(81 days)
The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.
Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.
The provided text describes a 510(k) premarket notification for a medical device called the "Bladeless Trocar - Artemis Lap Cannula" (K231400) and references a previous clearance (K230058) as a primary predicate. This document is a regulatory submission, not a study report, and thus focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical or analytical performance study with acceptance criteria and detailed outcomes in the same way one might describe an AI/ML device study.
Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly aspects like sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable or available in this type of regulatory document for this specific device.
This device (Bladeless Trocar - Artemis Lap Cannula) is a physical surgical instrument, not an AI/ML diagnostic or prognostic system. The performance claims for such devices typically revolve around mechanical properties, biocompatibility, and sterility, which are verified through non-clinical testing and comparison to legally marketed predicate devices.
However, I can extract information regarding the non-clinical testing performed and the conclusion drawn from it, which serves as a form of "proof" of meeting the regulatory requirements for substantial equivalence.
Non-Clinical Testing and Performance for Bladeless Trocar - Artemis Lap Cannula (K231400)
1. Table of Acceptance Criteria and Reported Device Performance (Derived from Regulatory Review)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Leak Testing: Demonstrate performance statistically equivalent to the predicate device. | "The leak test data demonstrates the proposed devices preform statically equivalent to the predicate device." |
| ISO 80639-7 Compliance: Meet criteria of the standard. | "Nonclinical testing in accordance with ISO 80639-7 was completed. The test data demonstrates success and met the criteria of ISO 80369-7." (Note: The provided text mistakenly refers to 80639-7 in the criterion and 80369-7 in the performance. Assuming 80369-7 is the correct standard, likely relating to small-bore connectors.) |
Explanation of "Acceptance Criteria" for this type of device:
For a physical surgical instrument like a trocar, "acceptance criteria" are typically defined by recognized consensus standards (e.g., ISO standards for medical devices, biomechanical testing standards) and comparison to predicate devices. The primary goal is to demonstrate that the new device is as safe and effective as a legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. Non-clinical testing typically involves a statistically relevant number of units for mechanical or material tests, but the exact count is not detailed here.
- Data Provenance: The testing was "Nonclinical Testing" conducted to support the 510(k) submission. This is laboratory-based testing, not human or patient data. The country of origin of the data is implicitly the country where the manufacturer (T.A.G. Medical Products Corporation, Ltd, Israel) conducted or commissioned the tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This information pertains to studies involving expert review for setting ground truth (e.g., for AI/ML algorithms). This device and its associated testing do not involve establishing ground truth from expert clinical review. The "ground truth" for non-clinical testing is typically defined by the test protocol, measurement standards, and device specifications.
4. Adjudication Method for the Test Set:
- Not applicable. This concept relates to reconciling disagreements among experts in setting ground truth for data. Non-clinical physical testing results are usually objective measurements, not subject to expert adjudication in the same manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is relevant for comparing the performance of human readers, often with and without AI assistance, on diagnostic cases. This device is a surgical instrument, not a diagnostic tool requiring such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to the performance of an AI algorithm in isolation. This device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- For the non-clinical tests (leak testing, ISO 80369-7 compliance), the "ground truth" is defined by:
- Established Test Standards: Adherence to the specified mechanical and performance characteristics outlined in the relevant ISO standard (ISO 80369-7).
- Predicate Device Performance: Comparison to the performance characteristics of the legally marketed predicate device (K230058) for specific attributes like leak resistance.
- Device Specifications: Meeting the manufacturer's own design specifications for the device.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of a physical medical device like a trocar. This concept applies to AI/ML algorithms that learn from data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, this question is not relevant.
§ 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.