(89 days)
The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, nonwoven surgical mesh and suture to ligaments of the pelvic floor.
The GYNECARE PROLENE Fastener consists of the implantable nonabsorbable PROLENE polypropylene Fastener.
The provided text describes the 510(k) Premarket Notification for the GYNECARE PROLENE Fastener System. This document focuses on establishing substantial equivalence to predicate devices through various performance tests, primarily mechanical and in-vivo evaluations of the fastener's strength and attachment capabilities.
The primary goal of this submission is not to validate an AI/ML device, but rather a medical device (a surgical fastener). Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, and standalone algorithm performance) are not applicable or extractable from this type of document.
The document describes engineering bench testing and an in-vivo comparison study, which are standard for physical medical devices.
Here's the information that can be extracted or inferred from the provided text, adapted to the context of a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table format. Instead, it lists various performance tests conducted to demonstrate safety and performance, implying that the device successfully met the requirements of these tests for substantial equivalence. The "reported device performance" is qualitative – the device passed these tests.
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Design Verification of the GYNECARE PROLENE Fastener with a Distributed Load | Device performs as intended under distributed load | Met (Supported substantial equivalence) |
| Design Verification of the GYNECARE PROLENE Fastener with a Point Load | Device performs as intended under point load | Met (Supported substantial equivalence) |
| Design Verification for the Tensile Strength of the GYNECARE PROLENE Fastener with GYNECARE GYNEMESH* PS | Device exhibits adequate tensile strength with mesh | Met (Supported substantial equivalence) |
| In-Vivo Comparison Between the Tissue Pullout Force of Suture and the GYNECARE PROLENE Fastener | Fastener's tissue pullout force is comparable/superior to suture | Met (Supported substantial equivalence) |
| Holding Strength of the GYNECARE PROLENE Fastener in the Sacrospinous Ligament | Device provides adequate holding strength in the sacrospinous ligament | Met (Supported substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. For mechanical testing, this typically refers to the number of fasteners or constructs tested in each experimental arm. For the in-vivo comparison, it would refer to the number of subjects (animals or cadaveric specimens) or sites studied.
- Data Provenance: Not explicitly stated. For in-vitro (bench) testing, the data is generated in a lab setting. For the in-vivo comparison, it's likely institutional, but the country of origin or whether it's retrospective/prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable for this type of device submission. Ground truth, in the context of physical device performance, is established through direct measurement (e.g., force, displacement) by engineers and scientists, not through expert consensus of visual data.
4. Adjudication Method for the Test Set
This is not applicable. As there is no "ground truth" established by experts in the sense of image interpretation, there is no adjudication method needed. Results are typically objectively measured and analyzed statistically.
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
This is not applicable as the device is a surgical fastener, not an AI/ML diagnostic tool or an imaging system requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be objective scientific measurements from the mechanical testing and the in-vivo comparison.
- Mechanical Tests: Ground truth is established by physical measurement of forces, displacements, and material properties.
- In-Vivo Comparison: Ground truth is established by measurable biological or biomechanical outcomes reported in the study (e.g., tissue pullout force observed in live tissue or cadaveric models).
8. The Sample Size for the Training Set
This is not applicable as this is a physical medical device and does not involve AI/ML models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
§ 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.