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The Medela® Single Use Silc Cup is intended to be used to facilitate the delivery of the fetus during childbirth. 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. It is larmedd by an external vacuum source and indicated for using during vaginal or cesarean delivery.

The Indications for use are

• Fetal distress in the second stage
• Maternal delay in the second stage
• Maternal conditions requiring a short second stage

The Medela® Single Use Silc Cup is a sterile, disposable device made of an elastomer and available in one size, 60mm inner diameter. The instrument is elastomer and consists of a handle and a suction cup to be used with an external vacuum pump and tubing.

The cup has a smooth external surface with a small longitudinal ridge, which makes it possible to observe any rotation. The inside of the cup is lined with mance it possible to objections enable the air between the cup and the child's Small projoctions: The projections that the cup sucks firmly against the child's head. The soft suction cup deforms, thereby ensuring optimal adhesion and minimizing trauma to the fetal scalp.

The provided text describes a 510(k) submission for the Medela Single Use Silc Cup, which is an Obstetrical Vacuum Delivery System. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing new acceptance criteria or proving performance through a new clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The core of this 510(k) submission is to assert that the Medela Single Use Silc Cup is substantially equivalent to legally marketed predicate devices, meaning its technological characteristics and intended use are similar enough that it does not raise new questions of safety and effectiveness.

Here's what can be extracted from the document based on your request, with the caveat that many points cannot be addressed due to the nature of a 510(k) submission for substantial equivalence:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than setting new acceptance criteria and reporting performance against them for this specific device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set data or sample sizes are mentioned. The submission relies on the established safety and effectiveness of predicate devices.

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. No new test set data requiring ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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 not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The submission relies on the established safety and effectiveness of predicate devices, not new ground truth data for this device.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the document's argument for meeting "acceptance criteria":

The "acceptance criteria" in this context are primarily the regulatory requirements for Substantial Equivalence under 21 CFR 884.4340, a Class II medical device. The study that "proves" the device meets these criteria is the comparison to predicate devices and the assertion that "The Technology of the Medela® Single Use Silc Cup is identical to the predicate... There are no technical differences which would raise new aspects regarding safety and effectiveness."

The key points of the submission are:

• Device Name: Medela® Single Use Silc Cup, Fetal Vacuum Extractor
• Common Name: Obstetrical Vacuum Delivery System
• Classification Name: Fetal Vacuum Extractor, Obstetrical and Gynecological Surgical (Class II, per 21 CFR Section § 884.4340)
• Predicate Devices:
  • Medela Inc. OB Vacuum Extractor (K841492)
  • Hollister Inc. Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor (K895700)
• Technological Characteristics: The submission explicitly states, "The Technology of the Medela® Single Use Silc Cup is identical to the predicate... There are no technical differences which would raise new aspects regarding safety and effectiveness."
• Biocompatibility: The materials are considered appropriate for their intended use.
• Conclusion: Based on the information presented, it is concluded that the proposed device is safe and effective for its intended use and is substantially equivalent to the predicate devices.

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The VacuLink is intended for obstetric use in the measurement and recording of data related to vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart.

The VacuLink is a small, battery powered single-use vacuum measuring device. It is connected in parallel to the vacuum chamber of commercial handheld vacuum assisted delivery systems (i.e. Mityvac & Kiwi PalmPump). As a redundant gauge to the vacuum gauges on those devices, it electronically measures the vacuum applied to the fetal head during a vacuum assisted delivery. It connects to the vacuum port of the maternal/fetal monitor (i.e. HP, Corometrics and Spacelabs) via electrical cable. The vacuum value is numerically displayed in centimeters of mercury (cm Hg). The vacuum value is also recorded from the uterine activity channel of the maternal/fetal monitor and it is permanently stored in the hospital database. The information may also be displayed on a video monitor as well.

The VacuLink incorporates a light sequence of red, yellow, and green. When the VacuLink is first connected to the maternal/fetal monitor, all three lights will flash in sequence as a quick test of the internal components. At the successful completion of the test, the green LED illuminates until the VacuLink is disconnected from the maternal/fetal monitor. A flashing yellow LED illuminates when the battery voltage is low and the VacuLink should be replaced. If a VacuLink that has been used previously and is reconnected, the red LED illuminates indicating the VacuLink is no longer operational.

