(129 days)
GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.
GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).
Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures
This document is a 510(k) premarket notification for the GIMMI ALPHA® Endoscopic Instruments & Accessories. It establishes substantial equivalence to various predicate devices and describes the general characteristics of the device. However, it does not contain a detailed study with specific acceptance criteria and performance results directly comparable to those criteria in a quantitative manner.
Instead, the document states general compliance and conformance without providing numerical performance metrics or detailed study designs.
Therefore, many of the requested sections regarding specific acceptance criteria, performance data, sample sizes, ground truth establishment, and expert involvement cannot be extracted from this document based on the provided text.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the provided text. The document broadly states "safety, effectiveness, and reliability."
- Reported Device Performance: Not reported numerically. The document states, "All results were in conformance with the cited harmonized device standards" and "The results of design validation raise no new issues of safety and effectiveness."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified, but likely from GIMMI GmbH's internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the document does not detail specific clinical or performance studies involving "ground truth" established by experts. The "ground truth" in this context would typically refer to definitive diagnoses or outcomes for a clinical study comparing the device's output to reality, which is not described.
4. Adjudication method for the test set
- Not applicable/not provided, as no expert-adjudicated test set is described.
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
- This is not applicable. The device is described as "Endoscopic Instruments & Accessories" and devices "for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications." It is a physical medical device, not an AI-powered diagnostic tool, and therefore, an MRMC study with AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a physical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/not specified for a clinical performance study involving "ground truth." The "performance and physical tests" would likely rely on engineering standards and measurements rather than medical ground truth.
8. The sample size for the training set
- Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
Summary based on the provided text:
The document serves as a regulatory submission confirming that the GIMMI ALPHA® Endoscopic Instruments & Accessories are "substantially equivalent" to predicate devices. It states that:
- The devices have the same intended use.
- They are made of the same materials.
- They are produced to the same international and FDA-recognized standards.
- "All materials used... were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices."
- "All results were in conformance with the cited harmonized device standards."
- "The results of design validation raise no new issues of safety and effectiveness."
However, it refrains from providing detailed study protocols, quantitative performance data, or specific acceptance criteria with reported numerical results. The substantiation relies on adherence to general standards and comparison to existing, cleared predicate devices rather than a new, detailed clinical performance study with defined acceptance criteria.
§ 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.