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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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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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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 Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.

The Tuohy 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 stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub. The Tuohy Epidural Needle will be provided as a sterile, single use, disposable device. The Epidural Needle will be available in a variety of lengths and gauges.

The provided document, K030562 pertaining to the Tuohy Epidural Needle, does not contain information related to acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven medical device.

This document is a 510(k) summary for a traditional medical device (an epidural needle) and focuses on establishing substantial equivalence to a predicate device. Therefore, none of the requested information regarding AI/algorithm performance, ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies is present or applicable.

Here's a breakdown of why the information is not present based on the provided text:

• Device Type: The device is a "Tuohy Epidural Needle," a physical medical instrument, not an AI or algorithm.
• Regulatory Pathway: The submission is a 510(k) for substantial equivalence, which primarily involves comparing the new device to a legally marketed predicate device, rather than demonstrating de novo performance against specific criteria through a clinical or algorithmic study.
• Non-Clinical Data Section: The document explicitly states: "Due to the fact that this product is purchased by Epimed from Manan Medical and is identical to the predicate device, bench testing to compare performance characteristics was not conducted." This confirms that no specific performance studies were performed for this particular submission.
• Conclusion: The conclusion focuses solely on substantial equivalence to the predicate device, not on meeting predefined performance criteria through a study.

Therefore, I cannot provide the requested information from the given text.

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Like other commercially available epidural needles, the Kendall Blunt Tip Tuohy Epidural Needle is used to administer anesthetic to the peridural space.

The Kendall Blunt Tip Tuohy Epidural Needle is a sterile single use device designed to be used for the induction of epidural anesthesia. The needle cannula and matched stylet are composed of stainless steel. A polycarbonate hub is insert molded onto the cannula. The hub is supplied in two configurations, a fixed wing design and a non-winged design. The cannula gauge, length and tip are equivalent to current commercially available epidural needles. A portion of the tip of a standard needle bevel is removed in a blunt grind process. The sharp cutting edges around the periphery of the needle bevel remain unchanged.

This document is a 510(k) summary for the Kendall Blunt Tip Tuohy Epidural Needle. It describes the device, its intended use, and compares it to a legally marketed predicate device (Kendall 18 Gauge Calibrated Tuohy Epidural Needle, K921288B).

However, the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, F-score, etc., which are common for AI/ML-based medical devices.

Instead, the "testing" described is focused on:

• Biocompatibility: Following ISO-10993, finding "no toxic diffusible substances." This is a material safety test, not a performance study in the AI sense.
• Functional/Mechanical testing: To determine "needle penetration force and hub pull-off force." These are engineering specifications, not performance criteria for a diagnostic or predictive device.

Therefore, I cannot provide the requested table and information based on the prompt. The provided document is for a physical medical device (an epidural needle) and not an AI/ML-based device.

If you intended to ask about the typical acceptance criteria and study designs for physical medical devices in a 510(k) submission (which often focus on safety, functionality, and substantial equivalence), the provided text partially addresses the testing performed, but it doesn't present "acceptance criteria" in the format of a table with reported performance against those criteria.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML device. For this physical device, the "acceptance criteria" would be internal engineering specs (e.g., maximum penetration force, minimum hub pull-off force) which are not explicitly stated here, nor are the precise "reported performances" against those specs, only that testing was "performed to determine" them.
2. Sample size used for the test set and the data provenance: Not applicable. The "tests" described are laboratory/bench tests on the device materials and components, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML devices (e.g., expert consensus on medical images or diagnoses) is not relevant here.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for a physical device is its adherence to design specifications and safety standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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