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For patients requiring fetal heart rate monitoring during labor.

The device consists of a stainless steel spiral needle electrode. It is fixed to the fetal scalp by penetration of the skin by the spiral needle and thereby obtains the fetal ECG signal. A guide tube and a drive tube are required to place the electrode and are then removed before monitoring is begun. A stainless steel reference electrode is included close to the body housing the spiral electrode. The electrode is connected to the fetal monitor using a reusable adapter cable. A disposable maternal reference electrode connection is built into the adapter cable.

The provided text is a 510(k) summary for a Fetal Spiral Electrode. While it mentions safety and effectiveness, it does not contain a detailed study report that proves the device meets specific acceptance criteria.

The document primarily focuses on establishing substantial equivalence to previously marketed devices based on shared intended use, basic technological characteristics, and material biocompatibility. It states that "The laboratory testing verified the performance," but it does not provide details of this testing, specific performance metrics, or acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and expert involvement cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

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

   • Acceptance Criteria: Not explicitly stated in terms of measurable performance parameters. The general acceptance criterion is "safety and effectiveness are similar to existing devices" and "performance verified by laboratory testing."
   • Reported Device Performance: Not provided with specific metrics or results. The document states "Effectiveness is the same as the predicate devices" and "The laboratory testing verified the performance," but without any quantitative data to support this.

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

   • Sample Size (Test Set): Not mentioned. "Laboratory testing" is referenced, but no details about participants or test cases.
   • Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

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 mentioned, as no specific clinical study with ground truth establishment is detailed.

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

   • Not mentioned.

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 a physical medical device (Fetal Spiral Electrode), not an AI/software device. Therefore, MRMC studies or AI assistance are not relevant to this submission.

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

   • No. Not applicable to this type of physical device.

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

   • Not mentioned, as no detailed clinical study with ground truth is provided. The evaluation appears to be based on "laboratory testing" for performance and biocompatibility.

8. The sample size for the training set:

   • Not applicable, as this is not an algorithm/AI device that requires a training set. The device's "effectiveness" is stated as being "the same as the predicate devices."

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

   • Not applicable.

In summary, the provided 510(k) notification focuses on demonstrating substantial equivalence to predicate devices through similarities in intended use, technological characteristics, materials, and general safety/effectiveness claims based on internal laboratory testing (the details of which are not disclosed in this summary). It does not present a detailed clinical study with specific acceptance criteria, performance metrics, ground truth establishment, or expert involvement in the way an AI/software medical device submission might.

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These catheters are for use on patients requiring gastrointestinal manometry testing. The Esophageal Pressure Catheter Model number GIM-6000E is for use with esophageal motility studies. The Ano-Rectal Pressure Catheter Model number GIM-6000A is for use in ano-rectal pressure studies.

Gastrointestinal pressure catheters with pressure-sensing membrane cavities along the length of the catheter and a port for balloon inflation for the Anorectal model. This product is non-sterile, single patient use catheter. The system includes reusable cables with reusable pressure transducers.

This appears to be a 510(k) premarket notification summary for the Latitude GI Pressure Catheters, not a comprehensive clinical study report. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, and expert adjudication will likely not be present. However, I will extract what can be found and explicitly state what is not provided.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, it implicitly states that "Effectiveness is the same as the predicate devices." and that "The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance."

Observation: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific numerical performance targets.

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

The document states "laboratory testing" was conducted, but it does not provide any details on:

• The sample size used for any test set (e.g., number of catheters, number of measurements).
• Data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The "laboratory testing" would typically involve technical experts, but their number and qualifications are not mentioned. Since this is a physical device, ground truth wouldn't typically be established by human experts in the same way as with an imaging AI model.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of "laboratory testing" for a physical medical device, human adjudication a medical sense (like 2+1 reading) is not applicable. The testing would be against established calibration standards or engineering specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this summary. This type of study is typically used for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes a physical pressure catheter, not an AI system that assists human interpretation.

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

Yes, the "laboratory testing" implicitly represents a standalone performance evaluation of the device. The device itself (the catheter and its associated pressure transducers) is the "algorithm" in this context, and its performance was "verified" in a lab setting, meaning without real-time human clinical intervention beyond operating the test equipment. However, it's crucial to understand this isn't an AI "algorithm" in the modern sense.

