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The Kogent TorUS® Ultrasonic Aspirator system is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard tissue (e.g. bone) is desired, including Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, and Thoracoscopic Surgery.

The Kogent TorUS® consists of a console that provides power and control of the ultrasonic aspiration and irrigation functions, three surgical handpieces that provide the ultrasonic mechanical energy to the surgical site, a foot pedal to allow the user control over the ultrasonics, titanium tips (variety of models), irrigation sleeves, suction/irrigation system (manifold tubing and a vacuum canister) and accessories used for assembly and reprocessing. The Kogent TorUS accommodates most commercially available suction canisters and optional specimen traps.

The provided text describes the Kogent TorUS® Ultrasonic Aspirator System and asserts its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria, reported device performance metrics in a quantitative table, or details of a study that directly prove the device meets such criteria.

Instead, the document highlights specific types of testing performed to demonstrate substantial equivalence, focusing on safety standards, biocompatibility, and general performance aspects relative to the predicate devices.

Let's break down what is and is not present based on your request:

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

• Not present. The document lists the types of bench testing performed (Thermal Effects, Suction and Aspiration Level, Surgical Bone Removal and Cutting, Soft and Fibrous Tissue Removal) but does not provide a table with "acceptance criteria" (e.g., "bone removal rate > X mm/sec") or "reported device performance" (e.g., "achieved Y mm/sec bone removal"). It states that the testing "indicates that the Kogent TorUS® Ultrasonic Aspirator System is substantially equivalent," implying the results met some unstated internal criteria for equivalence.

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

• Not present. The document mentions "bench testing" but does not specify the sample sizes used for any of the individual tests. It also does not explicitly state the "data provenance" (e.g., country of origin, retrospective/prospective). Given that it's bench testing, it would likely be laboratory data rather than patient data.

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

• Not present. This type of information is typically relevant for studies involving subjective human assessment (e.g., image interpretation, diagnostic accuracy). For a surgical aspiration device, "ground truth" would likely be established through objective physical measurements and comparisons to predicate device performance, not expert consensus on interpretations.

4. Adjudication method for the test set

• Not present. Similar to point 3, adjudication methods like "2+1" or "3+1" are used in studies where there's a need to resolve discrepancies in human interpretations or diagnoses. This is not applicable to the bench testing described for a surgical device's physical performance characteristics.

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 present. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems where human readers interact with the AI. This device is a surgical tool, and the documentation does not describe any AI component or human-in-the-loop diagnostic assistance for which an MRMC study would be appropriate. The focus is on the device's physical performance and safety.

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

• Not present. As mentioned above, there is no indication of an algorithm or AI component in this device. Therefore, a "standalone algorithm only" performance study is not applicable.

7. The type of ground truth used

• For the bench testing, the "ground truth" would implicitly be objective physical measurements and established engineering standards for performance characteristics (e.g., measuring actual aspiration rates, temperature changes, or material removal efficiency against specified targets or predicate device performance). The document does not explicitly state "ground truth" but implies comparison to predicate device performance.

8. The sample size for the training set

• Not applicable/Not present. Since there's no mention of an AI model or machine learning component, there would be no "training set" in the context of this device's evaluation.

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

• Not applicable/Not present. (See point 8).

Summary of available information related to performance evaluation, but not a direct answer to your table request:

The document states that Clinical Testing was not required and that "Bench testing" was performed to demonstrate substantial equivalence. The bench tests evaluated:

• Thermal Effects Testing at the Tip
• Suction and Aspiration Level Testing
• Surgical Bone Removal and Cutting Testing
• Soft and Fibrous Tissue Removal Testing

These tests were done to compare the Kogent TorUS® Ultrasonic Aspirator System to the predicate device (Stryker Sonopet iQ Ultrasonic Surgical Aspirator and Sonopet Model UST-2001 Ultrasonic Surgical Aspirator) with the conclusion that the new device is "substantially equivalent" in performance. No specific quantitative data points, acceptance thresholds, or sample sizes for these tests are provided in this document.

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The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels.

The Prime™ Adaptive Ultrasonic Scalpel System has three major components: Generator (with footswitch), Transducer Handpiece and instruments (or blades). The Prime™ 6000 Generator provides input/output control and operation interface to automatically adapt the ultrasonic power output for the tissue load encountered.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for the Prime™ Adaptive Ultrasonic Scalpel System, focusing on its substantial equivalence to predicate devices and adherence to various performance and safety standards.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily details:

• Device Name: Prime™ Adaptive Ultrasonic Scalpel System
• Indications for Use: Cutting and coagulation in open, laparoscopic, and endoscopic surgery where control of hemostasis and thermal spread is desired. Used for dissection, sealing, transection, and vessel coagulation. Can be an adjunct or substitute for electrosurgery, lasers, or steel scalpels.
• Key Components: Generator (Prime™ 6000), Transducer Handpiece, and Instruments/Blades.
• Technological Characteristics: Automatically adapts ultrasonic power output to tissue load, consistent vibration, non-sterile reusable blades validated for cleaning/sterilization, and a cable disconnect feature at the transducer handpiece for convenience.
• Predicate Devices: Ultracision® Harmonic Scalpel® series from Ethicon Endo-Surgery, Inc.
• Reference Device: Sonopet® Surgical Aspirator for its blue anodized blade tip surface.
• Standards Met: A comprehensive list of IEC, ISO, AAMI, CAN/CSA, and EN standards related to electrical safety, electromagnetic compatibility, biocompatibility, risk management, and software life cycle processes. These are general safety and performance standards for medical devices, not specific clinical performance criteria or results.

The document asserts "no new questions of safety or effectiveness" and concludes substantial equivalence, which is the basis for 510(k) clearance, rather than presenting a detailed clinical study demonstrating meeting specific performance criteria.

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