(101 days)
The Equipment Pouch is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.
The Equipment Pouch is a sterile and single-use specimencontainer designed for use in retrieving specimens during endoscopic surgery. The Equipment Pouch is supplied in a dispending tube for ease of insertion through a standard 10, 11, or 12mm trocar sheath.
The provided text describes a 510(k) premarket notification for a medical device called "Equipment Pouch". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo clinical effectiveness. Therefore, the information provided does not pertain to studies typically conducted for AI-powered devices or diagnostic tools that require a deep analysis of performance criteria against expert-established ground truth or clinical outcomes.
The testing described is primarily non-clinical bench testing to assess the physical performance and biocompatibility of the device, which is a sterile surgical pouch. There is no mention of a study involving human readers, AI assistance, or complex diagnostic tasks.
Given this context, I will address your specific points based on the available information, noting when information is not applicable or not provided in the document.
1. A table of acceptance criteria and the reported device performance
The document lists non-clinical (bench) tests and states that the device 'meets the requirements of its pre-defined acceptance criteria and intended uses.' However, the specific numerical acceptance criteria and the exact reported performance values for each test are not quantitatively detailed in this summary. Instead, a qualitative description of what each test demonstrates is given.
| Test | Acceptance Criteria (Qualitative) | Reported Performance (Qualitative) |
|---|---|---|
| Opening force | Sufficient smoothness | Demonstrates sufficient smoothness |
| Rope tension test | Can withstand at least 2kg of weight | Equipment Pouch rope can withstand at least 2kg of weight |
| Bag load-bearing | Can bear 1Kg weight and keep integrity | Demonstrates bag body can bear 1Kg weight and keep integrity |
| Tensile strength | Adequate weld strength | Demonstrates adequate weld strength |
| Bag Leak Test | No leaks | Demonstrates that the Pouch has no leaks |
Biocompatibility tests (ISO 10993 series) were performed, and the document implies they met acceptance criteria, but specific results or quantitative criteria are not listed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable or not provided for this type of device and testing. The tests are benchtop physical and chemical tests of the device itself, not studies on a patient population with specific data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or not provided. The 'ground truth' for these tests relates to engineering specifications (e.g., a bag holding 1kg, a rope withstanding 2kg), not clinical diagnoses or expert interpretations of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods are relevant for studies involving human interpretation (e.g., reviewing medical images), which is not the nature of the testing described here.
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 information is not applicable. This device is a surgical pouch, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device does not involve an algorithm. The "performance" refers to the physical characteristics of the pouch.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing described is based on engineering specifications and direct measurements of physical properties (e.g., weight capacity, tensile strength, leak integrity) as well as the results of standardized biocompatibility tests. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set (for AI), there is no ground truth established for one. The "ground truth" for the device's design and testing is based on established engineering principles and medical device standards.
§ 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.