Search Results

Assistance in the delivery of local anaesthetic after hamstring ligament reconstruction procedures

GRAFTSITE is 28.25 cm in length with an inner diameter of 2.6 mm and an outer diameter of 4.0 mm, sized to fit down the hamstring harvest site. It is rounded and blocked at the patient end and has a 6% female luer at the user end. There are lateral eyes over a length at the patient end of the catheter. A buttoned stylet consisting of a rigid stainless steel rod of diameter slightly less than the bore of the catheter, functions to stiffen the device. GRAFTSITE can be used to directly administer a bolus of the users chosen local anesthetic, via injection down the lumen of the catheter, into the terminus of the gutter at the site of comorbidity.

The provided text describes the GRAFTSITE Local Anesthetic Delivery Assistance Device. It details the device's characteristics and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

1. Table of acceptance criteria and the reported device performance

Since this is a non-clinical submission, the "acceptance criteria" are the ability to perform equally well as the predicate device in specific non-clinical tests. The "reported device performance" refers to the successful completion of these tests.

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

The document does not provide specific numerical sample sizes for each test set (e.g., number of devices tested for flow rate). However, it states that "GRAFTSITE was directly compared to the predicate in comparative performance tests" and that "comparative in vitro testing was performed, with the results for GRAFTSITE compared to the predicate."

The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer, Summit Medical Ltd. in the United Kingdom. The tests performed are non-clinical (in vitro and cadaveric usability), not human clinical studies, so the terms "retrospective" or "prospective" are not applicable in the same way they would be for patient data.

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 in the document. The tests performed are physical and mechanical performance evaluations against established standards, and a cadaveric usability study. While the cadaveric study would involve experts (e.g., surgeons/clinicians), the document does not specify their number or qualifications as ground truth experts for a diagnostic algorithm.

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

This is not applicable as the studies described are non-clinical, mechanical, and biocompatibility tests, and a cadaveric usability study. There's no "ground truth" to be adjudicated in the sense of medical image interpretation or diagnosis.

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 MRMC comparative effectiveness study was done. This device is a local anesthetic delivery assistance device, not an AI-powered diagnostic or interpretive tool.

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

No standalone algorithm performance study was done. This device does not involve an algorithm.

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

The "ground truth" for the non-clinical tests were established engineering and medical device performance standards (e.g., EN 1618, ISO 594-2, BS 6196, ASTM F640-12, ISO 10993-1, ISO 11137-1, ISO 11137-2). For the usability study, the ground truth was the ability to perform the intended function in a cadaveric model.

8. The sample size for the training set

This is not applicable since the device does not employ machine learning or AI models, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

Ask a specific question about this device

The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility -Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono - are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.

The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility are single use sterile and non-pyrogenic devices used to gain entry or puncture the tissue and inject anesthetics to induce single shot anesthesia and analgesia. The needles/ cannulas may be used during all anaesthetic and analgetic procedures according to the physicians indication. Cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility are standard cannulas/ needles equipped with CornerStone reflectors (cleared in K111374 - SonoPlex STIM) in order to significantly enhance ultrasound visibility. The cannulas basically consist of stainless steel tubing and an epoxy glued polycarbonate hub. The tubing is optionally coated for better insertion properties with NanoLine, a copolymeric coating cleared for market in K053283. In order to enhance ultrasound visibility the cannulas are equipped with a special reflector pattern named CornerStone imprinted to the cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.

The provided document is a 510(k) summary for a medical device (cannulas/needles enhanced for ultrasound visibility). It describes the device, its intended use, technological characteristics, and comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by the structure of the request.

The request's format (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)") strongly suggests it's looking for information related to the performance validation of an AI/Machine Learning device, where accuracy metrics, ground truth establishment, and test set details are critical.

The provided document describes a physical medical device (needles), and its validation revolves around:

• Bench Testing: Bending stability, breaking resistance, hub-to-needle-bondage.
• Biocompatibility: Compliance with ISO 10993-1.
• Sterilization: Validation of cleaning and sterilization process, shelf life.
• Technological Equivalence: Comparing dimensions, materials, and manufacturing processes to previously cleared predicate devices.

Therefore, I cannot fulfill the request as phrased because the provided document does not contain the type of AI/algorithm performance data, acceptance criteria, or study details that the prompt is asking for.

If the intent was to understand the acceptance criteria for a physical medical device as described in the document, here's a conceptual answer based on the document's content, reinterpreting "acceptance criteria" as the grounds for demonstrating "substantial equivalence":

Based on the provided document, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a physical medical device (ultrasound-enhanced needles) rather than an AI/algorithm. No specific quantitative performance acceptance criteria in terms of accuracy, sensitivity, or specificity are mentioned, as this is not an AI/diagnostic device.

