Search Results

The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are manufactured from a non-absorbable acetal polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

The provided FDA 510(k) clearance letter pertains to a new version of a physical medical device (surgical clips), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any of the information requested in points 2-9, as these points are specific to the evaluation and validation of AI/SaMD products, which involve concepts like:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC): This is relevant for diagnostic or predictive AI systems.
• Sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details: These are critical components of validating AI model performance to ensure its accuracy, robustness, and generalizability.

Since the Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are physical devices, their acceptance criteria and proof of efficacy are based on benchtop non-clinical performance testing and biocompatibility assessments, which are detailed in the "Performance Data" section (Section J) of the 510(k) summary.

Here's how to interpret the provided document in the context of your request:

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

The document lists the following non-clinical performance tests and biocompatibility assessments that were conducted. While explicit "acceptance criteria" are not numerically stated in this summary for each test (as they typically would be in a full test report), the statement "in order to ensure the device performed equivalently to the predicate" implies that the new device's performance in these tests met established safety and efficacy standards, likely mirroring or demonstrating similar performance to the predicate device.

For the remaining points (2-9), the information is not applicable to a physical device like surgical clips.

• 2. Sample sized used for the test set and the data provenance: Not applicable to physical clips. Testing involves benchtop models or animal studies for implantation, not human data sets.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for physical clips is established through engineering and biological testing standards, not expert annotation of data.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for AI/SaMD to compare human performance with and without AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concept applies to AI algorithms.
• 7. The type of ground truth used: For physical devices, ground truth for efficacy and safety is established through validated test methods (e.g., mechanical strength testing, leak resistance, biocompatibility standards, often with reference to predicate devices).
• 8. The sample size for the training set: Not applicable. This relates to AI model development.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the testing performed for a physical medical device (surgical clips) to demonstrate its substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility rather than AI/software performance metrics.

Ask a specific question about this device

The LMA® Fastrach™ ETT Single Use is indicated for tracheal intubation through the LMA® Fastrach™.

The Stabiliser Rod is indicated for use during removal of the LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the LMA® Fastrach ™ ETT Single Use in place.

The LMA® Fastrach™ ETT Single Use has been developed specifically for use with the LMA® Fastrach™. It is a straight, cuffed, wire-reinforced tube with a Murphy Eye and a standard 15mm connector.

The LMA® Fastrach™ ETT Single Use has a pilot balloon with a luer check valve and a unique, soft, moulded tip for atraumatic passage through the vocal cords. As a reference during intubation, the LMA® Fastrach™ ETT Single Use has depth markers to indicate the distance to the distal tip of the LMA™ airway. The LMA® Fastrach™ ETT Single Use is radiopaque along its full length and its tip is made out of a radio opaque material to enhance its visibility in x-rays.

Accessory device: The Stabiliser Rod Single Use is an accessory and it is indicated for use during removal of the reusable LMA® Fastrach™ and LMA® Fastrach™ Single Use after intubation to keep the Endotracheal Tube (ETT) in place.

The provided 510(k) clearance letter and summary for the LMA Fastrach ETT SU is for a medical device (a tracheal tube), not a diagnostic AI/ML algorithm. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets those criteria (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device, as is standard for 510(k) submissions of traditional medical devices. This is achieved primarily through:

• Comparison of features: Highlighting similarities in classification, product code, regulation number, size range, cuffed design, radiopacity, sterilization method, and eye (Murphy).
• Performance data (bench testing): Verifying that the new device performs similarly to the predicate in terms of physical characteristics and durability.

Here's an analysis of the provided text in the context of your request for AI/ML device study details:

Acceptance Criteria and Device Performance (Based on provided text for a non-AI/ML device):

The "acceptance criteria" for this traditional medical device are primarily about demonstrating that it is substantially equivalent to a legally marketed predicate device and that it meets established engineering performance standards for tracheal tubes. The "device performance" is shown through bench testing.

Addressing your specific points for an AI/ML device study (based on the absence of this information in the document):

1. A table of acceptance criteria and the reported device performance: As seen above, for a mechanical device, these are primarily about physical and material properties and substantial equivalence, not performance metrics like sensitivity/specificity for an AI/ML diagnostic.
2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing of a physical medical device. No "test set" of patient data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical tube's performance is established by engineering and material science standards, not expert medical opinion on a data set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudicators are mentioned as this is not a diagnostic device relying on interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a stand-alone physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a traditional mechanical device, "ground truth" is established by engineering standards, material specifications, and physical measurements (e.g., tensile strength, dimensional accuracy, sterilization efficacy).
8. The sample size for the training set: Not applicable. This device is not developed using machine learning; therefore, 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 an AI/ML model.

