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BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are indicated for the administration of anesthesia or analgesia into the epidural space, or to introduce a dedicated catheter for continuous administration of anesthesia or analgesia into the epidural space. They can also be used to introduce a spinal needle to perform a combined spinal and epidural procedure.

These devices are intended for adult and pediatric patients.

BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are single use, sterile needles which incorporate an ISO 594-1/-2 compliant connector. The needles are also available in bulk, non-sterile configurations (to be sterilized prior to use). Each type of needle consists of a hollow, stainless steel cannula, a translucent, polypropylene hub and a polypropylene shield over the needle. The cannula is bonded to the hub at one end. The BD Perisafe™ Epidural needles also contain a plastic stylet handle and are available in various needle lengths. The needle hubs are ISO 594-1 and ISO 594-2 compliant connectors. The stylet handle for the BD Perisafe™ Epidural needles is color coded and correlate to the gauge size per ISO 6009:2016.

The provided text is a 510(k) summary for the BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle. It describes the subject device, its indications for use, and compares it to a predicate device to demonstrate substantial equivalence.

Based on the information provided, this document deals with the regulatory clearance of a medical device (epidural needles) and not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and effect sizes, are not applicable to this submission.

The acceptance criteria and performance data provided are for physical and biological characteristics of the medical device, not for an AI algorithm's diagnostic or predictive performance.

Here's an attempt to answer the questions based only on the provided document, highlighting when the information is not applicable or not present for AI/ML-specific inquiries:

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

The document provides a comparison table between the subject device and the predicate device across various aspects, including functional testing and biocompatibility testing. The "Substantially Equivalent" column indicates that the subject device met the acceptance criteria by demonstrating equivalence or acceptable performance based on established standards or internal requirements.

Notes:

• The asterisks (*) indicate that for "Stylet Pull Force," "Handle/Hub Separation Force," and "Needle Shield/Hub Separation Force," the subject device had internal requirements and performed additional testing because the predicate device did not specify these tests, and there were design differences that necessitated these tests to ensure safety and effectiveness.
• "N/A" in the "Substantial Equivalence" column for some biocompatibility and additional tests indicates that these specific tests were performed by the subject device's manufacturer but were not explicitly specified for the predicate device in the comparison table. This implies the subject device met these criteria, contributing to substantial equivalence based on a broader assessment including materials equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as this is not an AI/ML-enabled device. The testing described focuses on physical and biological performance of the device itself (e.g., fluid leakage, material strength, biocompatibility), not on data-driven performance. The sample sizes for the functional and biocompatibility tests are not explicitly stated in this summary.

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. This is not an AI/ML-enabled device and no ground truth from expert readers/reviewers was established for its performance. The "ground truth" for this device's performance is based on established engineering standards (ISO standards, USP standards) and internal testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML-enabled device and no human adjudication process for performance was involved.

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 not an AI/ML-enabled device. No MRMC study or assessment of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML-enabled device. There is no algorithm to test in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is derived from:

• International Standards: ISO (International Organization for Standardization) standards (e.g., ISO 594, ISO 9626, ISO 10993, ISO 7864) for functional, mechanical, and biocompatibility properties.
• United States Pharmacopeia (USP) Standards: (e.g., USP, USP, USP) for specific biological and purity tests.
• Internal Requirements: For tests not explicitly covered by external standards but deemed critical by the manufacturer (e.g., Stylet Pull Force, Handle/Hub Separation Force, Needle Shield/Hub Separation Force). The rationale for these internal tests is provided, linking them to specific risks (e.g., user inconvenience, inability to use product, needle-stick injury).

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

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Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Spinal and Epidural needles are supplied in bulk nonsterile, or sterile by ethylene oxide gas in peel open packages and are intended for one-time use.

The RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles feature an ISO 80369-6 compliant connector that is about 20% smaller than the predicate device. The ISO 80369-6 hub design reduces the risk of cross connection when used with luer connectors developed under the same series of standards.

RELI® NRFit® Spinal Needles and Phoenix NRFit® Spinal Needles are composed of a stainless-steel cannula and stylet, a hub, and plunger. The spinal needle is supplied with either the Quincke Point (K-3 Point) or the Pencil Point tip configuration.

