(53 days)
The Pajunk Plexalong Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connectors to assist the physician pinpoint the area of application.
The Pajunk Plexalong sets are single use, sterile, non-pvrogenic and latex free conduction anesthesia sets intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. The Plexalong sets consist of a single use sterile, non-pyrogenic conduction needle with tubing, stilett, a catheter and catheter adapter. The stylet is used to stop tissue from clogaing the needle (during insertion) by blocking the opening at the tip of the needle. Pajunk changed the stilett material from a surgical stainless steel to polycarbonate. The Unipolar needles used in the Plexalong sets are available in three tip configurations. A Unipolar needle with a facet tip, Sprotte tip or Unipolar needle with a Tuohy tip. Only Plexalong sets with the Tuohy needles are affected by the stilett material change. To assist the physician pinpoint the area of application, an electrical stimulus can be applied to the tip of the conduction needle via a nerve stimulus connector.
The provided text is a 510(k) Summary for the Pajunk Plexalong Sets, a medical device intended for continuous conduction anesthesia. The document details the device description, intended use, and a summary of performance testing based on recognized consensus standards. However, it does not contain the kind of detailed study information (e.g., sample sizes, expert qualifications, specific performance metrics with numerical values) typically found in a clinical study report or a multi-reader, multi-case study that would enable the filling out of the requested table and answering questions 2-9.
The "Summary of Performance Testing" section primarily lists consensus standards that the device was designed to conform to. It does not provide specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or other quantitative measures) nor does it report the device's performance against such criteria. Instead, it implies conformance through meeting recognized standards, which are often related to material properties, sterility, and mechanical integrity, rather than clinical effectiveness or diagnostic accuracy.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's an attempt to answer the questions based only on the provided information, with explicit notes where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to DIN 13090/ISO 594 (Luer fittings w/wo locking feature) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN 13097 Part 1 (Medical injection cannula) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN 13097 Part 3 (Medical cannula) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN 17442/ISO 9626 (Steel for medical instruments) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 550 (Sterilization of med. Prod.; Validation & routine controls for sterilization with ETO) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 556 (Sterilization of medical products, requirements for medical products that are labeled "sterile") | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 724 (Guidance on the application of EN29001 and EN46001 for non-active medical products) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to PrEN 868-1 (Packaging materials for the sterilization of packaged goods. Part 1: general requirements for the validation of the packaging of sterilized end-packaged products) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 868-2 (Packaging materials for the sterilization of packaged goods. Part 2: sterilization packaging, requirements and tests.) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 980 (Graphic symbols for marking medical products) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 1441 (Risk analysis for medical products) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to EN ISO 14971 (Risk Management) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 1707 (6% Luer cone connections for injection cannula and particular medical equipment) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN/ISO 9626 and A1:2001 (Cannula tube of non-rusting steel (SS) for the manufacture of medical products) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to BS 6196 (Sterile epidural catheters and introducer needles for single use) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 30993-1 (Biological evaluation of medical products - instructions for selection of tests) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN EN 46001 (Particular requirements for medical products) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to DIN 17440 (Stainless Steels) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Conformance to BS 4843 (Single entry IV cannula) | Designed to conform to this standard. (No specific performance data provided beyond this statement). |
| Safety and effectiveness comparable to predicate devices. | Stated as "as safe and effective as the predicate devices when used according to the instructions". |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The performance testing refers to conformance to standards, not a specific clinical test set.
- Data Provenance: Not specified. The document is from Pajunk GmbH in Germany, implying the device development and initial testing might be based there, but no details on data origin (e.g., country of origin of data, retrospective or prospective) for any specific study are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The performance testing focuses on engineering and material standards rather than expert-adjudicated clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable as there is no mention of a human-adjudicated test set or a clinical study that would require such a method.
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 an anesthesia conduction kit, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This 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 performance testing cited is conformance to established engineering, material, and sterilization consensus standards (e.g., DIN, ISO, EN, BS standards for Luer fittings, cannula, sterilization). There is no mention of clinical ground truth (expert consensus, pathology, outcomes data) in this 510(k) summary.
8. The sample size for the training set
- Not applicable/Not specified. This is a physical device, and the summary does not refer to a machine learning model or a training set.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See explanation for #8).
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).