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The Indications For Use for this vacuum device in childbirth are the following:
Uterine inertia
Maternal Exhaustion - ineffective voluntary effort
Vertex Presentation
Engagement of the Head
Optional:
A. Maternal distress
B. Fetal distress

The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point, vacuum release valve and an adaptor for electric vacuum pumps.

The provided text describes a 510(k) premarket notification for a medical device, the "Swift Delivery Product #003 - Vacuum Extractor Cup." This submission is focused on demonstrating substantial equivalence to a predicate device (K970170). Therefore, the information provided primarily concerns the modifications made to the device and the rationale for their safety and effectiveness, rather than a rigorous study with formal acceptance criteria and statistical performance measures typically associated with new technology.

Based on the provided text, a formal study with defined acceptance criteria and performance metrics, as one would find for a novel AI or diagnostic device, was NOT conducted. The submission relies on a comparison to a predicate device and a survey of physicians to justify the improvements.

Here's a breakdown based on your requested information, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense of a new device performance study. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate device K970170.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: Not explicitly stated as a formal "test set" for performance evaluation.
  • A "survey was distributed to a select group of physicians in nine states." The exact number of physicians who responded or were part of this "select group" is not provided.
• Data Provenance: Retrospective (based on physician opinions about potential improvements to existing products). Country of origin is the United States (nine states mentioned).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. There was no "ground truth" to establish in the context of a performance study for this type of device submission. The "experts" were the "select group of physicians" surveyed, and their qualifications are generally described as "physicians," implying medical doctors who use vacuum extractors in practice. No specific years of experience or sub-specialty (e.g., OB/GYN) are detailed.

4. Adjudication Method for the Test Set

Not applicable. No formal test set or adjudication method was used. The "conclusions" were drawn from the collective opinions gathered in the survey.

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 is not an AI/software device. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of a formal performance study. The "ground truth" for the claims made (e.g., increased safety, reduced delivery time, improved cup) is based on the subjective opinions and perceived needs of the surveyed physicians. There is no objective, independently verified ground truth such as pathology, clinical outcomes, or expert consensus on specific cases.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this device. It is a modification of an existing physical medical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth for it.

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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

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.

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