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The ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The ELLAVI UBT is an 18 cm long intrauterine balloon tamponade device primarily comprised of thermoplastic elastomer. The balloon and internal tubing are made of thermoplastic elastomer, while the exterior tubing is made of polyvinyl chloride. A supply bag is the filled, connected, and hung at a pre-determined height based on the patient's systolic blood pressure. The device consists of a balloon that is inserted into the uterus transvaginally into the postpartum uterus after delivery and removal of the placenta. A valve is then opened, and this allows the fluid to inflate the balloon and apply pressure to achieve a hemostatic effect.

The ELLAVI UBT device, intended for temporary control or reduction of postpartum uterine bleeding, underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate device, the Bakri Postpartum Balloon. The provided documentation primarily focuses on mechanical, biocompatibility, sterilization, and shelf-life testing. No clinical study data is provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document details non-clinical performance data (mechanical, biocompatibility, sterilization, and shelf-life testing). It does not describe a "test set" in the context of clinical or image-based studies with human subjects. Therefore, information about sample size, country of origin, or retrospective/prospective nature of such a test set is not applicable from this document. The tests performed are laboratory-based evaluations of the device's physical and material properties.

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

Not applicable. The document describes non-clinical engineering and material science tests. "Ground truth" in the context of expert consensus for clinical diagnosis is not relevant to these types of tests.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical or diagnostic performance that would require an adjudication method. The reported performance is based on direct measurements and observations from laboratory testing.

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

No MRMC comparative effectiveness study was mentioned or conducted, as this documentation pertains to non-clinical testing for substantial equivalence of a medical device.

6. Standalone Performance Study

The documented studies are standalone in the sense that they evaluate the device itself (its mechanical properties, biocompatibility, etc.) without human interaction as part of the performance evaluation. However, this is not a "standalone performance" in the context of algorithm-only performance for a diagnostic device, as the ELLAVI UBT is a physical medical instrument.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is based on engineering specifications, material science standards, and established laboratory testing protocols. For instance:

• Mechanical Testing: Physical measurements against design specifications, established parameters (e.g., pressure ranges, fill volumes, time limits).
• Biocompatibility Testing: Compliance with ISO 10993 series standards, where reactivity or toxicity is evaluated against established biological models.
• Sterilization and Shelf-Life: Compliance with ISO 11135 and ASTM standards for sterility assurance levels, aging profiles, and package integrity.

8. Sample Size for the Training Set

Not applicable. The ELLAVI UBT is a physical medical device. It does not involve machine learning algorithms or a "training set" in the context of artificial intelligence.

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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The Bakri Essential Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Essential Postpartum Balloon is composed of a double lumen silicone balloon catheter and a stopcock. The balloon catheter has a balloon with maximum inflation volume of 500 mL and a 24 Fr silicone shaft with an overall length of 58 cm, which includes the working length of 54 cm and proximal fittings. The shaft has two lumens, one designated for drainage, and the other for balloon inflation. The Bakri Essential is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Essential Postpartum Balloon is packaged in a Tyvek®Polyethylene Peel-Open Pouch with five individually packaged and labeled products per marketing carton, is provided sterile, and is intended for one time use.

This document is a 510(k) premarket notification for the Bakri Essential Postpartum Balloon, a medical device. It does not describe a study involving an AI/ML device, therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific aspects cannot be extracted.

The document discusses the substantial equivalence of the Bakri Essential Postpartum Balloon to a predicate device (Bakri Postpartum Balloon, K170622). It focuses on non-clinical performance testing related to packaging modifications and the removal of a syringe from the product set, not on a study proving a device's performance against specific clinical acceptance criteria in the context of an AI/ML system.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance (in the context of an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size with AI assistance.
6. Whether standalone performance was done for an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The "Summary of Non-clinical Performance Testing" section details tests performed for the physical device's packaging and sterilization integrity, with specific acceptance criteria for those tests:

• Pouch Seal Strength Testing: Minimum seal strength shall meet or exceed 1.2N per 15mm when tested in accordance with ASTM F88-15.
• Bubble Leak Testing: Packaging shows no signs of cracks, pinholes, or imperfect seals indicated by bubbles, per ASTM F2096-11.
• Dye Penetration Testing: No packaging seal may be breached by dye per F1929-15.
• Additional distribution testing followed by functional verification: Device shows no signs of damage after sterilization and simulation distribution.

