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Koala Intrauterine Pressure Catheter is indicated for use on patients requiring intrapartum intrauterine pressure monitoring.

The Koala Intrauterine Pressure Catheter is a disposable, sterile, single patient use intrauterine pressure monitoring catheter, designed for measurement of intrauterine contraction pressures. The catheter is designed with a pressure-sensing membrane cavity at the tip (mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. The Koala Intrauterine Pressure Catheters utilizes a reusable cable with a reusable pressure transducer which is connected at the other end of the device. The sensor, located on the tip of the catheter is a 360° sensor that registers pressure in all directions. The tip is made of soft, malleable urethane. There are no electronics in the catheter. Clinicians can disconnect the catheter while it is in the uterus and zero the monitor while the transducer is exposed to atmospheric pressure, providing a true zero reading. The Koala Intrauterine Pressure Catheter has two different, clear lumens, one for the amnioinfusion, to confirm proper placement via amniotic fluid flashback, and another channel for sensor-charging. The amnioinfusion port has a hydrophobic and a tethered replacement cap.

The FDA Clearance Letter for the Koala Intrauterine Pressure Catheter (IPC-5000E) indicates that the device has met the requirements for substantial equivalence to a predicate device. However, the provided document does not contain information about clinical studies with specific acceptance criteria, sample sizes for test/training sets, or expert involvement for ground truth adjudication, particularly in the context of AI/ML performance. This is because the device is a physical medical device (catheter) for measuring intrauterine pressure, not an AI/ML-driven software device.

Therefore, many of the requested points related to AI/ML performance evaluation (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this specific device as described in the provided clearance letter.

The document focuses on demonstrating substantial equivalence through:

• Comparison of intended use and technological characteristics with a predicate device.
• Non-clinical performance tests, including biocompatibility, sterility, shelf-life, and functional testing.

Below is a table summarizing the functional acceptance criteria that were met by the device during non-clinical testing, as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

While the document doesn't explicitly list a "table of acceptance criteria" with numerical values alongside "reported device performance" in the typical AI/ML sense (e.g., sensitivity/specificity targets), it states that "All device samples met their acceptance criteria" for various functional tests. These functional tests are the "performance" demonstrated.

• Package Integrity (ASTM F1929-15, ASTM F88/F88M-21, ASTM F1886/F1886M-16) | Maintained package integrity and functional performance for proposed 6-month shelf-life. All samples met acceptance criteria. |
  | Functional Testing | Simulated Use (Balloon Pressure, Tip Pull-off force, Monofilament removal) | Functions as intended. All samples met acceptance criteria. |
  | | Pressure Accuracy | Functions as intended. All samples met acceptance criteria. |
  | | Leak Rate/Membrane Integrity | Functions as intended. All samples met acceptance criteria. |
  | | T-connector Bond Strength | Functions as intended. All samples met acceptance criteria. |
  | | Tip Bond Strength | Functions as intended. All samples met acceptance criteria. |
  | | Catheter Flexibility | Functions as intended. All samples met acceptance criteria. |
  | | Introducer Peel-force | Functions as intended. All samples met acceptance criteria. |
  | Performance Specifications | Operation Pressure Range | -50 to +150mmHg (Same as predicate) |
  | (with reusable cable) | Over-pressure Protection | -400 to +1200 mmHg (Same as predicate) |
  | | Operating Temperature | 15º C to 40º C (Same as predicate) |
  | | Amnio Lumen Flow | Min. 20 cc/min at a pressure of 65 mmHg (Same as predicate) |

Note: The phrase "All device samples met their acceptance criteria" is used consistently, indicating successful performance against predetermined thresholds, even if numerical specifics for each functional test aren't detailed in this summary.

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

• The document mentions "All device samples" for functional and shelf-life testing without specifying exact numerical sample sizes per test. These were non-clinical bench and material tests, not human patient data or a clinical test set in the AI/ML context.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests conducted are laboratory-based, demonstrating physical and material properties of the device.

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

• Not applicable. The ground truth for this medical device (a catheter) is established through engineering specifications, material science, and established international standards (e.g., ISO, ASTM). It does not involve expert readers adjudicating clinical "ground truth" to evaluate an algorithm's performance on patient data.