Here's an analysis of the provided text regarding the VacuLink device, focusing on acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on the device's accuracy and comparison to predicate devices, rather than explicitly listing "acceptance criteria" as pass/fail thresholds for a primary clinical endpoint. The "Claimed accuracy/tolerance" is presented as a characteristic of the device itself, which then needs to be demonstrated. The comparative accuracy against existing devices could be considered an acceptance criterion for market clearance.

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

• Sample Size (Clinical Phase): Not explicitly stated. The document mentions an "Initial clinical phase (feasibility study)" but does not provide details on the number of subjects or cases included in this study.
• Data Provenance: Not explicitly stated. Given that the device is manufactured by Medevco, Inc. in Dallas, TX, and the submission is to the FDA, it's likely the clinical feasibility study (if conducted with patients) was in the US. The nature of "Initial bench testing" and "Secondary bench testing" implies laboratory or engineering environments. It's a prospective study as implies "Initial clinical phase (feasibility study)" to study a new device.

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

Not explicitly stated. The document does not provide details on who established the "ground truth" for the clinical feasibility study, or if "ground truth" for vacuum measurements was established by a separate, highly accurate reference device independent of human interpretation.

4. Adjudication Method for the Test Set

Not explicitly stated. The document does not describe any expert adjudication process for the clinical feasibility study. For the bench testing, the "ground truth" would likely be established by a highly accurate, calibrated reference instrument, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The VacuLink is a vacuum measuring device, not an imaging or diagnostic device that typically involves human interpretation of results in an MRMC study. Its function is to provide an objective measurement (vacuum pressure) and record data. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant to this device.

6. Standalone Performance Study

Yes, a standalone performance study was done implicitly through the "Performance Data & Conclusions" section.

• The initial and secondary bench testing phases directly assess the standalone performance of the VacuLink device against certified reference instruments. The statement "Performance testing of VacuLink... reveals that the VacuLink is as accurate as the claimed accuracy" and "VacuLink was more accurate by a factor of 10" (in clinical use, compared to uncalibrated existing gauges) directly addresses its standalone measurement capability.
• The "Initial clinical phase (feasibility study)" would also have assessed its standalone functionality in a real-world setting, though specific data from this phase is not provided in detail.

7. Type of Ground Truth Used

• Bench Testing: Certified reference instruments (for vacuum measurement).
• Clinical Feasibility Study: Implicitly, the actual vacuum applied during an assisted delivery, as measured by the VacuLink and potentially compared to existing devices. The document highlights the "lack of calibration of the comparable vacuum gauges" in clinical use, suggesting the VacuLink aimed to provide a more reliable ground truth in that setting.

8. Sample Size for the Training Set

Not applicable. The VacuLink is a hardware device for measuring vacuum pressure and recording data. It is not an AI/ML-based device that requires a "training set" in the conventional sense. The "training" for such a device involves engineering design, component selection, and calibration, not machine learning model training on a dataset.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The accuracy of the device itself would be established through a rigorous calibration process using highly stable and accurate reference pressure gauges.

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The Silicone Vacuum Cup is to assist a clinician in delivery of an infant during childbirth.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (All Silicone Vacuum Suction) and does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The letter simply states that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The letter confirms substantial equivalence, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
6. If a standalone study was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document is a regulatory approval, not a clinical study report.

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Prism Enterprises, Inc.'s Mityvac® Merlin™ is intended to be utilized to assist a clinician in the delivery of an infant during childbirth. This device is indicated for use during vaginal delivery and Cesarean sections.

The Mityvac® Merlin™ System is a modification of the cleared Mityvac® MityOne™ System with M-Style® or MitySoft® Bell Cups (K011532). The primary difference between the Mityvac® Merlin™ System and the MityOne™ System is that the Merlin™ System utilizes a CO2 canister to create the energy for vacuum, while the MityOne™ uses a builtin hand driven pump as the energy source.

Let's break down the information about the Mityvac® Merlin™ Vacuum Assist Delivery System based on the provided document.