These criteria and tests relate to the physical integrity and sterility of the packaged device, not a performance study of a diagnostic or therapeutic AI/ML algorithm.

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The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

The subject of this submission is the Jada System kit, which includes 1) the Jada System, 2) a commercially available pre-sterilized vacuum tubing, and 3) a commercially available pre-sterilized luer lock syringe.

The Jada System is a 41 cm long intrauterine device made of silicone. The device consists of an intrauterine loop on the distal end of a translucent tube. The proximal end of the tube has a vacuum connector for connection to the vacuum tubing. Proximal to the connection of the intrauterine loop is a donut-shaped cervical seal. The cervical seal is filled with and emptied of 60-120 mL of sterile fluid by attaching a luer lock syringe to the seal valve. The intrauterine loop consists of a loop tube with 21 vacuum pores oriented toward the inside diameter of the intrauterine loop. On the outer surface of the intrauterine loop is a shield which overhangs the vacuum pores to protect tissue from vacuum and to prevent the vacuum pores from plugging with tissue and blood clots.

Before placing the Jada System device inside the uterus, the intrauterine loop is compressed. The compressed loop is inserted into the uterus transvaginally. The cervical seal is placed within the vagina, at the external cervical os, and inflated and filled with 60-120 mL of sterile fluid. The vacuum tubing is attached to the vacuum connector on the Jada System and vacuum is then applied to a maximum value of 90 mmHg until bleeding is controlled. The Jada System should be fixed to the thigh along the tube.

The provided text describes a 510(k) submission for the Jada System, a device intended for the control and treatment of abnormal postpartum uterine bleeding or hemorrhage. The submission argues for substantial equivalence to a predicate device (also the Jada System) based on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes various mechanical, packaging, biocompatibility, and sterilization tests performed, and states that these tests demonstrate "substantial equivalence" and that the device is "as safe and effective as the predicate device." The "performance" column below is derived from the descriptions of the tests and implies that the device met the implicit acceptance criteria for each test.

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

The document does not specify the sample sizes used for the mechanical, packaging, biocompatibility, or sterilization tests. It only states that these tests were performed to support substantial equivalence.

The data provenance is from non-clinical testing (laboratory/bench testing) performed by Alydia Health. There is no mention of clinical data, human subjects, or any specific country of origin for test data, as it appears to be primarily laboratory-based engineering and material testing.

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

This information is not applicable to the provided document. The studies described are non-clinical (bench testing) and do not involve human subject data requiring expert interpretation to establish a ground truth. The "ground truth" for these tests would be the specific pass/fail criteria defined by engineering and material standards.

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

This information is not applicable to the provided document, as it concerns non-clinical testing, not interpretation of clinical data where adjudication among experts would be necessary.

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

This information is not applicable. The device is an obstetric-gynecologic specialized manual instrument (Jada System) and not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

This information is not applicable. The Jada System is a physical medical device, not an algorithm, and its performance relies on human-in-the-loop operation for placement and activation.

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

For the non-clinical tests described:

• Mechanical Testing: The "ground truth" is defined by established engineering specifications, dimensional tolerances, force requirements, flow rates, and integrity standards (e.g., ability to withstand pressure, maintain dimensions, not leak, etc.).
• Packaging Testing: The "ground truth" is adherence to ASTM standards for transportation, leak detection, and seal strength.
• Biocompatibility Testing: The "ground truth" is the absence of adverse biological reactions as defined by ISO 10993-1 and specific test methodologies (e.g., no cytotoxicity, no sensitization, etc.).
• Sterilization and Shelf-Life Testing: The "ground truth" is achieving a Sterility Assurance Level (SAL) of 10^-6 and maintaining performance for the stated shelf-life as per ISO standards.

8. The sample size for the training set

This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model, so there is no "training set."