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

• Not applicable. This applies to expert review of clinical cases, which was not part of this device's non-clinical testing.

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 medical instrument, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

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

• Not applicable. This device is not an algorithm; it is a physical catheter designed for direct measurement.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on engineering specifications, material properties, and adherence to established international and national standards (e.g., ISO 10993 for biocompatibility, ISO 11737 for sterility, ASTM standards for package integrity and material testing). It's a "known" physical and chemical standard, not derived from expert consensus or patient outcomes data in a diagnostic sense.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device's design is based on engineering principles and previous iterations (as indicated by the predicate device K974389).

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

• Not applicable. See point 8.

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The babyLance safety heelstick is a single-use incision device used to obtain a blood sample from the heel of a neonate or infant. babyLance has a sharps prevention feature to protect the user from a needlestick injury.

The babyLance™ safety heelstick is a sterile, single-use device designed to be a one-handed, automated incision device for use in heel sticks of newborn and neonatal infants (also called preemie infants). A heel stick is a procedure in which a newborn baby's heel is pricked for blood collection for use in newborn screening tests.

The babyLance™ is constructed with a Nylon housing which holds the stainless-steel cutting blade and deployment mechanism. The babyLance™ has a sharps prevention feature to protect the user from a sharps injury. It is supplied in a sterile polypropylene tray with a Tyvek™ lid.

The outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. The user breaks off the trigger lock from the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision. Once the blade has been triggered, the blade is automatically retracted within the housing. The device is discarded in a sharps container after use.

I am sorry, but the provided text, while being an FDA 510(k) clearance letter and summary for a medical device (babyLance Safety Heelstick), does not contain any information about acceptance criteria or a study proving the device meets such criteria in terms of algorithmic performance, AI assistance, human reader improvement, or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device based on:

• Indications for Use: The device is a single-use incision device for obtaining blood samples from the heel of neonates or infants, with a sharps prevention feature.
• Technological Characteristics: Comparison of various design elements, materials, mechanical specifications (e.g., cut profile), safety features (sharps injury prevention, automatic retraction, reuse prevention), sterilization, and biocompatibility with the predicate device.
• Physical Characterization: Mention of tests conducted like biocompatibility, shelf-life, shipping, usability, simulated use, and user validation, but no specific performance metrics or acceptance criteria for an AI/algorithm component are presented.

The device described is a mechanical blood lancet, not an AI-powered diagnostic or imaging device. Therefore, the questions related to AI performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this document.

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The ebb Complete Tamponade System is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The ebb Complete Tamponade System should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

The ebb Complete Tamponade System is a disposable, multiple lumen catheter attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The device consists of two inflatable balloons: The upper uterine balloon is inflated inside the uterus and the lower vaginal balloon is inflated inside the vagina. Inflation is accomplished with isotonic intravenous fluid such as normal saline or Ringers Lactate. The uterine balloon catheter has separate lumens to enable inflation/deflation, irrigation and drainage. The vaginal balloon catheter has a lumen to enable inflation/deflation. The uterine and vaginal balloons are permanently assembled and are not to be separated. The device may be retained in position for up to 24 hours in the post-operative mode of treatment. The ebb Complete Tamponade System is supplied sterile in peel open pouches for one time use to a single patient.

This document describes a Special 510(k) notice for a modified medical device, the ebb Complete Tamponade System. It's a re-submission for a device that already has a predicate (K150573). The modification is specifically the addition of a UV Band around the proximal and distal ends of the vaginal and uterine balloons.

The information provided focuses on demonstrating that the modified device is substantially equivalent to its predicate, meaning the changes do not introduce new questions of safety or effectiveness. As such, the study described is a performance test to validate the modification, not a clinical trial to establish initial efficacy or performance against a broader set of acceptance criteria in a clinical setting.

Therefore, many of your requested points regarding clinical study design, ground truth, expert opinions, and comparative effectiveness are not applicable to this type of submission. The document primarily reports on bench testing to ensure the modified component maintains or improves strength.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not explicitly stated. The document mentions "the modified devices" and "none of the modified devices failed," implying multiple units were tested.
• Data provenance: Bench testing (laboratory environment), not country of origin of clinical data or retrospective/prospective human studies.

