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

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

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

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

Here's a breakdown of the available information:

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

• Not applicable. This is a physical medical device.

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

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

8. The Sample Size for the Training Set:

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

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

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

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

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

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

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

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

Device Acceptance Criteria and Performance

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication method for the test set:

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

7. The type of ground truth used:

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

8. The sample size for the training set:

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

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

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

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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.

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PAJUNK®s soft tissue biopsy, puncture and aspiration cannulas and needles are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration.

They are not appropriate for bone biopsies.

Chiba SONO cannulas/ needles enhanced for ultrasound visibility are single use sterile and nonpyrogenic devices used to gain entry or puncture the tissue and aspirate soft tissue for biopsy purposes. The needles/ cannulas may be used during all biopsy and puncturing procedures according to the physician´s indication. Additionally fluids for example for fluoroscopy may be injected.

Cannulas/ needles 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.

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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness for a medical device (Chiba SONO cannulas/needles). This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed, rigorous study proving new performance claims against explicit acceptance criteria in the way one might expect for a novel, high-risk AI-powered device. Therefore, some of the requested information (especially around AI-specific elements like MRMC studies, training set details, or complex ground truthing) is not applicable or not provided in this type of submission.

Acceptance Criteria and Device Performance

The document does not explicitly list numerical "acceptance criteria" and "reported device performance" in a quantitative table for, for example, diagnostic accuracy (sensitivity, specificity, etc.), because it's a submission for a biopsy needle based on substantial equivalence to existing devices, not a new diagnostic algorithm.

Instead, the "acceptance criteria" are implied by the requirements for substantial equivalence and the performance of the predicate devices. The "reported device performance" is a qualitative affirmation that the device meets these implied criteria by being substantially equivalent and passing standard industry tests.

Here's an interpretation based on the provided text:

Study Details

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

   • The document describes "bench testing" for mechanical properties and "bench marking" for general performance. It does not specify a "test set" in the context of patient data or images.
   • The "CornerStone" reflectors' efficacy is stated to be "demonstrated for each type of cannula" based on "clinical evaluation, the biocompatibility testing and the bench testing." However, details of this "clinical evaluation" (e.g., sample size, design) are not provided in this summary. Instead, the focus is on the device's technical and material equivalence to previously cleared devices.
   • Data provenance: Not specified for any "clinical evaluation." Bench testing would be internal to the manufacturer (Germany).

2. 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 as no specific "test set" requiring expert ground truth in a diagnostic sense is described. The evaluation is based on engineering tests and comparison to predicates.

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

   • Not applicable.

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 a physical medical instrument (a biopsy needle), not an AI-powered diagnostic system. Therefore, an MRMC study is not relevant or described.

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

   • No. This is not an algorithm; it's a physical device.

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

   • For biocompatibility, the ground truth is compliance with ISO 10993-1 and material composition identical to cleared devices.
   • For sterility, the ground truth is an SAL of 10^-6 and compliance with specific limits, validated by standard methods.
   • For mechanical properties, the ground truth is adherence to internal "standard testing" requirements for bending stability, breaking resistance, and hub-to-needle bonding.
   • The primary "ground truth" for marketing clearance is substantial equivalence to an existing predicate device based on material composition, intended use, and similar technological characteristics.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this physical device.

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

   • Not applicable.

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