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SonoMSK anesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The subject device, the SonoMSK needle is a single-use anesthesia conducting needle intended for for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The SonoMSK needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.

The SonoMSK needle is equipped with an injection tube. The distal connection of the tube is equipped with a LUER Connector according to ISO 80369-7.

The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes.

The SonoMSK cannulas are not for intrathecal use.

The SonoMSK cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.

Based on the provided FDA 510(k) Clearance Letter for SonoMSK, here's a detailed description of the acceptance criteria and the study proving the device meets them:

Disclaimer: This document is a 510(k) Summary, not the full submission. Therefore, it focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving novel performance claims directly against established acceptance criteria for a new type of device. The acceptance criteria described below are primarily related to meeting established international standards for similar devices and ensuring equivalence to the predicate. The "study" largely consists of performance testing against these standards and validation of manufacturing processes (sterilization, packaging, shelf life).

Acceptance Criteria and Device Performance for SonoMSK

The SonoMSK device, as per this 510(k) submission, demonstrates substantial equivalence to its predicate device (SonoTAP) by meeting a series of performance and safety standards, particularly concerning its materials, manufacturing processes (sterilization, packaging), and device characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by compliance with specific sections of recognized international standards for hypodermic needles and connectors. The reported device performance is a "Passed" status for each tested section, indicating compliance with the respective standard's requirements.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., "n=X needles for cleanliness testing"). However, it indicates that testing was performed "on a regular basis as well as type tests performed after design transfer" and "using process most challenging worst case devices."

• Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the referenced ISO standards. For shelf-life testing, "process most challenging worst case devices" were used.
• Data Provenance: The device is manufactured in Geisingen, Germany by PAJUNK GmbH Medizintechnologie. Sterilization is performed at Sterigenics Germany GmbH (Wiesbaden, Germany) and HA2 Medizintechnik GmbH (Halberstadt, Germany). The testing itself would have been conducted by the manufacturer or accredited labs in support of the submission, likely within Germany. The data is retrospective, as it covers tests completed before the 510(k) submission.

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

This submission does not involve clinical data or "ground truth" established by expert review in the sense of image interpretation or diagnostic accuracy. The "ground truth" here is adherence to engineering and safety standards (e.g., ISO, component specifications). Compliance is determined by objective measurements against these standards, not subjective expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the basis for "ground truth" is objective measurement against specified international standards, not subjective assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is an anesthesia conduction needle, not an AI-powered diagnostic imaging tool. The submission focuses on demonstrating substantial equivalence in physical characteristics, biocompatibility, sterilization, and basic performance parameters to a predicate device.

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

Not applicable. SonoMSK is a physical medical device (anesthesia needle), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" used is defined by the objective requirements and test methods outlined in the cited international standards:

• ISO 7864 (Sterile hypodermic needles for single use)
• ISO 9626 (Stainless steel needle tubing)
• ISO 80369-7 (Small-bore connectors for intravascular or hypodermic applications)
• ISO 10993-series (Biological evaluation of medical devices)
• ISO 11135-1 (Sterilization of health care products - Ethylene oxide)

These standards specify measurable parameters (e.g., dimensions, force, pH limits, sterility levels, residual limits) that the device must meet.

8. The Sample Size for the Training Set

Not applicable. SonoMSK is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for a physical device.

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SonoPlex STIM and SonoPlex II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gain entry and inject local anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician pinpoint the area of application.

The subject device, the SonoPlex STIM and SonoPlex II nerve block needle is a single-use anesthesia conducting needle intended to gain entry or puncture the tissue and inject anesthetics to induce regional anesthesia. The SonoPlex STIM and SonoPlex II needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoPlex STIM and SonoPlex II needle is equipped with an connecting cable, injection tube and NanoLine® coating (Parylene, no nanomaterials incorporated). The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6. The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes. The SonoPlex STIM and SonoPlex II cannulas are not for intrathecal use. The SonoPlex STIM and SonoPlex II cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.

The provided FDA 510(k) clearance letter and associated summary pertain to the SonoPlex STIM and SonoPlex II anesthesia conduction needles. This document focuses on demonstrating substantial equivalence to a predicate device (SonoBlock/SonoBlock II) and primarily addresses changes related to sterilization and packaging, rather than the performance of an AI/ML-driven device.

