(98 days)
Diamond-Flex® Graspers and Dissectors are designed to transmit grasping force through delicate working tips in both minimally invasive and open surgical procedures.
Each Diamond-Flex® Grasper and Dissector is comprised of a handle assembly, an elongate shaft and a 'distal end' which comprises a segmented flexible portion and the end-effector or jaw pattern.
Here's an analysis of the provided information regarding the Diamond-Flex® Graspers, focusing on the acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|---|
| Maintains pneumoperitoneum | Pneumo-peritoneum Test | PASS |
| Articulation system strength | Shape Forming Verification Test | PASS |
| Actuation system strength | Crimp Strength Test | PASS |
| Instrument to withstand repeated uses | Repeated Simulated Use Test | PASS |
| Instrument to meet customer needs for grasping, dissecting, and providing sufficient rigidity to the user in the actuated state | Customer Evaluation Report | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes used for each of the non-clinical tests. It only lists the tests performed and their outcomes ("PASS").
Regarding data provenance, these are non-clinical bench tests and simulations, not human clinical data. Therefore, concepts like country of origin for data or retrospective/prospective study design are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For the "Customer Evaluation Report" which assesses customer needs for grasping, dissecting, and rigidity, it implies feedback from users (customers). However, the document does not specify the number of "experts" (e.g., surgeons, medical professionals) involved in this evaluation, nor their specific qualifications.
For the other tests (Pneumo-peritoneum, Shape Forming, Crimp Strength, Repeated Simulated Use), the "ground truth" is established by direct measurement against engineering specifications and performance standards. No human experts are explicitly mentioned as establishing ground truth for these objective functional tests.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. Given that most tests are objective engineering performance tests with pass/fail criteria, an adjudication method for conflicting results would likely not be necessary unless specific subjective assessments were performed by multiple individuals.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically for image-based diagnostic or screening devices to assess human reader performance with and without AI assistance. This device is a surgical instrument.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device, the Diamond-Flex® Graspers, is a physical surgical instrument, not an algorithm or AI system. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable. The performance studies conducted evaluate the mechanical and functional integrity of the instrument itself.
7. Type of Ground Truth Used
The ground truth for the tests used in this submission are primarily:
- Engineering Specifications / Performance Standards: For tests like pneumoperitoneum, articulation system strength, actuation system strength, and repeated simulated use, the "ground truth" is defined by pre-established performance metrics and thresholds that the device must meet to be considered functional, safe, and effective.
- Customer Needs/Feedback: For the "Customer Evaluation Report," the ground truth is derived from the stated or perceived needs and expectations of the end-users (customers/surgeons) regarding the device's functional performance in a surgical context.
8. Sample Size for the Training Set
This device is a physical medical instrument developed through engineering and manufacturing processes, not an AI/ML algorithm that requires training data. Therefore, the concept of a "training set" and its sample size is not applicable to this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of device. Therefore, the method for establishing ground truth for a training set is 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.