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The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.

OLSEN Medical® Electrosurgical Monopolar and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate, cut or coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (bipolar or monopolar) to the specified output terminal of an electrosurgical generator. The bipolar forceps are intended for use with a maximum voltage of 500 volts while the monopolar forceps have a maximum voltage of 2000 volts. The forceps are offered either as single (disposable) or multiple-use (reuseable).

This document is a 510(k) Premarket Notification for Olsen Medical Bipolar and Monopolar Forceps. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study to prove acceptance criteria for a novel artificial intelligence or software-as-a-medical-device (SaMD) product.

Therefore, many of the requested categories for AI/SaMD performance studies (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this 510(k) submission.

However, I can extract the relevant information regarding acceptance criteria and the type of studies performed to show device safety and equivalence.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and 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)

• Not applicable. This document describes a 510(k) submission for conventional medical devices (bipolar and monopolar forceps), not an AI/SaMD. The "testing" refers to compliance with established international and national standards for medical device safety and performance (e.g., electrical safety, sterilization, biocompatibility), rather than a clinical study with a "test set" of patient 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. See point 2. Ground truth in the context of AI/SaMD studies involves expert interpretations of data. For these forceps, "ground truth" is adherence to engineering and safety standards.

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

• Not applicable. See point 2.

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 type of study is specifically for evaluating AI/SaMD performance in a clinical setting involving human readers/interpreters. It's not relevant for assessing electrosurgical forceps.

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

• No. This is not software or an algorithm.

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

• The "ground truth" for these devices is adherence to established engineering, electrical, biological, and sterilization standards for electrosurgical equipment (e.g., IEC 60601-2-2, ISO 10993, ANSI/AAMI HF18, ANSI/AAMI/ISO 11137-2). The ultimate validation is "substantial equivalence" to legally marketed predicate devices, meaning they function and are as safe and effective as existing, cleared devices.

8. The sample size for the training set

• Not applicable. No AI model is being trained.

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

• Not applicable. No AI model is being trained.

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The Olsen Medical Electrosurgical Cables/Adapters is intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.

The Olsen Medical Electrosurgical Cables/Adapters has been designed as an accessory to various electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments are; scissors, forceps, dissectors, lap electrodes and handles. The device connects to the high frequency generator on one end and the active instrument on the other end for cutting and coagulation. It is comprised of an insulated cord and a fixed instrument and generator connector on either end as the means of conveying high frequency electrosurgical energy from the generator to the standard electrosurqical instrument during surgery.

The adapter interfaces between the instrument cable and various model of electrosurgical generators to match a proper fit for ESU model output connection.

This document describes a 510(k) premarket notification for electrosurgical cables/adapters, which are accessories to existing medical devices. It is not a study assessing the performance of an AI-powered device, but rather a submission for regulatory clearance of a standard medical accessory. As such, the information requested in your prompt regarding acceptance criteria for AI devices and studies proving their performance is not applicable to this document.

The document focuses on demonstrating substantial equivalence to previously marketed predicate devices, a requirement for 510(k) clearance, rather than proving the performance of a new, innovative device feature through specific performance metrics like those for AI.

Here's a breakdown of why this document doesn't fit the requested format, based on the information provided:

• No AI-powered device: The device described is "Olsen Medical Electrosurgical Cables/Adapters," which are accessories for electrosurgical instruments. There is no mention of any AI component or functionality.
• No acceptance criteria for AI performance: The "Device Testing" section states, "The new device is technologically the same as the predicate device. Device qualification criteria meet or exceeds the minimum qualification criteria for the predicate device and conforms to applicable ASTM and ISO Standards for biocompatibility of materials. All tests will meet the applicable requirements of AAMI/ANSI/IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories." This refers to standard electrical and safety compliance for medical devices, not performance metrics like sensitivity, specificity, or AUC for an AI algorithm.
• No study proving AI device meets acceptance criteria: The document focuses on demonstrating that the device is "substantially equivalent" to predicate devices based on "intended use, materials, design, and technological characteristics," and that it meets established safety and performance standards for electrosurgical accessories. There is no mention of any study that would involve a "test set," "ground truth," "experts," "adjudication," or "training set" as these terms relate to AI performance evaluation.
• No MRMC comparative effectiveness study or standalone algorithm study: These types of studies are relevant for evaluating AI's impact on human performance or AI's intrinsic performance, neither of which is discussed here.

In summary, the provided text is a 510(k) submission for a non-AI medical accessory, and therefore, cannot be used to answer questions about acceptance criteria and studies for AI-powered devices.

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The Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (Catalog No. 20-0XXX) is a single use product sold sterile and is intended for use in electrosurgery for coagulation and irrigation of tissue. This device is intended for use with the OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set or similar design of Bipolar Cord and Irrigation Tubing.

OLSEN MEDICAL Single Use Bayonet Bipolar Irrigating Forceps is packaged sterile with a nonpyrogenic fluid pathway. It consists of an inlet pathway running into a transparent rigid PVC tube attached to the right hand prong of the bayonet forceps. This gives the surgeon a visual of the fluid pathway which facilitates the local fluid irrigation through the forceps. The device is for Single Use Only and is designed for use with bipolar electrosurgical units.

The provided text describes a 510(k) summary for the Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps. This is a medical device submission, and the document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving experts, algorithms, or ground truth as would be done for an AI/ML device.

