(53 days)
- Snare, grasp, hold & manipulate cervical and intravaginal tissue
- GYNEX Tenaculum Grasp/manipulate the cervix & soft tissue
- GYNEX Iris Hook Grasp/manipulate cervical tissue
- GYNEX Angle Hook Grasp/manipulate cervical tissue
The Gynex Iris and Angle Hooks & Emmett Tenaculums are made of 302 instrument grade stainless steel. All are used in similar way, each being a hook-like device used to snare, grasp, hold and manipulate the cervix, fundus and adjacent soft tissue. The important difference between the styles is that the radius of the hook tip is much smaller in the "Iris" and "angle" hook types. The devices are slender tapered metal rods, knurled on the proximal end and formed into a fine arc (hook) on the distal or working end. The devices are used to snare, hold and manipulate cervical and intravaginal tissue. Overall length of the hook/tenaculums is approximately 250mm for each type. The diameter of the hook tips is approximately 3mm for the Iris/angle styles and 8mm for the Emmett tenaculum style hook.
The Gynex Iris Hook, Gynex Angle Hook, and Gynex Emmett Tenaculum are manual surgical instruments, not AI/ML-driven devices. Therefore, the request regarding acceptance criteria and studies proving the device meets them in the context of AI/ML performance metrics (such as effect size of human readers with/without AI assistance, standalone algorithm performance, training set details, and ground truth establishment for AI models) is not applicable.
The provided document is a 510(k) premarket notification for traditional medical devices. The safety and effectiveness of these devices are established through substantial equivalence to legally marketed predicate devices, rather than through performance studies employing AI/ML specific methodologies.
Here's a breakdown of the available information relevant to traditional device clearance, framed to address the prompt where possible, noting the inapplicability of AI/ML-specific questions:
1. A table of acceptance criteria and the reported device performance
For these manual surgical instruments, "acceptance criteria" are typically met by demonstrating substantial equivalence to predicate devices, focusing on design, materials, indications for use, and sterilization. Performance is assessed qualitatively based on these similarities and the known safety of the predicate devices.
| Feature / Criteria (for Traditional Device Equivalence) | Gynex Iris/Angle Hook & Emmett Tenaculum Performance (as reported for equivalence) |
|---|---|
| Indications for Use(s): Snare, grasp, hold & manipulate cervical and intravaginal tissue | Substantially Equivalent (YES) to predicate devices with the same indications. |
| Design: Slender tapered metal rod | Substantially Equivalent (YES) to predicate devices. |
| Sterilization Method: Steam Autoclave | Substantially Equivalent (YES) to predicate devices. |
| Sizes: 3mm & 8mm tip diameter | Substantially Equivalent (YES) to predicate devices (3mm & 4mm tip diameter). The difference in the 8mm tip for Emmett Tenaculum is acknowledged, but considered equivalent in function. |
| Material: 302 Stainless steel | Substantially Equivalent (YES) to predicate devices. |
| Product Code: 84HDC | Substantially Equivalent (YES) to predicate devices. |
| Performance (general): Structural integrity is the chief criterion. | Implied to meet structural integrity criteria through material selection and established manufacturing practices, similar to predicate devices. |
| Cleaning and Sterilization: Devices are supplied "clean only" and must be cleaned/sterilized prior to each use per hospital practice (steam autoclave at 270°F for 30 minutes). | Recommended procedures are standard for surgical instruments and are considered safe and effective for the device materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. There was no "test set" in the context of an AI/ML study. The premarket notification relies on comparison to existing legally marketed devices (predicate devices) to establish substantial equivalence. No clinical performance data or specific test set for quantitative evaluation of device "performance" (beyond design and material specifications) is provided in this type of submission.
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)
This information is not applicable. There was no ground truth establishment for a test set as this is not an AI/ML device. The "ground truth" equivalent for a traditional device 510(k) is the established safety and effectiveness of the predicate devices based on their long history of use and regulatory clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There was no adjudication method used as there was no test set in the context of an AI/ML study.
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 information is not applicable. This is not an AI-assisted device, so no MRMC study involving AI assistance would have been conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of AI/ML ground truth. For a traditional 510(k) submission, the "ground truth" for demonstrating safety and effectiveness is primarily established through substantial equivalence to legally marketed predicate devices. This means the device performs similarly, has similar technological characteristics (materials, design, intended use), and therefore is considered as safe and effective as the predicate. The "truth" is that the predicate devices have proven safe and effective over time.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device, so there was no training set.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device, so there was no training set or ground truth establishment for it in that context.
§ 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.