(64 days)
The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery.
The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery. It is designed to be substantially equivalent to the presently marketed AMT Esophageal Overtube. The devices' internal flange is inserted into the incision site and allowed to expand freely. Once in place, the internal flange retains the device in place and allows for the access of a variety of surgical instruments. The shaft is angulated at 30° but can range from 20° to 90°, depending on the specific application. The external flange reduces site contamination and trauma. It also easily defines the access into the region. The Endoscopic Access Device is injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392). The Endoscopic Access Deivce is sold sterile for single use.
This 510(k) summary for K960232 provides very limited information about performance criteria and studies. It describes a medical device, an Endoscopic Access Device, and states its intended use. However, it does not include the detailed information requested in the prompt regarding acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement.
Here's a breakdown of why it's not possible to answer the prompt with the provided text, and what can be inferred:
Inference from the Provided Text:
The document is a 510(k) summary for a relatively simple medical device (an access portal for endoscopic surgery), not a diagnostic AI/ML device. This type of device typically relies on simpler performance tests like bench testing for mechanical integrity and biocompatibility, rather than complex clinical studies involving human readers, AI algorithms, or extensive ground truth adjudication.
Specific to the Prompt's Requirements:
1. A table of acceptance criteria and the reported device performance
* Not provided. The text only mentions "Bench testing has been performed on the minimum pull out force versus the the strength of the device to ensure mechanical integrity for functional performance (see Exhibit VIa)." It does not state specific acceptance criteria (e.g., "minimum pull-out force must be > X Newtons") nor does it report the tested performance values (e.g., "device demonstrated a pull-out force of Y Newtons").
2. Sample size used for the test set and the data provenance
* Not provided. The term "bench testing" implies laboratory testing of physical samples, but the number of samples tested is not mentioned. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Not applicable/Not provided. This device does not have "ground truth" in the diagnostic sense. Its performance is assessed through objective physical measurements (e.g., force, strength), not expert interpretation of outputs.
4. Adjudication method for the test set
* Not applicable/Not provided. No adjudication method would be used for bench testing of mechanical properties.
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
* No, and not applicable. This is not an AI/ML device, nor is it a diagnostic device that would involve human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* No, and not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not applicable. The "ground truth" for this device's performance would be the objectively measured physical properties (e.g., actual tensile strength, actual biocompatibility).
8. The sample size for the training set
* Not applicable/Not provided. This device doesn't have a "training set" in the machine learning sense. The design and manufacturing process would involve internal testing and iterations, but this isn't reported as a formal "training set."
9. How the ground truth for the training set was established
* Not applicable.
Summary of available information regarding performance:
- Test Performed: Bench testing on "minimum pull out force versus the strength of the device."
- Purpose of Test: To "ensure mechanical integrity for functional performance."
- Reference: "see Exhibit VIa" (which is not provided)
- Biocompatibility: Stated to be "injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392)," implying equivalence in material biocompatibility based on a previously cleared device. This acts as a form of "data provenance" for the material's safety.
§ 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.