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The Racz Neurostat RF Generator is intended for lesioning of neural tissue. It is indicated for use in the peripheral nervous system. It is to be used with Epimed RF probes and cannula.

The Racz Neruostat RF Generator is a touchscreen controlled Radio Frequency (RF) Generator used to lesion neural tissue for pain management. It has 4 outputs for delivering RF from a single source into the patient, it includes functions for nerve stimulation (Sensory and Motor), Continuous Thermal RF Lesioning, Pulsed RF Lesioning and Pulsed Dose RF Lesioning. The RF Energy is transmitted via each individual probe and a Neutral Electrode when in monopolar mode; or between probes when running in bipolar mode. The device will monitor the patient's impedance, probe temperature, along with the voltage and current of the RF Energy during a procedure.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, structured according to your requested information.

Based on the provided FDA 510(k) summary for the Racz Neurostat RF Generator (K232632), the information focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria that would typically be seen for a novel AI/software-based medical device.

The Racz Neurostat RF Generator is a radiofrequency lesion generator, a hardware device, and not an AI or software algorithm in the traditional sense that generates diagnostic output or assists human readers in interpretation. Therefore, many of the typical questions for AI/software performance studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not directly applicable or explicitly detailed in this type of submission.

The "acceptance criteria" discussed in this document are primarily related to safety, electrical performance, and functional equivalence to a predicate device, rather than diagnostic accuracy or clinical effectiveness in the way an AI algorithm would be evaluated.

Acceptance Criteria and Device Performance (as inferred from the 510(k) summary)

The "acceptance criteria" for a hardware device like this are generally satisfied by demonstrating compliance with recognized standards and functional equivalence to a legally marketed predicate device.

Detailed Study Information (Based on provided text):

As the device is a hardware RF generator with embedded software for control, the "study" is more akin to engineering testing and validation rather than a clinical trial assessing diagnostic performance.

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

• Test Set Sample Size: Not applicable/not specified in the context of an FDA 510(k) for a hardware device like this. The "test set" for this device refers to the specific physical units or simulated environments on which engineering and performance tests were conducted. These are not datasets of patient images or clinical data.
• Data Provenance: Not applicable. The "data" being generated and tested are electrical signals, temperature readings, and physical lesion formation, not patient-derived medical data. The tests are likely performed in a lab setting.

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

• Not applicable for this type of device. "Ground truth" for this device would be established by engineering specifications, physical laws, and recognized medical device standards (e.g., a specific power output measured by calibrated equipment, or a lesion size measured by a pathologist/engineer during comparative testing). There's no subjective expert interpretation required in the same way as for image-based diagnostics.

4. Adjudication method for the test set:

• Not applicable. The "adjudication" for this type of device involves comparing measured performance against engineering specifications and predicate performance, not resolving discrepancies between expert readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC study was not done. This type of study is relevant for AI systems that aid human interpretation (e.g., radiologists reading images). This device is a therapeutic generator, not a diagnostic aid.

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

• The device inherently operates as a "standalone" therapeutic device, meaning its core function (generating RF energy) does not require "human-in-the-loop" interpretation for its primary output. However, it is human-controlled to perform procedures. Performance testing was done on the device itself (hardware and embedded software), as detailed in the "Performance Testing" section.

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

• The "ground truth" for this device's performance would be established through a combination of:
  • Engineering specifications: (e.g., accurate power output, temperature control).
  • Measurement against calibrated standards: using specialized test equipment.
  • Physical demonstration: (e.g., the ability to generate a lesion of a certain size/shape in a controlled medium during "Comparative Lesion Testing").
  • Compliance with recognized standards: (e.g., IEC 60601 series).
  • Functional equivalence to predicate: demonstrating it performs the same functions as the already cleared predicate device.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning in a way that requires a "training set" for an AI model.

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

• Not applicable, as there is no training set for an AI model.

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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 RuloTM Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Rulo™ Radiofrequency Lesion Probe (Rulo Probe) creates radiofrequency (RF) lesions on nerves and can also create percutaneous nerve blocks by delivering anesthetic to the site. It is a single-use, surgically invasive device. It is inserted with the use of a flexible introducer accessory to contact a nerve in an area of the spine for less than 15 minutes to treat pain. The RF energy creates a lesion on nerve tissue that conducts pain signals. The tissue's ability to conduct electrical signals is disrupted by the lesion. The targeted nerve can be localized either by using RF electrostimulation through the cannula or by injecting contrast medium through the cannula with the use of the fluid injection port and using radiography concomitantly. The nerve may be blocked by injecting local anesthetic solution or making an RF lesion. The device is used by a trained physician in a clinical setting. The device is constructed with a steel cannula and uses a variety of polymers for the insulation, hub, cable, connector, cap and fluid injection port.