Acceptance Criteria and Device Performance

The provided document (K020447) is a 510(k) summary for a medical device. In this context, "acceptance criteria" and "device performance" are typically evaluated by establishing substantial equivalence to a predicate device, rather than explicit numerical performance metrics like sensitivity/specificity for a diagnostic AI model.

The core acceptance criterion for a 510(k) device is demonstrating that the new device is substantially equivalent in intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not applicable (N/A). This 510(k) submission for the Mityvac® Merlin™ is for a physical medical device (obstetrical vacuum assist delivery system), not an AI/ML-based device that would typically rely on a "test set" of data for performance evaluation in the way an AI model does.
• The evaluation is based on a comparison of the device's design, intended use, and technological characteristics to an existing predicate device (Mityvac® MityOne™). No specific patient "data" or "test set" in the computational sense is mentioned or implied.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. As explained above, this is not an AI/ML device, so there is no "ground truth" established by experts for a test set in this context. The FDA's review process itself involves expert evaluation by their staff, but this is an regulatory assessment, not a ground-truth labeling process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• N/A. No test set or associated adjudication is relevant to this type of device submission.

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:

• N/A. This is a physical medical device, not an AI-assisted diagnostic or treatment device. Therefore, an MRMC study is not applicable.

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

• N/A. This is a physical medical device; there is no "algorithm" or "standalone" performance in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• N/A. For this device, the "ground truth" for demonstrating safety and effectiveness relies on the legally marketed status and established safety/effectiveness profile of the predicate device (Mityvac® MityOne™). The manufacturer demonstrates that the new device is fundamentally similar and does not introduce new risks.

8. The sample size for the training set:

• N/A. No training set is relevant for this type of device.

9. How the ground truth for the training set was established:

• N/A. No training set is relevant for this type of device.

In summary, the provided document outlines a 510(k) submission for a physical medical device, not an AI/ML device. Therefore, many of the requested details concerning test sets, ground truth, experts, and AI-specific studies are not applicable to this type of regulatory submission. The device's "performance" and "acceptance" are determined through its substantial equivalence to a legally marketed predicate device based on its intended use and technological characteristics, as reviewed by the FDA.

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INDICATIONS FOR USE:

• 1. Non-reassuring fetal status.
• Failure of the fetus to deliver spontaneously following an appropriately 2. managed second stage.
• Maternal need to avoid voluntary expulsive effort. 3.
• 4. Inadequate maternal expulsive effort.
• Selective shortening of the second stage when the fetal head is at the outlet 5. as defined by ACOG technical bulletin # 196 Aug. 1994.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the Swift Low Profile Cup (Pro Cup) fetal vacuum extractor. It does not contain any information about acceptance criteria, device performance, or details of a study.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the provided text. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

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Use for fetal vacuum delivery assistance in conditions of: 1) dystocia, 2) uterine inertia, 3) maternal exhaustion (ineffective voluntary effort), or 4) maternal or fetal distress.

Standard vacuum extraction

Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions.

Trial of vacuum extraction

Vacuum delivery should be regarded as a "trial" 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known.

Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions. 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.

The Kiwi Complete Vacuum Delivery Systems are fetal vacuum extractors having a cup to attach to the fetal head, a handle with which to apply withdrawal force, and a vacuum pump built into the handle of the cup/handle combination. This palm pump includes a method for easily generating a vacuum by pumping the handle with the palm. A vacuum indicator and a vacuum relief valve are also integral to the palm pump. Two styles of cups are available; one of soft silicone (VFE-6000S) and the other of the Malmstrom design (VFE-6000M).

The provided text describes the Kiwi Fetal Vacuum Extractor and its 510(k) submission for market clearance. While it discusses the device's intended use, basic technological characteristics, and comparison to predicate devices, it does not provide detailed acceptance criteria or a specific study that proves the device meets such criteria.

The text generally states:

• "The safety and effectiveness are similar to existing devices as demonstrated in the laboratory and in clinical testing."
• "Biocompatibility testing shows that the materials used in the Kiwi Fetal Vacuum Extractors are safe for this application."
• "Effectiveness is the same as the predicate devices."
• "The laboratory testing verified the performance in terms of vacuum measurement and device integrity."

However, it lacks the specific data points to fill a comprehensive table of acceptance criteria and reported performance, nor does it detail the methodology, sample sizes, ground truth establishment, or expert involvement for the referred "clinical testing" or "laboratory testing."

