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The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis). transurethral prostatectomy (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder turnors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used to treat cancer of the prostate.

The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and intended for use in urological surgical procedures involving the vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH) bladder cancer, tumors, lesions, and neoplasms. The specific urological indications include transurethral electro vaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used in treating cancer of the prostate.

The ACE Electrosurgical Resection and Vaporization Electrodes Series consist of an active tip, PTFE color code identification, and an insulator between the electrode tube, a guiding tube, telescope clip and arm (shaft). The design and dimensions of the electrode tips vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops or buttons. The system includes single-use electrodes that can be connected to a working element (only WA22366A – K100275), or the use of the single-use electrodes together other compatible electrosurgical cables as applicable. Compatible Generators to any of the electrodes include generators with output specifications that meet the following criteria: 100-120/220-240V, ~50-60Hz/1000VA, 310-380 kHz, 320W/200 Ω, Int 10s/30s.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "ACE Electrosurgical Resection and Vaporization Electrodes Series." This document primarily discusses the substantial equivalence of the new device to a predicate device, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria through performance data.

Here's an analysis of the information, addressing your points where possible, and noting when the information is not present in this type of FDA submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or specific device performance metrics in the way you might expect from a clinical study report. Instead, it relies on demonstrating equivalence to an existing predicate device and conformance to recognized consensus standards.

Acceptance Criteria (Implied / Stated):

• Substantial Equivalence: The device must be substantially equivalent to a legally marketed predicate device (K120418, Olympus Winter & Ibe GmbH Electrosurgical Resection and Vaporization Electrodes Series) in terms of:
  • Indications for Use
  • Principles of Operation
  • Technological Characteristics
  • Materials
  • Performance (demonstrated through bench testing and conformance to standards)
• Safety and Effectiveness: Does not raise new issues of safety or effectiveness.
• Electrical Safety: Conforms to IEC 60601-1.
• Thermal Safety: Conforms to IEC 60601-2-2.
• Biocompatibility: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity.
• Sterilization: Ethylene Oxide (EO) with a Sterility Assurance Level (SAL) of 10-6.
• Risk Analysis: Performed in accordance with ISO 14971:2007.

Reported Device Performance:

The document states that "Design verification was performed to ensure the device functions according to its intended use, and the results met their acceptance criteria." However, it does not provide the specific numerical results of this design verification. It only confirms that the testing was performed and met the criteria.

The "Comparison of Characteristics" table (Table 5A) highlights the similarities between the applicant's device and the predicate device across various attributes. This comparison serves as the performance data in terms of demonstrating equivalence.

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

This document describes a 510(k) submission, which relies heavily on non-clinical (bench) testing and comparison to a predicate device, rather than a clinical trial with a "test set" of patients.

• Sample Size for Test Set: Not applicable in the context of human subjects or "test sets" as you might find in an AI/imaging study. The "test set" in this context refers to the samples used in bench testing (e.g., electrical safety tests, biocompatibility tests), the number of which is not specified in this summary.
• Data Provenance: Not applicable in terms of country of origin of patient data or retrospective/prospective studies, as no human clinical data is presented here to support the device's safety and effectiveness. The data provenance discussed relates to the manufacturer (Ace Medical Devices Pvt. Ltd., India) and the predicate device manufacturer (Olympus Winter & Ibe GmbH).

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

Not applicable. This is not a study involving expert review for establishing ground truth from patient data. The "ground truth" for this device's safety and effectiveness is established by its similarity to a device already on the market and its conformance to recognized engineering and safety standards.

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

Not applicable, as there is no "test set" in the context of human data 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

Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance in that way.

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

Not applicable for the same reasons as above. This is an electrosurgical device, not an algorithm.

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

The "ground truth" for the substantial equivalence claim is multi-faceted:

• Predicate Device Performance: The primary ground truth is that the predicate device (Olympus K120418) has a history of safe and effective use in the market.
• Consensus Standards: Adherence to recognized consensus standards like IEC 60601-1 (electrical safety) and IEC 60601-2-2 (thermal safety), and ISO 14971:2007 (risk management).
• Bench Testing: Internal design verification testing results (not detailed here) that confirmed the device functions as intended and met acceptance criteria for engineering specifications.
• Biocompatibility Testing: Results indicating the materials are biocompatible.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

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

Not applicable.

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