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The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.

The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wres, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.

The Introducer Sheath System devices consist of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface in length of 20cm on the distal portion.

The System consists of the following components:

• A One Introducer Sheath with hemostasis valve
• A One or two dilator(s)

The provided text describes a 510(k) premarket notification for a medical device called the Catapult Guide Sheath / Introducer Sheath System. It details the device, its intended use, comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the questions you've asked are typical for the evaluation of AI/ML-driven medical devices, especially related to diagnostic or classification tasks (e.g., image analysis for disease detection). The device described in the document (Catapult Guide Sheath) is a physical medical device (an introducer sheath system) used for physical introduction of interventional and diagnostic devices into the vasculature, not an AI/ML software device.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML device. Many of the questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are irrelevant to the type of device being reviewed in this FDA submission.

Here's why and what information is available:

• Type of Device: The Catapult Guide Sheath is a Class II physical medical device (introducer catheter). It's a tool, not a diagnostic or AI algorithm.
• Purpose of Submission (510(k)): This submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (Catapult Guide Sheath Introducer Sheath System, K240957). This is a common pathway for physical devices with modifications or new physical devices that are very similar to existing ones. The core of the substantial equivalence argument relies on demonstrating that the new device performs similarly to the predicate device, especially after a material change (insourced HVA).
• "Acceptance Criteria" for this device: For this type of device, "acceptance criteria" are related to mechanical performance, biocompatibility, sterilization, and shelf-life, ensuring the device functions as intended and is safe. These are detailed in Table 2, listing the tests performed and the applicable standards.
• "Study that proves the device meets the acceptance criteria": The document lists a series of non-clinical (laboratory) tests that were performed. These tests are the "study" demonstrating the device meets the performance requirements for substantial equivalence.

Therefore, I cannot fill out the detailed table and answer the specific questions about AI/ML device evaluation based on the provided text. The text focuses on the mechanical, material, and safety performance of a physical device, not the diagnostic or predictive performance of an AI algorithm.

If your intention was to ask about the evaluation of a physical medical device, I can re-frame the answer based on the provided document.

Assuming you are asking for information relevant to the physical medical device described, here's an attempt to interpret your questions in that context, recognizing that most are geared towards AI/ML:

Device: Catapult Guide Sheath / Introducer Sheath System

1. Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to meeting specifications derived from regulatory standards and predicate device performance. The "reported device performance" are the results of the listed tests that demonstrated compliance.

2. Sample Size for the Test Set and Data Provenance

For a physical device, "test set" refers to the number of units tested. The specific sample sizes for each mechanical test are not detailed in this summary (they would be in the full submission). The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer and external laboratories. It is not patient data, so "country of origin of the data," "retrospective or prospective" do not apply.

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

This question is not applicable. "Ground truth" in the context of AI/ML diagnostic devices refers to a definitive diagnosis or finding. For a physical device, the "ground truth" is established by the specifications and performance requirements derived from engineering principles and relevant ISO standards. No human experts are used to "establish ground truth" in this context; instead, engineers and technicians conduct specified physical and chemical tests.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" (e.g., consensus among readers) needed for a physical device's performance testing. Test results are quantitative measurements against defined criteria.

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

Not applicable. MRMC studies are for evaluating human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is not an AI diagnostic 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. Its "standalone performance" refers to its mechanical and material properties as tested in the lab.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for performance is defined by:

• International standards (ISO, AAMI, ASTM, EN): These standards define acceptable limits and testing methodologies for medical device properties (e.g., leakage, tensile strength, biocompatibility, sterility).
• Predicate device performance: The previously cleared predicate device provides a benchmark for expected performance characteristics of the new device.
• Manufacturer's internal design specifications and risk analysis: Derived from the intended use and safety considerations.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.

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

Not applicable. There is no "training set" or "ground truth" for training in the AI/ML sense for this device.

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The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

The Jiangsu Rong Fu Kang Medical Instruments Co. Ltd (here and after RFK) Electrosurgical Pencils and Electrodes are handheld instruments that are used for cutting and coagulation of soft tissue. They consist of a plastic handle, a connecting cable and plug, control buttons, internal PCB, and either a stainless steel uncoated or non-stick electrode tip. The Electrosurgical Pencils and electrodes are disposable and are supplied sterile.