This document is a 510(k) premarket notification for the Epimed Rulo™ Radiofrequency Lesion Probe. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study for novel performance claims. As such, many of the requested data points (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or available in this type of submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and device performance are primarily focused on engineering performance and biocompatibility, demonstrating that the device functions as intended and is safe for use, and is comparable to the predicate device. Specific quantitative performance targets typically seen in AI/diagnostic device studies are not present here because this is a physical medical device.

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

• Sample Size: Not specified for individual tests. The nonclinical testing involves laboratory and bench testing of device components and the complete device. This is not a study that uses patient data.
• Data Provenance: Not applicable in the context of patient data. The nonclinical test data is generated in a laboratory setting or through engineering assessments.

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

• This is not applicable as the submission reports on physical and chemical performance tests, not a diagnostic or AI algorithm that requires expert-established ground truth from images or patient data.

4. Adjudication Method for the Test Set

• Not applicable for the types of nonclinical performance and biocompatibility tests performed. These tests have defined pass/fail criteria based on 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, not an AI or diagnostic imaging device that involves human readers or an AI algorithm.

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

• Not applicable. This is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

• For performance tests: The ground truth is defined by the specifications in the referenced international and national standards (e.g., ISO, BS, ANSI/AAMI/EN).
• For biocompatibility: The ground truth is established by the specified tests and evaluation criteria outlined in ISO 10993 series.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. As above, there is no training set for this device.

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The Spirol® Block Continuous Peripheral Nerve Block Catheter permits placement of catheters next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

Epimed's Spirol® Block Continuous Peripheral Nerve Block Catheter has the following characteristics:

• · 19 Ga. & 20 Ga., 14" to 24" in length.
• · Offered in open and closed end distal tip configurations.
• · Offered in styletted and non-styletted versions.
• · Internal radiopaque, echogenic coiled reinforced wire to allow visibility under fluoroscopy and/or ultrasound.
• · Catheters to be provided in sterile kit/set style configurations or as a standalone replacement catheter.

The catheter is a single-use, disposable device consisting of a polymer coated stainless steel spring. The catheter is available in various lengths, as well as open-ended or closed-ended configurations; the closed-ended models having three eyes (injection ports) at the distal end. The Spirol® Block is also available in styletted or non-styletted versions, as well as 19 Ga. or 20 Ga. models.

The provided document is a 510(k) summary for a medical device called the "Spirol® Block Continuous Peripheral Nerve Block Catheter." This type of document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific acceptance criteria through a comparative effectiveness study or standalone performance.

As such, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this document because it describes a different type of device approval process.

Here's why and what information can be extracted:

• No Acceptance Criteria or Performance Metrics: The 510(k) process for this type of device does not typically involve defining specific numerical "acceptance criteria" and then demonstrating the device "meets" them in the way clinical trials for new drugs or AI algorithms might. Instead, the focus is on showing the new device functions similarly and is as safe and effective as a legally marketed predicate device.
• No "Study" as such for comparative efficacy: There isn't a "study that proves the device meets acceptance criteria" in the sense of a clinical trial or a performance study with human readers improvement. The "study" here refers to non-clinical testing to confirm technological characteristics and biocompatibility.
• No AI Component: This device is a physical catheter, not an AI or algorithm-based device. Therefore, questions related to AI-specific metrics (standalone performance, MRMC studies, human reader improvement with AI) are not relevant.

However, I can extract information about the non-clinical testing performed and the basis for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the non-clinical tests. Medical device bench testing often uses small, representative samples, but specific numbers are not provided in this summary.
• Data Provenance: The tests were performed internally by Epimed International, Inc. or by external labs for specific ISO 10993 testing. No country of origin for data is specified beyond the company's location in the USA. All testing described is pre-clinical/bench testing, not human clinical data.