Quincke point spinal needles feature fitted, close tolerance stylet and cannula bevel to minimize coring and trauma; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size; some sizes are also available with short bevel. Available in sterile and non-sterile packaging.

Pencil point spinal needles feature an atraumatic point with side-port dispensing to reduce loss of CSF; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size. Some sizes are available with tapered design to counter bending and minimize flexing during insertion. Available in sterile and non-sterile packaging.

The RELI® NRFit® Epidural Needles and Phoenix NRFit® Epidural Needles are composed of a stainlesssteel cannula, a polycarbonate hub and detachable wing, a stainless-steel stylet and plunger as Tuohy (Huber point) tip configuration in various needle gauge sizes and lengths.

Epidural needles feature large clear hub for enhanced tactile feel; wide metric marking for maximum visibility and accuracy in placement; color coded stylet/hub to identify needle gauge size. Epidural needles are available in sterile and non-sterile packaging.

The provided text is a 510(k) summary for medical devices (spinal and epidural needles) and does not describe the acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical performance testing (biocompatibility, functional, sterilization).

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document as it pertains to a different type of medical device assessment.

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The Arrow Epidural Needles are intended to inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.

The Arrow Epidural Needles are sterile, single use, disposable devices. They are used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.

The Arrow Epidural Needles consist of a plastic cannula hub with integrated wings that come with either Luer Connector and NRFit Connector, stainless steel cannula, and plastic stylet. The purpose of the stylet is to prevent tissue coring during needle insertion. The needle assembly is protected with a guard to prevent damage to the needle.

This document is an FDA 510(k) summary for the Arrow Epidural Needles. It does not present a study proving the device meets acceptance criteria in the way typically seen for AI/ML medical devices where performance metrics like sensitivity, specificity, or AUC are evaluated on a test set against a ground truth.

Instead, this document describes a traditional medical device submission where "acceptance criteria" are related to engineering performance standards, material characteristics, and biological safety, rather than diagnostic accuracy or clinical effectiveness in a comparative human-AI study.

Therefore, many of the requested fields are not applicable to the content provided. Here's a breakdown based on the provided document:

Device: Arrow Epidural Needles
Regulatory Class: Class II
Product Code: BSP (Anesthesia Conduction Needle)
K190026

1. Table of Acceptance Criteria and Reported Device Performance

The "Performance Data" section in the document outlines the tests performed to demonstrate substantial equivalence to a predicate device. These are engineering and biocompatibility tests, not clinical performance metrics for diagnostic accuracy.

Note: For traditional medical devices like this, the "acceptance criteria" are the successful completion of these standard tests, demonstrating that the device performs as intended and is safe and effective when compared to a legally marketed predicate device. The "reported device performance" is the successful completion of these tests, leading to the substantial equivalence determination. Specific numerical results are not typically summarized in the 510(k) summary unless critical for comparison.

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

• Sample Size: Not specified in the 510(k) summary. These tests are typically conducted on a sample number of manufactured devices according to the respective standards and internal quality control procedures.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are laboratory-based engineering and biological evaluations of the physical device. The testing was conducted by or for Teleflex Medical.

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

• Not applicable. This is not an AI/ML device requiring clinical ground truth establishment by medical experts for diagnostic accuracy. The "ground truth" for these tests is defined by the passing criteria of the international and industry standards (e.g., ISO, BS, ASTM, AAMI).

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or an algorithm. The tests are objective measurements against defined standards.

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

• No. This is not an AI/ML device that assists human readers.

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

• Not applicable. This device is a physical epidural needle, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the AI/ML sense. The "ground truth" for the performance tests described are the established specifications and pass/fail criteria defined by the relevant international and industry standards (e.g., tensile strength, resistance to breakage, corrosion resistance, Luer/NRFit connector integrity, biocompatibility, sterility) these devices are required to meet.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. There is no training set for this type of device.

In conclusion, this FDA 510(k) summary is for a traditional medical device (an epidural needle) and demonstrates substantial equivalence based on engineering performance, material characteristics, and biocompatibility testing against international and industry standards, not on clinical performance or diagnostic accuracy evaluated with a clinical test set and human readers as would be typical for an AI/ML medical device.

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Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia

Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Dr. J Spinal and Epidural Needles are supplied sterile, intended to be single use.

