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EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.

EDEN ControlCath consists of a flexible catheter, steering handle, and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use.

The provided text is a 510(k) summary for a medical device called "EDEN ControlCath." This document details the device's characteristics, intended use, and its comparison to a predicate device to demonstrate substantial equivalence.

However, the provided text DOES NOT contain information regarding:

• Acceptance criteria beyond "test criteria" for various bench tests.
• Specific device performance metrics that meet these criteria.
• Study design for proving acceptance criteria, particularly regarding clinical studies or AI model performance. The document explicitly states, "Clinical testing was not required for this submission."
• Sample sizes used for test or training sets for AI models.
• Data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone AI performance, or how ground truth was established, as these are typically relevant for AI/ML-based medical devices or diagnostics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate conventional medical device through bench testing and material comparisons, not an AI/ML device.

To answer your request based on the provided text, I can only state the following:

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

The document mentions that various properties were tested based on referenced standards, and "All the test results support substantial equivalence to the predicate devices." However, it does not provide specific numerical acceptance criteria (e.g., "tensile strength > X N") or measured device performance values. It broadly states that the device "passed the test criteria."

2. Sample sized used for the test set and the data provenance:
The document does not specify sample sizes for any of the bench tests or material evaluations. It refers to "bench test results" generally. It does not involve patient data, so concepts like "country of origin" or "retrospective/prospective" are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/ML diagnostic tool, and its evaluation relies on established engineering and materials testing standards, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no human adjudication process described for the non-clinical bench 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:
No. This is not an AI-assisted device, and no MRMC study was conducted or required.

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

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on compliance with international standards for medical devices (e.g., ISO, ASTM) through various physical and chemical bench tests (tensile strength, leakage, biocompatibility, etc.) and comparison to a legally marketed predicate device.

8. The sample size for the training set:
Not applicable. There is no training set mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. There is no training set involved.

In summary, the provided FDA 510(k) summary is for a traditional medical device (an anesthesia conduction catheter), not an AI/ML-driven product. Therefore, the detailed questions about AI model performance, data sets, and expert ground truth establishment are not addressed in this document.

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The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours.

The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.

The FX catheters are regional anesthesia catheres intended to provide, via percutaneous administration, continuous and/or internittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. The catheters may remain indwwelling for up to 72 hours. Routes of administration are epidural (peripheral nerve block (PNB)). The catheter is available in both open and closed tip designs. The open-tip polyamide catheter is intended to facilitate continuous delivery of anesthetic fluid via one opening at the tip, while the closed-tip polyamide catheter facilitates the administration of anesthetic through three sideports. Both catheters have ink markings, which are located in 10 mm increments along the catheter. The ink markings provide a visual indication of the depth of catheter insertion. When used according to the conditions listed on the product labeling, the FX Catheters may remain in a patient while in an MR environment.

This document is a 510(k) summary for the Perifix FX Catheter and Contiplex FX Catheter manufactured by B. Braun Medical Inc. It concerns a traditional medical device (anesthesia conduction catheters) and does not involve Artificial Intelligence (AI). Therefore, the questions related to AI device performance, such as acceptance criteria for AI, training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to this submission.

The 510(k) submission (K231242) focuses on demonstrating substantial equivalence to predicate devices (K991879 and K113059). The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

"MRI testing was performed. Testing supports the device being labeled as MRI Conditional. No changes have been made to the device therefore, the device continues to be safe and effective and performs the same as the predicate device."

This indicates that the primary testing performed was related to MRI compatibility, and the unchanged nature of the device from its predicates means that prior safety and efficacy data for the predicates are considered applicable.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details because this 510(k) submission is not for an AI device.

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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

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The SubQKath Catheter and Needle Kit is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with surgical procedures.

The HK SubOKath Subcutaneous Catheter is a device intended to provide a means of delivery of local analgesics into the human body via a fenestrated catheter. The device is a single lumen catheter available in a single gauge (16g) size. The distal end of the device allows for flow of analgesia into the surgical wound. The device is supplied sterile and is intended for single use.

This document describes the 510(k) premarket notification for the SubQKath Catheter and Needle Set (K193664). The acceptance criteria and study proving the device meets these criteria are primarily based on non-clinical performance data demonstrating substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithm performance.

