(43 days)
KleenSpec® Single Use Vaginal Speculum: The disposable 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 vaginal speculum can be used with or without the illuminator. KleenSpec® 790 Series Cordless Illuminator: When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery. The illuminator can be used independent of the speculum as a general-purpose light source.
The disposable 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 such as: Pap smears, dilation and curettage (D&C), biopsy, & electrosurgery. Models with a smoke tube assembled to the upper blade can be connected to a separate smoke evacuator during electrosurgical procedures. The vaginal speculum can be used with or without the illuminator. When used with the vaginal speculum, the cordless illurninator provides illumination during pelvic examinations. The illuminator can be used independent of the speculum as a general-purpose light source.
This 510(k) Premarket Notification for the Welch Allyn KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System does not contain the level of detail requested for acceptance criteria and a comprehensive study description as it applies to an AI/ML device.
This document is a submission for a traditional medical device (vaginal speculum and illuminator) under the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use, rather than detailed performance metrics derived from clinical studies with ground truth establishment in the way an AI/ML device would need. The FDA letter confirms the device is substantially equivalent to a predicate device.
Therefore, many of the requested fields cannot be filled from the provided text.
Here is what can be inferred or explicitly stated from the document, along with explanations for the missing information:
Acceptance Criteria and Device Performance for Welch Allyn KleenSpec® Single Use Vaginal Speculum and 790 Series Cordless Illumination System (K070964)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected Performance) | Reported Device Performance (Achieved) |
|---|---|---|
| Premarket Clearance | Substantial Equivalence to Predicate | Achieved (FDA determined substantial equivalence to KleenSpec Disposable Vaginal Speculum 580 series (K941272)) |
| Intended Use | Dilate vagina, expose interior, provide illumination for pelvic exams and other gynecological procedures. | The device meets this intended use, functioning as a non-metal vaginal speculum and a cordless illuminator for the specified medical procedures. |
| Safety & Effectiveness | Implied to be similar to predicate device (no new safety/effectiveness concerns). | Not explicitly detailed in performance metrics, but implicit in the substantial equivalence determination. |
| Functionality | Basic function of a vaginal speculum and illuminator. | Functions as described (dilates vagina, provides illumination). |
Explanation for Missing Information:
For a traditional medical device like this, acceptance criteria primarily revolve around demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The 510(k) summary does not include specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) derived from controlled studies, which are typically required for AI/ML devices.
Study Information Pertaining to K070964
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The submission is for a physical medical device, not an AI/ML algorithm. There is no "test set" in the context of an algorithm's classification or prediction performance. The "test" for substantial equivalence often involves comparing design specifications, materials, and intended use to a predicate device.
- Data Provenance: Not applicable. There is no data provenance in the context of clinical data used for AI/ML model evaluation.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Number of Experts: Not applicable. Ground truth establishment is not relevant for this type of device submission.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no test set in the context of AI/ML evaluation, and thus no adjudication method for ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is not an AI/ML device; therefore, no MRMC study comparing human readers with and without AI assistance would have been performed or would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable. Ground truth, in the context of AI/ML, refers to the verified correct answer against which an algorithm's output is compared. This concept does not apply to a physical device like a speculum or illuminator. The "truth" for this device relates to its physical properties, biocompatibility, and functional performance matching its intended use and predicate device.
8. The sample size for the training set
- Sample Size: Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
Summary of Device and 510(k) Context:
This 510(k) submission (K070964) is for a physical medical device: a vaginal speculum and a cordless illumination system. The submission's purpose is to demonstrate substantial equivalence to an existing legally marketed device (the KleenSpec Disposable Vaginal Speculum 580 series, K941272).
For such devices, the "acceptance criteria" are primarily related to:
- Meeting the same intended use as the predicate device.
- Having similar technological characteristics (e.g., materials, design principles).
- Raising no new questions of safety or effectiveness.
- Conforming to relevant performance standards (though not explicitly detailed in this summary).
The 510(k) mechanism is a premarket notification process for medical devices that do not require a Premarket Approval (PMA) application. It is fundamentally different from the regulatory pathway for AI/ML-driven devices, which would necessitate extensive data sets, ground truth establishment, and performance metrics like sensitivity, specificity, AUC, and studies evaluating human-AI interaction.
§ 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.