Conclusion from the provided document:

The provided FDA 510(k) clearance letter and summary pertain to a traditional medical device (a tracheal tube), not a software as a medical device (SaMD) or an AI/ML-driven diagnostic tool. Therefore, the document does not contain the information relevant to AI/ML device performance studies, such as data provenance, expert adjudication, or MRMC studies. The "acceptance criteria" and "proof" in this context are based on a demonstration of substantial equivalence to a predicate device and successful completion of standard bench testing for physical and material properties.

Ask a specific question about this device

QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the primary endpoint of the study, which was "successful control of bleeding." The reported performance directly addresses this.

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

• Sample Size: 603 patient cases.
  • Internal uses: 404
  • External uses: 199
• Data Provenance: Retrospective observational study of real-world data (RWD) from medical records. The data was collected from healthcare professionals at 74 individual sites across 27 states in the United States.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. It mentions "healthcare professionals from 74 individual sites...who performed the clinical procedures in which the device was used." This implies that the ground truth (successful control of bleeding, adverse events) was established by the treating healthcare professionals at the point of care, rather than a separate panel of experts reviewing the cases.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). Given it's a retrospective observational study where healthcare professionals recorded outcomes at the time of treatment, formal adjudication by a separate group of experts is unlikely to have occurred. The "ground truth" appears to be based on the clinical assessment and documentation by the treating clinicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The device is a hemostatic dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.

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

This section is not applicable. The device is a physical medical device (hemostatic dressing), not an algorithm or software. Its performance is inherent in its physical action and chemical properties, not in a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used was clinical outcomes data (successful control of bleeding, rates of hematoma, thrombus formation, and thromboembolism) as recorded in the medical records by treating healthcare professionals.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of this study. The device is a physical product, and the study described is for clinical performance evaluation, not for training a machine learning model.

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

As there is no mention of a "training set" or a machine learning model, this question is not applicable.

Ask a specific question about this device

The Arrow® Nitinol Wires are intended to facilitate the placement of central circulatory system or peripheral vasculature devices for diagnostic and interventional procedures.

The Arrow® Nitinol Wires are composed of a coil wire wrapped around a solid core wire, designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel to ensure proper tip placement of the catheter. The clinical benefit of the Arrow® Nitinol Wire is allow the clinician the ability to guide and control the advancing movement of the catheter body through the vessel gaining access to the vascular system through a single puncture site. The guidewires in Arrow / Teleflex Vascular finished goods are typically provided as Spring Wire Guide assemblies including additional components (straightener, Arrow Advancer, tubing clamps, snubber) for easier handling.

The provided document is a 510(k) Premarket Notification from the FDA for the Arrow® Nitinol Wire. It details the device description, indications for use, comparison to a predicate device, and various performance and biocompatibility tests conducted to support its substantial equivalence.

The document does NOT describe the acceptance criteria and study that proves the device meets the acceptance criteria for a software or AI/ML-driven medical device.

Instead, it pertains to a physical medical device – a guide wire – and the testing focuses on its physical properties, material compatibility, and engineering performance. Therefore, many of the requested points, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this type of device submission.

However, I can extract the relevant information from the document regarding the acceptance criteria and performance studies for the Arrow® Nitinol Wire.

Acceptance Criteria and Device Performance (for a Physical Medical Device)

1. Table of Acceptance Criteria and the Reported Device Performance:

The document provides two tables: one for Biocompatibility and one for Performance Data.

Biocompatibility Testing:

Ask a specific question about this device

2 Way Latex Foley Catheters

Indicated where routine drainage of the bladder is required ether postoperatively or for patients with conditions requiring urine drainage.

3 Way Latex Foley Catheter

Indicated where routine drainage of the bladder is required either postoperatively or for patients with conditions requiring urine drainage and for patients requiring bladder irrigation.

The Rüsch Latex Gold Foley Catheter is available as 2 Way catheter, with a proximal funnel, non-return inflation valve and bladder fixation balloon, and 3 Way catheter which includes an additional irrigation channel with proximal funnel. The catheter is manufactured of natural latex, provided sterile, single use, and disposable. The inflation valve is designed for use with Luer lock syringe tips. Balloon inflation volumes in millimeters, as well as shaft size in French gauge (Fr.), Charrière (Ch.), or millimeters (mm), are indicated on the funnel of each individual catheters are siliconized, or surface finished with Polytetrafluoroethylene (PTFE). The Gold Foley Catheter maximum use/indwelling period is less than 30 days. The device has different models of catheters namely PURE GOLD, Gold Pediatric, Gold, and the Gold Haematuria.

