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The E-Cath STIM acc. Tsui System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle removal, to assist the physician pinpoint conduction catheter placement, an electrical stimulus can be applied to the conduction catheter tip via the catheter adapter.

The E-Cath STIM acc. Tsui System is contraindicated for the epidural space.

The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula, E-Cath catheter, locking cap.

The provided document is a 510(k) premarket notification for a medical device (E-Cath STIM acc. Tsui). It is a special 510(k) for a device modification, intending to combine features from previously cleared devices. The document mainly focuses on demonstrating substantial equivalence to predicate devices through bench testing and compliance with recognized standards, rather than clinical studies with human participants. Therefore, several of the requested categories, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "sample size for the test set," "number of experts," "adjudication method," and "standalone (i.e., algorithm only) performance" are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with the referenced ISO/EN standards for medical device components. The tests refer to "tested cannulas" and "tested catheters."
• Data Provenance: Bench testing, compliance with international standards (ISO, EN, DIN). Results are compared against predicate and reference devices, implying these are internal company data.
• Retrospective/Prospective: Not applicable in the context of bench testing for a device modification. The tests are performed on the device itself.

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

• Not applicable. The ground truth for these tests is defined by international standards (e.g., ISO 9626, ISO 7864, DIN EN 1618, DIN EN 10555-1) and internal protocols for performance criteria where standards are not specific. This does not involve expert medical opinion for "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set:

• Not applicable. Performance is measured against predefined, objective, quantifiable acceptance criteria established by international standards or internal engineering/risk assessment protocols.

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 is a medical device (anesthesia conduction kit), not an AI diagnostic or image analysis system.

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

• Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the device's performance is established by compliance with recognized international standards for medical device components (e.g., mechanical properties, sterility, biocompatibility) and internal engineering/risk assessment protocols where standards allow for manufacturer-defined criteria (e.g., leak tightness, tensile strength, flow rate).

8. The Sample Size for the Training Set:

• Not applicable. This is not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, this is not a machine learning model.

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The Over-the-needle (OTN) Catheter System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The Over-the-needle (OTN) Catheter System is contraindicated for the epidural space.

The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula. E-Cath catheter, filter, FixoLong or FixoCath, locking cap and optional ultrasound cover.

The provided text describes a 510(k) premarket notification for a medical device, the "Over-the-Needle (OTN) Catheter System E-Cath." The purpose of the document is to demonstrate that this new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.

The supplied text pertains to a medical device, specifically an anesthesia conduction catheter, not an AI/imaging device. Therefore, many of the requested criteria for AI/imaging device studies (like MRMC studies, expert consensus for imaging, training set details) are not applicable to this document. The "tests" described are engineering and material property tests to ensure the physical device meets relevant standards and performs comparably to its predicate.

However, I can extract the relevant acceptance criteria and study information that is present in the document for this specific type of medical device:

Device Acceptance Criteria and Performance

The document demonstrates substantial equivalence by comparing the new device against predicate devices and relevant international standards through various bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (as applicable to a non-AI medical device 510k submission)

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

• The document does not explicitly state the sample sizes for the "bench tests" performed. It refers to standard test procedures (e.g., EN ISO 9626, EN ISO 7864, EN 13097, DIN EN 1618, DIN EN 10555-1). These standards typically specify minimum sample sizes for material and performance testing.
• The data provenance is from Germany (PAJUNK GmbH Medizintechnologie is based in Baden-Wuerttemberg, Germany, and the contract sterilizer is in Wiesbaden, Germany).
• The studies were prospective bench tests comparing the new device to the predicate and to established international standards.

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

• This is not applicable as the "ground truth" for this device is based on compliance with engineering and material standards and direct comparison of physical properties with an already FDA-cleared predicate device. It does not involve subjective expert assessment of medical images or clinical outcomes in the same way as an AI diagnostic tool. Compliance is proven by laboratory testing measurements.

4. Adjudication method for the test set:

• This is not applicable. The "tests" are objective measurements against defined engineering standards and comparisons to a physical predicate device, not subjective assessments requiring adjudication.

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 is not applicable. This is a physical medical device (catheter system), not an AI-assisted diagnostic tool. No human reader studies (MRMC or otherwise) were conducted or relevant for this type of submission.

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

• This is not applicable. This question pertains to AI algorithms. The device is a physical catheter system, not an algorithm. Bench tests were performed on the physical device itself.

