(78 days)
Vacuum Extractor Cup used in child birth
The new product is an improved vacuum extractor The improvement is found in the location of the vacuum tubing attachcup. ment point and vacuum release valve.
The provided text is a Premarket Notification (510k) Summary for a medical device from 1997. It describes a "Vacuum Extractor Cup" and an "improved vacuum extractor". However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/software as a medical device (SaMD) submission would.
Instead, it focuses on:
- Description of the device: A vacuum extractor cup with improvements in tubing attachment and vacuum release valve.
- Comparison to a predicate device: K890307 Mityvac Vacuum Extractor with release valve. It states the cup and stem are substantially equivalent, but the tubing attachment and release valve are different.
- Intended Use: Vacuum Extractor Cup used in childbirth to assist vaginal delivery.
- "Non-Clinical Performance Data": This is described as a "survey distributed to a select group of physicians in nine states. They indicated this improvement was needed in the vacuum delivery product."
Based on the provided information, I can answer some points by stating the information is not present or not applicable in the context of a modern device study.
Here's the breakdown of the information requested, as it relates to the provided 1997 document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document does not specify any quantitative or qualitative acceptance criteria for device performance. | Not provided. The document states a survey indicated "this improvement was needed" and presents unquantified claims of improved safety, reduced delivery time, and an improved cup. |
2. Sample size used for the test set and the data provenance
- Sample Size: A "select group of physicians" was surveyed. The exact number is not stated.
- Data Provenance: The survey was conducted in "nine states" (country of origin likely USA, given the 510k context). The data is retrospective in the sense that it's based on opinions about a needed improvement, not prospective data from a clinical trial with the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified beyond "a select group of physicians."
- Qualifications: "Physicians." No further details on their specialties or experience levels are provided.
- Note: This "survey" is not establishing ground truth in the way a clinical study would for a diagnostic or AI device. It's capturing opinions on product needs.
4. Adjudication method for the test set
- None. The document describes a survey of physician opinions, not a test set requiring adjudication of device performance or ground truth.
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
- No. This is not applicable. The device is a physical vacuum extractor cup, not an AI/SaMD diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used
- Not applicable. No formal "ground truth" (e.g., pathology, expert consensus, outcomes data) was established for the performance claims. The "non-clinical performance data" is physician opinion on the need for an improvement, not a measure of the device's actual safety or efficacy.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device submission, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device submission.
Summary of the Study (as described in the document):
The "study" referenced in this 510k summary is a non-clinical survey of physicians' opinions. It aimed to ascertain if improvements were desired in existing vacuum delivery products. The document presents the survey findings as evidence that the new product's features (tubing attachment and release valve location/design) address these identified needs. It then makes claims about the new product's potential benefits (increased safety, reduced delivery time, improved cup for physician) based on the belief that these design changes will lead to those outcomes, seemingly inferred from the physician feedback about needed improvements. This is not a study with quantitative acceptance criteria or clinical performance data in the modern sense.
§ 884.4340 Fetal vacuum extractor.
(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).