(59 days)
The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Lower GI Models are accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.
GripTract Lower GI Models are indicated for use in the large intestine with any standard endoscope as follows:
| Endoscope | Endoscope | GripTract |
|---|---|---|
| Distal Tip Outer Diameter (mm) | Working Length (cm) | Model # |
| 12.8 - 13.3 | 168 - 170 | GT-CL170 |
| 12.8 - 13.3 | 130 - 133 | GT-CL130 |
| 11.5 - 12.0 | 168 - 170 | GT-CM170 |
| 11.5 - 12.0 | 130 - 133 | GT-CM130 |
The GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) Lower GI Models are disposable, non-sterile accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. There are four (4) different GripTract Lower GI Models (GT-CL170, GT-CL130, GT-CM170, and GT-CM130) which are indicated for use in the large intestine with standard endoscopes that have specific tip outer diameters and working lengths.
The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.
Here's a breakdown of the acceptance criteria and study information based on the provided document, addressing each of your points:
Important Note: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator Lower GI Models). This type of document focuses on demonstrating substantial equivalence to an existing predicate device rather than proving clinical efficacy or diagnostic accuracy for an AI/software device. Therefore, many of your questions, particularly those related to AI-specific studies (MRMC, standalone AI performance, ground truth establishment for training AI, etc.), are not applicable to this device and information. The device described is not an AI/software device.
The document primarily details non-clinical performance data to support the substantial equivalence claim.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with numerical performance targets against which the device was measured like typical AI/diagnostic studies. Instead, it lists various non-clinical tests performed and states whether the device "passed" or exhibited "equivalent force transmission" or "exceeded reported maximum pull forces."
Here's a summary derived from the "Summary of non-clinical performance testing" table and the subsequent paragraphs:
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Verification of Product Specification | Device meets all product specifications after exposure to ambient, high temperature, and low temperature conditions. | Pass |
| Reliability | Device meets all product specifications following exposure to worst-case simulated use. | Pass |
| Bench Safety | Device is sufficiently safe during benchtop evaluations approximating worst-case scenarios and interactions with biological tissue. | Pass |
| Torsional Fatigue Strength | Device meets all product specifications following repeated worst-case torsional load. | Pass |
| Torque Comparison | Force transmitted to the Finger by different models is equivalent. | Equivalent force transmission |
| End Cap Force Comparison | Force required to remove End Caps exceeds reported maximum pull forces in colonoscopies. | Removal forces exceed reported maximum pull forces in colonoscopies |
| Accelerated Shelf Life | Device meets all product specifications after exposure to conditions simulating a two-year shelf life. | Pass |
| Shelf Life | Device meets all product specifications after exposure to real-time ambient conditions for two years. | Test is on-going |
| Biocompatibility | Device passes tests for cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity per ISO 10993-1. | Pass |
| Endoscope Viewing Area Comparison | The device does not block endoscope visualization. | Confirmed that GripTract Lower GI Models do not block visualization. |
2. Sample Size Used for the Test Set and Data Provenance
As this is a physical medical device (endoscopic tissue manipulator) and not an AI/software, the concept of a "test set" in the context of diagnostic data doesn't apply directly.
- Sample Size: The document does not specify particular "sample sizes" for the non-clinical tests in terms of number of devices tested. It refers to "worst-case simulated use," "repeated worst-case torsional load," and testing "at the dimensional extremes of the product line" for Torque Comparison. For Biocompatibility, it states "Final, finished devices tested."
- Data Provenance: Not applicable in the context of retrospective/prospective patient data or country of origin for such data. The data provenance is from bench performance testing conducted by the manufacturer, Actuated Medical, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" in the context of expert consensus on medical images or diagnostic outcomes is not relevant for this device's non-clinical performance testing. The "ground truth" for these tests would be the measured physical properties and performance characteristics against established engineering specifications and regulations.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies among expert readers in diagnostic AI studies. This is a non-clinical, bench testing document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
Not applicable. This device is a physical medical instrument, not an AI or software that assists human readers in diagnostic interpretation. An MRMC study would not be performed for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or software. It is a physical device operated by a clinician.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" is defined by:
- Engineering specifications and design requirements.
- Industry standards (e.g., ISO 10993-1 for biocompatibility).
- Quantitative measurements derived from bench testing (e.g., force measurements, dimensional checks, fatigue cycles).
- Simulated worst-case scenarios and interactions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no training set of data in that sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI training set, there's no ground truth establishment process for it.
§ 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.