(259 days)
The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.
The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement.
lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope.
An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again.
Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime.
On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO.
To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener.
During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.
The provided text is a 510(k) Summary for the medical device ENDOFIX EXO. It details the device's characteristics, comparison to a predicate device, and the non-clinical tests performed. However, it does not describe any acceptance criteria or studies involving AI / human reader performance.
Here's an analysis based on the provided text for the points that can be addressed:
The document clearly states that the ENDOFIX EXO is a manually operated surgical device. This means the device itself does not involve AI or algorithms for diagnosis or analysis, but rather for physical positioning of an endoscope. Therefore, many of the questions related to AI performance, such as acceptance criteria for algorithm performance, sample size for test/training sets, ground truth establishment for AI, MRMC studies, or standalone algorithm performance, are not applicable to this device as described.
The document discusses non-clinical performance tests to demonstrate the safety and effectiveness of the device compared to its predicate.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with reported performance values for specific metrics. Instead, it lists the types of non-clinical tests performed and broadly states that these tests were successful in demonstrating safety and effectiveness.
Non-Clinical Tests Performed:
- Lifetime test
- Lifetime test CONTROL
- Moving after fixation test
- Usability test
- Package drop test
Reported Device Performance (Implicit):
The summary states, "The non-clinical tests have shown that the ENDOFIX EXO device is as safe and effective as the predicate device." It also notes specific findings related to safety:
- Electromagnetic locks were mechanically tested according to IEC 60601-1:2005 + A1:2012, with no risks regarding safety observed.
- Displacement after fixation of the arm was tested, with no risks regarding safety observed.
- The device was tested with 5kg load, though its safe working load is specified as 1kg, and "no problems occurred."
- The absence of a battery in ENDOFIX EXO ensures continuous power operation safety. In case of power failure, the arm continues to hold position, and quick-release fasteners allow safe removal.
- Electrical safety tested according to IEC 60601-1, posing no danger to the user.
- Reprocessing and sterilization process validated, confirming no increased risk.
- Usability test with 15 American physicians did not negatively mention weight, despite the device being heavier than the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Sample Size: Not specified for most tests (e.g., lifetime test, moving after fixation test, package drop test).
- For the Usability Test: "15 American physicians."
- Data Provenance:
- Country of Origin: The usability test involved "15 American physicians," suggesting US-based data. For other tests, the origin is not explicitly stated but the applicant is based in Germany.
- Retrospective or Prospective: Not explicitly stated but implied to be prospective testing for device validation.
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 question is not applicable as this relates to AI/diagnostic performance where expert consensus is needed for ground truth. This device is a mechanical endoscope holder.
- However, for the Usability Test, "15 American physicians" were involved. Their specific qualifications beyond being "physicians" are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as there is no diagnostic or interpretative task requiring adjudication. The tests described are mechanical, electrical, and usability in nature.
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 question is not applicable as the device is a mechanical endoscope holder and does not involve AI for diagnostic assistance or human-in-the-loop performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as there is no algorithm or AI component in this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- This question is not applicable as the "ground truth" concept as typically applied to diagnostic AI is not relevant here. The "truth" for the mechanical/electrical tests would be adherence to engineering specifications and safety standards (e.g., proper functioning after a lifetime test, no displacement after fixation, meeting electrical safety standards).
8. The sample size for the training set
- This question is not applicable as there is no AI/algorithm component requiring a training set.
9. How the ground truth for the training set was established
- This question is not applicable as there is no AI/algorithm component requiring ground truth for a training set.
§ 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.