Here's an attempt to map the request's structure to the available information, noting significant gaps:

1. A 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 any of the "standard testing" (bending, breaking, bonding). The document implies routine internal testing for "each cannula" or "all cannulas," but not a specific study sample size for validation.
• Data Provenance: The testing is implied to be internal testing by PAJUNK® GmbH Medizintechnologie in Germany. No mention of retrospective or prospective study types in the context of device performance validation beyond "bench testing" and "biocompatibility testing."

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

• N/A. This question is relevant for AI/diagnostic devices where expert labeling establishes ground truth. For this physical device, "ground truth" refers to engineering specifications, material properties, and physical performance against established standards (e.g., ISO, internal company standards). No human "experts" are cited for establishing ground truth in the document's validation section.

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

• N/A. This is relevant for AI-assisted image interpretation or similar diagnostic tasks. Not applicable to the physical validation of a needle.

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:

• N/A. This is specific to AI/diagnostic devices. The device described here is a physical medical needle.

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

• N/A. Not an algorithm-only device.

7. The type of ground truth used:

• For Mechanical Performance: Engineering specifications, physical measurements, and compliance with internal (PAJUNK®) and potentially industry standards for bending, breaking, and bonding.
• For Biocompatibility: Compliance with ISO 10993-1 standards and material specifications.
• For Sterilization: Measured sterility assurance level (SAL), residual limits, and validated shelf life.
• For Ultrasound Visibility: Implied to be assessed in "clinical evaluation" (details not provided) and implicitly by the design ("CornerStone reflectors designed to optimally reflect ultrasound waves"). No explicit 'ground truth' definition like pathology or outcomes data is mentioned; it's a functional claim validated via unspecified means.

8. The sample size for the training set:

• N/A. No training set is involved as this is not an AI/Machine Learning device.

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

• N/A. No training set for an AI model.

In summary, the document details the substantial equivalence of a physical medical device (ultrasound-enhanced needles) to predicate devices through bench testing, biocompatibility, and sterilization validation, rather than the performance validation of an AI/algorithm.

Ask a specific question about this device

This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.

The NeuralMAS™ system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The NeuralMAS™ system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery. The monitor will assist early nerve identification by providing the surgeon with a tool to help locate and identify the particular nerve at risk to minimize trauma by alerting the surgeon when a particular nerve has been activated.

The NeuralMAS™ system consists of a reusable Patient Module, a Control Unit comprised of a touch-screen PC and an assortment of disposable conductive probes, stimulators, sensors, electrodes and electrode leads.

Here's a breakdown of the acceptance criteria and the study details for the NeuralMAS™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity or specificity targets). Instead, the study's acceptance was based on demonstrating "statistical agreement" and "correlation" with a predicate device.

1. The NeuralMAS™ system's principle functions are effective for ascertaining and monitoring spinal nerve status and location.
2. Data acquired by NeuralMAS™ during simulated surgical use in an animal model correlate well with data acquired simultaneously by a predicate device. |
   | Effectiveness of principle functions | Demonstrated effectiveness in ascertaining and monitoring spinal nerve status and location. |
   | Correlation of acquired data with predicate device | Good correlation between data acquired by NeuralMAS™ and data acquired simultaneously by a predicate device in an animal model. |
   | Safety and effectiveness comparable to predicate device | Concluded to be "as safe, as effective and performs as well as the legally marketed predicate device." |
   | Substantial equivalence in function to predicate device | Concluded to be "substantially equivalent in function to the legally marketed predicate device." |

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

• Sample Size: Not explicitly stated. The study mentions a "comparative performance evaluation was conducted in the sheep," implying a limited animal study, but the specific number of sheep or cases is not provided.
• Data Provenance: Prospective animal study conducted in "sheep" (animal model). The country of origin is not specified, but the submission is to the US FDA, so it's likely a US-based study or one adhering to US regulatory standards.

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

Not applicable. The study was a comparative performance evaluation between the subject device and a predicate device in an animal model, not an assessment against human-established ground truth. The "ground truth" was essentially the synchronous readings from the predicate device and the physiological responses observed during the animal experiment.

4. Adjudication Method for the Test Set

Not applicable. There was no mention of human expert adjudication for the animal study. The comparison was statistical agreement and correlation between the two devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The study described is a non-clinical animal study comparing the device to a predicate, not an MRMC study involving human readers.

