(42 days)
for collecting vaginal and cervical cell samples for cytological evaluation and infection diagnosis. The device is not indicated for endometrial cell sampling or for use on pregnant patients.
The Detect™ Cytology Brush II is a one-time use device for collecting vaginal and cervical cell samples for cytological evaluation and infection diagnosis. The device is not indicated for endometrial cell sampling or for use on pregnant patients. The materials of construction have undergone biocompatibility testing and met the requirements of the tests. Testing was also conducted to characterize the performance and integrity of the device. Results were comparable to those obtained when similarly testing a predicate device.
This 510(k) Premarket Notification for the Detect Cytology Brush II is a pre-amendment filing from 1996. It falls under a different regulatory framework than modern medical devices that rely on extensive clinical studies and AI performance metrics.
Therefore, the requested information regarding "acceptance criteria" based on device performance, "study that proves the device meets the acceptance criteria," "sample sizes," "expert ground truth," "adjudication methods," "MRMC studies," "standalone performance," and "training set details" is not applicable to this document.
This document describes a medical device, a cytology brush, that is substantially equivalent to predicate devices already on the market at the time. The 510(k) pathway for this type of device in 1996 primarily focused on:
- Indications for Use: Ensuring the new device is intended for the same purpose as existing devices.
- Technology/Design: Demonstrating that the technology and design are similar to already approved devices.
- Safety (Biocompatibility): Confirming that the materials used are safe for human contact.
- Performance and Integrity (Bench Testing): Showing that the device functions as intended and is robust, often through comparison to a predicate device in controlled lab settings.
- Manufacturing and Quality Assurance: Describing the processes in place to ensure consistent product quality.
Here's a breakdown of what can be extracted from the document in relation to your questions, and why most of your requested fields are not applicable:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for human contact. | "The materials of construction have undergone biocompatibility testing and met the requirements of the tests." |
| Performance and Integrity: Device effectively collects cell samples and maintains structural integrity. | "Testing was also conducted to characterize the performance and integrity of the device. Results were comparable to those obtained when similarly testing a predicate device." |
| Substantial Equivalence to Predicate: Similar indications for use and design. | "This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalency." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document describes bench testing and comparison to a predicate device, not clinical studies with human participants that would involve "test sets" for performance evaluation in the context of diagnostic accuracy. The "testing" mentioned refers to internal engineering and materials testing.
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):
- Not applicable. See point 2. No clinical "test set" requiring expert ground truth in the diagnostic sense was used for this premarket notification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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 device is a manual cytology brush, a physical instrument. It does not involve AI or human "readers" in the context of image interpretation or diagnostic effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this device involved engineering specifications and material science for biocompatibility and mechanical performance, and a comparison to an existing predicate device for functional equivalence. It doesn't relate to diagnostic accuracy ground truth.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, and therefore has no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This device does not use machine learning or AI, and therefore has no "training set."
In summary: The provided document is a 510(k) summary for a relatively simple, non-AI manual medical device from 1996. The regulatory requirements and the type of evidence presented are fundamentally different from what would be expected for a diagnostic AI device today.
§ 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.