The connecting cable is plugged into an Electro-Surgical Generator Unit (ESU) which provides the high-frequency energy to be deployed in the surgical procedure. The plastic handle has two buttons: cutting and coagulation. The cutting button activates the CUT mode of the ESU and the coagulation button activates the COAG mode of the ESU.

The electrode tip makes contact with the target tissue and delivers high frequency energy from the ESU to the target organs for the purposes of cutting and coagulation. This energy then passes through the body tissues and returns to the ESU via a return electrode (ground pad).

The provided document is a 510(k) premarket notification from the FDA for a medical device: a Sterile Single Use Electrosurgical Pencil with Non-Coated and Non-Stick Electrode. While it describes the device, its intended use, and substantial equivalence to a predicate device, it does not contain the level of detail typically found in a clinical study report or a submission for an AI/ML-based medical device that would include specific acceptance criteria for algorithm performance, sample sizes for test sets, expert ground truth establishment, or MRMC studies.

The document focuses on "Non-Clinical Bench Testing" to demonstrate substantial equivalence, primarily comparing physical characteristics, energy type, sterilization, and material properties, as well as thermal effects on tissue and electrical safety (EMC).

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving the device meets those criteria, as it would be relevant for an AI/ML-based device. The device in question is a physical instrument, and its performance evaluation relies on different types of testing.

However, I can interpret the available information to frame a response in the context of what is provided for this electrosurgical pencil.

Interpretation Based on Provided Document (Electrosurgical Pencil - Not an AI/ML Device):

This document describes the regulatory submission for a physical medical device, an electrosurgical pencil. The "acceptance criteria" in this context are not for an algorithm's performance (e.g., accuracy, sensitivity, specificity) but rather for the device's physical and functional characteristics demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving acceptance is the non-clinical bench testing performed.

Here's how the information can be mapped:

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

Since this is not an AI/ML device with performance metrics like accuracy or AUC, the "acceptance criteria" are implicitly the functional and safety equivalence to the predicate device. The "reported device performance" are the results of the bench tests confirming this equivalence.

• Energy Type: High-Frequency Monopolar
• Sterilization Type: EO Sterilization
• Single Use
• Electrode Type: Monopolar
• Electrode Material: Stainless Steel
• Standards Applied: IEC 60601-1, IEC 60601-2-2, ISO 11135, ISO 11607
• Biocompatibility: Conforms to ISO 10993
• Labeling: Conforms to 21 CFR Part 801
• Stability and Shelf Life: 3 Years | All characteristics are identical or demonstrably equivalent.
• Electrode non-stick coating: Subject device uses Silicon oxide; predicate uses Teflon. Demonstrated to be "similar" in performance without craters.
• Handle Length: Subject: 145mm; Predicate: 165mm. (Difference noted, but not deemed critical enough to prevent equivalence).
• Total Device Length: Subject: 190mm; Predicate: 210mm. (Difference noted, but not deemed critical enough to prevent equivalence). |
  | Thermal Effects Equivalence: Similar thermal damage zone sizes on ex-vivo tissues (kidney, liver, muscle). | "These tests showed that the thermal effects of our electrode are virtually identical to those shown in the predicate device." |
  | Non-Stick Performance Equivalence: Similar non-stick performance to predicate. | "The non-stick performance of our non-stick electrode was found to be similar to the predicate device but without occurring holes and craters as in the predicate device's non-stick coating." |
  | Electrical Safety (EMC) Compliance: Pass specified electrical tests. | "The device K231405 successfully passed the following electrical tests: Conducted Emissions, Radiated Emissions (30MHz-1GHz, 1GHz-18GHz), Electrostatic Discharge (ESD), Radio frequency electromagnetic field radiation immunity, Power frequency magnetic field." |
  | Package Integrity & Functional Performance for Shelf Life: Maintain integrity and function after aging. | "Subject device package integrity and functional performance tests were performed in-house in our Jiangsu facilities after aging and real-time stability tests to confirm the proposed shelf life." |