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

• This is not applicable. "Ground truth" in the context of expert consensus is typically for diagnostic interpretation tasks (e.g., radiology). For a physical medical device, "ground truth" refers to established engineering specifications, material standards (e.g., ISO 10993), and regulatory requirements. These were assessed through the non-clinical testing listed. While engineers and quality assurance personnel ("experts") would design and oversee these tests, their number and specific qualifications for "establishing ground truth" are not detailed.

4. Adjudication method for the test set:

• Not applicable. This concept applies to expert review of clinical cases. The tests described are objective, physical, and chemical tests against defined 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 device is a physical catheter, not an AI or imaging interpretation device, and no human reader studies were performed.

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

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

7. The type of ground truth used:

• For technological characteristics and functional performance: Engineering specifications, design inputs, and established performance of the predicate devices.
• For biocompatibility: ISO 10993 series of standards.
• For non-clinical testing (dimensional, strength, flow, etc.): Industry standards, internal specifications, and performance data from predicate devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The design validation and non-clinical testing confirm the device meets its intended specifications.

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

• Not applicable for the same reason as above.

In summary, the document demonstrates substantial equivalence through:

• Comparing the Intended Use and Indications For Use to Predicate Device #2 (K122027).
• Comparing the design, manufacture, and material composition to Predicate Device #1 (K981329).
• Presenting results from a series of non-clinical bench and laboratory performance tests (dimensional, substance compatibility, kink testing, stiffness, tensile strength, connector attachment, flow test, resistance to leakage, corrosion resistance, and skive testing) to show comparable performance to the predicate devices.
• Confirming biocompatibility according to ISO 10993 standards.

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

The RX 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 custom trimmed shaft and a molded plastic hub. The RX Epidural Needle will be provided as a sterile, single use, disposable device. The RX Epidural Needle will be available in a variety of lengths and gauges.

The provided text is a 510(k) summary for a medical device called the "RX Epidural Needle" and the FDA's response letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data on a pre-defined test set.

Therefore, many of the requested categories for describing acceptance criteria and study details cannot be filled from the given text. This type of submission relies on the established safety and effectiveness of a predicate device, not on a new clinical or performance study with defined acceptance criteria for a novel device.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

• Cannot be provided from the text. The document does not describe specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) because it's a 510(k) submission for substantial equivalence. It compares the device to a predicate based on "similar physical and technical characteristics" rather than new performance data against numerical targets.

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

• Not applicable / Cannot be provided from the text. No specific test set or associated data provenance is mentioned as this is a substantial equivalence submission, not a de novo study with a test set.

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 / Cannot be provided from the text. Ground truth establishment is not described as there is no specific "test set" and corresponding study in the provided text.

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

• Not applicable / Cannot be provided from the text. No adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable / Cannot be provided from the text. This device is an epidermal needle, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• Not applicable / Cannot be provided from the text. This device is an epidermal needle, not an algorithm, so standalone performance in that context is not relevant.

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

• Not applicable / Cannot be provided from the text. No ground truth is described.

8. The sample size for the training set

• Not applicable / Cannot be provided from the text. No training set is mentioned.

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

• Not applicable / Cannot be provided from the text. No training set or ground truth establishment is mentioned.

Summary based on the document:

The provided document describes a 510(k) summary for a medical device. The core of a 510(k) submission is to demonstrate substantial equivalence to a predicate, legally marketed device. This means the device is as safe and effective as a legally marketed device and does not require a new Premarket Approval (PMA) application.

In this specific case, the RX Epidural Needle is deemed substantially equivalent to the Epimed International Epidural Needle (K030562). The "study" (or rather, the basis for approval) is this comparison.

• Acceptance Criteria: Implicitly, the acceptance criterion for a 510(k) is demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate device.
• Reported Device Performance: The document states, "The RX Epidural Needle has similar physical and technical characteristics to the Epimed International Epidural Needle marketed under K030562." This is the reported "performance" in the context of this type of submission. Specific numerical performance metrics were not required or provided in the summary.
• Study Design: This was a comparison study based on device characteristics, not a clinical trial or performance study with a test set of data.

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The Stingray Epidural Catheter Connector is intended to provide various anesthetic and fluid administration devices with a single, common access point to an epidural catheter for delivery of anesthetics. The connector is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.

The Stingray Epidural Catheter Connector consists of two molded plastic body Sections that mate in a twist and lock motion. Between the two Sections is a molded bushing that compresses and grips an epidural catheter.