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

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

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The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

The Jada® System is a 41 cm long intrauterine device primarily made of silicone. The vacuum connector and seal valve are made of polyvinylchloride and acrylonitrilebutadiene-styrene. The device consists of an intrauterine loop on the distal end of a translucent tube. The proximal end of the tube has a vacuum connector for connection to a vacuum tube. Proximal to the connection of the Intrauterine Loop is a donut-shaped cervical seal. The cervical seal is filled with and emptied of 60-120 mL of sterile fluid by attaching a syringe to the seal valve. The intrauterine loop has 20 vacuum pores oriented toward its inside diameter. The outer surface of the intrauterine loop is a silicone shield which overhangs the vacuum pores to protect tissue from vacuum and to prevent the vacuum pores from plugging with tissue and blood clots.

Here's a breakdown of the acceptance criteria and the study details for the Jada® System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

• Cervical seal withstands 180 mmHg vacuum.
• Evacuates 400 mL simulated blood in ≤ 1 minute.
• Maintains 70mm diameter for 48 hours. | All mechanical tests performed and verified. (Specific quantitative results for each test are not provided in the summary but were affirmed as met during the review process.) |
  | Biocompatibility Testing | Compliance with ISO 10993-1, including Cytotoxicity, Maximization Sensitization, Vaginal Irritation, Systemic Toxicity, and Material Mediated Pyrogenicity. | All specified biocompatibility tests were conducted. (Results were deemed acceptable, allowing for substantial equivalence determination.) |
  | Sterilization & Shelf-Life Testing | Sterilized to SAL = 10-6 (ISO 11137-2:2013).
  Shelf-life of 4 years. | Sterilized using gamma radiation to a SAL = 10-6.
  A shelf-life of 4 years has been established based on real-time aging. |

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

• Test Set Sample Size:
  • Pivotal Study (effectiveness and safety): 107 subjects enrolled, 106 evaluable.
  • Initial pilot study: 10 women.
  • Initial phase of pivotal study: 13 women.
• Data Provenance:
  • Pivotal Study: United States (12 sites in the U.S.), prospective, multicenter, single-arm, open label.
  • Initial pilot study: Indonesia.
  • Initial phase of pivotal study: Uganda.

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

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" in the traditional sense for the clinical endpoints.

Instead, the primary effectiveness endpoint was externally benchmarked against a meta-analysis of literature data for the Bakri Postpartum Balloon. This implies that the 'ground truth' for setting the performance goal was derived from existing peer-reviewed clinical evidence rather than a panel of experts specifically adjudicating the cases of the Jada® study.

The safety endpoint involved assessing adverse events, which would typically be evaluated by the treating physicians and potentially reviewed by an independent safety committee (DMC/DSMB), but the document does not specify the number or qualifications of such reviewers.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes within the Jada® System pivotal study.

The study was a "single-arm, open label" design, meaning outcomes were assessed by the study investigators at each site. The performance goal for effectiveness was set based on external literature from the predicate device (Bakri Postpartum Balloon), rather than an internal expert adjudication process for the Jada® study's cases.

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 done. The pivotal study was a single-arm study comparing the Jada® System's performance to a literature-derived performance goal of a predicate device (Bakri Postpartum Balloon). It did not involve human readers interpreting images with and without AI assistance, as would be typical for an MRMC study in an imaging context.

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

The Jada® System is a physical medical device (an intrauterine device), not an imaging AI algorithm. Therefore, the concept of "standalone algorithm performance" or "human-in-the-loop performance" in the context of AI is not applicable to this device. The clinical study assessed the device's performance when used by healthcare professionals.

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

• Effectiveness Ground Truth (for performance goal): The performance goal for effectiveness (82.0% success rate) was established based on a meta-analysis of data from literature assessing the performance of the Bakri Postpartum Balloon. This can be considered a form of "outcomes data" derived from existing clinical evidence.
• Effectiveness Ground Truth (for Jada® study outcomes): The "control of postpartum hemorrhage" was defined by the avoidance of further non-surgical, second-line, or surgical interventions. This represents demonstrable clinical outcomes data as observed by the treating clinicians in the study.
• Safety Ground Truth: Adverse events were reported and classified in terms of incidence, severity, and seriousness, and assessed for their relatedness to the device or procedure. This is also based on clinical outcomes data and assessment by clinicians.

