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

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

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

1. Table of acceptance criteria and the reported device performance

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

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

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

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

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

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

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

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

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

No MRMC comparative effectiveness study was done. This device is a local anesthetic delivery assistance device, not an AI-powered diagnostic or interpretive tool.

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

Here is an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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