(47 days)
The Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for general gynecologic and electrosurgical procedures and is inserted into the vagina to expose the cervix. It is supplied non-sterile and is intended to be autoclavable for 100+ cycles.
The Ultimate Reusable, Plastic Vaginal Speculum is a device used to expose the interior of the vagina during general gynecologic and electrosurgical procedures. The non-conductive, specialized plastic stops dangerous grounding of the electrical current that a metal would not. The stainless steel metal parts will not rust and are away from the operating area. The three main parts are injection molded from a plastic called ULTEM, a General Electric Company product used for many years in the manufacturing of medical devices, where high temperature and chemical interaction is a concern. The speculum has been autoclaved and cold soak sterilized for many hours to be sure of its usability after repeated cycles and there is no coating to breakdown, crack, chip, or peel. The color is pink to stop light reflection (as opposed to white) and still light enough to show any surface damage that might happen in use. The surfaces are polished and all sharp edges are removed for the protection of the patient.
The provided documents describe a 510(k) premarket notification for a medical device, the "Wallach Ultimate Reusable, Plastic Vaginal Speculum." This type of submission focuses on establishing substantial equivalence to previously approved predicate devices, rather than conducting a de novo study to prove safety and effectiveness against specific acceptance criteria using a novel methodology.
Therefore, many of the typical acceptance criteria and study elements often found in submissions for AI/ML-driven diagnostic devices or more complex therapeutic devices are not applicable or explicitly detailed in this document. The device is a physical medical instrument, not a software or AI-based system.
Here's a breakdown based on the information provided, highlighting what is applicable and what is not:
1. A table of acceptance criteria and the reported device performance
For this device, the "acceptance criteria" are essentially defined by its substantial equivalence to predicate devices in terms of materials, sterilization, design, intended use, and where it is used. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) typically associated with AI/ML devices.
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance (Wallach's Ultimate Reusable, Plastic Vaginal Speculum) |
|---|---|
| Material: Ultem Plastic | Ultem Plastic |
| Sterilization: Autoclavable / Reusable | Autoclavable / Reusable (intended for 100+ cycles) |
| Design: | |
| 1. Plastic Injection Molded | 1. Plastic Injection Molded |
| 2. Non-conductive | 2. Non-conductive |
| 3. No coating to breakdown, crack, chip, or peel | 3. No coating to breakdown, crack, chip, or peel |
| Intended Use: To assist in electrosurgical procedures to expose the interior of the vagina | To assist in electrosurgical procedures to expose the interior of the vagina |
| Where Used: By a Physician | By a Physician |
| Safety: No new hazards compared to predicate device | Hazard analysis evaluations indicated no new hazards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical device, and the demonstration of substantial equivalence does not involve a "test set" of data in the manner of AI/ML or diagnostic devices. Performance is assessed through comparison of characteristics and safety evaluations, not data analysis.
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)
Not applicable. Ground truth establishment with experts is relevant for diagnostic or AI/ML devices where interpretation is involved. For this physical speculum, its function is directly observable and its safety/equivalence is assessed by regulatory bodies against defined characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" or diagnostic interpretation requiring adjudication.
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
Not applicable. This type of study is for AI/ML diagnostic tools. The speculum is an instrument used by a physician, not an AI-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The new device demonstrates "substantial equivalence" to this established standard based on its physical and functional characteristics.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study/Evidence:
The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to predicate devices) is primarily a comparative analysis of device characteristics and a hazard analysis.
- Design and Materials Comparison: The Wallach Ultimate Reusable, Plastic Vaginal Speculum was directly compared to two predicate devices:
- Adept-Med's Gravespec Reusable Nonmetal, Vaginal Speculum (K935636)
- CooperSurgical's Prima Series, Vaginal LEEP Plastic Reusable Specula (K951898)
The comparison covered materials (Ultem Plastic), sterilization methods (Autoclavable/Reusable), design features (plastic injection molded, non-conductive, no coating to breakdown), intended use, and user (physician). The Wallach device was found to be "Equivalent" or "Similar" to the predicate devices across these categories.
- Safety Evaluation: "Hazard analysis evaluations performed on the Ultimate Reusable, Plastic Vaginal Speculum indicated that there were no new hazards presented with the use of the Ultimate Reusable, Plastic Vaginal Speculum as compared to the predicate device."
- Performance Claim: The document states that "Testing that was performed on the Ultimate Reusable, Plastic Vaginal Speculum indicates that the devices are substantially equivalent in their performance and design of operation." While specific test details (e.g., details of autoclaving for 100+ cycles) are mentioned in the product description (e.g., "autoclaved and cold soak sterilized for many hours to be sure of its usability after repeated cycles"), the detailed results of these tests are not provided in this summary.
In essence, the "study" is a demonstration of equivalence based on documented technical specifications, material properties, and a safety assessment, rather than a clinical trial or performance study requiring patient data or expert interpretation.
§ 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.