Therefore, the requested information regarding AI/ML device performance (e.g., acceptance criteria for AI, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth definitions for AI models) cannot be extracted from this document, as it describes a traditional medical device and not an AI-powered one.

The "study" described in the document is a series of performance tests and validations for the physical properties, sterilization, and biocompatibility of the needles, and not a study validating an AI/ML diagnostic or assistive tool.

However, I can provide a summary of the acceptance criteria and the studies that prove the device (SonoPlex STIM and SonoPlex II needles) meets its acceptance criteria based on the information provided:

Acceptance Criteria and Device Performance (SonoPlex STIM and SonoPlex II Needles)

The acceptance criteria for the SonoPlex STIM and SonoPlex II needles are primarily based on established international standards for medical devices, specifically for anesthesia conduction needles. The studies performed were performance testing, sterilization validation, and shelf-life testing, demonstrating that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria are compliance with various ISO standards, ensuring the physical and biological safety and efficacy of the needles.

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

• Sample Size: The document repeatedly mentions that tests were conducted, but does not specify the exact sample sizes for each of the performance tests (e.g., how many needles were tested for patency, stiffness, etc.). It mentions "process most challenging worst case devices" were used for shelf life and sterility tests.
• Data Provenance: The devices are manufactured by PAJUNK GmbH Medizintechnologie in Geisingen, Germany. The contract sterilizers are Sterigenics Germany GmbH (Wiesbaden, Germany) and HA2 Medizintechnik GmbH (Halberstadt, Germany). The tests appear to be prospective (conducted specifically for this submission) in a laboratory/manufacturing setting.

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

This section is not applicable as the device is a physical medical needle, not an AI/ML diagnostic or assistive device that would require expert-established ground truth from medical images or clinical data. The acceptance criteria are based on engineering specifications and international standards.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. The tests performed are objective, quantitative measurements against defined standard specifications.

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

This section is not applicable. This is a physical medical device, not an imaging or diagnostic AI/ML tool that would be subject to MRMC studies. The document specifies that the new devices are "substantially equivalent" to predicate devices, and the dual guidance (ultrasound + electrical stimulus) for localization is considered "state of the art" and "safe and effective."

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

This section is not applicable. The device is a needle used by a human physician, possibly with assistance from an ultrasound machine and/or an electrical stimulator. There is no AI algorithm component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the specifications within the cited ISO standards (e.g., acceptable limits for fluid leakage, minimum breaking strength, chemical residue limits) and validated manufacturing processes (e.g., sterilization parameters, biocompatibility testing). It is not derived from patient outcomes, expert consensus on clinical findings, or pathology reports in the context of an AI/ML algorithm.

8. The Sample Size for the Training Set

This section is not applicable. There is no AI/ML component; therefore, no training set is relevant to this device submission.

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

This section is not applicable for the same reason as above.

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The SPROTTE® STANDARD (LUER/ NRFit®) lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection/ withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the spinal space.

The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

This document, an FDA 510(k) clearance letter and associated summary, pertains to a lumbar puncture needle – a physical medical device. The information provided heavily details the material composition, dimensions, and manufacturing processes (including sterilization and packaging) of the needle, and compares these characteristics to previously cleared predicate and reference devices.

Crucially, this document does NOT describe the acceptance criteria and study that proves a software algorithm or AI/ML device meets those criteria. It is about a physical medical device, not a digital health product that uses algorithms to process data or make predictions.

Therefore, I cannot extract the information required by your prompt, as it is designed for a different type of medical device (software/AI/ML).

To directly answer your numbered points based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML device. The document lists performance testing against physical standards (ISO 7864, ISO 9626, ISO 80369-6, ISO 80369-7) for the needle's physical properties (e.g., cleanliness, dimensions, bond strength, fluid/air leakage, stress cracking), with all sections reported as "Passed."
• 2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML device. For the physical device, testing appears to be based on compliance with ISO standards, implying a certain number of units were tested to demonstrate conformity. Data provenance specific to an AI/ML context (e.g., country of origin, retrospective/prospective) is not present.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML device. This document does not describe a process of establishing "ground truth" by experts reviewing medical images or data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for an AI/ML 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 for an AI/ML device. This type of study is for evaluating AI assistance to human interpretation, which is not relevant for a physical needle.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML device. The "ground truth" for a physical needle's performance is its adherence to mechanical, material, and sterility standards.
• 8. The sample size for the training set: Not applicable for an AI/ML device. There is no AI model being trained.
• 9. How the ground truth for the training set was established: Not applicable for an AI/ML device.

