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The Kyphon Discyphor Direct™ Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space.

The Kyphon Discyphor Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Direct™ Inner Needle and Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct ""Outer Needle is intended to be used only with the Discyphor Direct™ Catheter System.

The Kyphon Discyphor Direct™ Inner Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct " Inner Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Discyphor Direct" voner Needle is intended to be used only with the Discyphor Direct " Catheter System.

The Discyphor Direct™ Catheter System is comprised of a Discyphor Direct™ Catheter, a Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly, an EPI-Guard Catheter Anchoring Device, Adhesive Clips, a Sheet of Labels, 1-cc Syringes and a Discyphor Direct™ Outer Needle (with stylet) and a Discyphor Direct™ Inner Needle (with stylet). The Discyphor Direct™ Catheter is a micro-catheter with a double lumen shaft and an inflatable balloon at its distal end.

The Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly are intended to be connected to the lumens of the catheter and to provide access to the lumens. The Balloon Inflation Assembly consists of an a 3-cc Syringe and a pressure relief valve. The Stopcock Assembly consists of a Stopcock, a Touhy Borst adapter and a Wing Nut. The Injection Assembly consists of a Touhy Borst adapter, a One-way valve and a Wing Nut. The EPI-Guard Catheter Anchoring Devices secures the catheter close to the needle puncture site. The Adhesive Clips are used to secure the catheter to the patient.

The 1-cc Syringes can be used for injection of contrast, antibiotic, and/or saline into the disc space.

The labels provided on the Label Sheet are used to identify the solutions used during the procedure or to denote the level at which the Discyphor Catheter has been placed.

The Discyphor Direct " Outer Needle is manufactured from stainless steel and has a stainless steel stylet with a beveled tip and a polycarbonate wing.

The Discyphor Direct™ Inner Needle is manufactured from stainless steel and has a stainless steel stylet.

The provided text describes the Kyphon Discyphor Direct™ Catheter System and its components (Outer Needle, Inner Needle). It states that the device was submitted for a 510(k) premarket notification, indicating a claim of substantial equivalence to previously cleared predicate devices. The study performed is not a clinical study in the traditional sense, but rather a series of engineering and performance tests to demonstrate that the device meets specifications and is substantially equivalent to predicates.

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

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

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

The text does not specify the sample sizes used for each of the tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These are engineering and performance tests, not clinical studies involving human subjects in a traditional sense.

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)

This section is not applicable to this type of device and study. "Ground truth" in the context of expert consensus is typically relevant for studies evaluating diagnostic accuracy, where human expert interpretation is compared to an AI's output. The Kyphon Discyphor Direct™ system is a medical device for delivery of substances, and its performance is evaluated through engineering and functional tests against predefined specifications, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic tool would be.

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

This section is not applicable for the same reasons as in point 3. Adjudication methods are used in clinical trials or diagnostic accuracy studies to resolve discrepancies among expert readers. The tests performed for this device are objective engineering and performance tests.

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

There was no MRMC comparative effectiveness study done. This device is not an AI diagnostic tool; it is a catheter system for delivering substances. Therefore, a study comparing human readers with and without AI assistance is not relevant or applicable.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for the engineering and performance tests was based on predefined design specifications and industry standards for medical device performance, safety, and biocompatibility. For instance, dimensions must fall within specified tolerances, materials must meet certain tensile strength, and sterilization must achieve a specified sterility assurance level.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device. Manufacturing processes and design iterations might involve internal testing, but this is not analogous to an AI training set.

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

This section is not applicable for the same reasons as in point 8.

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