7. The type of ground truth used:

• The "ground truth" (or basis for acceptance) for this submission is:
  • International Engineering Standards: e.g., EN ISO 9626, EN ISO 7864, EN 13097, DIN EN 10555-1, DIN EN 1618 for physical properties, ISO 11135-1 for sterilization, ISO 10993-1/4/5/6/7/10/11 for biocompatibility.
  • Comparison to a Legally Marketed Predicate Device: Direct comparison of physical and performance characteristics to the Halyard - Irvine: On-Q QuikBloc Over-the-Needle (OTN) Catheter Set (K143164).
  • Internal Protocols and Clinical Evaluation: For some properties where international standards did not define specific pass/fail criteria (e.g., catheter leak tightness, tensile strength, flow rate), PAJUNK® established internal acceptable values based on risk assessment and clinical evaluation.

8. The sample size for the training set:

• This is not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• This is not applicable. As above, no training set for an AI model was used.

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PAJUNK®'s Wound Infiltration Catheter Kit called InfiltraLong is intended for continuous or intemittent praeoperative, perioperative or post-operative delivery of local anesthetics or narcotics to wounds and surgical wound sites. Routes of administration may be intraoperative or percutaneous.

PAJUNK®'s Wound Infiltration Catheter Kit called InfiltraLong is intended for continuous or intemittent praeoperative, perioperative or post-operative delivery of local anesthetics or narcotlcs to wounds and surgical wound sites. Routes of administration may be intraoperative or percutaneous. The sterile components are available seperately. The kit is available in two basic designs: Design 02 (Coiled catheter (1x/ 2x), Y-connector, FixoLong Catheter fixation device, Adapter, Puncture needle, Permanent teflon cannula, Flat filter) and Design 01 (Coiled catheter (1x/ 2x), Y-connector, FixoLong Catheter fixation device, Adapter, Tear-cannula (also referred to as Split-cannula), Flat filter).

The InfiltraLong Wound infiltration catheter kit from PAJUNK® underwent a 510(k) Premarket Notification Submission. The submission focused on establishing substantial equivalence to predicate devices already marketed, confirming the safety and effectiveness of the proposed device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define specific quantitative acceptance criteria for device performance in a table format. Instead, the "Conclusion" section within "Technology Characteristics" states:

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

• The document does not specify a sample size for a test set in the context of clinical data for performance evaluation.
• The evaluation relies on "Bench Testing" for technical characteristics and comparison with existing predicate devices.
• The data provenance is for the manufacturing and testing of the device itself rather than clinical patient data. The manufacturer is Pajunk GmbH, located in Germany, and the document indicates their US contact and contract sterilizer are also identified.

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

• There is no mention of experts or a "ground truth" establishment in the context of clinical performance data for a test set in this 510(k) submission.
• The assessment is based on compliance of the device components with established international standards (ISO, EN) and comparison to predicate devices, which implies an expert understanding of these standards by the device manufacturer's regulatory and R&D teams.

4. Adjudication Method for the Test Set

• No adjudication method is described because there is no multi-expert review or clinical performance test set analysis mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done. This device is a medical catheter kit, not an AI-assisted diagnostic or treatment system. The document does not discuss AI or human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No standalone (algorithm-only) performance study was done. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on compliance with international standards (ISO, EN) for medical devices and components, and the established safety and effectiveness of predicate devices. The claim of substantial equivalence is the central "ground truth" or foundational assertion for FDA clearance.
• There is no mention of pathology, outcomes data, or expert consensus in a clinical trial context.

8. The Sample Size for the Training Set

• No training set is applicable or mentioned. This is not a machine learning or AI device. The submission focuses on bench testing and comparison to predicate devices.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this device type.

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Pajunk RFTL Radiofrequency needles are electrically insulated and may be used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.

Pajunk RFTL Radiofrequency needles are intended for coagulation of soft tissues, such as in long term pain treatment via neurosurgical lesioning procedures, as determined by professional neurosurgeon/ anesthetist and the instructions for use. These RF-cannulas are single use, sterile, non-pyrogenic and latex free medical devices. The RF-cannulas have bevel tips with an active area of 2 - 10 mm.