Therefore, I cannot fulfill all parts of your request based on the provided input.

Here's what can be inferred and what is missing:

Acceptance Criteria and Study Details for Kiwi Fetal Vacuum Extractor

Missing Information: The provided document is a 510(k) summary and FDA clearance letter. It states that "clinical testing" and "laboratory testing" were performed to demonstrate safety and effectiveness similar to predicate devices, and that "laboratory testing verified the performance in terms of vacuum measurement and device integrity." However, it does not provide specific acceptance criteria, detailed results, study designs, sample sizes, or ground truth methodologies for these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Performance/Effectiveness (Inferred/General statements):

Note: Specific quantitative acceptance thresholds (e.g., vacuum pressure range, force limits, successful delivery rates) and actual measured performance values are not provided in this document.

The remaining sections cannot be addressed with specific details from the provided document as the information is not present.

2. Sample size(s) used for the test set and the data provenance

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective nature of the clinical/laboratory testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified, as details of clinical or laboratory study design are absent.

4. Adjudication method for the test set

• Not specified.

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/Not specified. This device is a physical medical instrument (fetal vacuum extractor), not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is a physical instrument for use by a clinician.

7. The type of ground truth used

• Not explicitly stated for the clinical or laboratory tests. For an interventional device like a vacuum extractor, ground truth would typically relate to successful delivery, Apgar scores, maternal/fetal complications, and physical integrity/functionality of the device.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

• Not applicable.

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The Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap is a sterile, single use, device intended to be connected to an externally powered fetal vacuum extractor to aid in vaginal or Cesarean delivery of term or near term infants. The Fluid Retention Trap is intended to collect fluids aspirated during the delivery procedure.

Indications For Use:

• Delay in second stage with the fetal head stationed at the outlet; on the pelvic floor; or in the . mid-pelvis.
• Delay in the second stage associated with borderline cephalopelvic disproportion .
• Fetal distress .
• Shortening of second stage labor for fetal or maternal benefit .
• Prolapse of the umbilical cord when the cervix is fully dilated ●

The purpose of this premarket notification is to add a fluid retention trap option to the current Ameda Disposable Vacuum Assist Cup in order to collect fluids that may be aspirated during the delivery procedure. The fluid retention trap consists of a housing segment that is constructed of high impact polystyrene and a polyurethane foam filter. The fluid retention trap, when used, is connected to the tubing of the device between the vacuum cup and the vacuum pump.

Here's an analysis of the provided text regarding the Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "laboratory testing" and "evaluations" for biocompatibility but does not provide specific sample sizes for these tests.
• Data Provenance: The studies were conducted by Hollister Incorporated and/or its material suppliers. The exact country of origin is not specified beyond "Libertyville, Illinois, USA" for Hollister. The studies described are retrospective in the sense that they are conducted on the device components or the assembled device to demonstrate its performance characteristics. They are not clinical trials involving human subjects to gather new prospective data on efficacy or safety in a clinical setting; rather, they aim to show equivalence to existing devices.

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

• Experts for Functional Performance: Not explicitly stated. For laboratory testing, the ground truth would be established by the testing methodology and measurements against predefined specifications. These specifications would likely be derived from industry standards, predicate device performance, or engineering requirements. The "experts" would be the engineers and technicians performing and interpreting these tests, presumably qualified in their respective fields.
• Experts for Biocompatibility: The assessment was "based on principles and guidelines established by various governmental and standard setting organizations, such as: ISO 10993, International Standard Organization (ISO) Standard; General Program Memorandum #G95-1, U.S. FDA Office of Device Evaluation; United States Pharmacopeia (USP)." The evaluations were contracted either by Hollister or the suppliers of the materials to "licensed commercial reference laboratories." The qualifications of the personnel at these laboratories would be in toxicology, material science, and regulatory compliance for medical devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated for any of the tests. For laboratory tests, the results would typically be objectively measured and compared to numerical criteria. For biocompatibility, the assessment would be based on established standards and expert interpretation of test results from commercial laboratories. There is no indication of a "2+1" or "3+1" type of expert adjudication process, which is more common in clinical image interpretation studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, there is no mention of an MRMC comparative effectiveness study involving human readers or AI. This submission is for a physical medical device (Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap), not an AI/imaging device. Therefore, the concept of "AI assistance" for human readers does not apply here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, this is not an AI/algorithm-based device. The "standalone" performance refers to the device's functional integrity as a physical product (e.g., fluid handling capacity, air flow resistance, biocompatibility) rather than an algorithm's performance. The laboratory tests performed are considered "standalone" in that they assess the device itself without direct human interaction as part of the test subject.

