(71 days)
The BaroSense ACE Stapler and Cartridge are indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.
The ACE™ Stapler is a surgical stapler used in hospitals or surgery centers for staple closure on the wall of the stomach or gastrointestinal tract. The single-patient-use, disposable stapler head is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. The stapler head is attached to a reusable, flexible stapler handle that controls the position and articulation of the stapler head. In use, the stapler is introduced into the patient through the mouth. A flexible endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication [tissue fold] in the GI tract, which is then compressed. The stapler then places a double, circular row of titanium staples. A non-absorbable ring helps reinforce the staple placement in the tissue. The tissue compression and stapling functions are controlled by commercially available inflation syringes. The stapler may be introduced over a guidewire. If multiple plications are required, an endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The guidewire, overtube, flexible endoscope, vacuum pump and inflation syringes used with the stapler are all commercially available medical devices, not the subject of this 510(k), and are not supplied with the stapler.
The BaroSense ACE Stapler and Cartridge underwent bench and animal testing to establish safety and effectiveness. The device's biological evaluation also conforms to ISO 10993-1:2009 for biocompatibility, ISO 11137-1:2006 for sterilization of healthcare products - radiation - Part 1, and ISO 11137-2:2006 for sterilization of healthcare products - radiation - Part 2. The report explicitly states that for each of these ISO standards, the test data demonstrated conformity and the standards themselves include acceptance criteria.
Here's a breakdown of the specific aspects you requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Biocompatibility (per ISO 10993-1:2009) | Patient contacting components composed of materials of known biocompatibility | All patient contacting components are composed of materials of known biocompatibility, meeting the requirements of ISO 10993. Test data demonstrated conformity to the requirements of this standard. |
| Sterilization - Radiation Part 1 (per ISO 11137-1:2006) | Standard defines acceptance criteria for radiation sterilization of healthcare products. | Test data for the device demonstrated conformity to the requirements of this standard. This standard includes acceptance criteria. |
| Sterilization - Radiation Part 2 (per ISO 11137-2:2006) | Standard defines acceptance criteria for radiation sterilization of healthcare products. | Test data for the device demonstrated conformity to the requirements of this standard. This standard includes acceptance criteria. |
| Bench/Animal Testing (General Safety and Effectiveness) | Acceptable results for safety and effectiveness through a series of bench and animal tests. | "All testing yielded acceptable results." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "a series of bench and animal tests" but does not specify the sample sizes for these tests. The country of origin for the data, whether it was retrospective or prospective, is also not provided in the given text.
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)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The evaluation mainly references compliance with recognized international standards (ISO) and general "bench and animal tests."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for test sets.
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
There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study being performed, nor is there any mention of AI assistance or human reader improvement with AI in the provided text. This device is a surgical stapler, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The BaroSense ACE Stapler is a medical device, not an algorithm or AI system. Its performance is inherent to its mechanical and material properties, and its functionality is directly operated by a human user (surgeon) with a flexible endoscope for visualization.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For biocompatibility and sterilization, the "ground truth" is adherence to the specifications and requirements defined within the referenced ISO standards (ISO 10993, ISO 11137-1, ISO 11137-2). For general safety and effectiveness, the document generally refers to "acceptable results" from bench and animal tests. No specific expert consensus, pathology, or outcomes data is detailed as the direct ground truth apart from the standards themselves.
8. The sample size for the training set
This question is not applicable as the device is a mechanical surgical stapler and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as 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.