(158 days)
The Unimax Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
The Unimax Specimen Retrieval System is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimax Specimen Retrieval System is supplied in a dispending tube for ease of insertion through a standard 10, 11 or 12mm trocar sheath.
This is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance and studies are not applicable.
Here's an analysis of the provided text regarding the Unimax Specimen Retrieval System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K103510) is a 510(k) premarket notification for a medical device. For such devices, acceptance criteria are typically established through a series of non-clinical tests to demonstrate safety and effectiveness. The document refers to "pre-defined acceptance criteria" but does not explicitly list these criteria or their specific values. Instead, it states that the device "meets the requirements of its pre-defined acceptance criteria."
The performance is described relative to a predicate device (Applied Medical Resources Corporation Specimen Retrieval System, K100959), asserting "substantial equivalence."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In vitro & In vivo Preclinical Physical Tests | "All the test results demonstrate the performance of Unimax Specimen Retrieval System meets the requirements of its pre-defined acceptance criteria and intended uses." |
| In vitro & In vivo Preclinical Mechanical Tests | "All the test results demonstrate the performance of Unimax Specimen Retrieval System meets the requirements of its pre-defined acceptance criteria and intended uses." |
| Biocompatibility Tests | "All the test results demonstrate the performance of Unimax Specimen Retrieval System meets the requirements of its pre-defined acceptance criteria and intended uses." (References ISO 10993-1, -10, -12 for evaluation framework) |
| Overall Safety and Effectiveness | "The result of bench testing indicates that the new device is as safe and effective as the predicate device." |
| Substantial Equivalence | "The Unimax Specimen Retrieval System...is substantially equivalent in intended use, design, principles of operation, materials and performance to the cleared Applied Medical Specimen Retrieval System..." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests" but does not specify the sample sizes used for these test sets. The data provenance is generally "bench testing" and "in vitro and in vivo preclinical tests," which are types of lab or animal studies, not human clinical trial data. There's no indication of country of origin for the internal testing data, but the submitter's address is in Taipei, Taiwan. The studies were prospective in the sense that they were conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For non-clinical tests on a medical device like this, ground truth is typically established against engineering specifications, material standards, and biological safety standards (like ISO 10993). It is not usually established by human expert consensus in the way it would be for an AI diagnostic tool.
4. Adjudication Method for the Test Set
This is not applicable as the tests are non-clinical and objective, based on measurements against predefined criteria and standards rather than human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI image analysis or diagnostic tools, not for a physical specimen retrieval system. Therefore, an effect size of human improvement with AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone algorithm study was not done. This device is a physical surgical tool and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests (physical, mechanical, biocompatibility) would be based on established engineering specifications, material science standards, and accepted biological safety standards (e.g., ISO 10993). For instance, a tensile strength test would have a pre-defined ground truth for the minimum acceptable strength. Biocompatibility would be evaluated against the absence of adverse biological reactions as defined by ISO standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
§ 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.