Therefore, many of the typical questions for AI/ML-based medical devices (like sample size for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable to this submission. This device is a physical medical device, and its safety and effectiveness are established through engineering testing and comparison to existing devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria in a quantitative table format for each test, but it states that "The subject device met the acceptance criteria of the above tests, and did not raise new questions of safety and effectiveness." The study design is focused on demonstrating physical and material properties, rather than diagnostic accuracy metrics.

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

• Sample Size: Not explicitly stated in terms of a "test set" as this is a physical device and testing involves material and functional evaluations, not typically patient data sets. The sample sizes for the various engineering and biocompatibility tests would be dependent on the specific test protocols (e.g., number of catheters tested for flow rate, number of samples for material strength). These details are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data provenance refers to the results of laboratory-based physical, chemical, and biological performance testing of the device itself. This would be generated from the manufacturer's testing facilities or contract labs.

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

• Number of Experts: Not applicable. Ground truth for a physical device is established through validated testing methodologies and adherence to standards (e.g., ISO, ANSI/AAMI). There's no "ground truth" derived from expert consensus on medical images or clinical outcomes in this type of submission.
• Qualifications of Experts: Not applicable in the context of clinical readers. The "experts" would be engineers, material scientists, and toxicologists conducting the specified tests and interpreting the results according to relevant standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring reader adjudication of medical data.

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

• MRMC Study: No. This is not an AI/ML diagnostic device, nor is it a device that would typically undergo a human-reader comparative effectiveness study. It's a physical catheter.
• Effect Size of Human Readers' Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device is based on engineering specifications, material science standards (e.g., ISO 9626, ISO 11607, ISO 10993-1), and functional performance requirements of similar, legally marketed predicate devices. For biocompatibility, it's the biological response measured against established safety thresholds.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve AI/ML and therefore does not have a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable.

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The Percutaneous Introducer is intended to allow for the percutaneous placement of devices, needles or probes, in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle/introducer.

The Percutaneous Introducer is a single-use, disposable device consisting of a flexible polymer sheath with a molded plastic hub. The device incorporates a stainless steel needle inside the flexible cannula and is removed after the introducer is placed. The inserted stainless steel introducer needle has a sharp distal point. The flexible cannula acts as a conduit for percutaneous introduction of medical devices, such as catheters, needles, or probes. A stylet or porous plug (to prevent aspiration during insertion) comes seated in the standard 6 degree luer fitting of the proximal end of the needle hub. The Percutaneous Introducers are used for a short period of time and are supplied sterile and non-pyrogenic. The Percutaneous Introducer is available in four lengths and a 14 gauge.

This document is a 510(k) summary for a "Percutaneous Introducer" device. It outlines the device description, intended use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in the way a clinical study might. Instead, it describes various tests performed and states that the device "meets the requirements" or "performs comparably" or has "successful results."

The tests and their reported outcomes are:

The study concludes that based on these results, the Percutaneous Introducer "performs comparably to, and is substantially equivalent to predicate device (K102460)."

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

The document does not specify the sample sizes used for any of the non-clinical tests (e.g., number of introducers tested for tensile strength, burst testing, etc.).
The data provenance is from non-clinical bench and laboratory testing, not human or animal studies. The data would originate from the manufacturing and testing facilities of Epimed International, Inc. or their contracted labs. It is inherently prospective in the sense that the tests were conducted specifically for this submission.

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

This section is not applicable in the traditional sense of clinical or diagnostic device ground truth. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and FDA guidance documents. The "experts" would be the qualified personnel within the testing laboratories who perform the tests according to these standards, generate the data, and interpret the results to ensure compliance. Their specific number or qualifications are not detailed here, as the focus is on adherence to standardized testing protocols.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers for diagnostic image interpretation or similar subjective assessments. The tests described are objective, standardized laboratory and bench tests where results are determined by measurement against specified criteria in the standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for an interventional medical device (introducer) and focuses on its physical performance, material safety, and substantial equivalence, not diagnostic accuracy or human reader performance.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance assessment was not done because the device is a physical medical instrument (a Percutaneous Introducer), not a software algorithm or AI-driven diagnostic tool. The concept of "algorithm only performance" does not apply to this type of device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established international standards and regulatory guidelines. For example:

• Mechanical properties: Defined by performance criteria within ASTM and ISO standards (e.g., specific force values, absence of collapse/peelback).
• Biocompatibility: Defined by the requirements and endpoints outlined in ISO 10993 series of standards (e.g., non-cytotoxic, non-sensitizing, non-irritating).
• Sterility and Packaging: Defined by standards like ASTM F1140, ASTM F1929, and general sterility assurance principles.
• Functional standards: Defined by the specific requirements of ISO 594-1, ISO 594-2, and ISO 10555-5.

