(59 days)
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
The Cervilenz Measuring Sound is a single use, disposable device used for measuring the depth and/or length of the uterus, cervix and vagina. The operating principle of the Cervilenz Measuring Sound is the same as that of cleared, commercially-available uterine sounds, and is based on insertion of the device into the cervical canal in order to obtain measurements. The Cervilenz Measuring Sound is fabricated from medical grade plastics of known biocompatibility and with a history of human use.
The provided text describes a 510(k) premarket notification for the "Cervilenz Measuring Sound," a single-use, disposable device for measuring the depth and/or length of the uterus, cervix, and vagina.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
Acceptance Criteria and Device Performance:
The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be within X mm"). Instead, it states the device was evaluated for its "accuracy and reproducibility of measurements" and found to perform "equivalently to commercially-available uterine sounds."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy of measurements equivalent to predicate devices | Found to perform equivalently to commercially-available uterine sounds. |
| Reproducibility of measurements equivalent to predicate devices | Found to perform equivalently to commercially-available uterine sounds. |
| No new issues of safety, effectiveness, or product performance | Technological changes do not raise any new issues of safety, effectiveness, or performance. |
Study Details:
The provided text offers very limited information about the study itself. It states "Brief summary of nonclinical tests and results: The Cervilenz Measuring Sound was found to perform equivalently to commercially-available uterine sounds when evaluated for accuracy and reproducibility of measurements."
Here's what can be extracted and what is not provided:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and 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 physical measuring sound, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not an algorithm. However, the "nonclinical tests" likely represent a standalone evaluation of the device's physical properties and measurement capabilities.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For a measuring sound, ground truth would likely be established through:
- Comparison to a highly accurate reference standard measurement tool.
- Known physical dimensions of objects being measured.
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The sample size for the training set: Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established: Not applicable.
Summary of Device Performance Claim:
The core claim is that the Cervilenz Measuring Sound performs equivalently to predicate uterine sounds in terms of accuracy and reproducibility. This equivalence is presented as sufficient proof that the device meets safety and effectiveness requirements, as its technological characteristics (dimensions, materials, operating principle) are also comparable and do not raise new safety or performance concerns. The specific details of the nonclinical tests conducted to support this equivalence are not provided in this summary.
§ 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.