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

• Sample Size: Not explicitly stated as a numerical count of units tested. For the "Thermal Effects on Tissue", it mentions "Ex-vivo kidney, liver, and muscle tissues were used." The quantity of each tissue type or the number of device samples tested is not provided. For electrical testing, it's typically a set number of units for compliance, but not specified here.
• Data Provenance: The thermal effects and package integrity/functional performance tests were conducted "in-house in our Jiangsu facilities." Electrical (EMC) testing was conducted by "Suzhou Yipin Quality Technical Service Co., Ltd." in Suzhou, China. Biocompatibility testing was performed by "Sanitation & Environment Technology Institute, Soochow University" in Suzhou, China. This indicates retrospective testing performed specifically for the 510(k) submission.

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

This concept is not applicable here as the device is a physical instrument, not an AI/ML algorithm requiring expert annotations for ground truth on images or data. The "ground truth" for this device's performance is established by direct physical measurements, electrical tests, and tissue studies.

4. Adjudication method for the test set:

Not applicable for this type of device testing.

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 not an AI/ML device that assists human readers.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for this medical device's performance relies on:

• Direct measurements and physical properties: Comparing specifications like dimensions, materials, and sterile status to the predicate device.
• Ex-vivo tissue studies: For thermal effects, the "ground truth" is the empirically measured thermal damage zone size on animal tissues, compared to the predicate device's effects.
• Standardized electrical test results: Compliance with international electrical safety standards.
• Material properties and biocompatibility studies: Compliance with ISO standards for materials and biological safety.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable.

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Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include: -ENT -Gynecology -Urology -General Surgery -Neurosurgery -Laryngeal Surgery -Orthopedic Surgery -Thoracic Surgery Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Heinrich single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current. HG Innovations, as a manufacturer, does not recommend a specific procedure. Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.

HG Innovations Ltd.'s electrical surgical instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, non-stick bipolar forceps and non-stick bipolar irrigating forceps (various sizes and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters: -Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.

This is not a medical device that utilizes AI and therefore does not have acceptance criteria, study data, or ground truth information as typically found in AI/ML device submissions.

The provided text is a 510(k) summary for Heinrich Single Use Non-Stick Bayonet Bipolar Forceps. This is a traditional medical device (bipolar forceps) and its clearance is based on substantial equivalence to predicate devices, not on performance metrics of an AI/ML algorithm.

Therefore, I cannot provide the requested information. The document focuses on comparing the new device's features and materials to existing cleared devices (predicates) and ensuring it meets safety and effectiveness standards for such devices (e.g., electrical safety, biocompatibility, sterility).

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McPherson Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters:

-Frequency range between 300 kHz-1,000 kHZ;

-Maximum generator operating voltage 600Vp.

Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:

-ENT

-Gynecology

• -Urology
• -General Surgery
• -Neurosurgery
• -Laryngeal Surgery
• -Orthopedic Surgery
• -Thoracic Surgery

Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.

HG Innovations, as a manufacturer, does not recommend a specific procedure.

Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.

The single-use, non-stick bipolar forceps and single-use, non-stick irrigating bipolar forceps (various sizes, designs and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters:

-Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.

The provided document describes the FDA's "Substantial Equivalence" determination for a device, not a study to prove acceptance criteria for a new AI/software medical device.

The document discusses various performance tests and comparisons to predicate devices for Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Irrigating Bipolar Forceps, which are mechanical electrosurgical accessories.

Therefore, the requested information about acceptance criteria, study design (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), and training set details for an AI/software device cannot be extracted from this document, as it pertains to a different type of medical device and a different regulatory review process.

The document consistently states "N/A" for "Software Verification and Validation Testing," "Animal Study," and "Human Clinical Performance Testing," further confirming that this is not an AI/software medical device submission requiring such studies.

However, I can provide a summary of the performance criteria and reported performance for the mechanical device as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria (General):

The document indicates that the device's performance was evaluated through various bench performance tests. These tests covered biocompatibility, electrical safety and electromagnetic compatibility (EMC), mechanical testing, sterility testing, and shelf-life testing. The report concludes that "HG Innovation's bipolar forceps are identical to the predicate device in their intended use/indications for use and materials used for the arms, and tips. No further testing necessary," implying that the performance data from these bench tests demonstrated substantial equivalence to the predicate devices. The details of these studies are not provided in this summary, but the results are reported as "Pass" for the relevant tests.