Dr. J Spinal Needles are composed of a stainless-steel cannula, a hub, a stainless-steel stylet and plunger.

A guide needle may be attached to this product. The spinal needle is supplied in either the Quincke Point (=K-3 Point) or the Pencil Point.

The Dr. J Epidural Needle is composed of a stainless-steel cannula with depth marker, a hub, a stainlesssteel stylet, a plunger and a wing. The Dr J Epidural Needle is supplied in Detachable wing type which has a curved needle tip design to protect the catheter from damage during catheterization.

This document is a 510(k) Premarket Notification from Dr. Japan Co., Ltd. for their Dr. J Spinal and Epidural Needles. It argues for substantial equivalence to a predicate device (Myco Medical Supplies, Inc.'s Dr. Japan's Phoenix Spinal & Epidural Needles, K990519). The core argument is that the "new" device is essentially the same as the predicate, with only a "modification to the outer box." As such, this is not a study proving a device meets acceptance criteria as would be done for a novel AI/ML medical device. Instead, it's a demonstration that the new version of an existing device continues to meet the safety and performance standards established for the old (predicate) device.

Therefore, the information regarding acceptance criteria and performance of an AI/ML device, as outlined in your prompt, is not directly applicable to this document. This document describes the "acceptance criteria" and "proof" in terms of adherence to established medical device standards and demonstrating that minor changes to a device do not negatively impact its existing, proven performance.

Here's a breakdown of how the provided text relates to your prompt, modified to reflect the nature of a 510(k) submission for a non-AI/ML device:

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

This document doesn't provide a table of acceptance criteria in the sense of performance metrics for an AI/ML system (e.g., sensitivity, specificity). Instead, it lists various non-clinical tests performed to ensure the safety and effectiveness of the device (spinal and epidural needles) against established industry standards. The "reported device performance" is a statement that the device "passed all the testing and successfully demonstrate that subject device is as safe, as effective, and performs as well as legally marketed device predicate."

Table: Non-Clinical Testing and Acceptance Criteria (from the document)

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

This document refers to "bench testing" and compliance with international standards (ISO, ASTM, EN, and Chinese/Japanese national standards). The sample sizes are not explicitly stated for each test, but it is implied that sufficient samples were tested to meet the requirements of the cited standards. Given the nature of medical device testing (e.g., destructive testing for mechanical properties, sterility, biocompatibility), these test sets are typically derived from production batches.

• Sample Size: Not specified quantitatively for each test, but implied to be sufficient as per the referenced standards (e.g., ISO, ASTM).
• Data Provenance: The document refers to the manufacturer as "Dr. Japan Co., Ltd." with an address in Tokyo, Japan, and "Tianjin Hanaco Medical Co., Ltd." potentially involved in manufacturing. The testing standards cited include those from China (e.g., GB/T14233) and Japan (e.g., ISO10993-7 reference for Japan). Therefore, the data provenance is likely from manufacturing and testing facilities in Japan and China.
• Retrospective or Prospective: These tests are generally prospective, as they are performed on newly manufactured devices specifically for the purpose of demonstrating compliance.

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

This is not applicable to this type of device submission. Ground truth, in the context of an AI/ML device, refers to expert-annotated data for training and evaluating an algorithm's performance. For a physical medical device like a needle, "ground truth" is established by the performance characteristics defined in international standards and verified through laboratory testing. There are no "experts" establishing a "ground truth" for the test set in the way you've described for AI/ML. The experts here are the engineers and quality control personnel performing the tests according to the established protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve disagreements among human annotators or readers for ground truth establishment. For physical devices, "adjudication" is inherent in successfully meeting the specified limits/criteria of the referenced test 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

Not applicable. This is a physical medical device (needles), not an AI/ML system. There are no "human readers" or "AI assistance" involved in its primary function or evaluation.

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

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

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

The "ground truth" for this device is defined by established international and national standards for medical device performance, safety, and biocompatibility. These standards represent a consensus within the medical device industry and regulatory bodies regarding the acceptable physicochemical, mechanical, sterile, and biological properties of such devices. For example, "ISO 7864 Sterile hypodermic needles for single use" defines the performance characteristics that a hypodermic needle must meet. The "proof" is the successful completion of tests demonstrating adherence to these standards.