This document, a 510(k) summary for the Stingray Epidural Catheter Connector, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The purpose of a 510(k) summary is to demonstrate substantial equivalence to a predicate device, not necessarily to present a de novo study with acceptance criteria and performance data in the format requested. While it mentions "The testing performed and comparison to the predicate device demonstrates that the Stingray Epidural Catheter is safe and effective," it does not elaborate on what that testing entailed, its methodology, or its results.

Therefore, I cannot provide the requested information for the following points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document states the device is "safe and effective" and "substantially equivalent" but provides no specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not present. No information about specific test sets, their size, or origin (country, retrospective/prospective) is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present. This type of information is typically for studies involving human interpretation (e.g., image analysis), which is not the primary focus of this device's 510(k) submission. No expert review for ground truth is mentioned.
4. Adjudication method: Not applicable/present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical connector, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. The "testing performed" likely referred to bench testing or engineering evaluations to ensure physical and functional equivalence to the predicate, rather than ground truth in the context of diagnostic performance.
8. The sample size for the training set: Not applicable. This device is not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide:

• Device Name: Stingray Epidural Catheter Connector
• Intended Use: A connection device to provide various anesthetic and fluid administration to an access point to an epidural catheter for delivery of anesthetics, used in conjunction with an epidural catheter for continuous administration of anesthetic agents.
• Predicate Device: B. Braun Medical Perifix® Catheter Connector (K032144)
• Conclusion: The device is "safe and effective and is substantially equivalent to the predicate device" based on "testing performed and comparison to the predicate device."

To obtain the detailed information requested, one would typically need to review the full 510(k) submission, which would include detailed test reports, protocols, and results. This summary, by its nature, is an abbreviated version.

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The Flexible Introducer Cannula is intended for the epidural placement, directly The Flexible Introducer cannuid is Inventour of the opents to elicit regional anesthesia.

The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.

This document is a 510(k) summary for a medical device called the "Flexible Introducer Cannula." It details the device's characteristics, its intended use, and its comparison to a predicate device to establish substantial equivalence.

Based on the provided text, there is no information available about acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for a study involving the device's performance, nor a study proving such criteria are met.

The document is a regulatory submission focused on establishing substantial equivalence for a physical medical device (anesthesia conduction needle), not a software or AI/ML-driven device that would typically have performance metrics and acceptance criteria for classification or detection tasks.

Here's a breakdown of why this information is not present and what is discussed instead:

• Acceptance Criteria and Reported Device Performance: This device is a physical instrument. The "acceptance criteria" here are related to physical and technical characteristics and safety/effectiveness as compared to a predicate device, rather than statistical performance metrics for a diagnostic or AI system. The document states:

  • "The Flexible Introducer Cannula has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device."
  • "The testing performed and comparison to the predicate device demonstrates that the Flexible Introducer Cannula is safe and effective and is substantially equivalent to the predicate device."
  • No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported.

• Sample size for the test set and data provenance: Not applicable. There is no mention of a "test set" in the context of diagnostic performance data. The "testing performed" would likely refer to engineering validation and verification tests (e.g., materials testing, sterility, functionality) and comparison of physical attributes to the predicate.

• Number of experts and their qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML performance studies is not relevant here. The "ground truth" for this device would be its physical conformance to specifications and its biological safety, established through standard engineering and biocompatibility testing.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable. There is no mention of human readers or AI assistance.

• Standalone performance study: Not applicable in the context of AI/ML. All the documentation describes the device's standalone characteristics and function.

• Type of ground truth used: For a physical medical device like this, "ground truth" means demonstrating the device meets design specifications, material properties, biocompatibility, and functional requirements. This is typically established through engineering tests, material science analysis, and preclinical studies where relevant. The summary provided does not detail these specific tests, but rather states that "testing was performed."

• Sample size for the training set: Not applicable. This is not an AI/ML device.

• How ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a traditional medical device (anesthesia conduction needle). It establishes substantial equivalence to a predicate device through comparison of physical and technical characteristics and intended use, rather than through performance metrics typically associated with AI/ML or diagnostic devices. Therefore, the specific questions regarding acceptance criteria, study details, and ground truth establishment in the context of AI/ML or diagnostic performance are not addressed by this document.

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The Flexible Spinal Needle is intended for the administration of anesthetic agents to provide regional anesthesia.