Essentially, the "ground truth" is compliance with these widely accepted benchmarks for medical device safety and performance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of an algorithm. The development and testing process involves engineering design, material selection, and verification/validation testing, not data-driven machine learning training.

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

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

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The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.

The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities.

The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections.

The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.

The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the CIMPAX C-CAT Anaesthesia Catheter kit. This document is a regulatory submission for medical devices, demonstrating substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria for an AI/ML product.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, AUC).
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets or data provenance for AI/ML model evaluation.
• Number of experts, qualifications of experts, or adjudication methods for establishing ground truth in the context of AI/ML.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML model evaluation (e.g., pathology, outcomes data).
• Sample size for training sets or how ground truth was established for training sets in an AI/ML context.

The document discusses acceptance criteria and studies, but these relate to the physical and biological safety and performance of a medical catheter, not an AI/ML device. For example, it mentions:

• Non-Clinical Testing: Bench testing including mechanical and performance testing (e.g., peak tensile force, burst pressure, kink testing, liquid leakage under pressure, radiopacity, flow testing), biocompatibility, sterilization, packaging, and shelf-life testing.
• Biocompatibility Testing: According to ISO 10993-1 series, covering cytotoxicity, sensitization, irritation, systemic toxicity, Ames Test, in vitro mammalian chromosome aberration, hemolytic properties, and material mediated rabbit pyrogen.
• Flow Test: Performed according to DS/EN 1618, measuring water flow through the catheter.
• Tensile strength: Tested in accordance with ISO 10555-1.
• Packaging: Complies with ISO 11607-1:2014 and EN 865-5:2009.
• Stability: Tested according to ASTM F 1980 Accelerated Aging and ISO 11607-1:2009.
• Sterilization: Method is Ethylene Oxide (EO), complying with EN ISO 11135-1.

In summary, the provided text describes the regulatory process for a physical medical device (an anesthesia catheter) and outlines its non-clinical performance and safety testing to demonstrate substantial equivalence, not information relevant to the performance and acceptance of an AI/ML device.

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The Medline Reinforced Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 22lbs. (10kg), for a duration of use up to 72 hours.

The Medline Reinforced Epidural Catheter is a single use device made of flexible polyurethane elastomer tubing. The subject device is sold sterile, and will be packaged inside of a convenience kit alongside a variety of other components that are outside the scope of this 510(k) submission. The proposed epidural catheter is designed as a closed tip device with two eyelets to provide for the dispersion of anesthetic agents. The catheter features a 19G design and is 913 millimeters (mm) long. The catheter has a marked tip, with 10mm increments up the length of the device (up to 913mm). The 100mm mark is indicated by two marks, 150mm by three marks, 200mm by 4 marks, and 250mm by 5 marks. In addition, the Medline Reinforced Epidural Catheter has an internal radiopaque inner spring that is evenly distributed inside the device, terminating 2+/-0.05mm from the liquid outlet end. As an added safety feature, a solid wide warning mark is featured on the proposed device to indicate exit of the catheter from a needle when used in conjunction with an epidural needle.

This document is a 510(k) premarket notification for a medical device (Medline Reinforced Epidural Catheter) and as such focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information typical of a study that would define acceptance criteria for AI/Algorithm-based device performance and then prove the device meets those criteria using clinical data and expert input.

Therefore, many of the requested elements (1-9) regarding acceptance criteria, reported performance, sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/algorithm performance are not applicable or not present in this document.

However, I can extract the information provided regarding the non-clinical testing and the company's conclusion of substantial equivalence.

Summary of Non-Clinical Testing and Conclusion of Substantial Equivalence:

The Medline Reinforced Epidural Catheter is seeking 510(k) clearance based on substantial equivalence to the ARROW® FlexTip Plus® Epidural Catheter (K140110). Instead of defining acceptance criteria for algorithmic performance, the submission focuses on demonstrating safety, performance, and functionality through various non-clinical tests.