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. This was a bench test focused on the mechanical strength of the device, not a diagnostic or treatment device requiring expert clinical ground truth. The "ground truth" was the physical performance of the device under stress.

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

Not Applicable. As this was a bench test, there was no clinical adjudication process involving human reviewers. Performance was measured by defined physical parameters (e.g., failure under stress).

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-assisted diagnostic or therapeutic device requiring human reader improvement studies. It is a physical medical device.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this performance study was determined by physical stress testing where the operational limits and failure points of the device were observed and measured under controlled laboratory conditions, particularly focusing on cyclic physiologic pressures.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not a machine learning/AI device.

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

Not Applicable. There is no "training set" as this is not a machine learning/AI device.

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The ebb Complete Tamponade System is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The ebb Complete Tamponade System should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

Both devices are disposable, multiple lumen catheters attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The devices consist of two inflatable balloons: The upper uterine balloon is inflated inside the uterus and the lower vaginal balloon is inflated inside the vagina. Inflation is accomplished with isotonic intravenous fluid such as normal saline or Ringers Lactate. The uterine balloon catheter has separate lumens to enable inflation/deflation, irrigation and drainage. The vaginal balloon catheter has a lumen to enable inflation. The uterine and vaginal balloons are permanently assembled and are not to be separated. The devices may be retained in position for up to 24 hours in the post-operative mode of treatment, and are supplied sterile in peel open pouches for one time use to a single patient. There are no differences in the material, chemical composition or energy source of the subject and predicate devices. The change in design of the subject device is limited to the modification to the bond of the distal end of the uterine balloon from a heat bond to a UV bond, to increase the bond strength.

This document, a 510(k) summary for the ebb Complete Tamponade System, describes modifications made to a previously cleared device (K091958 Belfort-Dildy Obstetric Tamponade System). The key modification is changing the bond at the distal end of the uterine balloon from a heat bond to a UV bond to minimize potential leaks and increase bond strength.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document mentions "none of the modified devices failed" and "we subjected the modified devices," implying a test set was used, but the exact number of devices tested is not provided.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer, Clinical Innovations, LLC, to support the device modification. There's no indication of clinical data or patient data being used for this specific performance testing.

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

• Not Applicable. This study is focused on the mechanical performance of the device (bond strength, leakage under pressure) rather than diagnostic accuracy or clinical outcomes that would require expert-established ground truth. The "ground truth" here is the physical failure or non-failure of the device under specific test conditions.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a mechanical performance study, there's no "adjudication method" in the typical sense of expert review for medical imaging or clinical diagnosis. The outcome (failure/non-failure) is objectively measurable based on the test protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a mechanical performance study of a physical medical device (uterine tamponade system), not a diagnostic algorithm or imaging system that would typically involve an MRMC study.

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

• Not Applicable. This device is a physical medical device, not an algorithm. Therefore, the concept of "standalone algorithm performance" does not apply. The performance described is the standalone function of the device itself.

7. The Type of Ground Truth Used:

• Engineering/Mechanical Performance Data: The "ground truth" for this study is derived from controlled laboratory testing measuring physical properties such as bond strength and resistance to leakage under pressure. This is objective experimental data rather than expert consensus, pathology, or outcomes data typically associated with diagnostic device ground truth.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning study that would involve a "training set." The testing performed is to verify a physical modification to a medical device.

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

• Not Applicable. There is no training set involved in this mechanical performance study.

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The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.

The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.

The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.

The Koala TOCO is a single-use tocodynamometer that is a transducer pressure-sensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each.

The Koala TOCO device is a pneumatic tocodynamometer that comprises a guard-ring with a thin elastic membrane stretched across a shallow depression in the center of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO.

The Koala IUP/TOCO Reusable Cable can be used for intrauterine pressure monitoring with the Koala Intrauterine Pressure Catheter. The Koala TOCO and the Koala IUP/TOCO Reusable Cable are compatible with Philips and Corometrics monitors.

