(29 days)
The Spacemaker™ Pro dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
The Spacemaker™ Pro blunt tip trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
The Spacemaker™ Pro structural balloon trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.
The Spacemaker™ Pro access and dissector system consists of combinations of three dissectors and two balloon access devices integrated into a single, modular device. There are a total of five Spacemaker™ Pro device combinations.
Blunt tip trocar with round dissection balloon
Blunt tip trocar with oval dissection balloon
Blunt tip trocar with cylindrical dissection balloon
Structural balloon trocar with round dissection balloon
Structural balloon trocar with oval dissection balloon
Each combination also includes two 5mm optical ports cleared under K112349, for use during the laparoscopic procedure, and also includes an Obturator accessory in a shorter length.
The provided text describes a 510(k) premarket notification for the "Spacemaker™ Pro Access and Dissector System." It details the device, its intended use, and compares it to a predicate device. The document lists various in vitro and in vivo tests conducted to demonstrate substantial equivalence, but it does not explicitly state specific acceptance criteria or report device performance details for these tests. It generally concludes that "The results of testing demonstrate that the modified Spacemaker™ Pro Access and Dissector System is substantially equivalent to the legally marketed Spacemaker™ Plus System(K042412)."
Therefore, I cannot provide a table of acceptance criteria and reported device performance as that specific information is not present in the provided text. I also cannot fulfill requests for sample sizes, data provenance, expert details, or multi-reader studies as these are not mentioned.
However, I can extract information related to the types of studies conducted:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: Not explicitly detailed in the provided text, beyond the general conclusion of substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified.
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):
- Not applicable as no expert-established ground truth is mentioned for the testing described. The studies appear to be performance-based engineering and functional tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 MRMC or AI-related studies are mentioned. This device is a medical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance is mentioned, as this is a physical medical device. The "in vitro" and "in vivo" performance studies described can be considered standalone performance for the device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the performance studies listed, the "ground truth" would be established by objective measurements and observations of the device's physical and functional characteristics against predetermined engineering specifications and safety standards, rather than expert consensus on diagnostic images or pathology. For example, for "Balloon Inflation Force" or "Dissector Balloon Leak Test," the ground truth is a pass/fail against a quantifiable threshold.
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.