7. Type of Ground Truth Used

For the laboratory testing, the ground truth would have been established by:

• Engineering Standards / Calibration Reference: For sensor accuracy, the device's readings would be compared against a known, highly accurate pressure reference source.
• Mechanical Specifications: For mechanical integrity, the device would be subjected to tests (e.g., tensile strength, fatigue, material composition) to ensure it meets predetermined engineering specifications for physical properties and durability.
• Biocompatibility Standards: For biocompatibility, tests would be conducted according to ISO or other relevant standards, comparing cellular responses or material characteristics against established safety profiles.

8. Sample Size for the Training Set

This concept is not applicable as this is a physical medical device, not a machine learning model that requires a training set.

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

This concept is not applicable for the same reason as above.

Summary of what's provided for acceptance criteria and study:

The document serves as a 510(k) summary demonstrating substantial equivalence. It states that laboratory testing was performed to verify sensor accuracy, mechanical integrity, and overall performance, and that biocompatibility testing was done. The overarching acceptance criterion is that the device's performance (effectiveness and safety) is "the same as the predicate devices." No quantitative performance metrics, specific study designs, sample sizes, or details about the ground truth establishment for these specific tests are provided beyond a general statement of verification.

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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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Demarcation of the cervical/vaginal junction during laparoscopy, laparoscopic-assisted vaginal hysterectomy, laparoscopic bladder surgery and other laparoscopic procedures where delineation of the junction is desired.

The Colpo cup is an accessory to the ClearView Uterine Manipulator that is used to demarcate the cervical/vaginal junction during laparoscopy. This product is a sterile, single patient use device.

Here's a breakdown of the acceptance criteria and study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "clinical evaluation" and "clinical trials" but does not explicitly mention the sample size or the country of origin for these clinical studies. It also doesn't specify if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The document refers to "clinical evaluation" and "clinical trials" but does not detail how the ground truth for these evaluations was established, nor does it mention the number or qualifications of experts involved.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document describes clinical trials comparing the Colpo Cup to a predicate device, focusing on "ease of use" and "device retention," but not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No, a standalone algorithm-only study was not performed. The Colpo Cup is a mechanical medical device, not an AI or algorithm-based product.

7. The Type of Ground Truth Used

The ground truth for the effectiveness claims ("ease of use" and "device retention") appears to be based on clinical evaluation/observation during "clinical trials," comparing the device's performance directly to the predicate device. For safety, it was based on laboratory testing and clinical evaluation.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Colpo Cup is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable and not provided, as there is no training set for this type of device.

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This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.

An intrauterine pressure catheter with a pressure-sensing membrane cavity at the tip (either inside the catheter or mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. This product is a sterile, single patient use catheter. The system includes a reusable cable with a reusable pressure transducer.

The provided 510(k) summary for the Koala Intrauterine Pressure Catheter focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria through a specific performance study against defined metrics. Therefore, the information requested for a detailed acceptance criteria study is largely not present in the provided text.

However, based on what is available, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Disclaimer: The document states that effectiveness is "the same as the predicate devices." This implies that the performance of the Koala IPC is expected to meet the established performance levels of the legally marketed predicate devices, but these specific levels are not quantified in this summary.

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

• Sample Size: Not specified. The document mentions "clinical testing" but does not provide details on the number of patients or samples.
• Data Provenance: Not specified, but "clinical testing" generally implies prospective data collected from patients. The country of origin is not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Not specified. The document only generically mentions "clinical testing."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study is not indicated or described in the provided text. This device is a measurement catheter, not an imaging interpretation or diagnostic aid system that typically involves human readers. The clinical testing mentioned would likely involve comparing pressure readings against a reference standard or assessing clinical outcomes, rather than human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Yes, in a sense. The document states "The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance." This "laboratory testing" would represent a standalone evaluation of the device's technical specifications and function without direct human interpretation in the loop (beyond operating the equipment). However, it's not an "algorithm" in the typical sense of AI/software.

7. The Type of Ground Truth Used

• The ground truth for sensor accuracy would typically be established against a highly accurate reference pressure measurement system in a laboratory setting.
• For mechanical integrity, ground truth would be against engineering specifications and failure criteria.
• For the "clinical testing" mentioned, the ground truth would likely be physiologic pressure measurements and/or clinical outcomes. Specific details are not provided.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical catheter with a pressure sensor; it is not described as having an AI algorithm that requires a "training set" in the machine learning sense. The "training set" concept is therefore irrelevant to the reported evaluations.