In summary: The provided text describes the regulatory clearance for a traditional, physical medical device (a lumbar puncture needle) based on its material properties, manufacturing processes, and adherence to established physical performance standards. It does not contain any information relevant to the testing and validation of an AI/ML-based medical device.

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The SonoTAP and SonoTAP II anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The subject device, the SonoTAP II needles are single-use anaesthesia conducting needles intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia. The SonoTAP and SonoTAP II needles are intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoTAP and SonoTAP II needles is equipped with an injection tube. The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6. The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes. The SonoTAP and SonoTAP II cannulas are not for intrathecal use.

The provided text is a 510(k) Summary for the SonoTAP and SonoTAP II anesthesia conduction needles. It focuses on demonstrating substantial equivalence to a predicate device (SonoTAP, K113207) primarily by addressing changes related to sterilization facilities and packaging materials.

The document does not describe a study involving an AI/human reader comparative effectiveness study, nor does it provide a standalone algorithm performance study data, nor does it typically include details on ground truth establishment for a diagnostic AI study. This submission is for a medical device (anesthesia conduction needles), not an AI-powered diagnostic device. Therefore, the questions related to AI performance, ground truth, expert adjudication, and training/test set sample sizes in the context of AI are not applicable to the scope of this regulatory submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for the needle itself, validating manufacturing processes and material changes, rather than a clinical performance study involving human interpretation of diagnostic images or AI output.

Here's an analysis based on the provided text, addressing the applicable points:

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

The document lists various sections of ISO standards as "sections tested" and reports "Pass / Fail" for them. This indicates that the tests successfully met the acceptance criteria defined by those standards. However, specific numerical performance results against acceptance thresholds are only given for one specific test:

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

• Sample Size: The document does not specify the exact sample sizes for each mechanical and sterility test, only that "worst case needles" were subjected to testing for hub-to-needle bonding strength and that "sample size" for ISO 9626 was "Passed," implying it met the standard's requirements. For sterility validation, ISO 11135 dictates specific sample sizes based on the method (e.g., overkill, half-cycle approach), which would have been followed but are not explicitly reported in quantitative terms in this summary.
• Data Provenance: The tests were conducted internally by PAJUNK GmbH Medizintechnologie (Germany) or by their contract sterilizers (Sterigenics Germany GmbH and HA2 MEDIZINTECHNIK GMBH, Germany). The data is generated from prospective testing of manufactured devices and packaging.

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

Not applicable. This is not a diagnostic AI device requiring expert ground truth for image interpretation. The "ground truth" here is the physical measurement results from standardized tests.

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

Not applicable. This is not a study assessing subjective interpretation (e.g., radiological reads). Quality control and engineering tests have defined pass/fail criteria.

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 physical medical device, not an AI-powered diagnostic tool.

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

Not applicable.

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

The ground truth used for these tests are objective, measurable physical and chemical properties and performance characteristics defined by international standards (e.g., force in Newtons for bonding strength, presence/absence of leakage, sterility assurance level).

8. The sample size for the training set:

Not applicable. As this is not an AI/ML device, there are no training sets.

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

Not applicable.

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The SPROTTE® STANDARD (LUER/ NRFit®) needles are anesthesia conduction needles which are used to administer anesthetic agent to the subarachnoid space.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the subarachnoid space. The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

The provided text describes a 510(k) premarket notification for a medical device, specifically SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology needles. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (SPROTTE NRFit™, Quincke NRFit™) by validating the addition of an alternative sterilization service provider and an alternative packaging material.

The document does not detail acceptance criteria or study results for AI performance or diagnostic accuracy. Instead, it focuses on the physical and biological characteristics of the needle itself, and the validation of manufacturing processes (sterilization and packaging) to ensure sterility and shelf life.

Therefore, many of the requested items (e.g., AI performance, expert ground truth, MRMC studies, training set details) are not applicable to this type of device submission. This is a traditional medical device submission, not an AI/ML-based device.

However, based on the provided text, we can address the applicable criteria:

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

The acceptance criteria are generally implied by adherence to relevant ISO standards and maintaining the same performance characteristics as the predicate device. The "reported device performance" is essentially a "Pass/Fail" determination against these standards.