Information NOT Applicable/Available (as per the document's content for AI/Software specific questions):

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device. The document mentions "bench performance testing" which are laboratory-based physical tests, not data-driven tests on patient sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are irrelevant for this type of mechanical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
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 concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable.

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The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected - with the appropriate cable - to the bipolar output of an HF generator. Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation.

SUPRA Non-Stick Bipolar Forceps are available in several working length and tip width. They are delivered with a 2pin plug to connect them to bipolar output of an HF generator. The devices are supplied in sterile state and are intended for single use only.

This document is a 510(k) premarket notification for a medical device, the Supra Non-Stick Bipolar Forceps. It does not contain information about an AI/ML enabled device or a study proving that such a device meets acceptance criteria. The document focuses on establishing substantial equivalence to a predicate device for a electrosurgical cutting and coagulation device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as this document does not pertain to such a device.

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Heel Stick Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.

The heel stick safety lancet is offered in various depth size (0.65mm, 0.85mm, 1.00mm, 1.50mm) and width size (1.50 mm, 1.75mm, 2.50 mm, 2.80 mm). It consists of blade base, blade, which is welded with the blade base, spring, top head, bottom, and pushing button. The top head and bottom are intended to provide physical protection to the blade, and PET blister along with the tyvek paper cover the primary sterile barrier system for the device. The product is individually primarily packaged and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. Heel stick safety lancet is intended to be used by professionals. The product is intended for prescription (Rx) only.

This document describes the premarket notification (510(k)) for the "Heel Stick Safety Lancet (HHZ-II, HHZ-III)" and does not involve an AI or Machine Learning (ML) enabled device. Therefore, many of the typical acceptance criteria and study components requested in the prompt, such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable.

The acceptance criteria provided for this device concern its physical and performance characteristics as a manual surgical instrument, not an AI model.

Here's an attempt to answer the prompt based on the provided document, highlighting where the requested information is not relevant due to the nature of the device:

Device: Heel Stick Safety Lancet (HHZ-II, HHZ-III)
Device Type: Manual Surgical Instrument For General Use (Lancet)

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing Acceptance and Results:

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

For the Simulated Clinical Use study to evaluate the safety mechanism:

• Sample Size: 600 device samples each for the HHZ-II and HHZ-III models (implicitly, 1200 samples total, though not explicitly stated as combined).
• Data Provenance: Not specified, but generally, bench testing and simulated clinical use for a medical device cleared via 510(k) are conducted by the manufacturer or their contracted laboratories to demonstrate compliance with standards. It's a prospective test of the device. Country of origin not specified for the test data, but the manufacturer is in China.

For the Non-Clinical (Bench) Testing (Appearance, Cleanness, Dimension, etc.):

• Sample Size: Not explicitly stated for each test, but standard quality control and performance testing typically involve a defined sample size from production batches.
• Data Provenance: Not specified, likely internal testing by the manufacturer.

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

This information is not applicable as the device is a manual lancet and the studies are performance/bench/biocompatibility tests, not studies involving expert adjudication of AI outputs or clinical interpretations. The "ground truth" for these tests is based on measurable physical properties and specified standards (e.g., ISO standards).

4. Adjudication Method for the Test Set

This is not applicable for the type of device and testing performed. Adjudication methods like "2+1" or "3+1" are typical for clinical studies involving human interpretation (e.g., for image reading in AI studies), not for mechanical device performance or biocompatibility testing. The "ground truth" (acceptance criteria) for the bench tests are against physical measurements and functional performance as per engineering specifications and relevant ISO standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation or diagnostic tools to assess the impact of AI on human reader performance. The Heel Stick Safety Lancet is a manual instrument.

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

No, a standalone algorithm performance study was not done. This is not an AI/algorithm-based device. The "simulated clinical use" mentioned is a physical test of the device's safety mechanism, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the Heel Stick Safety Lancet consisted of:

• Pre-defined engineering specifications and measurable physical properties: For criteria like appearance, cleanness, dimensions, firmness, launch performance, launch depth/width, activating force, and sharp access in safe mode.
• Compliance with international standards: Specifically, ISO 23908 for evaluating the safety mechanism and ISO 10993 series for biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical, manual medical device, not an AI/ML product that requires a training set.

