(27 days)
The Disposable Bipolar Cord connects the electrode that is inserted into the Resectoscope Working Element to an Electrosurgery unit (ESU). It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. It is intended to be sold as a sterile, single use disposable device.
The ACMI Bipolar Disposable Cord, Catalogue # DBC, interconnects electrosurgical unit (ESU) (source of RF power) to the Electrode that is inserted into the Bipolar Resectoscope Working Element. It allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. The Bipolar Disposable Cord is a component or accessory of the ACMI Bipolar Resectoscope System. It is sold as a sterile, single use disposable device. The Bipolar Disposable Cord consists of the following: a. Cord: containing a twisted wire pair that transmits power from the proximal two-pin connector to contacts in the distal molded connector part. The cable is shielded within an outer insulating jacket. b. Distal Connector: Two "c-spring" contacts with polyurethane over-mold and "T" shaped strain relief. The distal connector contacts the electrode, which is inserted into the Resectoscope Working Element. c. Proximal Connector: Two-pin (female) connector over-molded with polyvinyl chloride strain relief.
Here's an analysis of the provided text regarding the ACMI Disposable Bipolar Cord, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification to the FDA. It asserts substantial equivalence to a predicate device and describes the device. It does not present a detailed study report or specific acceptance criteria with quantifiable results. The document focuses on showing that modifications to an existing device are not substantial enough to require a new Pre-Market Approval (PMA) or a more rigorous 510(k). Therefore, many of the requested details about specific studies, sample sizes, and expert qualifications are not present in this type of document.
Acceptance Criteria and Device Performance (Based on available information)
The document primarily focuses on demonstrating that modifications to the ACMI Disposable Bipolar Cord do not significantly affect its safety or efficacy compared to a predicate device, the ACMI Disposable Active Cord (Preamendment & K890328). This implies that the acceptance criteria are largely centered on maintaining the performance and safety characteristics of the predicate device.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Design Specifications | Proposed modifications did not significantly affect safety or efficacy. The new design includes a twisted wire pair, shielded cable, new distal connector (c-spring contacts with polyurethane over-mold), and new proximal connector (two-pin female with PVC strain relief). |
| Performance Specifications | Proposed modifications did not significantly affect safety or efficacy. The device still allows RF power to be conductively transmitted from the ESU to the resectoscope electrode. |
| Dimensional Specifications | Proposed modifications did not significantly affect safety or efficacy. (No specific dimensions provided). |
| Material Specifications | Proposed modifications did not significantly affect safety or efficacy. (No specific material changes detailed beyond the connectors). |
| Intended Use | Remains the same: connects an electrode to an ESU for RF power transmission, sterile, single-use disposable. |
| Indications for Use | Remains the same. |
| Principles of Operation | Remains the same. |
| Packaging Materials | Remains the same. |
| Sterilization Parameters | Remains the same. |
Summary of the "Study" (or Basis for Equivalence)
The document itself is not a report of a new clinical or preclinical study with pre-defined acceptance criteria and quantified outcomes. Instead, it's a Special 510(k) Notification which argues for substantial equivalence based on modifications to an already cleared device. The "study" in this context is the analysis and comparison of the modified device against its predicate device, focusing on demonstrating that the changes are minor and do not alter the fundamental safety or effectiveness.
Here's how the requested points relate to the provided information:
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. This document does not describe a test set in the sense of a clinical trial or a formal performance study with a specific sample size of patients or devices. The equivalence is based on engineering assessment and comparison.
- Data Provenance: Not applicable/Not provided in the sense of geographical origin or retrospective/prospective study. The comparison is against the predicate device description and established performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. There was no "test set" in the sense of clinical data requiring expert review to establish ground truth. The evaluation was internal to the manufacturer, asserting equivalence based on design and technical specifications.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None. No formal adjudication process of clinical data is described.
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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 a medical device (cord for electrocautery), not an AI-powered diagnostic or imaging device. There are no human "readers" or AI involved in its direct function.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the clinical sense. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device. The modified device is asserted to meet this "ground truth" by maintaining similar design, performance, and operational characteristics.
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The sample size for the training set:
- Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable.
In conclusion, this particular 510(k) document is a regulatory submission for a modified medical device, not a report of a new, detailed performance study with comprehensive acceptance criteria and ground truth validation as one might find for an AI or diagnostic device. The "proof" of meeting acceptance criteria lies in the argument of "substantial equivalence" to a predicate device, meaning the modifications do not introduce new questions of safety or effectiveness.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.