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

Yes, in essence. The "comparative performance evaluation" in the sheep assessed the device's ability to ascertain and monitor nerve status and location, and its data acquisition, in direct comparison to the predicate device. This is a standalone assessment of the device's functional performance in a simulated surgical environment. Human interpretation or intervention as part of the performance measurement itself (beyond setting up and operating the devices) is not indicated.

7. The Type of Ground Truth Used

The "ground truth" for the test set was the data simultaneously acquired by the predicate device and the directly observable physiological responses in the animal model. The study aimed to show correlation and agreement between the NeuralMAS™ and the predicate device's readings. It did not rely on a separate, independent "gold standard" or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a medical device that records mechanomyographic signals and uses electrical stimulation. The device itself is not described as involving a machine learning algorithm that requires a "training set" in the traditional sense. The "training" for the device would have involved engineering development and calibration, not a data-driven machine learning training set as would be found in AI/ML device submissions.

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

Not applicable, as there's no mention of a traditional machine learning training set for this device.

Ask a specific question about this device

The Pajunk StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus. The catheter has to be removed or replaced after 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle. After placement of the conduction catheter in epidural space or peripheral an electrical stimulus can be applied to its tip via the catheter adapter. The set is to be used with adults and in pediatrics.

The Pajunk epidural (optional: peripheral) stimulation catheter is placed in the epidural space (optional: peripheral) to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

The Pajunk epidural stimulation catheter is placed in the epidural space to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

The Pajunk peripheral stimulation catheter is placed peripheral to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.

Pajunks Stimulation Adapter and Adapter cables are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and stimulation, for example Stimul.ong and Stimulong Tsui-Method.

Pajunks Injection valve and injection hose are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and optional stimulation, for example StimuLong and StimuLong Tsui-Method.

Pajunks peripheral NanoLine-coated cannulas are accessories to Pajunks sets for peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method.

Pajunk GmbH Medizintechnologie is submitting this 510(k) for the Pajunk StimuLong Tsui Method Set. The Tsui-Test is a well known technique in epidural anesthesia. It combines the advantages of epidural anestesia and stimulation via catheter in order to verify the area anesthesia is applied to. The Tsui test makes epidural anesthesia much more safe and effective as demonstrated and proven in several studies and articles published since the 1990 % (see section 20 of this submission. Physicians until now had to combine different devices in order to get a "self-made set acc. Tsui". Dr. Tsui combined Pajunks StimuLong set and technique deared for perifical use and Prayinks Epilong set and technique for epidural use to have a striking safe and effective alternative to "selfmade in-house devices". The devices for epidural Anesthesia (EpiLong) and peripheral Anesthesia employing stimulation via catheter (StimuLong) are already cleared for market seperately without claiming specific patient populations. The basis of this submission in the indications for use of this two cleared device: peripheral and epidural stimulation guided anesthesia. The components which are part of the subject device kit have already gained market clearance. They are combined under a new indication on customers demands. The predicate devices are Pajunks own products cleared for a non specified population, i.e. for use with adult patients. In order to demonstrate safety and effectiveness Pajunk provides clinical lieterature from Dr. Tsui as well as a clinical evaluation. Pajunks StimuLong Tsul Method Set are single use, sterile, non-pyrogenic and latex free medical device kits. They are intended for continuous peripheral or epidural anesthesia delivery using the Polyamide indwelling catheter. The catheter has to be removed or replaced after 72 hours. An electrical stimulus may be applied via catheter in order to precisely identify the area anesthesia is intended to be applied to.

The Pajunks StimuLong Tsui Method Set provides a coated Tuohy cannula, a StimuLong catheter, StimuLong adaptor, valve, adaptor cables, injection hose, filter, LOR-syringe, catheter fixation device, FixoLong and tightning adaptors. The coating on the cannula is laqueur or NanoLine coating, which has been cleared in K053283. The catheter comes with a catheter container, steel stylett and introductory aid for better handling and shape security. The catheter is closed at tip and equipped with three lateral holes, optional with open tip, an integrated spiral (for enhanced stability) and a stylett. There is no change in components compared to the StimuLong and EpiLong set already cleared for market. All components are available seperately. Within the indications for use and the components cleared for market the StimuLong Tsui method set is customizable.

This document is a 510(k) Premarket Notification Submission for Pajunks StimuLong Tsui Method Set. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Summary of Acceptance Criteria and Device Performance:

The primary acceptance criterion for this submission is demonstrating substantial equivalence to existing predicate devices already cleared for market. The study proving this involves a comparison of technology characteristics and a review of clinical literature.

Study Details:

The submission does not describe a traditional clinical study with a test set, ground truth experts, or formal adjudication. Instead, it relies on a literature review and comparison to predicate devices to demonstrate substantial equivalence.