The provided text is an FDA 510(k) Premarket Notification for a medical device: the Rüsch Latex Gold Foley Catheter. This document largely focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not describe acceptance criteria for an AI/software as a medical device (SaMD) or a study proving its performance against such criteria. The document explicitly lists nonclinical testing conducted for the physical Foley catheter, such as biocompatibility, sterilization validation, accelerated aging, and performance/functional testing per ASTM standards for a physical medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria for an AI/software device, its performance, sample sizes for test/training sets, expert qualifications, or details about MRMC studies, as these types of studies were not conducted or described in this document for the Rüsch Latex Gold Foley Catheter.

The document pertains to a physical medical device. The "acceptance criteria" discussed implicitly are related to the successful completion of the listed nonclinical tests and demonstrating substantial equivalence to the predicate device, YiKang Latex Foley Catheter (K173340), for FDA clearance. The "study that proves the device meets the acceptance criteria" refers to the nonclinical testing detailed in section 7 of the document.

Here's how I can answer based on the provided text, interpreting "acceptance criteria" and "study" in the context of a physical medical device:

Acceptance Criteria for the Rüsch Latex Gold Foley Catheter (Based on Nonclinical Testing):

Study Information (for a Physical Medical Device):

1. Sample sizes used for the test set and the data provenance: Not explicitly stated as numerical sample sizes. The document refers to "testing" and "assessment" for each standard. The data provenance is internal testing conducted by the manufacturer (Teleflex Medical, Inc.) to comply with FDA recognized standards. The data is retrospective in the sense that the tests were performed on manufactured devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are laboratory-based, objective performance tests on the physical device, not subjective expert reviews of data like in AI/SaMD studies. The "ground truth" is defined by the standards (e.g., successful sterilization, acceptable biocompatibility levels, functional performance specifications).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Testing is objective and based on meeting specified numerical or qualitative limits defined by the standards.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/SaMD.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical device, not an AI/SaMD.
6. The type of ground truth used:
   • Biocompatibility: In vitro and in vivo biological responses as defined by ISO 10993 series of standards (e.g., cell viability, skin irritation, systemic toxicity, tissue reaction on implantation).
   • Sterilization: Sterility assurance level (SAL) achieved through validated processes per ISO 11137.
   • Accelerated Aging: Functional performance of the device and integrity of the sterile barrier system after simulated aging.
   • Performance/Functional Testing: Physical and mechanical properties (e.g., balloon inflation, flow rate, material integrity) as specified by ASTM 623-19.
7. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML model.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) for a traditional medical device (Foley catheter) and does not contain the information requested for AI/SaMD performance studies.

Ask a specific question about this device

Pilling™ Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

Pilling™ Tracheostomy Tubes are stainless-steel tracheostomy tubes that are intended to provide tracheal access for airway management of tracheostomized patients. The tracheostomy tubes are reusable, single-patient devices that are provided non-sterile, and intended to be cleaned prior to initial use. Each tube consists of an outer cannula, inner cannula, and pilot/obturator. The inner and outer tubes fit closely to provide maximum airway. The distal edge of the inner tube is flush with, and fits very closely to, that of the outer tube to allow for complete cleaning. Variations in diameter, shape of the inner and outer tubes (radius of curvature), locking mechanism, and neck plate configurations are the basis of the various styles available.

The tubes are available in sizes ranging from 00 (4.5mm outside diameter, 2.4mm inside diameter) to 12 (16.3mm outside diameter. 12.7mm inside diameter) based on individual style. Insertable lengths range from 33mm (size 00) to 85mm (size 9 Extra Long) based on individual style. Shape of the device and specific design of the neck plate and locking feature is based on style (Jackson, Jackson Improved, and Mayo).

Some Pilling™ Tracheostomy Tubes are fenestrated to facilitate speech and all tubes can be fenestrated upon request. Certain inner tubes are compatible with the Shikani-French Speaking Valve (Product Code JOH, 510(k) K982128). Pilling™ Tracheostomy Tubes are available in models with or without permanently attached 15mm adapters.

Here's a breakdown of the acceptance criteria and study information for the Pilling™ Tracheostomy Tubes, based on the provided FDA 510(k) summary:

It's important to note that this document is a 510(k) summary for a medical device, not an AI or software device. Therefore, many of the typical questions related to AI acceptance criteria, ground truth, and reader studies are not applicable. The focus here is on demonstrating equivalence to a predicate conventional medical device.

