(90 days)
The Sharp Medical Reactor™ Trocar and Sleeve has indications in the creation of a port of entry into the thoracic cavity and allows the user to create and maintain limited access into the intention of chest tube placement.
The Reactor™ Trocar consists of an obturator with a flat tip at the distal end which encloses a circular scalpel shaped knife blade. The blade extends approximately 1mm and immediately retracts when the trigger is squeezed. The clear sleeve with printing accommodates instruments up to 36 Fr. or 12 mm.
This document describes a 510(k) premarket notification for a medical device called the "Reactor™ Trocar and Sleeve". This is a regulatory submission for a device to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to establish acceptance criteria and prove performance against them in the traditional sense of a clinical or analytical validation study for an AI/ML device.
Therefore, the specific information requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) is not applicable to this type of document, which focuses on demonstrating equivalence to an existing device through comparison of features and performance testing.
However, I can extract the information that is present concerning performance.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a quantitative table with corresponding reported performance metrics as one might see in a clinical trial report for a novel medical device. Instead, the "Performance Data" section describes the types of tests conducted to demonstrate equivalence to the predicate device. The implied "acceptance criteria" for these tests would be that the Reactor™ Trocar and Sleeve performs at least as well as, or comparably to, the predicate device in the specified tests to establish substantial equivalence.
| Performance Test Type | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dry Fire Test | Comparable performance to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device. |
| Tissue Insertion Test | Comparable performance to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device and validate the Reactor™ Trocar and Sleeve perform as intended. |
| Chest Tube Placement Test | Success in chest tube placement comparable to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device and validate the Reactor™ Trocar and Sleeve perform as intended. Success in chest tube placement was demonstrated in the TraumaMan surgical simulator. |
| Shaft Rotation Test | Comparable performance to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device. |
| Torque Test | Comparable performance to predicate device | Bench tests confirm the performance of the Reactor™ Trocar and Sleeve is substantially equivalent to the predicate device. |
| Surgical Imitation Tests (TraumaMan simulator) | Successful and intended operation within the simulated surgical environment, comparable to predicate device | These tests demonstrate the device performs as intended in a simulated surgical environment for chest tube placement. "Bench tests confirm the performance... is substantially equivalent... and validate the Reactor™ Trocar and Sleeve perform as intended." |
| Biocompatibility (ISO 10993) | Compliance with ISO 10993 (Biological Evaluation of Medical Devices) | The materials are biocompatible and comply with ISO 10993 (Biological Evaluation of Medical Devices). |
| Sterilization (ISO 11137) | Compliance with ISO 11137 (Sterilization of Healthcare Products) | The device is a single use, sterile product compliant with ISO 11137 (Sterilization of Healthcare Products). |
Note: The phrase "substantially equivalent" is the overarching "acceptance criterion" for a 510(k) submission, meaning the new device is as safe and effective as a legally marketed device. The performance tests are conducted to support this claim.
The following information is not present in the provided document:
- Sample size used for the test set and the data provenance: The document mentions "bench tests" and "surgical imitation tests in the TraumaMan surgical simulator." It does not specify the number of devices tested, the number of simulated cases, or any details about the origin of the test "data" (e.g., retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. The device is a mechanical surgical instrument, not an AI/ML diagnostic tool requiring expert ground truth for interpretation. Performance is assessed by direct physical testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of bench testing described.
- 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: This is not applicable as the device is a surgical instrument, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical devices like this, the "ground truth" for performance is typically objective physical measurements or successful completion of a task, not expert interpretation or pathological findings. In this case, successful performance in the described tests (e.g., successful tissue insertion, chest tube placement in a simulator) serves as the basis for performance evaluation.
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.