(203 days)
The Marionette™ SA is intended for use by surgeons for grasping, dissection, and tissue cutting during laparoscopic surgical procedures.
The Marionette™ SA is a manually operated, articulating mechanical surgical device. It is primarily composed of stainless steel, anodized aluminum and Delrin. The instrument provides for the one handed control (left or right hand) of the positioning/repositioning of an instrument that includes the ability to change disposable/reusable tips for grasping, dissection, and tissue cutting during laparoscopic surgical procedures. The device is sold non-sterile to the hospital institution to be cleaned and sterilized on site prior to each use. Some accessories that support the device are sold sterile and are single use components.
The provided 510(k) summary for the Marionette™ SA (K072811) does not contain details about acceptance criteria, device performance, or human subject studies with ground truth data.
This document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. For devices like the Marionette™ SA, which are manual surgical instruments (graspers, scissors, dissectors), the regulatory submission often relies on a comparison of design, materials, manufacturing processes, and intended use to existing legally marketed devices. Performance testing typically involves bench testing, biocompatibility, and sterilization validation, rather than clinical efficacy studies with specific acceptance criteria that would generate the kind of data requested in the prompt.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text.
Here's what I can extract from the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
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 (Test Set): Not specified.
- Data Provenance: Not specified. It's highly probable that any performance testing conducted would have been bench testing or internal validation, rather than clinical studies with human subjects.
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 human subject study with ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no human subject study with ground truth establishment is described.
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 study was mentioned. This device is a manual surgical instrument, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable as no human subject study with ground truth establishment is described.
8. The sample size for the training set
- Not applicable as no machine learning or AI component is described.
9. How the ground truth for the training set was established
- Not applicable as no machine learning or AI component is described.
Summary of what the document does provide:
- Intended Use: The Marionette™ SA is intended for use by surgeons for grasping, dissection, and tissue cutting during laparoscopic surgical procedures.
- Device Description: A manually operated, articulating mechanical surgical device primarily composed of stainless steel, anodized aluminum, and Delrin. It provides one-handed control and the ability to change disposable/reusable tips.
- Substantial Equivalence: The device claims substantial equivalence in application and function to the Endolink True Movement System (K043541), Cambridge Laparo-Angle (K061425), and Microline Re-New laparoscopic instrument (K962119). This is the primary basis for its clearance, implying that its performance characteristics are considered comparable to these predicate devices based on design and intended use, not necessarily through clinical trials directly comparing performance metrics.
§ 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.