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 exact sample sizes for each test (e.g., number of tubes tested for biocompatibility, locking mechanism, or separation). This is common for traditional medical device bench testing where the focus is on design verification against established standards and predicate characteristics, rather than statistical significance across a large patient dataset as seen in AI/Clinical studies.
• Data Provenance: Not applicable in the context of clinical data. The tests described are non-clinical performance testing (bench testing and biocompatibility analysis) of the manufactured device. These tests are inherently prospective, conducted by the manufacturer. There is no mention of country of origin for "data" in a patient/clinical sense.

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

• This question is not applicable for this type of medical device submission. Ground truth, in the AI/clinical sense, typically refers to expert annotations or diagnoses on medical images/data. For a physical device like a tracheostomy tube, "ground truth" is established by adherence to engineering specifications, recognized international standards (like ISO 10993 and ISO 5366), and direct physical measurements or functional tests of the device itself. Experts involved would be engineers, materials scientists, and quality control professionals, ensuring the device meets its design requirements and regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, particularly for AI, to resolve discrepancies in expert opinions on ground truth. For the described non-clinical bench testing, results are typically objective (e.g., does it lock, does it separate at a certain force, are materials biocompatible). Any discrepancies would be handled through standard engineering and quality control procedures (e.g., re-testing, root cause analysis), not through expert adjudication in the medical sense.

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

• No. An MRMC study is designed to evaluate the performance of human readers (e.g., radiologists) with and without the assistance of an AI tool on a set of cases. This submission is for a physical medical device (tracheostomy tube), not an AI system. Therefore, no MRMC study was performed.

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

• No. This question is specific to AI algorithms. The Pilling™ Tracheostomy Tube is a physical medical device. There is no algorithm involved to perform a standalone study.

7. The Type of Ground Truth Used

• Engineering Specifications and International Standards: For this device, the "ground truth" is primarily based on:
  • Biocompatibility: Confirmation by laboratory testing that materials meet the requirements of ISO 10993-1:2018.
  • Functional Performance: Verification through bench tests that the device components (locking mechanism, connector fit, obturator) operate as designed according to internal engineering specifications.
  • Security of Attachment: Demonstration of compliance with ISO 5366:2016 related to the physical integrity and attachment strength of specific components.
  • Comparison to Predicate: The ultimate "ground truth" for a 510(k) is demonstrating that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness, based on its characteristics and performance.

8. The Sample Size for the Training Set

• Not applicable. This question refers to the training data for an AI algorithm. As established, this is a physical medical device, not an AI product.

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

• Not applicable. This question pertains to AI algorithm development.

Ask a specific question about this device

Hem-o-lok® Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.

The provided text is a 510(k) summary for the Hem-o-lok® Ligating Clips. This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and performance testing. It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the kind of clinical performance study to prove the device meets acceptance criteria as typically understood for AI-based medical devices.

The product codes FZP, and regulation 21 CFR 878.4300, specifically describe an "Implantable Clip," which is a physical surgical device, not a software or AI-based diagnostic tool.

Therefore, the requested information regarding acceptance criteria, study details (sample size for test/training sets, experts, adjudication, MRMC studies, standalone performance, ground truth, etc.) for an AI/ML device's performance cannot be extracted from this document, as it pertains to a different type of medical device entirely.

The "Performance Data" section (J.) describes non-clinical benchtop verification testing for physical characteristics like clip latching, resistance to leakage, and clip removal, as well as biocompatibility testing according to ISO 10993 standards. This is for a physical implantable device, not an AI or diagnostic software.

In summary, this document is not relevant to the posed question about a study proving an AI/ML device meets acceptance criteria.

Ask a specific question about this device

SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions for use.

The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.

The Arrow FlexBlock Continuous Peripheral Nerve Block Kit Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.

Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.

The provided text is a 510(k) summary for the Arrow SnapLock Catheter Adapter. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document outlines performance testing for the new device to show it meets specific "acceptance criteria." However, it is not a study that proves a device meets acceptance criteria in the context of medical AI/imaging devices, which typically involves clinical studies with human readers, ground truth establishment, and statistical analysis of performance metrics like sensitivity, specificity, AUC, etc.

The acceptance criteria and performance data described here are for mechanical and material properties of a medical device (a catheter adapter), not for an AI/imaging diagnostic device. Therefore, many of the requested points in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document's content.