8. The sample size for the training set

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

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

Not applicable. There is no "training set" or "ground truth for training" for this physical device. The device is manufactured to precise specifications, and its performance is verified through testing against established standards.

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The PORTEX® Tuohy and Hustead Needles with NRFif™ connectors are intended to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics.

The sterile, single use Tuohy and Hustead needles with NRFit™ connector are for insertion into the epidural space for either single shot doses of anesthetic or narcotics or as an introducer for epidural catheters or spinal needles. The Tuohy needles are marked at 10 mm graduations to enable the depth of needle insertion to be determined. The Tuohy needles are supplied with a removable wing which allow the needle to be used as a winged or non-winged needle. The stylet hub is color-coded for ease of identification. The intended target population is pediatrics and adults.

The provided text describes the non-clinical testing performed on the PORTEX® NRFit™ Epidural Needles to demonstrate their substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test. It broadly states that "All testing met pre-established specifications."

The data provenance is from non-clinical performance testing, meaning these are laboratory tests on the device itself, not clinical data from patients. There's no information about country of origin for the data or whether it's retrospective or prospective, as it's not clinical data.

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 section is not applicable. The "ground truth" in this context refers to established standards (e.g., ISO, ANSI/AAMI, USP) and the physical properties and performance of the device. There were no human experts establishing ground truth for a diagnostic outcome, as this is a device for fluid delivery and catheter placement, not a diagnostic imaging device.

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

This section is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed for ambiguous cases. These were non-clinical, objective tests against established 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

This section is not applicable. This document describes the testing for an epidural needle, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This section is not applicable. This document describes the testing for a physical medical device (epidural needle), not an algorithm or AI system.

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

The "ground truth" for the non-clinical testing was established by recognized international and national standards and test methods. These include:

• ISO 80369-6 (for connectors for neuraxial applications)
• ISO 9626-2016 (for stiffness and bending force of needles)
• PWI-10005073-Test Method for Needle Penetration Force
• ISO 11607 (for packaging)
• ISO 11135 (for sterilization)
• ISO 10993 series (for biocompatibility)
• ANSI/AAMI ST72 (for bacterial endotoxins)
• USP 788 (for particulate matter)

These standards define the acceptable performance parameters and methodologies for testing.

8. The sample size for the training set

This section is not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."

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

This section is not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply here.

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PORTEX® products and components with the NRFit™ Connector are intended for the injection or infusion of regional anesthetics or narcotics.

The PORTEX® LOR Syringe with NRFit™ Connector is intended for use with NRFit™ compatible components to verify needle tip placement in the epidural space by the Loss of Resistance technique using air or saline. The NRFit™ connector is designed to be used with regional anesthesia systems only.

The PORTEX® EpiFuse Catheter with NRFit™ Connector is intended for use with the catheter and compatible components for the injection or infusion of regional anesthetics or narcotics. The key is a tool for re-opening the catheter connector.

PORTEX® Epidural Flat Filter with NRFit™ Connector is designed for use when administering injections and/or infusions of regional anesthetics or narcotics to a patient via compatible system components. The NRFit™ Connector is designed to be used with regional anesthesia systems only.

The PORTEX® Filter Needle with NRFit™ Connector and PORTEX® Filter Straw with NRFit™ Connector are intended to draw up medication when using the PORTEX® LOR Syringe.

The PORTEX® Regional Anesthesia Portfolio with NRFit™, consisting of five (5) categories of product including PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector and the PORTEX® Filter Straw with NRFit™ Connector.

PORTEX® products and components with NRFit™ connector are intended for the injection or infusion of regional anesthetics or narcotics.

The NRFit ™ connector conform to ISO 80369-6. Small bore connector for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which are intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.

The PORTEX® Regional Anesthesia Portfolio with NRFit™ connector are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This looks like a 510(k) summary for a medical device modification, specifically for the PORTEX® LOR Syringe with NRFit™ Connector, PORTEX® EpiFuse Catheter with NRFit™ Connector, PORTEX® Epidural Flat Filter with NRFit™ Connector, PORTEX® Filter Needle with NRFit™ Connector, and PORTEX® Filter Straw with NRFit™ Connector.

