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The LCCS VC-S RF Cannula is intended for use in RF heat lesion procedures for the relief of pain.

The LCCS VC-S RF Cannula is used in conjunction with the RF electrode for the use in RF heat lesion procedures. The LCCS VC-S RF Cannulas are offered in a variety of lengths, gauges to accommodate various anatomical locations and differences in patients' anatomy. The LCCS VC-S RF Cannula is a stainless steel cannula with an insulated shaft having one exposed tip and one side port located at the end of the cannula to diffuse the anesthesia closer to the lesion site and deliver the RF energy to the tissue. When RF Electrode was inserted into LCCS VC-S RF Cannula and came out from the side port, both active tip and RF Electrode section stuck out of side port can deliver Radio Frequency energy. This RF cannula is provided as a sterile, single use, disposable device. This RF Cannula is offered in a variety of length and Needle outside Dimension to accommodate various anatomical locations and differences in patient anatomy. The LCCS VC-S RF Cannula is consisted of: Protection Sleeve, Needle Tube, Insulating layer, Needle hub, Stylet, Stylet Hub.

The provided text is a 510(k) summary for the LCCS VC-S RF Cannula, which is a medical device. This document focuses on demonstrating the substantial equivalence of the proposed device to existing predicate devices, primarily through a comparison of design features, intended use, technology, and non-clinical testing.

Crucially, this document does not contain information about a clinical study involving human patients or a study comparing the device's performance to specific acceptance criteria related to a machine learning or AI algorithm's performance (e.g., sensitivity, specificity, or AUC). The "acceptance criteria" discussed in this document refer to the device's design specifications and performance against established safety and engineering standards (e.g., sterilization, biocompatibility, mechanical safety), not diagnostic or predictive performance metrics of an AI system.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria for an AI algorithm's performance, a test set, ground truth establishment, MRMC studies, or training sets, as that information is not present in the provided context.

The document's "conclusion" (on page 8) states that the device is considered "as safe, as effective, and performance is substantially equivalent to the predicate devices." This substantial equivalence is based on the comparison table and non-clinical tests, not on a human-in-the-loop or standalone AI study.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance:
   The document includes a "Comparison to Predicate Devices" table (pages 5-6) that lists features like intended use, material, needle gauge, needle tube length, structure, method of sterilization, and biocompatibility. The "reported device performance" is essentially that these features are "identical" or "equivalent" to the predicate devices and that the device complies with certain voluntary standards (e.g., AAMI/ANSI ES 60601-2-2, ISO 7864, ISO 10993-1). There is also a "Summary of Non-Clinical Tests" table (page 7-8) which shows test results for biocompatibility (Cytotoxicity, Acute Systemic Toxicity, Sensitization, Intracutaneous Reactivity, Pyrogen) and concludes "Non-Cytotoxic," "Non-Acute Systemic Toxicity," etc. This is the closest the document comes to defining acceptance criteria and performance, but it's for the physical device, not an AI.

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. No test set for an AI algorithm is mentioned. The testing refers to non-clinical, biocompatibility, and engineering tests of the device itself.

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. No ground truth for an AI algorithm is established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.

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. No AI algorithm or MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI algorithm performance is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for an AI algorithm is mentioned. The "ground truth" for this device's acceptance is its conformity to design specifications, material properties, and safety standards demonstrated through non-clinical testing.

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

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LCCS Radiofrequency (RF) Electrode is indicated for use in temperature-controlled RF heat lesson procedures of peripheral nerve tissue for the relief of pain.

LCCS Radiofrequency (RF) Electrode is used in conjunction with RF Generator to create RF lesions of nerve tissue or for use in percutaneous nerve blocks. The RF Electrode connects with RF Generator and thermocouple side which fits in with RF Cannula. The RF generator applies temperature-controlled RF energy into targeted nerve tissue via an RF Electrode to create a heat lesioning of peripheral nerve tissue.

