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For the simultaneous cutting and cauterization of soft tissue during surgery.

The Starion Instruments Thermal Cautery Probe is a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cauterized. The Thermal Cautery Probe features a handle, a finger/footswitch control and power cord for connection to a Starion Instruments power supply.

The provided text is a 510(k) summary for the Starion Instruments Thermal Cautery Probe, which describes its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and details because the information is not present in the given document.

The document primarily focuses on the regulatory submission process and the FDA's determination of substantial equivalence based on the device's intended use, target population, energy source, and principles of operation being similar to the predicate device. It does not include a technical performance study with quantitative results against specific acceptance criteria.

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The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.

The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study data for the Di-rhex Ophthalmic Diathermy System:

Summary of Device Performance Data and Acceptance Criteria:

This 510(k) submission for the Di-rhex Ophthalmic Diathermy System relies on substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria and performing a rigorous statistical study to meet those criteria. The primary "acceptance criterion" appears to be demonstrating that the device is equivalent in safety and efficacy to existing legally marketed devices, as summarized in section (c) of the "Performance Data."

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Non-clinical Tests: No sample size is specified for power output tests or software validation. Data provenance would be from internal testing by Ophthalmic Technologies Inc.
• Clinical Tests: The document states "The Di-rhex has had a clinical evaluation in Canada."
  • Sample Size: Not specified. No number of patients or procedures is mentioned.
  • Data Provenance: Canada (prospective, as it was an "evaluation" of the new device).

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

• Clinical Evaluation: Not specified. The document does not describe how ground truth was established for the clinical evaluation. Given it was a "clinical evaluation," it would inherently involve medical professionals, but their number and specific qualifications (e.g., years of experience, subspecialty) are not provided.
• Non-clinical Tests: Ground truth for these would typically be defined by engineering standards and internal specifications, not expert consensus in the medical sense.

4. Adjudication Method for the Test Set:

• Not specified. There is no mention of an adjudication process for the clinical evaluation.

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

• No. The document does not mention an MRMC study. The clinical evaluation appears to be a single-center, uncontrolled assessment, rather than a comparative effectiveness trial involving multiple readers and cases. The claim of equivalence is based on the overall performance compared to predicate devices, not through a direct comparative study with human readers assisted by AI. (Note: Diathermy is a direct energy delivery device, not an imaging AI device, so an MRMC study in the context of interpreting results with AI assistance would not be applicable here.)

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

• N/A. This device is a surgical instrument. "Standalone" performance with "algorithm only without human-in-the-loop performance" doesn't directly apply as it's not an AI diagnostic/interpretive algorithm. Its "standalone" performance lies in its ability to deliver the specified energy (which was assessed via power output tests) and function safely (software validation, safety tests). The intended use inherently involves a human operator.

7. The Type of Ground Truth Used:

• Non-clinical Tests: Ground truth for power output tests would be the device's engineering specifications and calibration standards. For software validation, it would be the software requirements and functional specifications.
• Clinical Evaluation: The type of ground truth used for the clinical evaluation is not explicitly stated. However, for a surgical device evaluation, it would implicitly be the clinical judgment of the operating surgeons and post-operative assessment of patient outcomes (e.g., successful hemostasis, coagulation effect) based on standard medical practice. It's not pathology, or a separate "consensus" in the diagnostic sense, but rather the observed clinical results.

8. The Sample Size for the Training Set:

• N/A. This device is a hardware system, not an AI algorithm that requires a "training set" of data in the machine learning sense. The device is designed, tested against specifications, and evaluated clinically.

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

• N/A. As above, it's not an AI algorithm with a training set. The "ground truth" for its design and testing would be engineering principles, safety standards, and clinical requirements for ophthalmic diathermy.

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The Pao Bipolar Coaxial Coagulator is for cauterizing microscopic vessels on the conjunctiva and sclera. It is for extraocular surgery and it is not to be used for intraocular surgery (within the anterior or posterior segment of the eye).

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "PAO BIPOLAR COAXIAL COAGULATOR." It indicates that the device has been found substantially equivalent to a predicate device. However, this type of document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications as it is a regulatory clearance, not a study report.

Therefore, I cannot provide the requested information from the provided text. The document only states that the device is cleared for marketing based on substantial equivalence.

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The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.

Storz D8200 series Ophthalmic Bipolar Cautery devices are accessories to Storz DAISY®, Protege®, and PREMIERE® Ophthalmic Microsurgical Systems. The D8200 is a reusable bipolar forceps, D8201 is a reusable bipolar eraser, and the D8203 is a reusable bipolar intraocular eraser. The D8202 bipolar cord is used to connect the three cautery instruments to the Storz DAISY® Microsurgical System; the D8204 bipolar cord is used to connect the three cautery instruments to the Storz Protege® and PREMIERE® Microsurgical Systems. All three instruments and both cords have Lemo™ locking connectors. The D8200 forceps are composed of surgical grade stainless steel; the D8201 and D8203 erasers are composed of surgical grade stainless steel and spring steel, and liguid crystal polymer insulation. These materials raise no questions of biocompatibility.

This 510(k) summary describes Storz Ophthalmic Bipolar Cautery Instruments and Bipolar Cords (models D8200, D8201, D8203, D8202, D8204). The submission demonstrates substantial equivalence to predicate devices, thus no specific acceptance criteria or studies proving device performance are explicitly stated in the provided text.

The document focuses on comparing the new Storz devices to existing predicate devices (Kirwan Ophthalmic Bipolar Forceps, Pencils, and Cord; and Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers) based on their intended use, material composition, system compatibility, connector type, reusability, and sterility.

Therefore, many of the requested details about acceptance criteria and studies cannot be extracted from this summary.

Here's a breakdown of what can be inferred or directly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided. The document does not list specific performance metrics (e.g., coagulation time, temperature thresholds, tissue damage limits) or acceptance criteria for those metrics. Instead, it relies on substantial equivalence to predicate devices. The "reported device performance" is implicitly that it functions similarly to the predicates for ophthalmic bipolar cautery.

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

Not applicable. This document is a 510(k) summary for substantial equivalence, not a report of a new clinical or performance study for the Storz devices themselves to establish novel performance claims. The comparison is based on the design and intended use relative to predicates.

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

Not applicable. The comparison is based on device specifications and intended use, not on expert-adjudicated ground truth data from testing.

4. Adjudication Method

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not mentioned as it's not relevant for a substantial equivalence determination for this class of device based on the information provided.

6. Standalone Performance Study (Algorithm Only)

No. This device is a physical medical instrument (cautery devices and cords), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable / Implicit. For substantial equivalence, the "ground truth" is that the predicate devices are legally marketed and safe/effective for their intended use. The Storz devices are considered substantially equivalent if they share similar technological characteristics and intended use.

8. Sample Size for the Training Set

Not applicable. This pertains to AI/ML models, not a physical medical device submission for substantial equivalence.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8.

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