(13 days)
The Apple Medical OB Mobius Elastic Retractor is indicated for use to assist in laparotomy procedures. It is intended to provide incision retraction and to protect against wound contamination during open surgery.
The Apple Medical OB Mobius Elastic Retractor is used for laparotomy procedures where a transverse suprapubic incision is made in the abdominal wall allowing access to the peritoneal cavity. Once the incision is made, the internal o-ring is manually collapsed and inserted through the abdominal incision where it is allowed to spring open against the parietal peritoneum. The external quad-ring is then pulled upward placing the cylindrical sleeve in tension and the operator rolls the ring down the sleeve until the ring sits firmly against the skin. The radial force of the two rings act to retract the abdominal wall to the desired circular geometry.
The provided text is a 510(k) summary for the Apple Medical OB Mobius Elastic Retractor. It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical properties testing. However, it does not contain information typically found in acceptance criteria or a study proving the device meets said criteria for an AI/ML medical device.
The document states:
- "The Apple Medical OB Mobius Elastic Retractor has been shown to be substantially equivalent to the predicate Alexis™ device through mechanical properties testing."
- "The subject device has the same technological characteristics as the predicate devices. The only changes involve a change to the dimensions and labeling for the OB Mobius device. These changes do not affect the safety and effectiveness of the device."
This indicates a comparison to a predicate device, which is a common pathway for 510(k) clearance, rather than a detailed study with acceptance criteria and performance metrics as would be typical for an AI/ML device.
Therefore, many of the requested details about acceptance criteria, study design, and AI-specific metrics (like sample size for test/training sets, expert ground truth, MRMC studies) are not available in this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Alexis™ Wound Retractor, K031889) based on mechanical properties. | "The Apple Medical OB Mobius Elastic Retractor has been shown to be substantially equivalent to the predicate Alexis™ device through mechanical properties testing." |
| No adverse impact on safety and effectiveness due to changes in dimensions and labeling. | "The only changes involve a change to the dimensions and labeling for the OB Mobius device. These changes do not affect the safety and effectiveness of the device." |
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This is a mechanical device, not an AI/ML device relying on "test sets" of data. The "testing" referred to is mechanical properties 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 is a mechanical device and does not involve establishing ground truth from experts in the way an AI/ML device would.
4. Adjudication method for the test set
- Not applicable/Not provided. No "test set" or human adjudication is described for a mechanical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This is a mechanical device, not an AI/ML device. MRMC studies are not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a mechanical device, not an algorithm.
7. The type of ground truth used
- Not applicable. For this mechanical device, the "ground truth" for proving substantial equivalence relates to its physical and mechanical properties being comparable to the predicate device, not to diagnostic outcomes.
8. The sample size for the training set
- Not applicable/Not provided. This is a mechanical device, not an AI/ML device using a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is a mechanical device, not an AI/ML device.
In summary, the provided document details the regulatory clearance of a physical medical device (an abdominal retractor) based on its substantial equivalence to a predicate device, supported by mechanical properties testing. It does not provide the kind of information requested for an AI/ML device's acceptance criteria and validation study.
§ 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.