(200 days)
The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
The EndoFast Reliant™ SCP (Sacrocolpopexy) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices; each preloaded with a spider fastener composed of . metal and includes the MRI Safety Information that is stated in the labeling.
- . Plastic Handle; connects to the Fixation Device.
- . Surgical mesh composed of monofilament polypropylene material; cut in a rectangular shape of 8x20cm.
The device is introduced through a 5mm trocar in a laparoscopic approach. The mesh is attached to the vaginal vault and the vagina is pulled towards the posterior pelvic bony part. The other end of the mesh is attached to the promontorium, using two fixation points, to restore the normal anatomical position of the uterus and cervix.
The EndoFast Reliant™ LAP (Laparoscopic) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices, each preloaded with a spider fastener composed of . metal and include the MRI Safety Information that is stated in the labeling.
- Plastic Handle; connects to the Fixation Device. .
The fasteners are introduced through a 5mm trocar in laparoscopic procedures.
This document primarily details the substantial equivalence of the "EndoFast Reliant™ SCP" and "EndoFast Reliant™ LAP" devices to predicate devices. It describes various performance and non-clinical tests conducted, but it does not provide specific acceptance criteria or detailed study results in a format that would allow for the direct extraction of "reported device performance" to compare against acceptance criteria for an AI/software device.
The document focuses on the physical and functional characteristics of a surgical mesh fixation system, not on an AI or software device. Therefore, many of the requested categories for AI/software studies are not applicable or cannot be extracted from this text.
However, I can extract the information related to the performance testing that was conducted for this medical device, which is a physical surgical tool.
Acceptance Criteria and Study for EndoFast Reliant™ SCP and LAP (Surgical Devices)
This submission describes the performance testing of the EndoFast Reliant™ SCP and EndoFast Reliant™ LAP, which are physical surgical devices for mesh fixation. The document emphasizes substantial equivalence to predicate devices based on a series of non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted but does not explicitly state quantitative acceptance criteria or detailed numerical performance results in a table format for direct comparison. Instead, it broadly states that tests were performed to "demonstrate appropriate functionality," "validate endurance," "verify deployment reliability and pullout force," and "assure adequate performances." The overall conclusion is substantial equivalence, implying that the device met internal criteria derived from the predicate.
| Acceptance Criteria Category (Derived) | Stated Purpose of Test | Reported Device Performance (Summary from Text) |
|---|---|---|
| Functional Characteristics | To demonstrate appropriate functionality characteristics after sterilization, vibration, drop test, and shelf life study. | Performed; implies appropriate functionality demonstrated. |
| Fastener Support Endurance to Cyclic Loads | To validate the endurance of the SCP Spider Fastener in supporting the cyclic load on the surgical mesh. | Performed; implies endurance was validated. |
| Fastener Deployment Reliability & Pull-Out Force | To verify deployment reliability and pullout force required for fastener failure. To verify no influence of surgical mesh/artificial tissue on fastener deployment. | Performed; implies reliability and adequate pull-out force verified, and no negative influence on deployment. |
| Fixation Device and Handle Reliability & Force | To verify reliability of the Fixation Device and Handle in deploying fasteners without fault and to test deployment force. | Performed; implies reliability and force during deployment verified. |
| Comparative Pull-Out Tests | To assess the new products' equivalency with predicate devices. | Performed; implies equivalency with predicate devices was demonstrated. |
| Gamma Sterilization Validation | To assure products' SAL 10⁻⁶ using 25 kGy. | Performed; implies SAL 10⁻⁶ achieved. |
| EtO Sterilization Validation | To assure products' SAL 10⁻⁶ using overkill approach. | Performed; implies SAL 10⁻⁶ achieved. |
| Shelf Life Tests | To assure adequate performances during shelf life using accelerated aging. | Performed; implies adequate performances during shelf life demonstrated. |
| Biocompatibility | Evaluated with accordance to ISO 10993-1 and FDA Blue Book Memorandum, G95-1. | Performed; implies compliance with biocompatibility standards. |
| MR Compatibility | To assure safe use of the device at MRI environment. | Performed; implies safe use at MRI environment is assured. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "two cadaver studies were performed" but does not specify the sample size (number of cadavers or fasteners tested) for these studies or any other non-clinical tests.
The data provenance is from non-clinical tests and cadaver studies, implying laboratory and controlled anatomical specimen testing rather than human clinical data. The studies were conducted by the applicant, Israel Biomedical Innovations Ltd.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or not provided as the tests are non-clinical, mechanical, and sterilization validations, not involving human expert assessment for "ground truth" in the context of diagnostic interpretation.
4. Adjudication Method
This information is not applicable or not provided as the tests are non-clinical and do not involve human diagnostic interpretation.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This is not applicable as the device is a physical surgical tool, not an AI or imaging diagnostic aid for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This is not applicable as the device is a physical surgical tool, not an AI algorithm.
7. Type of Ground Truth Used
For the non-clinical tests:
- Engineering specifications and standards: For functional characteristics, endurance, reliability, pull-out force (e.g., meeting predefined force thresholds, successful deployment rates).
- Biological safety standards: For sterilization (SAL 10⁻⁶) and biocompatibility (ISO 10993-1, G95-1).
- Comparative data: For pull-out tests, implicitly comparing against the performance of predicate devices.
- Anatomical relevance: For cadaver studies, simulating surgical use.
8. Sample Size for the Training Set
This is not applicable as this document describes a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a physical medical device, not an AI or machine learning model.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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.