(210 days)
The ClearSpec Single-Use Vaginal Speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
The ClearSpec Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, used to dilate the vagina and expose the interior of the vagina and exterior of the cervix, and employs a unique flexible polyurethane sheath that is designed to assist in keeping the lateral walls of the vagina clear of the viewing area. The vaginal speculum can be used with or without an illuminator. The ClearSpec® Single Use Vaginal Speculum is made available in various sizes from extra small to large to accommodate vagina cavity size.
The provided text describes the 510(k) submission for the ClearSpec® Single-Use Vaginal Speculum. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic device. Therefore, many of the requested elements are not applicable to this type of regulatory submission.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Sheath material ability to survive stresses encountered during use without failure | "The results of the testing show the new device to perform as intended." (Implicitly, the sheath survives stresses) |
| Sufficiency of sheath to speculum bond strength | "sufficiency of sheath to speculum bond strength such that the sheath does not detach from the speculum during insertion, during the examination, or during withdrawal." (Implicitly, the bond strength is sufficient) |
| Equivalence to predicate devices in performance | "The results of the testing show the new device to perform as intended and equivalent to the predicate device." |
| Biocompatibility per FDA GPM G95-1 and ISO 10993-1 for limited contact duration, surface contacting mucosal membrane device | "found to be suitable for the intended use of this product." |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The text mentions "bench testing has been conducted using simulated actual use conditions" but does not quantify the number of tests or devices used.
- Data provenance: Not explicitly stated, but based on the nature of bench testing, it would be internal lab data from ClearSpec LLC. It is prospective testing designed to evaluate the new device. Country of origin not specified, but the company is based in Boca Raton, FL, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was bench testing, not a clinical study involving expert interpretation of medical data. The "ground truth" was based on established engineering and materials science principles, and the performance of the device itself under simulated conditions.
4. Adjudication method for the test set
Not applicable. Bench testing typically involves objective measurements and comparisons to predefined engineering specifications or predicate device performance, not expert adjudication in the manner of diagnostic performance studies.
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 is a medical device (vaginal speculum) and not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the bench testing was based on:
- Engineering specifications and material properties (e.g., strength, durability, bond integrity).
- Established regulatory standards for biocompatibility (FDA GPM G95-1 and ISO 10993-1).
- Comparison to the performance of predicate devices which are already deemed safe and effective.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.