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

This information is not applicable as there is no AI/ML training set for this device.

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The Rhythmlink MR Conditional Sticky Pad Electrode is intended for use with recording, monitoring, and stimulation equipment in the study of biopotentials such as Electroencephalograph (EEG), Surface Electromyography (EMG), or Nerve Conduction Evoked Potential Signals (EP). This device is non-sterile, single-use only, and may remain on the patient in a MRI environment under specific conditions.

The MR Conditional Sticky Pad Electrode is intended to be used in medical environments where quick electrode application is required with minimal skin preparation. The device provides an easy-to-apply solution by combining conductive material used to record biosignals with a hydrogel designed for patient skin adhesion. This combination of materials, with an electrically conductive leadwire designed to fit with patient monitoring and stimulation equipment, provides a fast and easy way to record brain and muscle activity, provide stimulation for evoked potentials, and serve as a ground or reference electrode during monitoring. The MR Conditional Sticky Pad Electrodes have been specifically engineered to remain safely on a patient during MR imaging under the conditions specified in the labeling. Each MR Conditional Sticky Pad Electrode comprises the hydrogel electrode attached to a 240mm long leadwire (MR Conditional Electrode Assembly), which pairs with and connects to a 1.0m to 2.5m long, MR Unsafe Extension Cable. The extension cable provides a quick disconnect function to allow patient to be quickly moved into MR imaging without removing the hydrogel electrodes from the patient. Between 2 and 48 total MR Conditional Electrode Assemblies may remain on the patient during MR imaging in either 1.5T or 3.0T systems. The MR Conditional Electrode Assemblies are marked with yellow "MR Conditional" symbols, and the MR Unsafe Extension Cables are marked in duplicate (one at each end) with red "MR Unsafe" symbols to ensure proper use).

This document describes the regulatory approval for a medical device (MR Conditional Sticky Pad Electrode), not an AI/ML-based device. Therefore, many of the requested criteria, such as those related to AI model training, ground truth establishment, expert review, and MRMC studies, are not applicable.

However, I can extract and present the information available regarding the device's acceptance criteria and the study that proves it meets them, focusing on the non-clinical performance data provided.

Understanding the Device:

The Rhythmlink MR Conditional Sticky Pad Electrode is a cutaneous electrode designed for use with recording, monitoring, and stimulation equipment for biopotentials (EEG, EMG, EP). Its key feature is its ability to remain on a patient in an MRI environment under specific conditions, a modification from its predicate device. This MRI compatibility is a primary focus of its testing and acceptance criteria.

Acceptance Criteria and Device Performance (Non-Clinical):

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (K052188 - Rhythmlink Cutaneous Electrode) and ensuring MRI compatibility and functional performance. The "study" proving this involves a series of non-clinical, benchtop tests.

Acceptance Criteria Table and Reported Device Performance

Detailed Study Information (Non-Clinical, as applicable):

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

   • The document does not specify the exact number of electrodes or test runs used in the benchtop testing. It refers to "benchtop testing" and "MR Safety evaluation."
   • Data Provenance: The tests were conducted internally by the manufacturer, Rhythmlink International, LLC. The testing appears to be prospective in nature, as it was performed to support the 510(k) submission for this new device. No geographical origin of data (e.g., country) is specified beyond the manufacturer's location in Columbia, South Carolina, USA.

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

   • Not Applicable. This is a hardware device undergoing physical, electrical, and MRI compatibility testing, not an AI/ML system requiring expert interpretation of medical images or data. Ground truth here refers to validated engineering measurements and compliance with established standards for medical device safety and performance.

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

   • Not Applicable. As this is non-clinical benchtop testing, there is no "adjudication method" in the sense of reconciling different expert opinions. Test results are presumably directly measured and compared against pre-defined engineering and regulatory limits.

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:

   • Not Applicable. This is not an AI/ML-based device, and no MRMC study was conducted. The assessment focused on the device's intrinsic function and safety, particularly in an MRI environment.

