(222 days)
The Miret Surgical Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold and manipulate soft tissues.
Fabricated from a stainless steel alloy, Miret Surgical Instruments are single-use disposable devices designed for grasping, holding and manipulating tissue. They consist of an integrated needle/cannula shaft that attaches to a working instrument. The shaft can be introduced percutaneously to the surgical site, after which the working instrument can be operated. The working instrument is controlled through a handle and locking mechanism on the proximal end of the device. The Miret Surgical Instruments can be used in a variety of surgical applications, including laparoscopic surgery after insufflation, and are available in either a Maryland or Alligator grasper configuration.
The provided document describes the 510(k) premarket notification for the Miret Surgical Instruments and includes a comparison to a predicate device. However, the study described is a non-clinical performance test to verify substantial equivalence, rather than a clinical study establishing diagnostic performance metrics like accuracy, sensitivity, or specificity against established ground truth.
Here's an analysis based on the information provided, highlighting what is available and what is typically not found in a 510(k) summary for a surgical instrument focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides the following non-clinical performance evaluations and conclusions about equivalence to the predicate device. It does not provide numerical acceptance criteria or specific performance metrics (e.g., in units measuring grip strength, tissue damage, etc.).
| Evaluation | Reported Device Performance (vs. Predicate K070686) |
|---|---|
| Ability of grasper to grip tissue | Equivalent or better |
| Ability to actuate grasper after navigation to surgical site | Equivalent or better |
| Simulated use | Equivalent or better |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The document refers to "non-clinical performance testing."
- Data Provenance: Not applicable as these are non-clinical (laboratory/bench) tests, not involving human or animal subjects for data collection (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the non-clinical performance tests described. "Ground truth" in this context would typically refer to a gold standard for a diagnostic task, which is not what these tests are designed to evaluate. For these evaluations, the "ground truth" implicitly would be established mechanical or material properties, or functional performance standards for surgical instruments.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used in clinical studies when human readers or assessors evaluate results, often to resolve discrepancies in diagnoses or interpretations. These are non-clinical engineering tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was one done? No, an MRMC comparative effectiveness study was not done. Such studies are generally for diagnostic AI devices where multiple human readers evaluate cases with and without AI assistance to measure performance improvement.
- Effect size of human reader improvement: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was one done? No, a standalone algorithm performance study was not done. This device is a manual surgical instrument, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests would be defined by engineering specifications and expected functional performance of surgical instruments (e.g., direct measurement of grip force, observation of successful actuation, assessment of tissue integrity post-manipulation in simulated environments). It is not "expert consensus, pathology, or outcomes data" in the typical clinical sense.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical surgical instrument, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study was a series of non-clinical performance tests conducted to demonstrate that the Miret Surgical Instruments are substantially equivalent to the predicate device, MINI LAP Instruments (K070686). The primary goal was to verify functional performance aspects relevant to their intended use (grasping, holding, and manipulating soft tissues).
The evaluations included:
- Ability of grasper to grip tissue: This likely involved testing the force or efficacy with which the grasper could hold various simulated tissues without slippage or excessive damage.
- Ability to actuate grasper after navigation to surgical site: This probably tested the smooth and reliable operation of the grasper mechanism after being navigated through a simulated surgical pathway.
- Simulated use: This would encompass a broader range of functional tests mimicking practical surgical scenarios to ensure overall performance.
The acceptance criterion for each test was that the Miret Surgical Instruments performed "Equivalent or better" than the predicate device. This indicates a comparative performance standard rather than absolute numerical thresholds provided in the summary. The exact methodology, specific parameters measured, and the number of repetitions or samples used for each test are not detailed in this 510(k) summary, which is common for such submissions focused on substantial equivalence for mechanical devices.
§ 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.