(459 days)
The LSI Solutions® ForniSee™ is intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures to identify the vaginal fornices and manipulate the uterus.
LSI SOLUTIONS® ForniSee™ System will provide aid in the tissue manipulation typically encountered in patients requiring a hysterectomy. The ForniSee™ System provides single-patient use FS Devices and its companion reusable FS Sounds; these components are made from common surgical metals and polymers. Sterile disposable, mostly plastic, FS Device surgical hand tools will be offered in three different sizes designated as either FS-30, FS-35 or FS-40, with the number indicating the increasing diameter of the inside of the device's distal cervical cups. The FS Device is designed with an optional integrated vaginal illumination component. FS Sounds are reusable implements, which are essentially customized angled shafts or sounds constructed of cleanable and resterilizable surgical quality metal; the distal ends of these FS Sounds will be offered in four different sizes ranging in length from 6 to 8 to 10 to 12cm. FS Devices fit over FS Sounds to provide an effective means of uterine manipulation during laparoscopic surgery. FS Devices and FS Sounds will be manufactured at our facility in Victor, New York.
The LSI SOLUTIONS® ForniSee™ System Uterine Manipulator and Accessories, a medical device intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures, demonstrated its effectiveness and safety through various performance tests and clinical studies.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the LSI SOLUTIONS® ForniSee™ System are implicitly derived from the successful outcomes observed during its clinical performance testing and the comparison to the predicate device. The primary criteria revolve around safe and effective uterine manipulation and delineation of vaginal fornices during laparoscopic hysterectomy procedures, without causing device-related adverse events, maintaining pneumoperitoneum, and facilitating successful surgical outcomes.
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived from Study) | Reported Device Performance (Summary) |
|---|---|---|
| Safety | No device-related Adverse Events | Achieved: No device-related Adverse Events reported. Two non-device-related iatrogenic cystotomies, immediately recognized and repaired without sequelae. |
| No ureteral injuries | Achieved: No ureteral injuries occurred. | |
| Acceptable blood loss | Achieved: Estimated Blood Loss (EBL) ranged from 20cc to 300cc, with an average of 124cc at one site and 60cc at the other, resulting in an average of 96cc for both sites combined. This range is generally considered acceptable for laparoscopic hysterectomies. | |
| Effectiveness | Successful accomplishment of pre-planned hysterectomy procedure | Achieved: 49 of 50 hysterectomies (98%) were accomplished as pre-planned (38 Total Laparoscopic Hysterectomies and 11 Laparoscopic Supracervical Hysterectomies). One conversion to Total Abdominal Hysterectomy due to an extremely large uterus was noted. |
| Maintenance of pneumoperitoneum | Achieved: Pneumoperitoneum was maintained throughout the procedure in 47 of 49 patients (96%), with only a slight loss in 2 patients. | |
| Effective uterine manipulation and forniceal exposure | Achieved: Both Principal Investigators (PIs) reported the use of the study devices as highly effective, especially in patients with challenging anatomy. | |
| Post-operative Patient Outcome | Normal post-hysterectomy course | Achieved: All patients, except one with coincidental diverticulitis, were reported to have a normal post-hysterectomy course at follow-up. Other minor post-operative observations were considered non-attributable to the device or normal for recovery. |
| Biocompatibility | Meet ISO standards for biocompatibility | Achieved: ISO Vaginal Irritation, Guinea Pig Maximization, and MEM Elution cytotoxicity tests (ISO 10993-10:2002/A1:2006 and ISO 10993-5:2009) were completed. |
| Sterilization | Meet validation for steam/Sterrad/EO sterilization and residuals | Achieved: Steam and Sterrad sterilization validation (10^-6 SAL), EO Sterilization validation (ANSI/AAMI/ISO 11135-1:2007), and EO residuals testing (ISO 10993-7:2008) were completed. |
| Durability/Integrity | Meet accelerated aging and shipping standards | Achieved: Accelerated aging (ASTM F 1980-07) and Shipping testing (ASTM D4169-09) were completed. |
| Functional, destructive, and life testing | Achieved: Bench testing included functional, destructive, and life testing, as well as thermal testing of the illumination feature. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 50 elective hysterectomy patients.
- Data Provenance: Prospective. The clinical performance testing was achieved through Institutional Review Board (IRB) approved studies. The studies were conducted at two separate medical centers within the USA, each with its own gynecological surgeon Principal Investigator (PI).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: At least two gynecological surgeon Principal Investigators (PIs) (one at each medical center) were involved in conducting the studies and evaluating the device's performance.
- Qualifications: The experts were described as "gynecological surgeon Principal Investigator (PI)s." While specific experience levels (e.g., "10 years of experience") are not provided, their role as PIs in IRB-approved surgical studies implies significant clinical expertise in gynecological surgery and hysterectomy procedures.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set in the traditional sense of resolving discrepancies between multiple independent expert assessments of an outcome.
Instead, the clinical performance results were directly reported by the "gynecological surgeon Principal Investigator (PI)s" at each of the two medical centers. Observations and outcomes, including adverse events, estimated blood loss, pneumoperitoneum maintenance, and overall effectiveness, were reported by these PIs. For example, "Several minor intra-operative observations were noted but deemed by the PIs as expected in their patients or of no significant consequence." This suggests that the PIs' individual clinical judgment served as the primary basis for evaluating events and outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or performed. The study focused on the standalone performance of the ForniSee™ system in a clinical setting, without directly comparing its AI-assisted performance (as no AI component is mentioned) against human readers or human readers without AI assistance. The comparison was primarily against a predicate device's technological characteristics and overall intended use, not its clinical outcomes in a head-to-head MRMC trial.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, from the perspective of the device itself (not an algorithm in the AI sense), a standalone performance assessment was conducted through the clinical study. The ForniSee™ System was used by surgeons in a real-world surgical setting, and its direct performance (e.g., ability to manipulate the uterus, identify fornices, maintain pneumoperitoneum) was evaluated by the operating surgeons (PIs). The study assessed the device's efficacy and safety when used as intended, independent of a comparison to a human performing the task without the device.
7. Type of Ground Truth Used
The ground truth for the clinical performance testing was established by expert clinical assessment and surgical outcomes data. The PIs (gynecological surgeons) directly observed and assessed the device's performance during surgery, recorded clinical outcomes (e.g., successful hysterectomy, blood loss, pneumoperitoneum maintenance, adverse events), and conducted post-operative follow-ups. This involved:
- Clinical observation: Direct assessment by operating surgeons of the device's functionality and impact during the procedure.
- Surgical outcomes: Documentation of successful completion of the hysterectomy, conversion rates, and intra-operative issues.
- Patient follow-up: Post-operative examinations and patient reports to assess recovery and any long-term complications.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI development. The device is a mechanical uterine manipulator, not an algorithm that requires a training set. The "development" of the product line involved "Cadaver research" and extensive "non-clinical tests" (biocompatibility, sterilization, aging, shipping, bench testing), which serve as pre-clinical development and validation phases, rather than a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since the device is a mechanical instrument and not an AI algorithm, there is no "training set" in the conventional sense of machine learning, nor a "ground truth" to be established for such a training set. The development process, including "Cadaver research" and extensive "non-clinical tests," provided data and insights that informed the device's design and confirmed its physical and material properties, but this is distinct from establishing ground truth for algorithmic training.
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.