8. The Sample Size for the Training Set

The Jada® System is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. The clinical data serves as the basis for demonstrating safety and effectiveness.

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

As explained in point 8, the concept of a training set and its associated ground truth is not applicable here because the Jada® System is not an AI algorithm.

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The ESM-UBT device is intended to provide temporary control of postpartum uterine bleeding when conservative management is warranted.

The Every Second Matters - Uterine Balloon Tamponade ("ESM-UBT") device is a single use product that consists of the kitting of 510(k)-cleared or off-the-shelf ("OTS") class I exempt components. The kit also contains an antiseptic prep pad that is marketed under an OTC monograph and is intended for use as an accessory with and during the assembly of the class I medical device components of the ESM-UBT device:

• Urinary catheter
• Luer lock valve
• Condom
• Syringe
• Elastic O-ring
• Catheter holder
• Antiseptic (povidone iodine) prep pad

The components will not be modified from their packaged state, and the entire kit will be re-labeled as the ESM-UBT device. The device is assembled in an ISO certified clean room using the Foley urinary catheter, Luer lock valve, condom, and a green elastic O-ring. The assembled condom-catheter is inserted into the bleeding uterus through the cervical opening. Upon placement within the uterine cavity, the balloon on the Foley catheter is inflated first with 15 mL of saline. This small balloon helps secure the catheter inside the uterus. One port on the Foley catheter is used for the syringe to inject saline into the small balloon, whereas the other port is used to inflate the condom balloon with saline. This condom balloon should be inflated until tamponade occurs as evidenced by bleeding cessation. The maximum fill volume of 500 mL was verified in bench tests. The device should be fixed to the thigh at the end using the catheter holder.

The provided text is a 510(k) summary for the Every Second Matters-Uterine Balloon Tamponade ("ESM-UBT") device. It describes the device, its intended use, and comparative information with a predicate device. However, it does not explicitly define acceptance criteria in a quantitative manner as typically expected for device performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and positive clinical outcomes from peer-reviewed publications.

Here's an analysis based on the provided information, addressing your questions as best as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria are not presented in a traditional tabular format within this document. The device performance is largely established through a combination of non-clinical (mechanical, biocompatibility) testing and clinical evidence from publications demonstrating safety and effectiveness compared to the predicate and in the intended population.

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

The document references "peer-reviewed publications" for clinical data.

• Sample Size: Over 900 devices have been used based on the collective data from these publications.
• Data Provenance: Retrospective, derived from devices used in India, Tanzania, Kenya, Senegal, Sierra Leone, and Nepal. This suggests a multi-national and real-world setting.

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

The document states: "Ujenzi assessed the severity, expectedness, and relatedness of each reported death and provided this information to an independent committee for review."

• Number of Experts: An "independent committee" was used. The exact number of experts in this committee is not specified.
• Qualifications of Experts: Not explicitly stated beyond being an "independent committee."

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

For reported deaths, the adjudication involved an "independent committee for review." The specific adjudication method (e.g., how disagreements were resolved) is not detailed. For the broader clinical effectiveness, the peer-reviewed nature of the publications implies some level of expert review, but a formal adjudication method for a test set (like for a diagnostic device) is not described because this is a therapeutic device.

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, an MRMC comparative effectiveness study was not done. This device is a physical therapeutic device (uterine balloon tamponade), not an AI-assisted diagnostic or imaging device that would typically involve "human readers" or AI assistance in that context. The "effect size" mentioned would be irrelevant here.

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

• No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm or AI program.

7. The Type of Ground Truth Used

For the clinical data, the ground truth was outcomes data (survival rates, complication rates, bleeding cessation) observed in real-world clinical practice, as reported in peer-reviewed publications. The severity and relatedness of deaths were also adjudicated by an independent committee.

