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The Diros OWL cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using 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 Diros OWL Sterile Single Use Disposable 16Ga Cannulae models 466, DHC are identical in construction, materials, energy source and intended use to predicate devices. They are single use disposable devices to be used with the Diros OWL RF Generators.

The 466 series 16Ga cannula consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

The DHC series 16Ga cannula consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the handle. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for a medical device (Diros OWL Sterile Single Use R.F. Insulated Cannulae, Models 466 and DHC) applying for substantial equivalence to predicate devices.

While it mentions several types of nonclinical testing performed (biocompatibility, electrical safety/EMC, mechanical, and performance testing), it does not provide:

• Specific acceptance criteria values or thresholds for these tests. It only states that the results demonstrated compliance and matched the performance of predicate devices.
• Detailed study designs or raw data from these tests beyond general categories.
• Information about sample sizes for test sets, data provenance, ground truth establishment, or expert involvement as these types of studies (e.g., studies involving human interpretation or AI performance) are not typically applicable to the substantial equivalence review of this type of medical device (radiofrequency lesion cannulae), which relies heavily on physical and electrical performance rather than diagnostic or interpretative accuracy.
• Any information about multi-reader multi-case (MRMC) studies or standalone algorithm performance, as this is not an AI/software device designed for interpretation.
• Information about training sets, as this is a hardware device undergoing a substantial equivalence review, not an AI model requiring a training phase.

The document focuses on demonstrating that the new device is "substantially equivalent" to already marketed predicate devices by showing similar materials, intended use, technological principle, and performance in standardized engineering and safety tests. The primary performance metric mentioned being different, and expectedly so, is the "larger lesion" created by the larger gauge cannulae, which is then explicitly compared to a predicate device of the same larger gauge.

Therefore, I cannot construct the requested table or provide details about sample sizes, ground truth, or expert adjudication from the provided text.

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The Diros OWL cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using 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 Diros OWL Sterile Single Use Disposable Cannulae models 466, 467, DXE, DRC, DST, DHC are single use disposable cannulae designed for use with the Diros OWL RF Lesion Generator, model URF-3AP. The models DRC, DXE, DHC and DST provide flexible injection ports and are used to administer for the delivery of local anaesthesia. The DXE and DHC models along with the standard RF cannulae product line additionally provide the capability for delivery of RF therapy. The DHC model includes an embedded thermocouple for thermally controlled lesion generation. The Diros OWL Sterile Single Use Disposable Cannulae are available in multiple sizes. The cannulae gauge ranges from 18 to 24 and the length from 30mm to 200mm. All cannulae in this submission are for single use only and are supplied sterile.

This submission for 510(k) K102566 describes the Diros OWL Cannulae, which are injection needles intended for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The provided document does not specify quantitative acceptance criteria or a direct performance study to demonstrate that the device meets such criteria. The submission for the Diros OWL Cannulae relies on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because its intended use, technological characteristics, material properties, and dimensions are the same as or very similar to devices already legally marketed.

   Therefore, a direct table of acceptance criteria and reported device performance, in the typical sense for a new clinical efficacy study, cannot be generated from this document. The "performance" demonstrated is its similarity to existing, approved devices.

   • Acceptance Criteria (Implicit): The device's characteristics (intended use, technological characteristics, material properties, dimensions) are sufficiently similar to legally marketed predicate devices to raise no new questions of safety and effectiveness.
   • Reported Device Performance: The document states, "The Diros OWL Sterile Single Use Disposable Cannulae models 466, 467, DXE, DRC, DST and DHC have the same intended use, technological characteristics, material properties, and dimensions as the identified legally marketed predicate devices."

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

   No test set in the sense of a clinical trial or performance study on humans or biological models is described for this 510(k) submission. The submission relies on comparative analysis with predicate devices. Therefore, there is no sample size for a test set or data provenance to report in this context.

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

   Not applicable. Since no test set or clinical study is described, there's no ground truth established by experts in this context. The determination of substantial equivalence is made by the FDA based on the provided technical and comparative information.

4. Adjudication Method for the Test Set:

   Not applicable. No test set requiring expert adjudication 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. This device is a physical cannula, not an imaging or diagnostic AI-powered device. Therefore, an MRMC study or AI-related effectiveness study is not relevant.

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

   Not applicable. This device is a physical medical instrument, not a software algorithm.

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

   Not applicable in the traditional sense of a clinical study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices through their long-term market history and prior FDA clearances. The applicant asserts that their device shares these fundamental characteristics.

8. The sample size for the training set:

   Not applicable. There is no training set mentioned or implied as this is not an AI/ML device or a device requiring a statistical model to be trained.

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

   Not applicable. There is no training set for which ground truth would be established.

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