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

• Not applicable, as there is no "training set" for this device.

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This accessory is used with a Koala Intrauterine Pressure System and is used in priming the catheter.

The pre-filled Syringe is 10 cc syringe filled with 0.9% isotonic saline and is an accessory to the Koala Intrauterine Pressure System used in priming the catheter. This product is a sterile, single-use device.

This submission is for a medical device (pre-filled syringe) and does not involve AI/ML. Acceptance criteria and study details as requested for AI/ML devices are not applicable.

Here's a summary of the information provided in the document:

Device: Pre-filled Syringe for Koala Intrauterine Pressure Catheter

Intended Use: To prime the catheter in an intrauterine pressure monitoring system.

Predicate Devices: Pre-filled syringes used with the Medex MX 4042 Series Intrauterine Pressure Catheter and the Quest (formerly Healthdyne Cardiovascular) ISOFLO Intrauterine Pressure Monitoring & Amnio.

Basis for Substantial Equivalence:

• Same intended uses: Priming catheters in intrauterine pressure monitoring.
• Same basic technological characteristics: A syringe pre-filled with saline.
• Same or similar materials: All materials are biocompatible and function well in the intended application.

Safety and Effectiveness Documentation:

• Safety and effectiveness are similar to existing devices as demonstrated in the laboratory.
• Biocompatibility testing shows that the materials used in the pre-filled syringe are safe for this application.
• Effectiveness is stated to be the same as the predicate devices.

Regulatory Classification: Class II, 21 CFR §884.2700, Product code: 85 HFN.

Note: The document is a 510(k) summary for a relatively simple medical device (a pre-filled syringe). It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and materials, rather than detailed performance metrics or clinical study data typically associated with more complex or AI-driven devices. Therefore, many of the specific questions regarding acceptance criteria and studies (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone performance for AI) are not applicable to this type of submission.

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This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.

STORC™ is a Disposable Intrauterine Pressure Monitoring System. This product is a sterile, single patient use catheter.

This document, K954952, describes a 510(k) premarket notification for a medical device called the STORC Intrauterine Pressure Catheter. The submission aims to demonstrate substantial equivalence to predicate devices already on the market.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a quantitative table of acceptance criteria with specific thresholds (e.g., "accuracy > 95%"). Instead, it
qualitatively describes areas where the STORC catheter's performance was compared to predicate devices.

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

The document mentions "clinical studies" and "clinical trials" but does not specify the sample size for the test set (number of patients or cases).

The provenance of the data is limited to "clinical studies" and "laboratory testing." It does not specify the country of origin of the data or explicitly state whether the clinical data was retrospective or prospective. Given the context of a 510(k) for a new device, it is most likely that the clinical studies were prospective.

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

The document mentions "physician evaluation" as part of the safety verification in clinical studies. However, it does not specify the number of experts used to establish ground truth for the clinical effectiveness assessments, nor does it detail their specific qualifications (e.g., "obstetrician with X years of experience").

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the assessment of the clinical studies. The mention of "physician evaluation" suggests subjective assessment, but the process for resolving discrepancies or reaching consensus is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focuses on comparing the device's performance to predicate devices, but there's no indication of a structured MRMC design to measure human reader improvement with or without AI assistance, as AI is not a component of this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the STORC Intrauterine Pressure Catheter is a physical medical device, not an AI algorithm. Therefore, there is no "algorithm-only" performance to assess.

7. The Type of Ground Truth Used:

For safety, the ground truth appears to be based on:

• Bench testing results (e.g., direct measurement of perforation likelihood on fresh placenta).
• Clinical physician evaluation (qualitative assessment of safety in a real-world setting).
• Biocompatibility test results from an independent lab.

For effectiveness, the ground truth appears to be based on:

• Clinical trial results and physician evaluation: Assessing attributes like signal integrity, ease of use, access, retention, and signal stability, likely through direct observation, patient outcomes, and user feedback.
• Laboratory testing: Verifying sensor accuracy and overall performance against established standards for pressure measurement.

8. The Sample Size for the Training Set:

This question is not applicable as the STORC Intrauterine Pressure Catheter is a physical medical device. It does not use machine learning or AI, and therefore, there is no "training set" in the context of data used to train an algorithm.

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

This question is not applicable for the same reason as point 8.

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