The provided text describes a 510(k) summary for the Koala TOCO and Koala IUP/TOCO Reusable Cable. This submission focuses on establishing substantial equivalence to a predicate device through non-clinical testing. Crucially, it explicitly states "Not Applicable" for clinical testing. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not Available. The provided document does not specify quantitative acceptance criteria or performance metrics for the device in a clinical context. The non-clinical testing focused on establishing substantial equivalence in terms of design, materials, and specific physical/electrical characteristics compared to 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 Available. Since no clinical study was performed, there is no test set or data provenance from a clinical perspective. The non-clinical tests would have involved specific test samples (e.g., of materials, components), but the sample sizes for these are not detailed in this summary.

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 clinical test set or ground truth established by experts is mentioned, as no clinical study was conducted.

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

• Not Applicable. No clinical test set was used.

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 medical device (tocodynamometer and cable), not an AI-powered diagnostic system. No MRMC study or AI-related effectiveness is discussed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable for clinical ground truth. The substantial equivalence claim is based on non-clinical testing, comparing technological characteristics (e.g., physical dimensions, materials, sensing technology) to a predicate device. The "ground truth" for these tests would be established engineering standards, material specifications, and performance against defined test parameters for the device itself, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not Applicable.

Summary of available information:

The 510(k) summary explicitly states "Not Applicable" for clinical testing. The device's acceptance is based on demonstrating substantial equivalence to an existing predicate device (FeatherLite™ Tocodynamometer - K013477) through non-clinical performance testing.

The non-clinical testing included:

• Predicate comparison testing
• Simulated use testing
• Hardware testing
• Electrical performance testing
• Biocompatibility testing according to ISO 10993-1
• Intrauterine pressure catheter (IUPC) compatibility testing

The conclusion is that the differences between the proposed device and the predicate device (minor differences in visual appearance, weight, sensing technology, and transducer location) are minor and do not impact safety and effectiveness, thus supporting substantial equivalence.

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The ClearView Total is intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

Clinical Innovations' ClearView Total is a single-use sterile device used for uterine manipulation. Uterine manipulation is essential for laparoscopies involving the female pelvic organs (uterus, tubes, ovaries) when a uterus is present. Uterine manipulators may be helpful when clinicians perform tubal ligations, diagnostic laparoscopies for evaluating pelvic pain and infertility, treatment of endometriosis, removal of pelvic scars (adhesions) involving the uterus, fallopian tubes and ovaries, treatment of ectopic pregnancy, removal of uterine fibroids, removal of ovarian cysts, removal of ovaries, tubal repair, laparoscopic hysterectomy, laparoscopic repair of pelvic bowel or bladder, sampling of pelvic lymph nodes, laparoscopic bladder suspension procedures for treatment of incontinence, and biopsy of pelvic masses.

The ColpoCup accessory is a plastic cup which is mechanically screwed into the uterine manipulator. The ColpoCup is compatible with typical surgical devices, including harmonics and electrosurgical tools. Three different sizes of ColpoCups will be included with the device; 3.0cm, 3.5cm. and 4.0cm. Each ColpoCup will be a high contrast color in order to provide the surgeon with clear visibility during laparoscopic dissection.

At the base of the ColpoCup, past the tip pivot point, is a pre-attached Occluder constructed of an inflatable balloon and will be included to seal off the vagina and prevent pnuemoperitoneum loss. The Occluder Balloon is connected to a separate inflation valve which is located proximally from the balloon and allows for inflation after placement.

The provided text is a 510(k) Summary for a medical device called the "ClearView Total," a uterine manipulator. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices, but it does not outline specific acceptance criteria or report performance in the format of a clinical study assessing a device against predefined performance metrics.

Instead, the document focuses on demonstrating that the ClearView Total is "substantially equivalent" to existing, legally marketed predicate devices through comparison of indications for use, technical characteristics, and various integrity and biocompatibility tests.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth type, training set size) are not applicable or cannot be extracted from this document, as the study described is not a clinical effectiveness study with performance metrics in the way these questions imply for an AI/diagnostic device.

