(143 days)
The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.
The IOB disposable vaginal speculum consists of up and under plastic blades and handle with three different sizes (smail, medium and large). The speculum is used by medical professionals to visualize interior of vagina and cervix during patient examination.
The provided 510(k) summary does not contain the level of detail typically found in a clinical study report for AI/CADe devices. This device is a disposable speculum, a physical medical instrument, not an AI/CADe system. Therefore, the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not directly applicable in the same way it would be for a software-based diagnostic tool.
However, I can extract the relevant information regarding performance and acceptance based on the content available for this physical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this physical device, acceptance criteria relate to its physical properties, manufacturing, and biological safety, rather than diagnostic accuracy metrics like sensitivity or specificity. Performance is primarily about functionality and equivalence to a predicate device.
| Category | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Suitable for limited contact duration (per FDA G95-1 and ISO 10993-1 requirements for cytotoxicity, irritation, and sensitivity). | "Biocompatibility testing (cytotoxicity, irritation and sensitivity) according to ISO 10993 for a limited contact device was demonstrated to be suitable for the intended use of the product." |
| Functional Performance | Able to survive stresses encountered during use without failure; performs equivalently to the predicate device. | "Bench testing was performed by simulating actual usage comparing the device with the predicate speculum. The testing results show that the new device performs equivalent to the predicate device. Both bench testing and stability study show that the device is able to survive stresses encountered during use without failure." |
| Material | Constructed from commonly used medical-grade polystyrene. | "The new device is constructed using polystyrene that is commonly used by the medical device industry for like and similar devices." (Implies meeting industry standards for material suitability). |
| Intended Use | Same as predicate device (dilate vagina, expose interior of vagina and exterior of cervix). | "The IOB Disposable Speculum has the same technological characteristics and indications for use as the predicate device." "The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures." |
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 and not provided in the document. The device is a physical speculum; its testing involved "bench testing" and "stability study" simulating usage, not a clinical "test set" with patient data in the typical sense of a diagnostic algorithm.
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 is not applicable and not provided. "Ground truth" in the context of this device's testing would relate to physical performance metrics (e.g., structural integrity, ease of use), not diagnostic interpretation by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of diagnostic data, which is not what was performed for this physical device.
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. An MRMC study is relevant for evaluating the impact of AI/CADe systems on human reader performance for diagnostic tasks. This device is a physical instrument, not an AI/CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical speculum and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for performance would likely be based on:
- Biocompatibility Standards: Adherence to ISO 10993 standards.
- Engineering Specifications: Meeting pre-defined physical strength, flexibility, and dimensional requirements.
- Predicate Device Comparison: Functional equivalence observed during simulated usage against the predicate device.
8. The sample size for the training set
This is not applicable. The concept of a "training set" refers to data used to train an AI algorithm. This device is a physical instrument.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a physical device.
§ 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.