Search Results

The Laurimed Discectomy System is indicated for use in aspiration of disc material during open discectomies in the lumbar region of the spine.

The Laurimed Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Dilator, Straight Cannula, Curved Cannula (qty. 2) and Trocar), a Device Cleaner, and a Discectomy Device
The Laurimed Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.

Here's an analysis of the provided text regarding the acceptance criteria and study information:

Based on the provided 510(k) summary, there is no specific acceptance criteria or study that proves device performance in a clinical or standalone setting using human data. The submission relies solely on a comparison to a predicate device and non-clinical (i.e., bench or lab) testing.

Here's a breakdown of why and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. The summary explicitly states "Summary of Non-Clinical Data." This indicates that no human test set data was used or presented in this 510(k) summary. The testing was likely limited to bench or laboratory evaluations to demonstrate functionality and safety characteristics (e.g., cutting efficacy, aspiration flow, material compatibility, sterilization effectiveness).

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

• Not applicable / Not provided. Since there's no clinical test set with human data, 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 / Not provided. As no human test set was used, 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 a surgical tool (discectomy system) and does not involve AI or human readers for image interpretation. Therefore, an MRMC study or AI-assisted performance is not relevant to this submission.

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

• No. This device is a physical surgical tool, not an algorithm. Standalone performance as typically understood for AI/software devices is not applicable. The "standalone" performance here would refer to the device's mechanical and functional performance, which was assessed through non-clinical testing.

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

• Not applicable / Not provided. For the non-clinical testing mentioned, the "ground truth" would likely be defined by engineering specifications, material properties, and established test methodologies (e.g., force measurements, flow rates, visual inspection of cut tissue substitutes). No clinical or expert-based ground truth is discussed.

8. The sample size for the training set:

• Not applicable / Not provided. This is a hardware medical device, not an AI or software algorithm that requires a training set of data.

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

• Not applicable / Not provided. As above, no training set data is relevant to this device.

In summary, this 510(k) submission for the Laurimed Discectomy System primarily relies on:

• Substantial Equivalence: A direct comparison to a legally marketed predicate device (Laurimed Percutaneous Discectomy System, K082194) regarding intended use and technological characteristics.
• Non-Clinical (Bench) Testing: To validate the device's performance, ensure it functions as intended, and meets design specifications. This testing covers aspects like safety and effectiveness without involving human subjects.

The absence of clinical study data, expert adjudication, or AI-related metrics is typical for many Class II medical devices cleared via the 510(k) pathway, especially those that are similar in design and function to existing predicate devices and do not introduce novel technology requiring extensive new clinical evidence.

Ask a specific question about this device