(35 days)
The intended use is interconnection of devices for transmission of light.
The intended use is to illuminate area of view.
The intended use is the interconnection of devices for transmission of light.
Not Found
The information provided is insufficient to describe acceptance criteria and study details as it appears to be a 510(k) summary for a medical device (Glo-Spec™ Connector, Vaginal Speculum) seeking substantial equivalence to a predicate device, rather than a performance study report with specific acceptance criteria and detailed study methodology.
The document primarily focuses on establishing equivalence based on intended use, physical/technical characteristics, and materials. It mentions the device "complies with all acceptance criteria listed above" but these criteria are not a quantitative set of performance metrics for proving efficacy or safety in a controlled study. Instead, they are statements of similarity to a predicate device.
However, based on the provided text, I can extract the following information which relates to acceptance but isn't a direct performance study:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Intended use: interconnection of devices for transmission of light | "Have the same intended use of transmitting light" |
| Intended use: to illuminate area of view | "Have the same intended use of transmitting light" |
| Manufactured through injection molding | "Manufactured through injection molding" |
| Made with same materials | "Made with same materials" |
| Maintain same rigidity of part | "Maintain same rigidity of part" |
| Both have clear plastic for viewing | "Both have clear plastic for viewing" |
| Both have windows that allow heat to escape | "Both have windows that allow heat to escape" |
| Does not alter the utilization, safety or efficacy of the Nu-Spec D while affording light for visualization | "Does not alter the utilization, safety or efficacy of the Nu-Spec D while affording light for visualization" (This is a claim, not a measurement of performance in a study within this document) |
| Glo-Spec portable connector has no body or membrane contact | "Glo-Spec portable connector has no body or membrane contact" (Difference from predicate, implying an advantage or different aspect from the predicate's contact) |
| Glo-Spec portable connector will allow for other different light sources to be used | "Glo-Spec portable connector will allow for other different light sources to be used (i.e. penlights, etc.)" (Difference from predicate, implying an advantage) |
| Glo-Spec portable connector place is above and out of area where bleeding may contaminate this device | "Glo-Spec portable connector place is above and out of area where bleeding may contaminate this device" (Difference from predicate, implying an advantage) |
| Constructurally equivalent to the Welch Allyn's Kleenspec, and other predicate devices | "Constructurally equivalent to the Welch Allyn's Kleenspec, and other predicate devices which have already been subjected to millions of applications" |
None of the following information can be extracted from the provided text as it is not a performance study report:
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is described.
- 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 device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for performance is described.
- The sample size for the training set: Not applicable. This device does not use a training set in the context of machine learning.
- How the ground truth for the training set was established: Not applicable. This device does not use a training set.
Summary of the study/submission:
The provided document is a 510(k) Premarket Notification for the Glo-Spec™ Connector, Vaginal Speculum. The "study" concept here is not a clinical performance study with statistical metrics, but rather a demonstration of substantial equivalence to a predicate device (Welch Allyn's Kleenspec). The acceptance criteria are primarily based on qualitative and objective comparisons of intended use, materials, manufacturing processes, and design features with the predicate device. The "performance summary" states that the device is "constructurally equivalent" to existing predicate devices that have undergone millions of applications, implying its safety and effectiveness are established through the history of its predicate.
§ 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.