This document does not describe a study involving AI/ML performance, human readers, or expert adjudication for image analysis. Instead, it focuses on the non-clinical performance testing of a new medical device connector (NRFit™) to demonstrate its substantial equivalence to a predicate device. The acceptance criteria and the "study" that proves the device meets them are based on these non-clinical, bench-top tests, primarily conforming to existing ISO standards.

Therefore, for aspects related to AI/ML, human readers, expert ground truth, and training data, the response will state that this information is not applicable to this type of device submission.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a set of medical connectors, and the "performance" here relates to physical and biological safety and efficacy as defined by recognized standards.

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

This document does not specify a "test set" in the context of AI/ML or image data. The testing described is non-clinical (bench testing) for device components. The sample size for each specific non-clinical test (e.g., number of connectors tested for axial load) is not explicitly provided in this summary but would be detailed in the full test reports. Data provenance is not applicable here as it refers to physical and biological testing of manufactured products, not patient data.

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

Not applicable. This is a submission for physical medical devices and their connectors, not an AI/ML diagnostic or prognostic device that relies on expert interpretation of data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to physical product testing against international standards, not a diagnostic or classification task requiring expert 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

Not applicable. This is not an AI-assisted diagnostic or imaging device.

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

The "ground truth" for this device's performance is established by objective measurements and assessments against recognized international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788) for functional performance, sterility, packaging, and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm.

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Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.

The Tuohy Epidural Needle is a device used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.

Tuohy Epidural Needles consist of a plastic cannula hub, containing a stainless steel bushing, affixed to a stainless steel cannula with medical grade adhesive and a stainless steel stylet affixed to a plastic stylet hub with medical grade adhesive. The cannula hub has the option of a permanent, fixed wing or a removable wing depending on user preference. The needle assembly is protected with a polypropylene sheath.

Tuohy Epidural Needles are provided as a sterile, single use, disposable devices. The Tuohy Epidural Needles will be available in a variety of lengths and gauges. They may be packaged individually or included in regional anesthesia trays (kits).

This FDA 510(k) premarket notification for the Remington Medical Inc. Tuohy Epidural Needle does not describe a study involving an AI/CADe device or its performance criteria, as it is for a physical medical device (an epidural needle).

Therefore, I cannot provide information on acceptance criteria and study details related to AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, or ground truth types in the context of an AI device.

The provided document details the substantial equivalence of a physical medical device (Tuohy Epidural Needle) to predicate devices. It focuses on the physical and functional characteristics of the needle.

However, I can extract the acceptance criteria and reported device performance for the physical device as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):

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

• Sample Size: The document does not specify the exact sample size for each performance test. It broadly states "Tests were performed on the Remington Medical Inc. Tuohy Epidural Needles."
• Data Provenance: The tests are described as "non-clinical testing" conducted to internal functional specifications and relevant ISO standards. No information on country of origin of data (likely internal company testing) or whether it was retrospective or prospective is given, as it refers to engineering and laboratory testing, not human subject data.

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 a physical epidural needle, not an AI/CADe system requiring expert-established ground truth from images or other medical data. The "ground truth" for this device's performance is objective measurement against engineering specifications and relevant ISO standards.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is mentioned as it is not a clinical study involving subjective interpretation. Performance is measured against objective 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:

• Not applicable. This is not an AI device. No MRMC study was conducted.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used:

• For the physical properties and performance (e.g., bond strength, flow, biocompatibility): The "ground truth" is established by international standards (ISO 7864, ISO 6009, ISO 10993-1) and internal functional specifications. These are objective, measurable criteria. For catheter placement, visual inspection under magnification was used to confirm no negative impact.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

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

• Not applicable. As this is not an AI device, there is no training set or ground truth in that context.

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St. Jude Medical Neuromodulation Division percutaneous trial leads and compatible accessories are indicated for spinal cord stimulation in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach.

OctrodeX™ and QuattrodeX™ trial leads and their accessories are intended to be used during a spinal cord stimulation trial period for a maximum of 30 days.

OctrodeX TM, IntrodeX™, Epidural Needle, Stylets

The provided text is a 510(k) premarket notification approval letter for St. Jude Medical Neuromodulation devices. This document does not contain any information about acceptance criteria, study details, or device performance against such criteria.

The letter confirms that the FDA has determined the devices (OctrodeX™, QuattrodeX™, IntrodeX™, Epidural Needle, Stylets) are substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide any clinical study results or performance data.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided input.