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

• Sample Size: The document indicates that for ISO 9626, "5.7 Sample size" was "Passed", implying a specific sample size was used as per the standard, but the exact number is not provided. For sterility and shelf-life testing, "process most challenging worst case devices" were used, but specific numbers are not given.
• Data Provenance: The manufacturing and testing are stated to occur at PAJUNK GmbH Medizintechnologie in Geisingen, Germany, and the contract sterilizers are in Wiesbaden, Germany (Sterigenics) and Halberstadt, Germany (HA2 Medizintechnik). The data is derived from prospective testing conducted to validate the manufacturing and sterilization processes.

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

This is not applicable. This submission concerns the physical and biological characteristics of a medical device (anesthesia needle) and the validation of its manufacturing and sterilization processes, not the performance of an AI/ML algorithm or diagnostic accuracy involving expert review.

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

This is not applicable. No adjudication method for expert reviews or ground truth establishment is mentioned as this is not an AI/ML or diagnostic performance study. Performance is measured against specific ISO standards and validated processes.

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 not an AI-assisted device; it is a physical medical device.

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

This is not applicable. This is not an AI/ML algorithm.

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

The "ground truth" in this context is the adherence to established international standards (ISO series) for medical device design, manufacturing, sterilization, and biocompatibility. For instance, sterility is validated to an SAL of 10^-6 (a defined standard), and material properties are tested against specified values in the ISO standards. The performance characteristics of the new device are directly compared to existing predicate devices and their proven specifications, and confirmed by testing against the same engineering and safety standards.

8. The sample size for the training set:

This is not applicable. This is not an AI/ML device that requires a training set.

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

This is not applicable.

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SonoBlock and SonoBlock II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gam entry and inject local anaesthetics to induce regional anaesthesia.
Warning:
SonoBlock and SonoBlock II Needles are not intended for RF ablation or any other type of ablation procedure.

The subject device, the SonoBlock II nerve block needle is a single-use anaesthesia conducting nerve block needle intended for performing peripheral nerve blocks.
The SonoBlock and SonoBlock II nerve block needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.

The provided document is a 510(k) Summary for the SonoBlock and SonoBlock II needles. It focuses on demonstrating substantial equivalence to a predicate device (SonoPlex II) and primarily addresses changes in manufacturing processes (hub-to-needle bonding), sterilization providers, and packaging materials.

The document does not contain information related to software performance, AI assistance, or human reader effectiveness studies. Therefore, I cannot provide details for criteria 5, 8, and 9, and some parts of other criteria will be marked as "Not Applicable" or "Not Provided."

Here's the breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against "reported device performance" in the context of device function/efficacy. Instead, it discusses compliance with international standards and the results of various performance tests. The focus is on ensuring that changes to manufacturing and sterilization do not negatively impact the device's physical and material properties.

Here's a compilation of the relevant performance tests and their outcomes:

Study Details

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

   • Bending Rigidity & Bonding to Hub: Specific item codes are listed with individual deflection or force values. However, the number of units tested for each item code is not explicitly stated in the summary, nor is the total sample size for these tests.
   • Breakage: The number of complete cycles (20) is mentioned, but the number of needles tested is not specified.
   • Penetration Force: Not specified.
   • Hub/Connection Performance: Not specified.
   • Sterilization Validation: Refers to "process most challenging worst case devices" and "1 sublethal cycle, 1 full cycle" for the Overkill Approach, but the specific number of devices tested is not provided.
   • Shelf Life: Refers to "process most challenging worst case devices" and "similar characteristics made from the same material," but the specific number of devices tested is not provided.
   • Data Provenance: The manufacturing site is PAJUNK GmbH Medizintechnologie, Geisingen, Germany. The sterilization facilities are Sterigenics in Wiesbaden, Germany, and HA2 Medizintechnik in Halberstadt, Germany. The tests appear to be conducted internally or by contract labs associated with the manufacturer, rather than clinical studies with patient data. The studies are prospective in the sense that they are validations performed for regulatory submission, but they are not clinical studies in the traditional sense.

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

   • Not Applicable. This document describes engineering performance tests and sterilization/biocompatibility validations, not studies requiring expert review for ground truth in clinical image interpretation or similar contexts.

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

   • Not Applicable. The tests are governed by international standards (e.g., ISO, EN) which define the test procedures and acceptance criteria objectively.