LCCS RF Electrode includes LCCS Disposable RF Electrode and LCCS Reusable RF Electrode. LCCS Disposable RF Electrode Part No. includes RE2750-D-LC, RE27100-D-LC, RE27150-D-LC, and RE27200-D-LC.

LCCS Reusable RF Electrode Part No. includes RE2750-R-LC, RE27100-R-LC, RE27150-R-LC, RE27200-R-LC, RE2550-R-LC, RE25100-R-LC, RE25150-R-LC, and RE25200-R-LC.

This document describes the LCCS Radiofrequency (RF) Electrode, a device for temperature-controlled RF heat lesion procedures of peripheral nerve tissue for pain relief. The submission focuses on demonstrating substantial equivalence to predicate devices (OWL Sterile Single Use RF Probes and OWL Reusable RF Probes) through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the “Passed” status in the non-clinical testing table, indicating the device met the requirements of the specified test methods and standards. The reported device performance is that all tests passed.

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

The document does not specify the sample sizes used for each of the non-clinical tests. It only states that "All nonclinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate devices." The data provenance is implied to be from laboratory testing conducted by the manufacturer or a third-party testing facility, likely in China (given the applicant and consultant information). The studies are evidently prospective, as they were conducted to support the 510(k) submission.

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

There is no mention of experts being used to establish a "ground truth" for the non-clinical test set in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" for these engineering and biocompatibility tests is established by the specified international standards (e.g., ISO, IEC) and internal performance specifications. The tests themselves are designed to objectively measure physical and chemical properties.

4. Adjudication Method for the Test Set

Not applicable. As described above, the non-clinical tests are objective measurements against established standards, not subjective interpretations requiring 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 a medical device for therapeutic intervention (radiofrequency ablation), not a diagnostic device involving human readers or AI assistance in interpretation.

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

Not applicable. This device is a physical electrode used in conjunction with an RF generator and is operated by a medical professional; it is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical studies is based on established international standards (ISO, IEC) for medical devices, materials, and electrical safety, along with the device's own design specifications (e.g., dimensions, temperature range and tolerance). For instance, for biocompatibility, the ground truth is defined by the Pass/Fail criteria outlined in the ISO 10993 series. For temperature accuracy, the ground truth is the ±5% tolerance within the 40-100 °C range.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an artificial intelligence/machine learning device.

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

Not applicable, as there is no training set.

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AN-E epidural needle is intended for the transient delivery of anesthetics to provide neuraxial anesthesia or to facilitate placement of an epidural catheter.

AN-SI spinal needle and AN-SII spinal needle are intended for the transient delivery of anesthetics to provide neuraxial anesthesia.

The proposed device, Anesthesia conduction needles, including Epidural Needle for Single Use (AN-E), Spinal Needle for Single Use (AN-SI, AN-SII) was developed by LCCS Products Limited to meet urgent demands on prevention of cross- infection. Anesthesia conduction needles, is a kind of sterile and sharp hollow-device used for transferring anaesthetic to epidural cavities. The device can be used for introducing dedicated ducts into epidural cavities for convenience of injecting anaesthetic continuously. Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space. The needle tubing is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for neuraxial anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.The stylet hub is made of HDPE, the needle hub is made of resin, the raw material of the needle tubing and stylet is stainless steel, the jacket is PP, all the raw materials are biocompatible.

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

Device: AN-SI spinal needle, AN-SII spinal needle, AN-E epidural needle

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are primarily based on established international standards for medical needles and a comparison to a predicate device. The performance data is reported as meeting these standards and being similar to the predicate.

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

• Sample Size: The document does not explicitly state the specific numerical sample size used for the performance tests. It generally refers to "each size of the needles" being tested. For biocompatibility, it mentions "appendix B1 AN-E biocompatibility test and appendix B2 AN-SI biocompatibility test," implying samples of AN-E and AN-SI were tested.
• Data Provenance: The tests were conducted by the submitter (LCCS Products Limited) or their manufacturing partner, likely in China (Guangzhou, Guangdong, China is the submitter's representative address). The nature of the tests (material properties, dimension conformance) indicates they are likely laboratory-based prospective testing of manufactured devices.