The needle puncture depth depends on the path chosen by the surgeon to reach and to eliminate the nerve bundle site. This required needle length is the patient contact part of the thermolesion needle. The nerve causing constant pain will be disrupted by utilizing the thermolesion heat radiating from the needle tip. Heat is generated by radio frequency and radiates only from the non-insulated needle tip. This limited heat radiation is used for focussed heat treatment depending on the surgeon's method of operation.

This document is a Premarket Notification Submission (510k) for the Pajunk Thermolesion Cannula "RFTL Radiofrequency Needle". A 510k submission primarily demonstrates substantial equivalence to a predicate device, rather than conducting a de novo study with acceptance criteria and performance reporting as might be expected for a novel device. Therefore, the information provided below will reflect the nature of a 510k submission.

Here is an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. The performance is then judged on how well it matches or is considered equivalent to the predicate.

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

This is a 510(k) submission focused on demonstrating substantial equivalence to predicate devices, not on a clinical study that would involve a "test set" in the traditional sense with patient data. Therefore, details regarding a specific sample size for a test set or data provenance (country of origin, retrospective/prospective) are not applicable to this document as no such study is described. The demonstration of equivalence relies on comparing technical characteristics and intended use, not on new clinical performance data from a dedicated test set.

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

As explained above, no separate "test set" with ground truth established by experts is discussed in this 510(k) submission. Therefore, this information is not applicable. The "ground truth", in a broader sense for a 510(k), is the established safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set

Again, no "test set" or clinical study requiring an adjudication method is described in this 510(k) submission. This information is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned or implied in this 510(k) submission. This information is not applicable. The submission focuses on device characteristics and equivalence, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device (a radiofrequency needle) is a physical medical instrument, not an algorithm or AI system. Therefore, the concept of a "standalone algorithm performance" is not applicable. Its use invariably involves a human neurosurgeon/anesthetist.

7. The Type of Ground Truth Used

For a 510(k) submission, the "ground truth" is typically the established safety and effectiveness of the legally marketed predicate devices. The new device aims to be substantially equivalent to this established standard. In this case, the predicate devices are "Radionics thermo lesion needles K021942" and "Stryker's RF cannulas K032406". The comparison also references other Pajunk devices previously cleared by FDA for sterilization and packaging equivalence (K000722, K043130, K033018, K042979, K023218, K013041, K053283).

8. The Sample Size for the Training Set

No "training set" in the context of an algorithm or AI development is mentioned in this document. This information is not applicable.

9. How the Ground Truth for the Training Set Was Established

As no "training set" or AI/algorithm development is described, the method for establishing its "ground truth" is not applicable.

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The Pajunk EpiLong anesthesia conduction kit is indicated for administration of epidural anesthesia.
The Pajunk catheter is placed in the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).
The Pajunk Loss of Resistance (LOR)-Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
The Pajunk anesthesia conduction flat filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
The Pajunk Tuohy Borst Adaptor is connected to the needle via Luer connector. It ensures sealing and fixation of the catheter end and allows attachment of a Luer Lock syringe or infusion device.

Pajunk's EpiLong set is a single use, sterile, non-pyrogenic and latex free medical device kit. It is a epidural anesthesia kit consisting of a needle for insertion into the epidural space (a special Tuohy Cannula), a catheter for anesthesia administration to the epidural space, a flat filter as well as an adapter. After administration of immediate epidural anesthesia, the epidural catheter may be placed via the cannula into the epidural space. The cannula is then withdrawn, leaving the Epidural Catheter tip in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).

The provided document is a 510(k) Premarket Notification Submission for the EpiLong Anesthesia Conduction Kit. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving de novo safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics.

Instead, the submission states:

• Conclusion: "The comparison between the predicate device and the proposed devices in section 12 of this submission demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices." (Page 1)
• FDA's finding: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (Page 2)

In summary, there is no study described in this document that proves acceptance criteria are met, as the regulatory pathway chosen (510(k)) relies on substantial equivalence to a predicate device, not on meeting specific, pre-defined performance acceptance criteria through the types of studies typically associated with AI/software devices.

The document primarily focuses on:

• Device description and indications for use.
• Identification of predicate devices (BBrauns Perifix K813186).
• Mention of sterilization processes.
• A "detailed discussion of substantial equivalence" in a section (Section 12) that is not included in the provided text.

Without Section 12 or other detailed performance testing reports, it's impossible to extract the requested information.

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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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