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The DiscCath Needle Set is intended to provide access into the intervertebral disc for discography and injection of fluids. The device is intended for adult patients.

The DiscCath Needle Set is a single-use intradiscal injection needle comprised of a 17 gauge x 6" Introducer Needle and a 21 gauge x 10.2 inch (nominal) Injection Catheter. The Introducer Needle is comprised of a stainless-steel cannula and metal hub with a stainless-steel stylet with metal hub. The Introducer Needle has a cannula and stylet match ground bevel point at the distal tip which allows for penetration into the intervertebral disc. The Injection Catheter is comprised of a nitinol shape-set tube and a molded plastic hub. The injection catheter tubing is flexible with a curved tip welded closed at the distal end and includes a laser cut side-hole that allows for the injection of a fluid. When used as intended, the Introducer Needle and stylet are first inserted percutaneously and advanced adjacent to the target anatomy. After removing the Introducer Needle stylet, the curved catheter is then inserted through the Introducer Needle cannula and slowly advanced to the target anatomy. The DiscCath Needle Set is sterilized by ethylene oxide and intended for single use.

The provided text does not contain information about the acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The document is an FDA 510(k) clearance letter for a medical device called the "DiscCath Needle Set," which is an instrument, not an AI/ML software. The clearance is based on substantial equivalence to a predicate device, focusing on engineering specifications, material properties, sterilization, and biocompatibility, as opposed to performance metrics that would be associated with an AI/ML algorithm (e.g., sensitivity, specificity, AUC).

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving an AI/ML device meets them, as this information is not present in the provided text.

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The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath™ & Acutherm™ catheters.

The Stryker Intradiscal RF Generator when used with the separately cleared Stryker RF Intradiscal Adapter and the separately cleared Smith & Nephew SPINECATH™ Intradiscal Catheter (K993967) ACUTHERM ™ Decompression Catheter is is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The provided documentation, K063489, is a 510(k) Summary for the Stryker Intradiscal RF Generator, submitted in 2007. It establishes substantial equivalence to a predicate device, the Smith & Nephew ElectroThermal 20S Spine Generator (K033981), rather than presenting a study with specific acceptance criteria and performance data for the Stryker device itself.

Therefore, many of the requested details regarding a study proving acceptance criteria are not directly available in this document. The submission asserts equivalence based on intended use, technological characteristics, operating principles, and similar performance characteristics.

Here’s an analysis based on the provided text, indicating what is not present in the document due to its nature as a 510(k) summary relying on predicate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. This 510(k) submission does not describe a new clinical or performance study with a test set for the Stryker Intradiscal RF Generator. It relies on the substantial equivalence to a previously cleared device.

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 test set or ground truth establishment by experts is described for this submission.

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

• Not Applicable. No test set or 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. The device is a radiofrequency generator, not an AI-based diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not present in this document.

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

• Not Applicable. The device is a physical medical instrument (RF generator), not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics, and its safety relies on its design and manufacturing.

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

• Not Applicable. As no specific performance study for this device is detailed, no ground truth data type is mentioned. The submission relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.

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

• Not Applicable. As above, this is not an AI/machine learning device.

Summary of the K063489 Submission:

The K063489 submission for the Stryker Intradiscal RF Generator establishes substantial equivalence to the Smith & Nephew ElectroThermal 20S Spine Generator (K033981). This means that instead of conducting new performance studies, the applicant demonstrated that their device shares the same intended use, technological characteristics, operating principles, and similar performance characteristics as a device already legally marketed. Therefore, the detailed information typically found in a clinical or performance study (such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not provided in this 510(k) summary for the Stryker device itself. The FDA cleared the device based on this comparative assessment.

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The Stryker RF Intradiscal Adapter is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Adapter will be used with the previously cleared Stryker Intradiscal RF Generator and catheters such as Smith & Nephew SPINECATH™ & Acutherm™ catheters.

The Stryker RF Intradiscal Adaptor when used with the separately cleared Stryker RF Generator and the separately cleared Smith & Nephew SPINECATHTM Intradiscal Catheter(K993967) and ACUTHERM TM Decompression Catheter or equivalent. The Stryker RF Intradiscal Adaptor is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The provided text is a 510(k) summary for the Stryker RF Intradiscal Adapter. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, this document does not contain information about clinical studies with acceptance criteria, reported device performance, or details about test datasets, expert involvement, or adjudication methods for AI performance.

Instead, the submission for this device relies on the concept of substantial equivalence to already legally marketed devices. This means that Stryker is asserting that their device is as safe and effective as a previously cleared device, based on similarities in intended use, technological characteristics, and principles of operation, rather than on new clinical performance data from a standalone study.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the provided document does not include such a study.

Here's a breakdown of why the requested information cannot be extracted from this document, specifically addressing each point you asked for:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to predicate devices based on design and intended use, not on quantifiable performance metrics from a dedicated study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is mentioned, as no new clinical performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring ground truth establishment is detailed.
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: Not applicable. This device is an adapter for electro-surgical equipment, not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is hardware, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

The "Safety and Effectiveness" section explicitly states: "Based upon the comparison to the predicate devices, the Stryker RF Intradiscal Adapter is substantially equivalent to a legally marketed device." This confirms that the approval pathway relies on equivalence, not on new performance data demonstrating the device meets a predefined set of acceptance criteria.

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