7. Type of Ground Truth Used

• Functional Performance: Ground truth was based on pre-defined engineering specifications, performance metrics (e.g., specific fluid volumes, air pressure differentials) established through internal R&D, and comparison to predicate device characteristics.
• Biocompatibility: Ground truth was based on established international (ISO 10993) and national (U.S. FDA, USP) standards and guidelines for biological safety of medical device materials, as well as historical data for biomaterials.
• Substantial Equivalence: Ground truth for comparison was the characteristics (intended use, materials, manufacturing processes, fluid collection capabilities) of legally marketed predicate devices (Ameda Dolphin Dispo-Soft Vacuum Extractor, Mityvac Extractor Cup System, Tender Touch).

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable in the context of this device and its testing. "Training set" typically refers to the data used to train a machine learning model. This document describes the evaluation of a physical medical device. While Hollister would have internal design and development processes with various iterations and tests that could be loosely considered 'training' for the device's design, it's not a "training set" in the machine learning sense. The laboratory testing and predicate device comparisons serve as the validation of the final design.

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

• Ground Truth for Training Set: Not applicable. As mentioned above, this is not an AI/ML development. The design and development of the device would have involved engineering principles, material science, and adherence to medical device regulations. The "ground truth" for the design validation (analogous to proving performance) was established through laboratory measurements and comparisons to predicate devices and standards.

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To facilitate delivery of a fetus during vaginal deliver

Prism's Mityvac and Gesco's Vac-U-Nate consist primarily of the following components: (1) a suction cup and shaft; and (2) handle and valve assemblies. Each device's cup and shaft have a positioning reference printed on them and the shaft has three molded ridges on it. Both devices have the same components. These components are composed of the same materials and processed in the same manner.

This is a 510(k) premarket notification for a medical device called Mityvac, an obstetrical vacuum cup. The submission aims to demonstrate substantial equivalence to a predicate device, Gesco International, Inc.'s Vac-U-Nate. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving device performance is not typically found in this type of submission.

Here's why and what information is available:

This document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study in the way you've outlined.

In a 510(k), the manufacturer argues that their new device is as safe and effective as a legally marketed predicate device. This is achieved by comparing the intended use, technological characteristics, and principles of operation. Clinical studies to establish new safety and effectiveness (and thus, acceptance criteria and performance data) are usually required for Premarket Approval (PMA) applications, which are for higher-risk devices or those without a substantially equivalent predicate.

Therefore, for this specific document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not define specific performance acceptance criteria for the Mityvac, nor does it report performance data from a study designed to meet such criteria. It states that the Mityvac has the "same intended use and very similar indications, principles of operation, and technological characteristics" as the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no test set or associated data mentioned for a novel performance study.

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, as there is no specific test set requiring expert ground truth establishment mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 physical obstetrical vacuum cup, not an AI or imaging device with "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the context of device performance studies is not relevant to this 510(k) submission.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

What the document does provide in lieu of a performance study is a "Summary Basis for the Finding of Substantial Equivalence":

• Comparison to Predicate Device:
  • Intended Use: Identical to the predicate device (Gesco's Vac-U-Nate) for facilitating fetal delivery during vaginal childbirth.
  • Indications for Use: Mityvac's only indication (vaginal delivery) is the same as one of the predicate device's indications.
  • Principles of Operation: Identical (connection to vacuum, cup insertion, attachment to fetal scalp, negative pressure application, traction, release/removal).
  • Technical Characteristics: Consist of the same primary components (suction cup, shaft, handle, valve assemblies), which are composed of the same materials and processed in the same manner.

This approach demonstrates that because the Mityvac is so similar to a device already deemed safe and effective, it can also be considered safe and effective without requiring a new, extensive clinical trial.

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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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