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. This device is an anesthesia conduction needle and does not involve AI assistance or human readers.

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

   • No. This device is a medical instrument, not an algorithm. The "standalone" performance refers to the device's physical and material characteristics as tested against international standards.

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

   • The "ground truth" for the performance tests in this document is defined by the acceptance criteria specified in the referenced international standards (e.g., ISO 9626, ISO 7864, ISO 80369 series, ISO 11135-1, ISO 10993-7). These standards provide objective and measurable criteria for physical properties, material strength, sterility, and biocompatibility.

7. The sample size for the training set:

   • Not Applicable. This device does not use machine learning or AI that requires a "training set."

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

   • Not Applicable. As there is no training set mentioned, the method for establishing its ground truth is irrelevant.

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As a powered muscle stimulator (NMES) the Stim2Go is indicated for the following conditions:

• Relaxation of muscle spasm
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

As a transcutaneous electrical nerve stimulator (TENS) for pain relief the Stim2Go is indicated for the following conditions:

• Symptomatic relief and management of chronic (long-term), intractable pain
• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

As a biofeedback device the Stim2Go is indicated for the following condition:

• Muscle re-education purposes

As a functional neuromuscular stimulator, the Stim2Go is indicated for the following conditions:

• Helps to relearn voluntary motor functions of the extremities

The movement-based biofeedback can only be used for patients with an active range of motion (ROM) which is defined as the ability of volitional movement resulting in a change of the concerned limb inclination angle of at least 10 degrees.

The Stim2Go is a portable, hand-held / body-worn electrical stimulation device mainly for the treatment of neurological patients with motor and/or sensory impairments. Stim2Go offers transcutaneous electrical stimulation of peripheral nerves (motor and/or sensory).

Typically, Stim2Go is used to elicit muscle contractions (known as Neuro Muscular Electrical Stimulation (NMES)), to treat pain (known as Transcutaneous Electrical Nerve Stimulation (TENS)) or to be applied as Functional Electrical Stimulation (FES).

Stim2Go uses a built-in sensor to analyze the patient's movement data in real time. Based on the analysis result, pre-configured stimulation patterns can be triggered to achieve a specific, predetermined effect based on the patient's movements.

Stim2Go is intended for use in a clinical setting or when used by end users in home care, then necessarily with assistance. It is intended for use as an on-demand service - not permanently.

Stim2Go is controlled wirelessly by a smart device – the App is freely available in the Appstore. The App allows users to execute a variety of therapy programs and even to control parameters on a very detailed level. Stim2Go is tested and certified according to the international standards for medical electrical devices and systems.

The provided text describes the acceptance criteria and the study proving the device's compliance, focusing on its substantial equivalence to a predicate device.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents the acceptance criteria and device performance through side-by-side comparison tables between the new device (Stim2Go) and the predicate device (STIWELL med4) for various modes: Powered Muscle Stimulator (NMES), Functional Electrical Stimulation (FES), Biofeedback, and Transcutaneous Electrical Nerve Stimulator (TENS). The "Comment" column in these tables explicitly states whether the new device is "Substantially equivalent" to the predicate device for each characteristic or specification.

Since no specific numerical acceptance thresholds were stated in terms of diagnostic performance metrics (e.g., AUC, sensitivity, specificity, accuracy), the "Acceptance Criteria" for this submission appears to be demonstrating substantial equivalence to the predicate device across various technical and functional specifications. The "Reported Device Performance" is the new device's specifications as measured and compared to the predicate device.

Given the extensive nature of these tables (pages 6-29), summarizing them entirely in a single table here would be too long. Instead, I will provide a representative excerpt and describe the general approach to demonstrating compliance.

General Acceptance Criteria & Performance Approach:

The overall acceptance criterion for this device appears to be the demonstration of substantial equivalence to the legally marketed predicate device (STIWELL med4, K080950) across all specified functionalities (NMES, TENS, FES, Biofeedback) and safety standards. This is proven by showing that the new device's characteristics and performance are either identical or that any differences do not raise new questions of safety or effectiveness.

