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The change of coating material from lacqueur to Parylene does not affect the Indications for use of the predicated devices marketed under K042979 (Pajunk Plexolong Sets), K033018 (Pajunk Stimulong Plus Catheter Sets), K023218 (Pajunk Plexolong Sets), K013041 (Pajunk Plexolong Anesthesia Sets), K999722 (Unipolar Needles with Standard and Sprotte-tip). The change in coating has no effect on the Indications for use of these devices already cleared for market.

Pajunk's PlexoLong and StimuLong sets consist of a Pajunk unipolar needle, an open ended conduction catheter and a catheter adapter, as well as a filter. The coating of the needle will be chnaged to NanoLine. Pajunk's Unipolar needles marketed separately as single shot needles under the trade name UniPlex have a lacquer coating, which will be changed to NanoLine coating, Only the coating material of the needles is affected by this change. The anesthesia conduction catheters and the packaging materials are the same as those used for Pajunk's PlexoLong sets cleared for market by FDA under 510(k) numbers K013041, K023218 and K042979. The NanoLine coating is equivalent to HDC's Insul-Cote PTM needles and CLA kit (nerve stimulation) marketed under K994059. (In fact NanoLine is a better material because of a higher grade of purity. For a precise discussion of this topic see section 15 "Biocompatibility" of this submission of a special 510(k)). The contract sterilizer other than a company name change (was IBA Griffith Micro Science, and now is Sterigenics) and the stepally hame change (was film inford Sterice, and este sets.

The provided text is a 510(k) Premarket Notification Submission for Pajunk's Anesthesia Conduction NanoLine Coated Needles. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a dedicated study with statistical data.

Therefore, the information required to populate the table and sections about acceptance criteria and a study proving their fulfillment is not present in the provided text. The submission indicates that the change is primarily a material change for the coating (from lacquer to NanoLine/Parylene), and the primary evidence presented is through comparison to predicate devices and biocompatibility testing. There is no mention of a clinical or performance study with specific acceptance criteria that the device's numerical performance is being compared against.

Here's a breakdown of why each requested item cannot be extracted from the given text:

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

• Acceptance Criteria: Not explicitly stated as numerical performance targets for this device. The submission aims to show "substantial equivalence" to predicate devices, implying similar performance rather than meeting new, distinct numeric thresholds.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, signal strength) are reported for the NanoLine coated needles. The document asserts that the change in coating does not affect the performance or indications for use.

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

• No specific test set or clinical study is described that would have a sample size mentioned. The submission relies on comparisons and biocompatibility data.

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)

• No human-expert-reviewed test set is mentioned.

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

• No test set requiring adjudication 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

• This device is an anesthesia needle, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.

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

• Not applicable as this is a medical device (needle), not an algorithm.

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

• No ground truth data relevant to clinical performance is discussed for a new study. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable, as this is not an AI/ML device that requires a training set.

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

• Not applicable.

Summary of Device Rationale from the Text:

The premise of this 510(k) submission is to demonstrate that the new NanoLine coating material for anesthesia conduction needles does not alter the fundamental safety and effectiveness of the devices compared to their previously cleared predicate devices, which used a lacquer coating. The key arguments are:

• Material Change Only: The primary change is the coating material from lacquer to NanoLine (described as Parylene).
• Substantial Equivalence: The NanoLine coating material is considered "substantially equivalent" to HDC's Insul-Cote PTM needles (K994059), which is a predicate device. Furthermore, NanoLine is presented as "a better material because of a higher grade of purity."
• No Impact on Indications for Use: The change in coating material "does not affect the Indications for use of the predicated devices."
• Biocompatibility Testing: "Biocompatibility testing of Pajunk's anesthesia conduction needles & sets... has been accomplished with best results." This is the primary "study" mentioned, confirming the safety of the new material, but specific acceptance criteria and detailed results are not provided in this summary.
• Design Control Activities: Changes were "validated using the same protocols used to validate cleared devices. Results can be found in the summary of Risk-Analysis and in the Validation Reports of Section 09." (Section 09 is not provided in the extract). This implies internal testing and validation rather than a clinical performance study with external acceptance criteria.

In conclusion, the document seeks to establish substantial equivalence through material comparison, biocompatibility testing (which is a form of acceptance criteria for material safety), and leveraging the established safety and performance of predicate devices. It does not present a de novo clinical study with specific performance acceptance criteria and corresponding device performance data as would be typically found for new functional claims or diagnostic devices.

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