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

   • No explicit "test set" in the sense of patient data is described. The evaluation relies on a comparison with predicate devices and existing clinical literature.
   • Data provenance is primarily from "clinical literature from Dr. Tsui" and "several studies and articles published since the 1990's" (referred to in Section 20 of the submission, though not provided in the excerpt) related to the Tsui-Test technique and the predicate devices. The country of origin for the studies is not specified in the provided text. The submission itself is from a German manufacturer (Pajunk GmbH Medizintechnologie).

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

   • No direct ground truth establishment by experts for a novel test set is described. The efficacy and safety are inferred from the existing body of clinical literature and the established use of the technique (Tsui-Test) and the predicate devices. The clinical literature cited refers to Dr. Tsui, implying his expertise underpins the technique.

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

   • No adjudication method is relevant or described, as there isn't a new test set requiring expert review and consensus.

4. 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 MRMC study was conducted. This device is a medical instrument (catheter set) and not an AI-assisted diagnostic tool.

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

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

6. The type of ground truth used:

   • The "ground truth" for the device's safety and effectiveness is established through:
     • Clinical literature review: Citing published studies and articles (e.g., from Dr. Tsui) supporting the safety and effectiveness of the "Tsui-Test" technique and the use of stimulation via catheter for precise application of anesthesia.
     • Predicate device history: The components and the general techniques (epidural and peripheral anesthesia with stimulation) are already cleared and established through the predicate devices (Pajunks StimuLong Set and Pajunks EpiLong Set).

7. The sample size for the training set:

   • Not applicable. This is a medical device submission, not a machine learning model.

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

   • Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

The Pajunk Plexolong 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 Plexolong sets contain single use sterile and non-pyrogenic needles with tubing. with or without a plastic cannula and catheters intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.

This 510(k) summary describes a medical device, specifically an Anesthesia Conduction Kit. For this type of device, "acceptance criteria" are typically defined by adherence to recognized consensus standards and "device performance" is demonstrated through testing to ensure conformance to these standards, as opposed to clinical performance metrics for an AI-enabled device.

Let's break down the information requested based on the provided document:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The PAJUNK Plexolong Sets are designed to conform to recognized national and international consensus standards relevant to medical devices, particularly those for needles, cannulas, Luer fittings, sterilization, packaging, and risk analysis. The study demonstrating that the device meets these acceptance criteria involved performance testing to verify conformance to these applicable standards.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding AI/Machine Learning Specific Questions:

The provided document describes a conventional medical device (anesthesia conduction kit) and does not refer to any AI or machine learning components. Therefore, the following AI/ML-specific questions are not applicable to this submission.

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

• Not applicable. This document describes a physical medical device, not an AI/ML algorithm or software that uses test data in the conventional sense. Performance testing was conducted on samples of the physical device according to industry standards.

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)

• Not applicable. Ground truth in the context of expert consensus is not relevant for this physical device. Performance is assessed against engineering and material specifications as defined by consensus standards.

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

• Not applicable. This relates to AI/ML model performance evaluation, not a physical medical device.

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 does not involve human "readers" or AI assistance.

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

• Not applicable. There is no algorithm or software component described.

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

• For this device, "ground truth" is established by the specifications outlined in the referenced consensus standards. Device components (e.g., Luer fittings, cannula dimensions, material properties, sterility assurance) are tested against these published, accepted industry standards.

8. The sample size for the training set

• Not applicable. This device does not involve a training set for an AI/ML model.

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

• Not applicable. This device does not involve a training set for an AI/ML model.

Ask a specific question about this device

The PAJUNK Plexolong sets consist of Pajunk Unipolar conduction needle with a plastic cannula placed over the needle. They 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 connector to assist the physician pinpoint the area of application.

The PAJUNK Plexolong sets are single use sterile, Latex free and nonpvrogenic needles, with a plastic cannula and catheter intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. 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 connector to assist the physician pinpoint the area of application.

This document is a 510(k) Summary of Safety and Effectiveness for the PAJUNK Plexolong Sets. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets reported performance metrics.

The 510(k) process is primarily a premarket notification to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove specific performance against acceptance criteria in the way a clinical trial or a formal validation study would.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on:

• Device Description: What the device is composed of and how it works.
• Intended Use: The medical purpose for which the device is designed.
• Predicate Device: The legally marketed device to which the new device is compared for substantial equivalence.
• Technological Characteristics: How the new device's components compare to the predicate device.
• Conclusion: A statement that the device is as safe and effective as the predicate device.
• FDA Clearance Letter: Confirmation of substantial equivalence.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or number of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used or how it was established for training or testing.

Ask a specific question about this device