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The Disc-FX System is intended for use in ablation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine.

The Disc-FX® System is a single-use, disposable kit which is intended for use in ablation and coagulation of intervertebral disc material during discectomy procedures in the cervical, thoracic, and lumbar spine. This device originally received requlatory clearance under 510(k) number K052241 with indications for use limited to the lumbar spine. The design of the Disc-FX® System remains unchanged; the purpose of this 510(k) submission is solely to expand the existing indications of use to include both cervical and thoracic applications.

The Disc-FX® System consists of the following components:

1. Trigger Flex® Bipolar System
2. Triager Flex® Depth Stop
3. Surgical guidewires
4. Straight cannula
5. Beveled cannula
6. Tapered dilator
7. Trephine

This document is a 510(k) premarket notification for the Disc-FX System, seeking to expand its indications for use from only the lumbar spine to include cervical and thoracic applications. The submission primarily relies on demonstrating substantial equivalence to a previously cleared version of the Disc-FX System (K052241) and the Arthrocare Coblator IQ™ Perc-D® Spinewand® (K100353).

The document does not contain acceptance criteria or detailed results of a study proving the device meets specific acceptance criteria in the typical format of a clinical performance study with sensitivity, specificity, or similar metrics. The information provided focuses on non-clinical testing to support substantial equivalence for the expanded indications.

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

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/device performance study. The non-clinical testing sections broadly mention "various performance tests including mechanical testing and simulated use tests" and "Comparison of the thermal effect of the subject device on intervertebral tissue as compared to predicate." However, specific numerical acceptance criteria and reported numerical results against those criteria are not provided for these tests in this summary.

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

• Test Set Sample Size: Not applicable. This submission does not describe a clinical performance study with a test set of patient data to evaluate algorithmic performance. The submission uses non-clinical testing (mechanical, simulated use, thermal effect, electrical safety, biocompatibility).
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

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

Not applicable.

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 such study is mentioned or described in this document. The submission explicitly states: "Clinical testing was not included in this submission."

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

Not applicable. The device is an electrosurgical system, not an AI algorithm. Its performance is evaluated through non-clinical functional tests.

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

Not applicable. For the non-clinical tests, "ground truth" would relate to engineering specifications, material properties, safety standards, and physiological responses in simulated environments, rather than clinical ground truth diagnoses.

8. The sample size for the training set

Not applicable. The device is a medical instrument (electrosurgical system), not an AI/machine learning algorithm that requires a training set.

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

Not applicable.

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The electrodes are accessories to the Ellman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.

Ellman has been manufacturing and distributing electrodes for many years. The Ellman electrodes are used with an electrosurgical generator (such as Ellman Surgi Max K061174, Ellman Surgitron K052241). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by the RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellman family of electrodes are available in various shapes and sizes depending on the need of the surgeon. The Ace-Tip electrodes are composed of the new noble alloy. Several of the classical Ellman electrodes are now available in the new noble alloy including: Loop Electrode 3mm and 5mm, Micro Incision Needle Electrode, Ball Electrode 2mm, Tapered Ball Electrode 3mm, Fine Wire Electrode, VariTip Electrode.

The provided 510(k) document (K071343) for Ellman Ace-Tip Electrodes describes a device intended for electrosurgical cutting and coagulation. However, it does not include detailed acceptance criteria or a specific study proving the device meets performance criteria in the way typically expected for complex AI/ML medical devices.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Ellman Electrodes Preamendment) based on technological characteristics and material properties. The provided text details the device, its intended use, and a general statement about its performance, but lacks the specific, quantifiable performance metrics, study designs, and statistical analyses requested in your prompt.

Here's a breakdown of why the requested information cannot be fully extracted and what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Reasoning for "Not explicitly stated": The document claims "The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics." This type of 510(k) relies on the similarity to a device already on the market, rather than a de novo demonstration of performance against predefined criteria.

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

• Sample size: Not applicable or not provided. There is no mention of a clinical or in vitro performance test set with a defined sample size for evaluating the device's cutting or coagulation performance against a specific ground truth.
• Data provenance: Not applicable or not provided.

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

• Not applicable or not provided. There is no mention of a test set requiring expert-established ground truth.

4. Adjudication method for the test set

• Not applicable or not provided. As there's no described test set, no adjudication method 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

• No. This device is an electrosurgical electrode, not an AI/ML diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.

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

• Not applicable. This is a physical electrosurgical electrode, not an algorithm.

7. The type of ground truth used

• The concept of "ground truth" as it applies to AI/ML or diagnostic devices is not relevant here. The "proof" of performance for these electrodes is based on their physical and electrical specifications, biocompatibility, and functionality being similar to existing (predicate) electrodes. The ground truth for such a device would likely be its ability to safely and effectively cut and coagulate tissue, which is implicitly accepted by its substantial equivalence to a pre-amendment device.

8. The sample size for the training set

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

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

• Not applicable.

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

The "study" or justification for equivalence presented in this 510(k) is a comparison to a predicate device (Ellman Electrodes Preamendment). The core argument is based on:

• Technological Characteristics: The Ace-Tip electrodes are described as using a "new noble alloy" and are available in various shapes and sizes, similar to existing Ellman electrodes.
• Performance Data: The document states, "The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device." This implies that material safety (biocompatibility) and electrical integrity/functionality have been verified to be acceptable and comparable to the predicate.
• Conclusion: The changes in the new electrodes are considered "minor," and the devices are concluded to be "as safe and effective as the predicate device."

In essence, this 510(k) relies on the principle of substantial equivalence, where detailed de novo performance studies with specific statistical metrics are not required or provided, because the device is deemed sufficiently similar to a device already on the market.

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