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An Epidural Needle is indicated for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter.

Epidural needles are instruments used for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter into the epidural space for continuous infusion of anesthetic agents into the epidural space for subsequent pain relief if required.

The needle consists of a plastic Luer hub, a stainless steel cannula, a plastic stylet and removable wings. The needle cannula has 10cm depth markings on it to assist in the needle placement.

The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The needles are provided with a Tuohy point in both 17g and 18g sizes.

This document describes the FDA 510(k) submission for Epidural Anesthesia Needles, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics. Therefore, many of the requested elements for an AI/device performance study are not applicable or explicitly stated in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document states that the new device has "the same technological characteristics as the predicate devices" and "meets performance standards where applicable for: ISO 9626, ISO 594-1 and ISO 594-2, ISO 7864." The performance is reported as performing "equivalently to the predicate device" and that "data submitted demonstrates that the epidural needle performs equivalently to the predicate device" across visual, performance, and dimensional characteristics. Specific numerical performance results against these ISO standards are not provided in this summary.

Regarding the Absence of an AI/Device Performance Study:

The provided text is a 510(k) summary for a medical device (Epidural Anesthesia Needles) seeking substantial equivalence to a predicate device. It is not an AI/ML medical device submission, nor does it describe a study establishing clinical performance of a diagnostic or therapeutic AI product. Therefore, the following points are not applicable to this document as it does not describe such a study:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device; no test set of data is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for data is established.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for 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: Not applicable. This is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth for data is established.
• 8. The sample size for the training set: Not applicable. No training set for an algorithm.
• 9. How the ground truth for the training set was established: Not applicable. No ground truth for an algorithm.

Summary of the Study (as described in the 510(k) summary):

The "study" described is a non-clinical data submission aimed at demonstrating substantial equivalence to a predicate device (K000495, Ballard Medical Products Epidural and Spinal Needles).

• Study Type: Non-clinical (bench testing, materials verification).
• Objective: To show that the Epidural Anesthesia Needles have the same technological characteristics and perform equivalently to the predicate device.
• Data Provenance: Not specified, but generally refers to internal company testing and adherence to international standards (ISO 9626, 594-1, 594-2, 7864).
• Ground Truth: The "ground truth" in this context is the established performance and safety of the predicate device and compliance with relevant ISO standards. Equivalence is the metric.
• Clinical Data: Explicitly stated as "Not required," indicating that the non-clinical data was sufficient for the substantial equivalence determination for this device type.

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The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.

The RK Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stainless steel stylet with a molded plastic hub is also provided with the device. The RK Epidural Needle will be provided as a sterile, single use, disposable device. The RK Epidural Needle will be available in a variety of lengths and gauges.

This 510(k) summary for the RK Epidural Needle (K072005) does not contain the information requested about acceptance criteria or a study proving the device meets said criteria.

The document is a traditional 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a dedicated study.

Here's why the requested information is absent:

• Substantial Equivalence: The primary method for clearance in this type of 510(k) is to show that the new device has "similar physical and technical characteristics" and the same "intended use" as legally marketed predicate devices. This approach argues that if the predicate devices are considered safe and effective, and the new device is substantially equivalent, then the new device is also safe and effective. It does not require a new clinical trial or performance study proving specific acceptance criteria are met in the same way a novel device or a device requiring a PMA would.
• Device Type: This is a Class II device (Anesthesia Conduction Needle). For such devices, often bench testing, material safety, and performance data comparing it to predicates (e.g., tip design, material strength, flow rates if applicable) are used to demonstrate equivalence, but not necessarily a formal clinical study with acceptance criteria in the sense of accuracy, sensitivity, or specificity.
• Content of the Summary: The provided text is a summary of the 510(k) application. It lists:
  • Company information
  • Date prepared
  • Trade and common name
  • Product class and classification
  • Predicate device(s)
  • Description of the device
  • Intended Use
  • Comparison to Predicate
  • Conclusion affirming substantial equivalence.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or ground truth details from this document because it is not present. The document states that the comparison to predicate devices demonstrates that the RK Epidural Needle is safe and effective, implying that the safety and effectiveness are inferred from its similarity to already cleared devices, not from a new study designed to meet specific acceptance criteria.

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