studies related to acceptance criteria for such components. The submission is a traditional 510(k) for a physical medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these concepts are not applicable to the content provided.

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The Atrion Medical Coated Lacrimal Intubation Set is valuable in the reconstruction of the lacrimal outflow system and also useful in canaliculus repair, lacrimal obstruction and complicated and uncomplicated dacryocystorhinostomy procedures.

Indications For Use:

1. Maintenance of lacrimal outflow post primary DCR surgical procedures.
2. Maintenance of lacrimal outflow post failed open DCR surgical procedures with complete obstruction.
3. Reconstruction of the canaliculi.

The Atrion Medical Coated Lacrimal Intubation Set consists of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible coated silicone tube of varying thickness. The intubation set is a single-use product, sterilized by radiation.

This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification summary and a subsequent FDA substantial equivalence letter for a physical medical device: the Atrion Medical Coated Lacrimal Intubation Set.

The document discusses:

• Device Name: Atrion Medical Coated Lacrimal Intubation Set
• Intended Use: Reconstruction of the lacrimal outflow system, canaliculus repair, lacrimal obstruction, and dacryocystorhinostomy procedures.
• Technological Characteristics: The device is similar to a predicate device but has a coating on the tube for increased lubricity and easier insertion.
• Summary of Safety Testing: Biocompatibility testing (cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous toxicity, implantation test, histology) was conducted to demonstrate substantial equivalence to the predicate device.
• FDA Determination: The FDA found the device substantially equivalent to a legally marketed predicate device (Ryder International Lacrimal Intubation Set, K962151) based on the safety testing and intended use.

Since this document pertains to a traditional medical device and not an AI/ML-driven device, the requested information (acceptance criteria, device performance metrics like sensitivity/specificity, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or present within the provided text.

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The inflation device is intended for single use while performing gastrointestinal (GI), gastrouterine (GU) and lacrimal duct balloon catheter dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

The Atrion Medical Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger. a manometer to measure pressure and a connecting tube. The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to between 10 and 20 atm, depending on the manometer attached.

The provided text describes a medical device, the Atrion Medical Balloon Catheter Inflation Device, and its clearance through the 510(k) pathway. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

This document is a "Summary of Safety and Effectiveness" and a subsequent FDA Letter, both primarily focused on establishing substantial equivalence to a predicate device (Ryder International Urological Balloon Catheter Inflation Device). The safety testing mentioned refers to material compatibility with contrast solution, not the functional performance of the inflation device itself in a clinical or simulated clinical setting.

Therefore, I cannot populate the requested table or answer most of the questions using the provided text.

Here's what can be extracted based on the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
Not provided in the document. The "safety testing" mentioned refers only to material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical or performance testing requiring expert ground truth is described.

4. Adjudication method for the test set:
Not applicable. No clinical or performance testing requiring adjudication 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 mechanical inflation device, not an AI-assisted diagnostic tool, and no MRMC studies are mentioned.

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:
For the "Summary of Safety Testing," the ground truth used was compliance with "USP guidelines" for material testing with contrast solution. No clinical ground truth is mentioned.

8. The sample size for the training set:
Not applicable. This is a medical device, not an AI model, and no training set is mentioned.

9. How the ground truth for the training set was established:
Not applicable. This is a medical device, not an AI model.

In summary: The provided FDA submission documents focus on comparing the Atrion Medical Balloon Catheter Inflation Device to a predicate device for substantial equivalence, with an emphasis on technological characteristics and material safety. They do not contain the type of performance study data, acceptance criteria, or ground truth information typical for diagnostic or AI-driven medical devices.

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The Atrion Medical Autogenous Tissue Collector is useful in the collection of bone or other tissue for reconstruction, implants and repair procedures, for collection of tissue for pathological analysis and for retrieving root tips and precious metals.

The Atrion Medical Autogenous Tissue Collector consists of a screen, a gasket, screen support, plastic cover and elastomer tube. The device is a single-use product, sterilized by gamma or E-Beam irradiation.

This document is a 510(k) premarket notification for the Atrion Medical Autogenous Tissue Collector, and it does not contain a study that proves the device meets acceptance criteria in the way a clinical trial or performance study would for an AI/ML device.

Instead, this submission focuses on establishing "substantial equivalence" to a predicate device (SciTech Clearline® Filter, K930144). The "Summary of Safety Testing" section explicitly states: "Based on the 510(k) "Substantial Equivalence" decision-making process and the information provided herein, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving performance, as this type of data is not present in the provided text. The device's suitability is based on its similarity to an already approved device, not on specific performance metrics established through a novel study.

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