(86 days)
The intended uses are interconnection of devices for transmission of light, hold suction tubes and instruments.
The devices are made of injected molded parts. Does not require assembly (simple product). Has vents to allow heat to escape. No contact with body surfaces. Has interlocking cone for device attachment. The device is for single use only.
The provided text describes a medical device called "Glo-Spec I, II and III," which are connectors for medical devices, primarily used for transmitting light and holding suction tubes and instruments. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance metrics.
Therefore, many of the requested elements for a rigorous device performance study are not explicitly stated or applicable in this 510(k) summary. The document does not describe a performance study with numerical acceptance criteria and results in the way a clinical trial might. Instead, it relies on a comparison to a predicate device.
Here's an analysis based on the provided text, addressing the points where information is available or inferable, and explicitly stating when information is not provided.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of numerical acceptance criteria. Instead, the acceptance criteria are implicitly based on demonstrating substantial equivalence to a predicate device, the Welch Allyn Kleenspec, and other devices. The "performance" is summarized as being "constructurally equivalent" and complying with "all acceptance criteria listed above" (referring to the characteristics listed under "Physical/Technical Comparison").
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Glo-Spec I, II and III) |
|---|---|
| Same intended use of transmitting light, hold suction tubes and instruments | Yes, meets this. |
| Manufactured through injection molding | Yes, made of injected molded parts. |
| Made with same materials | Yes, made with same materials. |
| Maintain same rigidity of part | Yes, maintains same rigidity. |
| Both have clear plastic | Yes, has clear plastic. |
| Both have windows that allow heat to escape | Yes, has vents to allow heat to escape. |
| Does not alter the utilization, safety or efficacy of the predicate device (when afforded light for visualization) | Yes, "Does not alter the utilization, safety or efficacy of the Nu-Spec D while affording light for visualization." |
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 provided. The submission relies on a comparison to "millions of applications" of predicate devices, implying a general understanding of the predicate's performance rather than a specific test set for the Glo-Spec.
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 information is not provided. As no specific test set or clinical study is detailed, the concept of expert-established ground truth for a test set is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. There is no described test set or adjudication process.
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
An MRMC study was not done. This device is a passive connector, not an AI-assisted diagnostic tool or an imaging device for which MRMC studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done or described. This device is a physical connector, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in diagnostic device studies is not applicable here. The performance is assessed based on functional equivalence to predicate devices, which are assumed to be safe and effective based on their established market history ("millions of applications").
8. The sample size for the training set
This information is not provided. There is no training set mentioned as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not provided. As there is no training set, this is not applicable.
§ 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.