8. The Sample Size for the Training Set

No specific "training set" is mentioned as this device is a physical medical device, not a machine learning algorithm. The clinical data cited from "over 900 devices" used across multiple countries served as supporting evidence for its safety and effectiveness.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The clinical evidence was gathered from real-world usage and documented in peer-reviewed publications.

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Bakri® Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Bakri® Postpartum Balloon with Rapid Instillation Components is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The proposed devices are offered in two configurations, the Bakri Postpartum Balloon (henceforth referred to as Bakri) consisting of a double lumen silicone balloon catheter, a stopcock, and a 60 mL Luer-tip syringe and the Bakri Postpartum Balloon with Rapid Instillation Components (henceforth referred to as Bakri RI) configuration which additionally includes a dual check valve and polymer tubing. The tubing is fitted with a Luer lock-type connector to the dual check valve and a non-vented bag spike with a vented cap that connects to a saline bag (not included in the device).

The balloon catheter common to both configurations is designed as a dual lumen silicone shaft with 500 mL balloon. The proximal end of the catheter has a lighthouse adaptor designed to accept a drainage bag connector and a side arm which is fitted with a Luer Lock-type adaptor to which a stopcock is attached and subsequently a Luer tip syringe or a dual check valve can be connected. The distal end of the catheter has two sideports spaced 180° opposite of each other, and the tip is rounded to a smooth finish. The polymer tubing of the Bakri RI rapid instillation components is 180 cm in length. Both the Bakri and the Bakri RI is supplied sterile and intended for one time use.

This document describes the Cook Incorporated Bakri® Postpartum Balloon and Bakri® Postpartum Balloon with Rapid Instillation Components (K170622). It is a medical device intended to provide temporary control or reduction of postpartum uterine bleeding.

Here's an analysis of the provided text with respect to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document refers to a series of tests conducted to demonstrate that modifications to the balloon catheter and the addition of rapid instillation components met "applicable design and performance requirements to support a determination of substantial equivalence" to a predicate device (K062438). The document lists several specific laboratory and engineering tests (Inflated Balloon Reliability, Dimensional Evaluation, Integrity, Tensile Test of the Distal Tip, Sideport Drainage and Deflation Reliability, Radial Pressure, Balloon Inflation Testing, Simulated Use and Leak Test, Tensile Testing).

However, the provided text does not include detailed results for each test against the acceptance criteria. It broadly states that the tests were performed and the results support a determination of substantial equivalence. It does not quantify the specific performance values achieved for each test, such as the exact drainage time or the specific load withstood during tensile testing.

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

• Sample size for the test set: Not explicitly stated in the provided text for any of the performance tests.
• Data provenance: Not explicitly stated (e.g., country of origin). The tests are described as "Test Data" conducted by Cook Incorporated, implying in-house testing. The nature of these tests (e.g., mechanical, simulated use) suggests they are laboratory-based rather than involving patient data.
• Retrospective or prospective: These are laboratory/engineering tests, not clinical studies involving patients, so the terms "retrospective" or "prospective" do not directly apply in a clinical data sense. They are likely prospective tests conducted on manufactured device samples.

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

This information is not applicable to the type of tests described. The "ground truth" here is the physical and mechanical properties of the device, measured against engineering specifications and performance requirements, not diagnostic interpretations requiring expert consensus.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or similar expert-driven evaluations. The tests described are objective, quantifiable engineering and performance tests.

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:

This information is not applicable. An MRMC study is for evaluating diagnostic devices, typically involving human readers interpreting images, often with and without AI assistance. This document describes a physical medical device (a postpartum balloon) and its mechanical performance tests, not a diagnostic AI system.

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

This information is not applicable as the device is not an algorithm or an AI system. It is a physical medical device.

7. The type of ground truth used:

The ground truth for the tests described is based on engineering specifications and performance requirements, derived from the intended use of the device and comparison to a predicate device, rather than expert consensus, pathology, or outcomes data. For example, the "ground truth" for the radial pressure test is 100 mm Hg for 3 hours without leakage.

8. The sample size for the training set:

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The tests are for the physical device itself.

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

This information is not applicable as there is no "training set."