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

   • Not Applicable. This is a physical device, not a standalone algorithm. Its "performance" is its physical and electrical characteristics.

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

   • The "ground truth" for this device's performance is based on established engineering standards, physical measurements, and regulatory requirements for cutaneous electrodes and MRI compatibility (e.g., ASTM standards for MRI safety of medical devices). This includes:
     • Electrical performance parameters (DC Offset Voltage, AC Impedance)
     • Magnetic field interactions (displacement force, torque)
     • Radiofrequency heating (SAR distribution, temperature rise)
     • Image artifact evaluation in MRI
     • Biocompatibility

7. The sample size for the training set:

   • Not Applicable. No AI/ML training set was used.

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

   • Not Applicable. No AI/ML training set was used.

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The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600Vp.

The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended include:

• ENT
• Gynecology (except for use in female sterilization)
• Urology
• General surgery
• Neurosurgery
• Laryngeal Surgery
• Orthopedic Surgery
• Thoracic Surgery

The Adeor Medical AG Bipolar Forceps are electrosurgical instruments used to grasp, manipulate, cut or coagulate tissue. Bipolar forceps have various lengths and tip configurations, as well as irrigation and suction technologies. Both reusable and single-use forceps are available, with flat plug or two pin plug configurations. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of a high frequency generator and may be used only with bipolar coagulation current. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHz: maximum generator operating voltage 600Vn.

This FDA 510(k) summary for the "Adeor Medical nxt Non-stick Bipolar Forceps" focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this document does not contain data related to these aspects for an AI/ML product.

The document primarily discusses the physical characteristics, intended use, and non-clinical testing (electrical safety, wear, function (drop testing)) of surgical forceps, comparing them to legally marketed predicate devices to establish substantial equivalence.

The information provided in the document is about a traditional medical device (bipolar forceps), not an AI/ML device.

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Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue.

Sutter Swyng® non-stick bipolar forceps, single-use are electrosurgical instruments. The bipolar forceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

The provided text describes a 510(k) submission for the Sutter Swyng® non-stick bipolar forceps, single-use. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against pre-defined acceptance criteria for a new AI/software device.

Therefore, many of the requested categories related to AI/software performance (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission.

However, I can extract the acceptance criteria and performance data relevant to this medical device's physical and functional properties, as described in the "Non-Clinical Performance Data" section.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

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

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:
  • For "Thermal effects on tissue," tests were performed in triplicate for three different types of tissue.
  • For other tests (Electromagnetic Compatibility, Electrical Safety, Mechanical Strength, Functionality, Sterilization, Shelf Life, Biocompatibility), specific numerical sample sizes are not explicitly stated in the provided text. The text refers to "performance testing has been executed in line with the internal R&D process and in compliance with the proposals and recommendations of the FDA guidance."
• Data Provenance: The studies were internal to Sutter Medizintechnik GmbH (Germany). The type of study (retrospective or prospective) for the bench tests is not specified, but given their nature, they would be considered controlled laboratory experiments.

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. This submission pertains to physical medical devices and their functional and safety characteristics, not AI/software performance requiring expert ground truth for classification or diagnosis. "Thermal effects on tissue" involved "visual comparison as well as digital morphometric measurement using histology," implying expert evaluation, but the number and qualifications are not specified.

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

• Not applicable. See point 3.

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 is not an AI/software device. No MRMC study was performed.

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

• Not applicable. This is not an AI/software device.

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

• For "Thermal effects on tissue," the ground truth involved histology for digital morphometric measurement and visual comparison against the predicate device.
• For other tests, the "ground truth" refers to compliance with established international standards (IEC, ISO) and internal design specifications for safety and performance.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

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Faulhaber Single Use Non-Stick Bipolar Forceps sterile and Single Use Non-Stick Bipolar Irrigating Forceps sterile/ non-sterile are intended for use by a physician familar with electrosurgery for bipolar coagulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non-sterile.

Products supplied non-sterile must be cleaned, disinfected and sterilized prior to their use by the validated cleaning, disinfection and sterilization process.