Here's an interpretation based on the provided document, addressing the applicable points:

Device: Arrow SnapLock Catheter Adapter (a non-AI medical device; specifically, an adapter for pain management and nerve block catheters)
Purpose of the Study (as described in the document): To demonstrate substantial equivalence to predicate devices through performance testing related to mechanical properties, material biocompatibility, and functional aspects.

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

The document provides tables for Biocompatibility Testing and Performance Testing with their respective acceptance criteria and results.

Table 1: Biocompatibility Testing Acceptance Criteria and Results

Ask a specific question about this device

2 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.

3 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.

The Rusch SoftSimplastic Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Rusch SoftSimplastic Foley Catheter, not an AI/ML medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and studies for an AI/ML device (e.g., sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device (Rusch Simplastic Foley Catheters) based on:

• Intended Use: Similar indications for use for bladder drainage and irrigation.
• Technological Characteristics: Similar balloon retention type, materials (PVC), sizes, lumens, sterilization method, single-use, and radiopacity. The key differences highlighted are a change in PVC plasticizer, extended shelf life, and slightly different size ranges.
• Non-Clinical Performance Testing: This includes:
  • Biocompatibility testing (e.g., cytotoxicity, sensitization, systemic toxicity, implantation) according to ISO 10993 standards.
  • Bench performance testing (e.g., visual inspections, strength, connector security, balloon safety, flow rate, kink stability, tensile force, radiopacity) according to ISO 20696, ASTM F623, and ASTM F640 standards.
  • Sterilization and Packaging validation according to ISO 11135-1, ISO 10993-7, ISO 11607, ASTM D4169, ASTM F1886, ASTM F88, EN 868-5, and ASTM F2096.

The document explicitly states: "Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness." and "Performance test results demonstrate that the subject device is as safe and effective as the predicate device."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document pertains to a traditional medical device demonstrating substantial equivalence through non-clinical bench and biocompatibility testing, not an AI/ML algorithm requiring clinical performance studies against defined ground truth with human reader involvement.

Ask a specific question about this device

For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases up to 24 hours. For patients ≥ 12 years old, the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

The EZ-IO Intraosseous Vascular Access System previously cleared with K202492 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

The provided document is an FDA 510(k) clearance letter for the EZ-IO Intraosseous Vascular Access System. It describes a Special 510(k) submission, which means the device being submitted is very similar to a previously cleared predicate device, with only minor changes. In this case, the only change is the sterilization of the EZ-IO Power Driver.

Therefore, the document does not describe a study involving AI performance, human reader improvement with AI assistance, or the establishment of ground truth by expert consensus for an AI-based device. It focuses on demonstrating the substantial equivalence of the modified (now sterile) power driver to the existing non-sterile one through non-clinical performance testing.

Consequently, much of the requested information (related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth for AI) is not applicable to this document.

However, I can extract the information relevant to the provided text:

Acceptance Criteria and Device Performance (for the change in sterility of the driver)

The acceptance criteria for this 510(k submission are not directly stated as clinical performance metrics for the device's indications for use. Instead, they are related to demonstrating that the change (sterilization of the power driver) does not negatively impact the safety and effectiveness compared to the predicate device. The performance is demonstrated through non-clinical testing.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Detailed Information as per Request:

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

2. Sample sized 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 terms of clinical patient numbers. The testing appears to be primarily bench/laboratory testing on physical devices and packaging.
   • Data Provenance: Not specified, but generally, such non-clinical testing for FDA submissions would be conducted in controlled laboratory environments, likely within the US or by certified labs adhering to international standards. The tests are prospective in nature as they evaluate the manufacturing process and design changes.

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

   • Not applicable. Ground truth in the context of expert consensus for AI models is not relevant here. The ground truth for this submission is established through adherence to recognized international standards for sterilization, packaging, and functional performance testing, which are objectively measurable.

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

   • Not applicable. Adjudication methods are typically for subjective assessments by multiple human readers, often in the context of AI performance evaluation. Here, the "truth" is determined by objective measurements against established engineering and sterilization standards.

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 as this clearance is not for an AI-enabled device or one that involves human interpretation of medical images.

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

   • Not applicable. This submission is not for an algorithm.

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

   • The "ground truth" for this submission is based on engineering standards, validated sterilization processes, and functional performance specifications of the medical device components (specifically, the power driver). It is objective and measurable, rather than being derived from subjective expert consensus, pathology, or clinical outcomes data in the context of a diagnostic or treatment outcome.

8. The sample size for the training set:

   • Not applicable. This submission does not involve an AI model or a training set.

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

   • Not applicable. This submission does not involve an AI model or a training set.

Ask a specific question about this device