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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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BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.

The BT-Cath consists of an extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, ruptured sinuses, lacerations and other tissue evoking hemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract. For ease of filling the balloon with multiple syringes, a check valve is also provided at the proximal end. The device is latex-free and provided sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BT-Cath device:

1. Table of Acceptance Criteria and Reported Device Performance

• Relationship of volume of saline infused into the balloon and resulting balloon diameter.
• Burst volume of the balloon.
• Ability of the balloon to hold its shape and not leak during repeated and prolonged inflations. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the mechanical integrity requirements for the balloon, matching the predicate.) |
  | Mechanical Integrity - Catheter | Structural integrity of the catheter using leak tests. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the mechanical integrity requirements for the catheter, matching the predicate.) |
  | Tensile Strength | Tensile strength in each joint in the devices. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the tensile strength requirements for joints, matching the predicate.) |
  | Clinical Performance/Safety | Device consistently achieving its intended purpose without reported likelihood of patient injury. | "Clinical feedback was obtained after about 840 uses of BT-Cath by U.S. clinicians that indicates the device consistently achieved its intended purpose without any reported likelihood of patient injury." (This is presented as evidence of field performance meeting the safety and efficacy expectations.) |

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

• Sample Size: "about 840 uses"
• Data Provenance: "U.S. clinicians" (prospective, real-world clinical feedback after deployment, rather than a controlled test set from a formal clinical trial for pre-market submission directly).

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

• The document mentions "U.S. clinicians" providing feedback. It does not specify a number of experts or their qualifications for establishing a ground truth in the context of a controlled test set with expert consensus. The feedback provided is general clinical observation rather than a structured expert review of specific cases.

4. Adjudication Method for the Test Set

• No formal adjudication method is described. The "clinical feedback" appears to be an aggregation of observations from multiple clinicians.

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 MRMC comparative effectiveness study was done, nor is AI involved with this device. This is a medical device, specifically a balloon tamponade catheter, not an AI/software-as-a-medical-device (SaMD).

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

• Not applicable as this is a physical medical device and does not involve an algorithm.

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

• The "ground truth" for the clinical performance assessment seems to be real-world clinical outcomes and observations as reported by clinicians using the device. This is more akin to post-market surveillance data contributing to a pre-market submission, rather than a pre-defined ground truth for a structured clinical trial.

8. The Sample Size for the Training Set

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

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

• Not applicable as this is a physical medical device.

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The Belfort-Dildy Obstetric Tamponade System (OTS) 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 OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

The Belfort-Dildy Obstetric Tamponade System (OTS) 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 Belfort-Dildy Obstetric Tamponade System (OTS) is supplied sterile in peel open pouches for one time use to a single patient.

The provided text describes a medical device, the Glenveigh™ Belfort-Dildy Obstetric Tamponade System (OTS), and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and reported device performance in the typical sense of a diagnostic or AI-driven system.

This document details the regulatory submission for the Belfort-Dildy OTS, which is a physical medical device. The "performance data" section states that "Design verification performance test results demonstrate that the Belfort-Dildy Obstetric Tamponade System performs its intended use and is equivalent to the Bakri predicate device." It also mentions "Bench testing versus the predicate Bakri device has demonstrated that the Belfort-Dildy Obstetric Tamponade System is functionally equivalent to the Bakri predicate device and that any minor differences do not affect safety or effectiveness."

Because this is not a study of an AI or diagnostic device that would typically have metrics like sensitivity, specificity, or reader accuracy, many of the requested fields are not applicable.

Here's an attempt to answer the questions based on the provided text, noting where information is not available or not applicable:

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

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

Not applicable. This is not a study involving a test set of patient data, but rather bench testing and design verification of a physical medical device.

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. "Ground truth" in the context of expert consensus on data is not relevant to this type of device submission.

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 is not an AI-assisted diagnostic or imaging device.

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

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

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

The "ground truth" for this device's performance is based on bench testing against predicate devices and design verification performance testing, demonstrating functional equivalence and performance for intended use. Biocompatibility was established through testing according to ISO 10993-1.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable.

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