(32 days)
The VersaOne™ bladeless trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Modifications to the design of the current VersaOne™ Bladeless Trocar (K151548) include diameter change to the cannula and obturator components to accommodate an 8mm instrument.
Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided text.
Important Note: The provided document is a 510(k) summary for a VersaOne™ Bladeless Trocar, a surgical instrument. It is NOT an AI/ML medical device submission. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML systems (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance, and training set ground truth establishment) are not applicable to this type of device. The document focuses on demonstrating substantial equivalence to a predicate device through engineering performance testing and biocompatibility.
Acceptance Criteria and Device Performance for VersaOne™ Bladeless Trocar
Since this is a traditional medical device (trocar), the "acceptance criteria" are not based on metrics like accuracy, sensitivity, or specificity as seen in AI/ML systems. Instead, they are comparative performance metrics against a predicate device and adherence to relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through comparative testing against its predicate, the VersaOne™ Bladeless Trocar (K151548), and adherence to standards.
| Acceptance Criteria (What was tested for equivalence/compliance) | Reported Device Performance (How the device met the criteria) |
|---|---|
| Design Modification: Accommodate 8mm instrument | Diameter change to cannula and obturator components to accommodate an 8mm instrument was implemented. Performance testing (bench top and animal) demonstrated functional equivalence. |
| Sterilization Equivalence (EO sterilization processes) | Performed to confirm equivalency to predicate per ISO 11135 requirements. |
| Sterilization Equivalence (EO residuals) | Performed to confirm equivalency to predicate per ISO 10993-7 requirements. |
| Shelf Life Performance | Assessed per Covidien standard operating procedures to confirm product performance over time. |
| Biocompatibility | Confirmed all components are comprised of materials in accordance with ISO 10993-1 for their intended patient contact profile. |
| Bench Top Functional Performance: | Demonstrated equivalence to the predicate device. Specific tests included: |
| - Leak rate | Results supported substantial equivalence. |
| - Insertion force & Removal force | Results supported substantial equivalence. |
| - Penetration force & Fixation force | Results supported substantial equivalence. |
| Animal Functional Performance: | Demonstrated equivalence to the predicate device. Specific tests included: |
| - Penetration force & Fixation force | Results supported substantial equivalence. |
Conclusion: The regulatory submission asserts that "The results of testing demonstrated the modified VersaOne™ Bladeless Trocar 8mm is substantially equivalent to the legally marketed device."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. For a traditional device, "sample size" would refer to the number of devices or test repetitions in bench-top and animal studies. Data provenance (country, retrospective/prospective) is also not specified, as the studies are likely internal engineering and animal model testing, not human clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable for this type of device submission. Ground truth for an AI/ML system involves expert labeling of data. For a surgical instrument, "ground truth" is established through engineering specifications, validated test methods, and compliance with industry standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies for resolving discrepancies in expert labeling. For this device, performance is measured against objective engineering parameters and physical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a surgical trocar.
6. If a Standalone Performance (Algorithm Only Without Human-in-the Loop) was Done
No, a standalone performance study was not done. This concept applies to AI algorithms operating independently, not to a physical surgical instrument. The performance testing described (bench top, animal) assesses the physical characteristics and function of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Engineering Specifications and Design Requirements: The device must meet predefined physical dimensions, material properties, and functional performance targets.
- Predicate Device Performance: The modified device must perform equivalently to its legally marketed predicate.
- Compliance with Standards: Adherence to international standards like ISO 11135 (sterilization) and ISO 10993-1/7 (biocompatibility and EO residuals).
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no corresponding ground truth establishment process.
§ 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.