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

• This information is not applicable in this context. The review is for a Class II medical device (needles) primarily based on engineering performance standards and substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" is defined by industrial standards (ISO) and direct comparison to the predicate device specifications.

4. Adjudication Method

• N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert interpretation of images or clinical outcomes, to establish a "ground truth" when there's disagreement among experts. This type of study is not described for this device.

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

• No, an MRMC comparative effectiveness study was not done. These studies are relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to measure diagnostic accuracy and efficiency. This device is an anesthesia conduction needle, which is a physical tool, not a diagnostic algorithm.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

• Yes, in a sense, the primary performance evaluation for this device is "standalone." The device (the needle itself) is tested directly against physical and material standards (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2) and compared to the predicate device's specifications. There is no "human-in-the-loop" component in the device's intended function that would require such a study design. The performance relates to its physical integrity and dimensional accuracy.

7. Type of Ground Truth Used

The ground truth used for this device evaluation is primarily:

• Industry Standards: International Organization for Standardization (ISO) standards (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2) define the acceptable physical and material properties.
• Predicate Device Specifications: The established characteristics (dimensions, materials, design) of the legally marketed predicate devices (IMD's Tuohy needle; Quincke needle; Pencil Point needle K070354).

8. Sample Size for the Training Set

• N/A. This is not an AI/ML device where a "training set" would be applicable. The development of the needle relies on engineering design and manufacturing processes, not machine learning.

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

• N/A. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The design and manufacturing process would adhere to established engineering principles and standards.

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The Single Use Grounding Pad is applied to the patient during electrosurgical procedures to provide a path for the RF current to leave the patient and return to the generator.

The single use grounding pad is a non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode and the patient. The grounding pad is to be used on any patient where full skin contact and a suitable placement site can be obtained. Use of this device for unintended application could lead to an unsafe condition.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LCCS Products Limited Single Use Grounding Pad (K132136):

Device: Single Use Grounding Pad
Premarket Notification Number: K132136

1. Table of Acceptance Criteria and Reported Device Performance

The provided document indicates that the device met the requirements of IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. However, it does not explicitly list specific acceptance criteria values or show them in a table format alongside the reported device performance results. It only states that the device "meets applicable sections of the standards referenced."

Therefore, based only on the provided text, a table with specific criteria and performance values cannot be fully constructed. The acceptance criteria are implicitly defined by the referenced standard, and the reported performance is a general statement of compliance.

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

The document does not specify the sample size used for performance testing (e.g., number of grounding pads tested).

The data provenance is not explicitly stated. Given that the submitter is LCCS Products Limited in Hong Kong, and the primary contact is in China, it's likely the testing was conducted in Asia, but this is an inference, not a stated fact. The document does not indicate whether the testing was retrospective or prospective.

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

This information is not provided in the document. The testing described appears to be technical performance testing against a recognized electrical safety standard (IEC 60601-2-2), which typically relies on instrumentation and engineering measurements rather than expert human interpretation to establish 'ground truth'.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Technical performance testing against an electrical safety standard typically does not involve an adjudication method in the way medical device clinical studies might. Results are generally objective measurements.

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 information is not provided and is not applicable. The device is a "Single Use Grounding Pad," which is a passive medical accessory for electrosurgery. It is not an AI-powered diagnostic or therapeutic device, nor does it involve human readers or AI assistance.

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

This information is not provided and is not applicable. The device is a physical grounding pad, not an algorithm.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" was established by the requirements and methodologies outlined in the IEC 60601-2-2 standard. This standard specifies objective performance and safety criteria for high-frequency surgical equipment and accessories. The testing would have involved engineering measurements to verify compliance with these objective criteria.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a physical medical accessory, not a software or AI model that requires a "training set."

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

This information is not provided and is not applicable for the reasons stated in point 8.

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