However, I can extract information related to the device integrity and biocompatibility testing that served as the "study" for this submission.

Here's a breakdown of the information available based on your request, with relevant sections marked as "Not Applicable" or "Not Provided" where the document does not contain the specific information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present quantitative acceptance criteria or device performance in the typical format of a clinical study for diagnostic or AI devices. Instead, it states that all tests "met the specified requirements" or "met the appropriate acceptance criteria."

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

This document describes engineering and biocompatibility tests, not a clinical test set with patient data.

• Sample Size: Not specified (refers to device units tested for engineering and biocompatibility).
• Data Provenance: Not applicable (these are laboratory/bench tests on device components/materials).

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

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

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. (Testing results would likely be determined by laboratory technicians or engineers against predefined test specifications.)

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

• MRMC Study Done: No. This document describes a submission for a physical medical device, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.
• Effect Size of Human Readers with vs. without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This device is a physical surgical instrument, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the engineering tests (Accelerated Age, Balloon Leak/Burst, Cup Security/Break), the "ground truth" would be the pre-defined engineering specifications and performance limits for the device's physical properties. For biocompatibility tests, the "ground truth" would be established by industry standards (e.g., ISO 10993 series) for material safety.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable.

Summary of the Study Description:

The "study" described in the 510(k) summary involves device integrity testing and biocompatibility testing.

• Device Integrity Testing: Included Accelerated Age Testing, Balloon Leak/Burst Testing, and Cup Security and Cup Break tests. The document states that "All device integrity tests for the ClearView Total met the specified requirements." These tests would assess the physical and mechanical performance of the device under various conditions to ensure its structural integrity and functionality.
• Biocompatibility Testing: Included Cytotoxicity, Intracutaneous Reactivity Irritation, and Sensitization tests. The document states that "All testing met the appropriate acceptance criteria." These tests are conducted to ensure that the device materials are safe for contact with human tissue and do not elicit adverse biological reactions.

The purpose of these studies was to support the claim that the ClearView Total is "substantially equivalent" to predicate devices, meaning it is as safe and effective as devices already on the market, without introducing new questions of safety or effectiveness.

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The Clinical Innovations ROM Plus fetal membrane rupture test is a rapid, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of ROM. The test detects AFP (alpha-fetoprotein) and PP12 (placental protein 12 or insulin growth factor binding protein) from amniotic fluid in vaginal secretion. The test is for prescription use by health care professionals to aid in the detection of rupture of membranes (ROM) in pregnant women in conjunction with other signs and symptoms.

The ROM Plus Quality Control Kit monitors the performance of the ROM Plus Fetal Membranes Rupture Test for the purposes of external quality control. The lyophilized human positive protein control is an assayed control material for qualitative testing.

The ROMPlus is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. ROM Plus is available in packages of 5 tests. Each individual test pack contains a sterile polyester swab. specimen extraction buffer solution in a plastic vial and a cassette with integral timer containing the lateral flow strip packed in a foil pouch with desiccant.

The ROM Plus Controls contain one vial each of negative, and positive controls, with integral reconstitution solution.

Here's a breakdown of the acceptance criteria and the study details for the ROM Plus device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria in the form of target sensitivity, specificity, PPV, or NPV percentages. Instead, it presents the achieved performance in clinical studies for review. The reported performance is summarized below:

| Metric | Combined (All Gestational Ages) | ≥ 37 Weeks EGA | 34-37 Weeks EGA |

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This device is used to grasp, crush and cut the penile foreskin on full term, newborn (up to 10 days) male infants.

AccuCirc Circumcision clamp/cutter

The provided text is an FDA 510(k) clearance letter for the AccuCirc Circumcision clamp/cutter. This document does not contain information regarding detailed acceptance criteria, study methodologies, or performance data for the device. Therefore, I cannot generate the requested table and study description based solely on the provided text.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than through a study demonstrating it met specific, quantitative performance acceptance criteria.

To answer your questions, I would need access to the actual 510(k) submission document (K061539) which would contain the performance testing data and acceptance criteria if such tests were conducted and submitted.

Therefore, I cannot provide the requested information from the given text.

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