Representative Excerpt from Compliance Tables (e.g., for Powered Muscle Stimulator):

Notes on Comments (as explained in the document):

• (PMS1): Different number of channels, but both comply with IEC 60601-2-10 and difference doesn't impact essential performance, basic safety or substantial equivalence.
• (PMS4): The new device has a lower max frequency (100 Hz) and higher max pulse width (750 µs) than predicate, but still complies with IEC 60601-2-10 requirements and differences do not impact essential performance, effectiveness, safety or substantial equivalence. Parameters only adjustable by therapists.
• (PMS5): Higher max phase charge (75 µC) for new device vs. (40 µC) for predicate, but still considered safe per 21CFR890.5850 and complies with IEC 60601-1 and IEC 60601-2-10. Differences don't impact effectiveness, safety, or substantial equivalence.

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

This submission is a 510(k) premarket notification for a Class II medical device (Powered Muscle Stimulator, Product Code IPF). For devices like this, the primary method of demonstrating safety and effectiveness is often through comparative testing against a predicate device and compliance with recognized performance standards, rather than extensive clinical trial data or large observational test sets with human subjects.

The document states that performance testing / standard testing was carried out. This includes:

• Electrical Safety tests according to IEC 60601-1 and IEC 60601-2-10.
• Battery Safety tests according to IEC 62133-2.
• Mechanical and temperature/climate Safety tests according to IEC 60601-1.
• Electromagnetic Compatibility tests according to IEC 60601-1-2.
• FCC Radio Frequency Testing according to 47 CFR 15.247.
• Software Verification in accordance with FDA guidance and IEC 62304.
• Usability/Human Factors Testing.

For these types of tests, the "sample size" refers to the number of devices or components tested, and it is usually a small, representative sample (e.g., a few units) to ensure manufacturing consistency and functionality, not a large patient cohort. The document does not specify the exact number of devices tested for each performance/standard test, but it implies that standard engineering and quality control practices were followed.

Data Provenance:

• The tests were carried out at "certified test house" for electrical safety, battery safety, mechanical/temperature safety, electromagnetic compatibility, and FCC RF testing.
• Software verification testing was carried out "internally", but an "external test house approved the compliance against IEC 62304."
• Usability/Human Factors testing was carried out with both "formative and summative usability evaluation," and an "external test house approved the compliance against IEC 60601-1-6."

The data is prospective in the sense that these tests were specifically conducted for the purpose of demonstrating compliance for this 510(k) submission. There is no information regarding country of origin of the data beyond the certified/external test houses.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission does not involve clinical data that would require expert-established ground truth in the context of diagnostic accuracy (e.g., reading medical images). The "ground truth" here is defined by:

• Industry Standards: Compliance with recognized international and national standards (IEC 60601 series, IEC 62133-2, IEC 62304, FCC regulations, etc.).
• Predicate Device Specifications: The established performance and safety profile of the legally marketed predicate device (STIWELL med4).

The "experts" involved are the personnel at the certified/external test houses who perform the standard-defined tests and the company's internal engineers and quality assurance personnel. Their qualifications would be expertise in electrical engineering, biomedical engineering, regulatory affairs, quality assurance, etc., with demonstrated experience in device testing and standard compliance. The document does not specify the exact number or detailed qualifications of these individuals, as it's implied by their role in certified testing facilities.

4. Adjudication Method for the Test Set

As there is no clinical test set involving human interpretation of data for diagnostic or prognostic purposes, an adjudication method (like 2+1, 3+1) is not applicable. The "adjudication" in this context is the process of comparing the new device's measured performance against the specified tolerances within the relevant standards and against the predicate device's specifications, which is done through rigorous engineering and regulatory review.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices where human readers' diagnostic performance with and without AI assistance is being evaluated. The Stim2Go is a powered muscle stimulator, not a diagnostic imaging AI device. Its performance is evaluated through technical specifications and hardware/software compliance, not human reader improvement.

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

The concept of "standalone performance" primarily applies to algorithms that interpret data and provide outputs (e.g., classifications, measurements) without immediate human intervention for diagnosis. While the Stim2Go device does have software and embedded algorithms for controlling stimulation and interpreting sensor data (e.g., inclination calculations for biofeedback and triggered FES), its "performance" is evaluated by its ability to meet the output specifications and safety standards as a functional medical device, not as a standalone diagnostic algorithm. The compliance tests (electrical safety, EMC, etc.) can be considered "standalone" in that they verify the device's technical performance independent of patient use at a fundamental level.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

• Technical Specifications and Performance Metrics: Parameters defined in engineering specifications for electrical stimulation, sensor accuracy (e.g., 1 degree for inclination angle), and mechanical operation.
• Compliance with Recognized Standards: The "ground truth" for safety and basic effectiveness is established by the requirements of international medical device standards (e.g., IEC 60601 series, IEC 62133-2, IEC 62304) and FDA regulations (21 CFR 898, etc.). The device's ability to pass these standard tests forms the core evidence.
• Predicate Device Performance: The established safety and effectiveness profile of the STIWELL med4 (K080950) serves as a benchmark for substantial equivalence comparisons.