No information provided in the document refers to an AI/algorithm-based device, nor does it contain data on acceptance criteria, reported device performance (in the context of AI), sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/algorithm evaluation.

The document describes non-clinical testing for a physical medical device. Here's a summary of the non-clinical tests conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define quantitative acceptance criteria for algorithm performance or report such performance metrics. Instead, it lists various non-clinical tests conducted to demonstrate the safety and functionality of the physical catheter. The "reported device performance" is implied by the successful completion of these tests in accordance with relevant standards.

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance: See the table above. Note that these are for a physical device, not an AI/algorithm.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for an AI/algorithm. For the non-clinical tests, sample sizes would be defined by the selected standards and internal protocols, but are not specified in this summary. Data provenance is not specified.
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 as this is not an AI/algorithm study requiring ground truth derived from expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing of a physical device.
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 not an AI/algorithm device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/algorithm device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as this is not an AI/algorithm study. The "ground truth" for a physical device is its ability to meet engineering specifications and safety standards through physical and chemical testing.
8. The sample size for the training set: Not applicable; there is no training set mentioned, as this is not an AI/algorithm device.
9. How the ground truth for the training set was established: Not applicable; there is no training set mentioned, as this is not an AI/algorithm device.

Conclusion stated in the document:
Based on the non-clinical testing, Medline Industries, Inc. concludes that the Medline Reinforced Epidural Catheter is substantially equivalent to the predicate device, ARROW® FlexTip Plus® Epidural Catheters (K140110).

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For administration of anesthetic agents into the epidural space to provide epidural or caudal anesthesia.

EPINAUT Spring Guide Epidural Catheter is constructed of a stainless steel continuous spring. EPINUAT Spring Guide Epidural Catheter offers two types of catheter. The catheter types, L330 & L600 have an uncoated distal tip which is flexible, smooth and rounded with coils slightly spread for maximum flexibility and lateral distribution of injectant. The other catheter types, C310 & C600 have a distal end which is entirely coated by tube for maximum smoothness. There are 16 models in EPINAUT: L33011320, L33013820, L33011315, L33013815, L60011320, L60013820, L60011315, L60013815, C31011320, C31013820, C31011315, C31013815, C60011320, C60013820, C60011315 and C60013815. Each model is characterized by different length of catheter, length and outer diameter of wire, inner diameter of adapter, length and diameter of introducer needle and needle cap.

EPINUAT Spring Guided Epidural Catheter have enhanced tensile/ break strength and restrict longitudinal catheter stretch, while the spring coils make the catheter resistant to kinking and collapsing. Wire is also provided with the device which consists of a stainless steel and a molded plastic hub.

The introducer needle is inserted into the epidural space through the sacral hiatus under intermittent fluoroscopy. After appropriate determination of the epidurogram and target area, the catheter with the wire in it is advanced through the introducer needle to the concerned area as determined by MRI or symptomatology. When the catheter is approached to target site, the wire is removed from the catheter and then the medication can be injected by attaching the adapter to a syringe.

The medical device in question, EPINAUT, is an Anesthesia Conduction Catheter. The provided context does not include information about clinical studies involving human patients or AI-based performance metrics. The information focuses on non-clinical testing to establish substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various non-clinical tests performed to evaluate the performance of EPINAUT and to demonstrate substantial equivalence to the predicate device, the Racz Epidural Catheter. The acceptance criteria are implicitly met if the test results "met the pre-set criteria" or "supported that the subject device is substantially equivalent." Specific numerical acceptance criteria are not explicitly stated for all tests; rather, the successful completion of the test according to a standard often serves as the acceptance.

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The Catheter Clamping Adapter, a connection device, is used to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics.

The connector is used in conjunction with catheters for continuous administration of anesthetic agents.

The Catheter Clamping Adapter with either NRFit™ Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7. The device is intended to provide a specified connection (either NRFit™ Connector according to ISO80369-6 or LUER-Connector according to ISO80369-7) to an unspecified proximal end of a 20G anesthesia conduction catheter (epidural or peripheral). Therefore it may also be considered an accessory for epidural and peripheral anesthesia conduction catheters. The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile intended to be sterilized prior to use to re-packagers/ medical device manufacturers.