Therefore, many of the requested points are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document

• states the device "meet[s] or exceed[s] the minimum qualification criteria for the predicate device."
• "conforms to applicable ASTM and ISO Standards."
• "Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition."

However, specific numerical acceptance criteria (e.g., "coagulation time

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The OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set (Catalog No. 40-3xxx) is a single use product sold sterile and is intended for use with a standard bipolar irrigating forceps like the OLSEN MEDICAL Bipolar Irrigating Forceps and the Codman & Shurtleff, Malis™ CMC® Bipolar Systems to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. This device is intended for use with the Codman/Malis™ CMC® -II and the CODMAN/MALISTM CMC®-III Bipolar Cut and Coagulation System (or equivalent) Electrosurgical Generator.

Bipolar forceps specifically designed for irrigating are required for use with this tubing and cord set. Please read the instruction manuals supplied with the irrigation module and the bipolar coagulator or electrosurgical systems before using this product.

The OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set is packaged sterile with a nonpyrogenic fluid pathway. It consists of inlet spike with protective cap, and on/off clamp silicone tubing and fittings, a male LUER-LOK™ connector, two plugs and a female twin-pin socket connector. A co-extrusion process integrates a single use bipolar cord with irrigation tubing set. This integrated set provides the system with one unit delivery conduit and cable for carrying irrigating solution and electrosurgical energy to the Bipolar Irrigation Forceps for coagulation and irrigation of selected tissue.

The provided text is a 510(k) summary for the Olsen Medical Integrated Irrigation Tubing and Bipolar Cord Set. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the new device.

Therefore, it does not contain the information requested in points 1-9 regarding a study proving the device meets acceptance criteria.

The document states:

• "The new device is technologically the same as the predicate device."
• "Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device."
• "The device conforms to applicable ASTM and ISO Standards."
• "Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition."

These statements indicate that the device was tested to ensure it meets general industry standards and performs similarly to its predicate, but specific acceptance criteria and detailed study results (like sample sizes, ground truth establishment, expert qualifications, etc.) are not provided in this regulatory summary. The FDA's letter also confirms that the review was based on a "premarket notification of intent to market" and a "substantial equivalence determination" to a legally marketed predicate device.

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The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.

The Olsen Medical Anterior Cervical Vertebrae Plate System consists of plates and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2 to C7). The Olsen Medical Dynamic and Semiconstrained Plate Systems each come in lengths ranging from 23mm to 109mm. All of the plates, regardless of the length, are 16mm and 19mm wide at the cephalad and caudal ends of the plate, respectively. The Dynamic Plates have slots to receive the screws and the Semiconstrained Plates have round holes to receive the screws. All other plate dimensions are the same. Both plates each have tack holes and drill guide holes at the cephalad and caudal ends of the plate. Both plates are curved both in the longitudinal and lateral planes. The implants of these systems are manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM 1472.

The provided text describes a 510(k) summary for the Olsen Medical Anterior Cervical Vertebrae Plate System, which is a medical device. It is important to note that a traditional acceptance criteria table and a study proving device performance as typically understood for an AI/CADe device (e.g., sensitivity, specificity, AUC) are not applicable to this type of device submission.

This 510(k) submission is for a spinal intervertebral body fixation orthosis, which is a physical implant. The "performance data" section clearly states: "Testing for substantial equivalence to the Synthes CSPL Variable Angle device is done per ASTM 1717 in accordance with FDA Guidance for Spinal System 510(k)s, May 3, 2004." This indicates that the performance evaluation focuses on mechanical properties and biocompatibility, as per established engineering standards for orthopedic implants, rather than diagnostic accuracy or algorithmic performance.

Therefore, many of the requested fields related to AI/CADe device studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not relevant to this document.

However, I can extract the relevant information regarding the "acceptance criteria" (which in this context refers to the standards met for substantial equivalence) and the "study" (referring to the testing conducted).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of patient/case count. For mechanical testing of implants, "sample size" typically refers to the number of test articles (e.g., plates, screws) subjected to mechanical loads. This specific quantity is not detailed in the provided summary, but ASTM F1717 would define the required number of samples.
• Data Provenance: Not applicable in the context of clinical patient data. The testing is laboratory-based mechanical testing.

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

• Not applicable. Ground truth in this context is defined by objective engineering measurements (e.g., fatigue strength, pull-out force) as per ASTM standards, not expert medical consensus.

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

• Not applicable. Adjudication methods are relevant for clinical endpoints or diagnostic accuracy, not mechanical 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/CADe device.

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

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

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

• Ground Truth: Objective mechanical properties and material specifications as defined by engineering standards (ASTM F1717, ASTM F136, ASTM F1472). These standards outline quantifiable metrics for performance (e.g., stiffness, strength, durability) and material composition.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device.

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

• Not applicable. This is not a machine learning device.

Summary of the study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is a bench-top mechanical performance testing study conducted in accordance with ASTM F1717, and raw material verification against ASTM F136 or ASTM F1472. This testing demonstrates that the Olsen Medical Anterior Cervical Vertebrae Plate System possesses comparable mechanical and material properties to the predicate device (Synthes CSKP Variable Angle Cervical Plate Locking System, K031276) and is suitable for its indicated use. The specific details of the individual test results (e.g., ultimate tensile strength, fatigue life cycles) are not provided in this summary but would have been part of the full 510(k) submission to the FDA. The submission states compliance with "FDA Guidance for Spinal System 510(k)s, May 3, 2004," further solidifying the methodology used to establish substantial equivalence.

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