(87 days)
The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.
The g-Lix Tissue Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is comprised of a proximal rotation knob, flexible or rigid shaft and distal helix tip.
The g-Lix Tissue Grasper is a manual surgical instrument for general use. The provided text is a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics or conducting extensive clinical efficacy studies with specific acceptance criteria as would be done for AI/ML devices or more complex medical devices.
Therefore, the requested information elements (1-9) which are typically associated with AI/ML device evaluations or detailed clinical studies for performance validation are not fully applicable or derivable from this submission for a simple manual grasper.
However, I can extract the relevant information concerning bench testing which serves as the "study" for this type of device and functional equivalence as the implicit "acceptance criteria."
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance for g-Lix Tissue Grasper
1. A table of acceptance criteria and the reported device performance
For a manual surgical instrument like the g-Lix Tissue Grasper, the "acceptance criteria" are primarily established in relation to its intended use and functional equivalence to legally marketed predicate devices. The performance is assessed through bench testing to ensure it functions as designed without specific quantitative metrics provided in this summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs as intended for tissue grasping and mobilization, comparable to predicate devices in terms of intended use, technology, and materials. | Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use. |
| Safety: Does not introduce new safety concerns compared to predicate devices. | The 510(k) summary asserts substantial equivalence to predicate devices, inferring comparable safety profiles. |
| Sterility: Device is sterile for single-patient use. | "The g-Lix Tissue Grasper is a sterile, single patient use device..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the 510(k) summary. Bench testing typically involves a number of samples to ensure reproducibility and reliability, but the exact quantity is not disclosed.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by USGI Medical (the manufacturer in San Clemente, CA, USA). The testing would be prospective in nature as it's performed on new devices to validate their design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a manual surgical instrument, "ground truth" in the context of expert review is typically not established for bench testing. The testing would likely involve engineers and technicians evaluating mechanical performance, grasping capabilities, and material integrity against design specifications and functional requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, this type of testing does not typically involve expert adjudication methods commonly seen in clinical or diagnostic studies.
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 a manual surgical instrument, not an AI/ML diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly defined as "ground truth" in the context of this 510(k) submission. The "ground truth" for bench testing of a manual instrument generally refers to adherence to engineering specifications, functional performance requirements (e.g., grasping strength, material durability, rotation capability), and comparison to the performance of predicate devices. These are typically assessed through objective measurements rather than expert consensus on a diagnostic outcome.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied for this manual device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.