There is no mention of "expert consensus," "pathology," or "outcomes data" in the typical sense of clinical studies used for diagnostic accuracy.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a physical medical device, not an AI/ML-driven diagnostic algorithm that relies on a "training set" of data in the machine learning sense. Therefore, the concept of a "training set" and its sample size is not applicable here. The device's internal algorithms (e.g., for inclination calculation, as mentioned under FES5/BF1 discussion) are likely based on established physics and signal processing principles, not learned from a large dataset.

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

Since there is no "training set" in the context of machine learning, this question is not applicable. The underlying principles for the device's functions (like electrical stimulation parameters, sensor data processing for inclination) are based on fundamental scientific and engineering principles, and their accuracy/performance is verified through the various compliance and performance tests described.

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The Disposable Pre-calibrated Biopsy Needle for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The Disposable Pre-calibrated Biopsy Needle is provided in a set.

The Disposable Pre-calibrated Biopsy Needle is a dual cannula device made from stainless steel. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue.
Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained.
Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest.
Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation.
There are different versions of the Disposable Brain Biopsy Needle 2.0 for following use-cases:
Guide: In the use case "Guide" the Biopsy Needle shall be used with Brainlab optical cranial navigation system with Brainlab VarioGuide. Brainlab Frameless Biopsy System or Brainlab VarioGuide Robotics. Therefore, a tracking marker array attached to Biopsy Needle shall allow the depth tracking of the instrument and calculation of the cutting window position.
Frame: In the use case "Frame" the Biopsy Needle shall be used with the Elekta Leksell stereotactic frame. A defined length and exact stop shall allow the precise inserting of the Biopsy Needle in the stereotactic frame.

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Pajunk GmbH Medizintechnologie regarding their Disposable Pre-calibrated Brain Biopsy Needle 2.0. The core of the information provided for acceptance criteria and device performance relates to MRI conditional labeling.

Here's an analysis of the provided information, structured to address your questions. Please note that many of your points (e.g., sample size for training set, number of experts for ground truth, multi-reader multi-case studies) are not applicable to this specific submission because it pertains to a physical medical device (a biopsy needle) and not an AI/ML algorithm or software as a medical device (SaMD). The acceptance criteria here are for the device's physical safety and compatibility, specifically in an MRI environment.

Acceptance Criteria and Device Performance for Disposable Pre-calibrated Brain Biopsy Needle 2.0

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the MRI testing. It refers to "the test object 'Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm'". This wording suggests that the testing was performed on at least one representative unit of the device. For physical device testing, particularly for magnetic properties, often a single, representative sample is sufficient if the manufacturing process ensures consistency.
• Data Provenance: The testing was conducted in a laboratory setting, likely in Germany (where Pajunk GmbH Medizintechnologie is located), using a Siemens Magnetom Vida MR scanner. This is a controlled, prospective laboratory study to assess device properties. It is not patient or clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• N/A. This submission is for a physical medical device (biopsy needle), not an AI/ML or diagnostic software. Ground truth in this context refers to physical properties tested in a lab, not expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

• N/A. As above, this is laboratory testing of a physical device, not an interpretation task requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not a study involving human readers or diagnostic interpretation. It is a study on the physical properties of a medical device (MRI compatibility).

6. Standalone (Algorithm Only) Performance

• N/A. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

• The ground truth for the device's MRI compatibility testing was established by physical measurement against a recognized standard (ASTM F2052-15) using a 3 Tesla MR scanner. The "truth" is whether the device exhibits magnetic displacement, as defined by the standard's criteria (e.g., deflection less than 45 degrees).

8. Sample Size for the Training Set

• N/A. There is no "training set" as this is a physical device, not an AI/ML model.

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

• N/A. As above, there is no training set.