The bipolar forceps have not been shown to be effective for tubal coagulation for sterilization procedures and should not be used for these procedures.

The types of surgery intended are

• General surgery
• Laryngeal coagulation
• Orthopedic coagulation
• Thoracic coagulation
• Neurosurgical coagulation
• Gynecological coagulation (except for use in female sterilization)
• Urological coagulation
• Ear-, Nose-, Throat coagulation

The product family "Single Use Bipolar Forceps", including Faulhaber Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Bipolar Irrigating Forceps, are intended to be used for bipolar coagulation and irrigation of tissue by physicians familiar with bipolar coagulation in medical practices and clinics.

The Single Use Bipolar Forceps are single use products and must not be reused. They are provided sterile as well as non-sterile. Products delivered non sterile must be cleaned, disinfected and sterilized before use.

For the application the Single Use Bipolar Forceps have to be connected by appropriate bipolar cable to the bipolar output of an HF generator. Bipolar cables and ESU are not part of the subject device.

The Single Use Bipolar Forceps are provided in bayonet design with non-stick tips and are identical in design, construction, materials and manufacturing to the reusable device EGON FAULHABER Bipolar Non-Stick Forceps (K101080). The principles of operation and mechanism of action are identical as well.

In addition to the cleared and leqally marketed EGON FAULHABER devices, the products are with irrigation function available. The irrigation function works via a drain running along the forceps tines from tip to handle height, the drain is connected by Luer-Lock via an irrigation tubing with an irrigation pump.

This FDA 510(k) summary describes the "Single Use Non-Stick Bipolar Forceps sterile/non-sterile" and "Single Use Non-Stick Bipolar Irrigating forceps sterile/non-sterile" and their substantial equivalence to predicate devices. However, the document does not provide acceptance criteria in a tabular format with reported device performance for specific clinical metrics. Instead, it focuses on demonstrating safety and efficacy through non-clinical performance tests and comparison to a predicate device.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The document does not present acceptance criteria and reported device performance in a formal table with specific numerical metrics commonly associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating compliance with recognized standards and successful completion of engineering tests.

The general "acceptance criterion" implicit throughout the document is that the subject device performs as safely and effectively as the predicate devices and meets relevant electrical safety and mechanical strength standards.

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

The document describes non-clinical performance testing.

• Sample Size: The document does not specify general "sample sizes" in terms of number of devices tested for each performance test. For the thermal effects on tissue, it states "three different types of tissue (liver, kidney and muscle) were coagulated." This refers to the tissue types, not the number of devices or test repetitions.
• Data Provenance: The tests are described as in vitro or bench tests conducted "in accordance with the Guidance for industry and food and drug administration staff 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' from August 15, 2016." The location of these tests or the "country of origin of the data" is not explicitly stated, but the manufacturer is based in Germany, and European standards (DIN EN IEC) are cited. These are non-clinical, controlled tests, not derived from clinical 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 applicable to this submission. The device is a medical instrument (electrosurgical forceps), not an AI/ML device that generates diagnoses or interpretations requiring human expert "ground truth." The performance is evaluated based on objective physical, electrical, and thermal properties as per engineering standards and guidance.

4. Adjudication method for the test set

This information is not applicable. As stated above, this is not an AI/ML device evaluating clinical cases requiring expert 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as this is not an AI/ML device that assists human readers.

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

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used

For this electrosurgical device, "ground truth" is established by:

• Compliance with recognized international standards for electrical safety (DIN EN IEC 60601-2-2) and biocompatibility (ISO 10993-1).
• Demonstration of mechanical integrity through drop testing.
• Demonstration of appropriate thermal effects on tissue, tested on "three different types of tissue (liver, kidney and muscle)" in comparison to a predicate device and meeting "pre-defined acceptance criteria." This could be considered a form of "bench test ground truth" where expected thermal effects are the standard.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device and therefore does not have a "training set."

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

This is not applicable as this is not an AI/ML device and does not have a "training set."

In summary, the provided document describes a device submission for an electrosurgical instrument, not an AI/ML-driven device. Therefore, many of the requested details regarding AI/ML device evaluation (like expert ground truth, MRMC studies, training sets) are not relevant to this specific K182773 submission.

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