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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 Round Window E-Cath™ is indicated for irrigation of the middle ear including the round window area of the middle ear and/or the recording of evoked electrophysiological inner ear potentials.

The RW E-Cath™ is an accessory to a tympanostomy tube. The RW E-Cath™ consists of a single triple-lumen tube opening into a hollow fenestrated reservoir tip on the distal end. Two lumcns are empty and are intended to allow fluid inflow and outflow. The third lumen encases the electrode wire lead and insulates it from the other two lumens. The atraumatic blunt distal tip of the electrode is the only part of the electrode that is exposed. The exposed distal tip of the electrode is located on the outside edge of the distal tip where it is intended to come into contact with the floor of the bony round window niche. The proximal end of the electrode contains a lead connector which the treating physician or audiologist can attach to a standard evoked potential recording instrument.

The provided text describes a medical device called the "RW E-Cath™" and its performance testing, but it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device meets acceptance criteria, detailed sample sizes, expert involvement, or comparative effectiveness studies.

The document is a 510(k) Summary submission to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria against specific performance targets.

Here's a breakdown of what is available and what is missing:

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

• Missing. The document states: "A bench test protocol was developed to assess the performance of the RW E-Cath™ in terms of pressure vs. flow, distal tip bond strength, tensile strength of the catheter body, proximal hub bond strength, and clectrode integrity." However, it does not provide the specific acceptance criteria (e.g., "pressure vs. flow must be X to Y") nor the reported performance values from these tests. It only mentions that "All tests will be conducted on final sterile product" and "Sufficient samples will be used for each test."

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

• Missing. The document states, "Sufficient samples will be used for each test." No specific sample sizes, data provenance, or study design (retrospective/prospective) are mentioned. The testing described is "bench testing," not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. The described testing is bench testing of physical properties (pressure vs. flow, bond strength, tensile strength, electrode integrity). This type of testing does not involve establishing ground truth from experts in the way an imaging or diagnostic device would.

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

• Not applicable. As above, bench testing of physical properties does not typically involve expert adjudication for a "test set" in the context of clinical or diagnostic performance.

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

• No. This device is a medical catheter with an electrode, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

• Not applicable. This device is hardware (a catheter with an electrode) used for irrigation and electrophysiological potential recording. It does not operate as a standalone algorithm.

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

• Not applicable / Missing. For the bench tests ("pressure vs. flow, distal tip bond strength, tensile strength of the catheter body, proximal hub bond strength, and clectrode integrity"), the "ground truth" would be the objective measurements obtained from standardized testing methods against pre-defined engineering specifications. These specifications and the results are not provided.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is a hardware device undergoing bench testing, not a machine learning model.

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

• Not applicable. As above, no training set or machine learning model is discussed.

In summary, the provided document focuses on the description, intended use, principles of operation, technological characteristics, and a high-level overview of bench performance testing for a medical device submitted for 510(k) clearance. It lacks the detailed information about acceptance criteria, specific test results, sample sizes, expert involvement, and study designs typical of performance claims for diagnostic or AI-driven devices.

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