In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical device (a brain biopsy needle) to a predicate device, with a specific emphasis on the addition of "MR Conditional" labeling. The "study" in question is a performance test (specifically, magnetic displacement) conducted under lab conditions, adhering to an ASTM standard, to prove the device's safety in an MRI environment.

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The Disposable Brain Biopsy Needle 2.0 for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The Disposable Brain Biopsy Needle 2.0 is provided in a set.

Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained.

Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest.

Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation.

There are different versions of the Biopsy Needle for following use-cases:

Guide: In the use case "Guide" the Biopsy Needle shall be used with Brainlab optical cranial navigation system with Brainlab VarioGuide, Brainlab Frameless Biopsy System or Brainlab VarioGuide Robotics. Therefore, a tracking marker array attached to Biopsy Needle shall allow the depth tracking of the instrument and calculation of the cutting window position.

Frame: In the use case "Frame" the Biopsy Needle shall be used with the Elekta Leksell stereotactic frame. A defined length and exact stop shall allow the precise inserting of the Biopsy Needle in the stereotactic frame.

The provided text describes a 510(k) premarket notification for a medical device, the Disposable Brain Biopsy Needle 2.0. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the detailed information typically found in a study designed to prove a device meets acceptance criteria, especially not for an AI/ML powered device. This submission focuses on comparing the new device's design and performance characteristics to a previously cleared predicate device (K060808, BrainPro/BrainPro ACCESS).

Here's why the requested information cannot be fully provided based on the given text:

• No new clinical study details: The 510(k) process for this type of device (a modified existing device with unchanged intended use) often relies on design verification and validation testing to show that the modifications do not negatively impact safety or effectiveness, and that the new device performs comparably to the predicate. It does not typically involve human subject clinical trials with AI/ML-specific acceptance criteria.
• Focus on Substantial Equivalence: The document explicitly states, "Performance of the subject device is verified and validated through testing with the predicate device as well as by additional testing." This implies bench testing and non-clinical performance comparisons, not a clinical trial with human readers or AI algorithms.
• No AI/ML Component: The device described is a physical biopsy needle, not an AI/ML software device. Therefore, acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, reader improvement, standalone performance) are not applicable.

However, I can extract information related to the device's comparison to its predicate, which serves a similar function to demonstrating "acceptance" within the 510(k) framework for this type of device.

Based on the provided document, here's an attempt to address your questions, highlighting where the requested information is not applicable or not present:

The information provided describes a 510(k) premarket notification for a physical medical device (a brain biopsy needle), not an AI/ML-powered software. Therefore, many of the questions related to AI/ML specific performance studies (e.g., MRMC studies, standalone algorithm performance, expert consensus for AI ground truth) are not applicable to this submission. The "acceptance criteria" here are framed within the context of demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) for a physical device where the intended use is identical and modifications are primarily design updates, "acceptance criteria" revolve around ensuring the new device performs as safely and effectively as the predicate. The document states:

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

• Sample Size: Not specified in the provided summary. Performance testing for this type of device (bench testing) would typically involve a sample size sufficient to demonstrate consistency and equivalence, but it's not a "test set" in the context of clinical AI/ML validation data.
• Data Provenance: The testing is likely retrospective (on manufactured devices/materials) and conducted by the manufacturer (PAJUNK® GmbH Medizintechnologie) in Germany. It refers to "Design verification process" and "testing with the predicate device," implying lab-based, non-clinical tests.

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

• Not Applicable. This is a physical device, and the "ground truth" for its performance is established through engineering design verification and validation (bench testing, material testing, functional testing), not through expert clinical interpretation of data as it would be for an AI/ML algorithm.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this isn't a study involving human readers or AI requiring adjudication of results. "Adjudication" for this device would refer to internal design control processes and quality assurance.

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

• No. An MRMC study is a clinical study design used to evaluate the diagnostic accuracy of imaging interpretations, especially with AI assistance. This device is a biopsy needle, not an imaging interpretation tool.

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

• Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on adherence to engineering specifications, functional performance requirements (e.g., ability to acquire tissue, cut precisely), material properties, and sterility assurance, as demonstrated through a rigorous design verification and validation process (bench testing, mechanical testing, material compatibility, sterilization validation). This is typically compared directly to the predicate device during testing.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set." The development process involves design and manufacturing, not model training.

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

• Not Applicable. As above.

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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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