The Flexible Spinal Needle consists of a coated flexible stainless steel cannula with a molded plastic hub. A stylet is also provided with the device which consists of a stainless steel cannula and a molded plastic hub. The Flexible Spinal Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.

This document is a 510(k) summary and FDA clearance letter for a Flexible Spinal Needle. It describes the device and its intended use, and compares it to predicate devices. However, the document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• Type of device: This is a medical device (a spinal needle), not a software or AI-driven diagnostic device. The questions about "algorithm only without human-in-the loop performance," "effect size of how much human readers improve with AI," and "sample size for the training set" are specific to AI/ML or diagnostic software and are not applicable to a physical medical instrument like this.
• Study Design: The document states "Bench Testing performed on the Flexible Spinal Needle to compare performance characteristics to the predicate device(s) confirmed that the performance of the Flexible Spinal Needle is similar to the predicate device(s)." This is a very high-level summary and doesn't provide the specifics requested in your prompt.

Therefore, most of the requested information cannot be extracted from the provided text.

Information that can be inferred or stated as not available:

1. Table of acceptance criteria and reported device performance: Not provided. The document generally states "performance... is similar to the predicate device(s)," but no specific criteria or performance metrics are listed.
2. Sample size used for the test set and data provenance:
   • Sample size: Not specified. "Bench Testing" is mentioned.
   • Data provenance: Not specified. Assumed to be lab/bench test data, not patient data in the typical sense requested by "country of origin" or "retrospective/prospective."
3. Number of experts and qualifications: Not applicable/Provided. Bench testing doesn't typically involve human experts in this context.
4. Adjudication method: Not applicable/Provided.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not conducted/applicable as this is not an AI/ML diagnostic system.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device.
7. Type of ground truth used: Not explicitly stated for bench testing, but likely derived from engineering specifications and predicate device performance standards.
8. Sample size for the training set: Not applicable. There is no "training set" for a physical device undergoing bench testing for 510(k) clearance in this manner.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a 510(k) clearance for a physical medical device (spinal needle) based on substantial equivalence to predicate devices through bench testing. It does not provide the detailed study design, acceptance criteria, or performance metrics typically found in documentation for AI/ML or diagnostic software evaluations, as implied by most of your detailed questions.

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The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.

The Epimed RF Introduction Cannula consists of a coated stainless steel cannula with a stainless steel stylet and molded plastic hub. The cannula will be available in various lengths, gauges and tip configurations.

This document describes a 510(k) premarket notification for the "Epimed RF Introduction Cannula," and as such, it does not detail acceptance criteria and a study proving device performance in the way a clinical trial or AI device study would. Instead, it demonstrates substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a bench testing comparison to predicate devices, not a clinical study with a "test set" in the context of AI or clinical efficacy. The "test set" here refers to the Epimed RF Introduction Cannula itself, which was subjected to bench tests.
• Data Provenance: The data comes from "Bench Testing performed on the Epimed RF Introduction cannula." No information on country of origin or retrospective/prospective nature is given beyond being bench tests.

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

• Not Applicable. Ground truth in the context of expert consensus or clinical outcomes is not relevant for this type of regulatory submission, which relies on bench testing comparisons for substantial equivalence. The "ground truth" for the bench testing would be the measured physical and technical characteristics of the device and its predicate.

4. Adjudication method for the test set

• Not Applicable. No explicit adjudication method is mentioned. The comparison seems to be direct measurements of physical/technical characteristics against those of predicate devices.

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, not done. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• Not Applicable. This is a physical medical device (cannula), not an algorithm or AI system.

7. The type of ground truth used

• For the non-clinical data, the ground truth was the measured physical and technical characteristics of the Epimed RF Introduction Cannula and the referenced predicate devices, assessed through bench testing.

8. The sample size for the training set

• Not Applicable. This is not an AI device with a training set.

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

• Not Applicable. This is not an AI device with a training set.

Summary of the Study (Bench Testing):

The study performed was Non-Clinical Bench Testing. This testing aimed to compare the performance characteristics of the Epimed RF Introduction Cannula to its predicate devices. The conclusion from this bench testing was that the performance of the Epimed RF Introduction Cannula is "similar to the predicate device(s)," leading to the determination of substantial equivalence in terms of safety and effectiveness. The specific parameters measured during these bench tests are not detailed in this summary.

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