The PAJUNK Catheter Clamping Adapter NRFit (ISO80369-6) and Catheter Clamping Adapter LUER (ISO80369-7) have been determined to be substantially equivalent to a legally marketed predicate device (BBraun Perifix Catheter Connector, K022019) based on a detailed comparison and performance testing.

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 specific sample sizes used for each individual performance test (e.g., liquid leakage, axial load). It indicates that tests were conducted according to the specified ISO standards (ISO 80369-6, ISO 80369-7) and internal protocols. The standards themselves typically outline sample size requirements.

The data provenance is not explicitly mentioned as "country of origin" or "retrospective/prospective." However, the testing was performed by PAJUNK® GmbH Medizintechnologie (based in Germany) and its contract sterilizer (Sterigenics Germany GmbH). The testing would be considered prospective for the purpose of demonstrating substantial equivalence for this submission.

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

This section is not applicable. The device is a medical connector, and its performance is evaluated against engineering and material standards (e.g., ISO for connectivity, leakage, tensile strength, biocompatibility), not against a diagnostic "ground truth" established by experts.

4. Adjudication Method for the Test Set

This section is not applicable for this type of device and testing. Performance is measured objectively against predefined engineering standards and specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic devices involving human interpretation of data (e.g., medical images), which is not relevant for this device.

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

Yes, a standalone performance evaluation was conducted. The device's performance (e.g., leak tightness, tensile strength, connectivity) was tested directly against established physical and material standards without human intervention in its function. The "algorithm" in this context is the physical design and manufacturing process of the device, and its performance was evaluated inherently without human-in-the-loop.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation is based on established international and internal engineering standards and specifications. This includes:

• ISO 80369-6 (for NRFit connectors)
• ISO 80369-7 (for LUER connectors)
• ISO 11135 (for sterilization)
• ISO 10993-7 (for residuals)
• ISO 10993-1 (for biocompatibility)
• Internal protocols for leak tightness and security of connection.

These standards define the objective, measurable criteria for acceptable device performance for safety and effectiveness.

8. The Sample Size for the Training Set

This section is not applicable. This device is a manufactured medical product, not an AI or algorithm-based system that requires a "training set" in the computational sense. The "development" and "refinement" of the product involve engineering design, material selection, and manufacturing processes, culminating in validation testing.

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

This section is not applicable for the reasons stated in point 8.

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The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.

The B. Braun Tear-Away Introducer Needle is a sterile, single-use, disposable device, that consists of a Stainless Steel Needle Hub. Tear-Away Sheath Hub. Tear-Away Sheath Shaft (tube) and a Protective Guard over the needle.

The B. Braun Tear-Away Introducer Needle is a manually operated device inserted into a patients skin by a surgeon in a clinical hospital setting for the percutaneous introduction of a catheter.

The plastic guard is removed and the B. Braun Tear-Away Introducer Needle is placed through the patient's skin with the bevel tip up. The needle is then withdrawn from the Tear-Away Introducer Sheath and discarded.

The Tear-Away Introducer Needle Sheath remains in the patient to facilitate the placement of an introduction catheter. An introduction catheter is inserted thru the Tear-Away Introducer Needle Sheath and into the patient. Once the introduction catheter is placed to the desired location, the Tear-Away Introducer Needle Sheath is withdrawn by sliding the sheath back towards the hub of the catheter. The Tear-Away Introducer Needle Sheath is then split apart and peeled away from the catheter while holding the hub of the sheath at the T-handle. The Tear-Away Introducer Needle Sheath is then discarded.

The provided text describes the B. Braun Tear-Away Introducer Needle and its substantial equivalence to a predicate device (Summit Medical Products, ambIT® Introducer) for FDA 510(k) clearance.

Based on the document, this is not an AI/ML device. It is a physical medical device (an introducer needle). Therefore, many of the requested criteria related to AI/ML device testing (such as sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.

However, I can extract and present the information provided regarding the device's acceptance criteria and the (non-clinical) study that proves it meets them.

Device: B. Braun Tear-Away Introducer Needle

Type of Device: Physical Medical Device (Catheter Introducer/Introducer Needle) - NOT AI/ML

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO standards.

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