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The Panpac Word/ Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.

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I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, or any studies related to the Panpac Word/Bartholin Catheter.

The document is a 510(k) premarket notification letter from the FDA to Panpac Medical Corporation, informing them of the substantial equivalence determination for their device. It focuses on regulatory compliance, outlining general controls provisions and other applicable regulations. It also includes the "Indications for Use" statement for the device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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Used for the treatment of abscesses and cysts of the Bartholin gland.

The Word Catheter-Silicone Bartholin Gland Balloon Set is used for treatment of abscesses and cysts of the Bartholin gland. The Word Catheter-Silicone Bartholin Gland Balloon Set is a 3 ml balloon catheter which is 5.5 cm in length and constructed of silicone. The catheter is sold with a 1" 21 gauge needle and a scalpel with a # 1 blade is used to lance the Bartholin gland cystlabscess, the syringe with needle is used to inflate the balloon catheter, and the catheter is placed in the cyst or abscess remaining for up to 28 days to allow the duct to re-epithelialize. The devices are provided sterile and are intended for one time use.

Here's an analysis of the provided information regarding the Word Catheter-Silicone Bartholin Gland Balloon Set, structured to address your specific requests:

The provided document describes a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical outcomes or performance against a predefined threshold. Instead, it focuses on demonstrating equivalence through technical comparisons and standard engineering/biocompatibility testing.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence rather than a clinical trial demonstrating performance against specific clinical acceptance criteria for a novel device, the "acceptance criteria" are predominantly related to manufacturing and material standards, as well as functional equivalence to predicate devices.

Important Note: The document does not specify quantitative acceptance criteria (e.g., "burst pressure must be > X psi") or quantitative performance results for the device. Instead, it states that the device was tested according to recognized standards and demonstrated substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it meets these standards and is equivalent to a legally marketed device.

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

• Sample Size: The document does not specify a "test set" of patient data or clinical samples. The testing described is primarily non-clinical (bench testing) and biocompatibility for the device itself.
• Data Provenance: Not applicable, as this is a non-clinical submission. The testing was conducted in a laboratory setting.

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

• Not applicable. This submission focuses on the technical characteristics and safety of a medical device (catheter) through bench testing and material biocompatibility, not on a diagnostic algorithm or interpretation requiring expert review of data. There is no "ground truth" to be established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

• Not applicable. As there is no clinical test set or expert review process, no adjudication method 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

• No. This information is not present in the document. The device is a physical medical instrument (catheter), not an AI-assisted diagnostic or interpretive tool.

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

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

7. The type of ground truth used

• Not applicable. In the context of a medical device like a catheter, "ground truth" often refers to fundamental scientific principles, engineering standards (like those for materials strength or biocompatibility), and the established performance characteristics of the predicate devices. There is no patient-specific "ground truth" in this submission.

8. The sample size for the training set

• Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set."

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

• Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set" with ground truth.

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The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.

The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair. The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly.

The provided text describes a submission for a medical device called the Glenveigh Vaginal Repair Balloon Catheter. However, it does not include the detailed information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• Type of Device: The Glenveigh Vaginal Repair Balloon Catheter is a physical medical device (an obstetric-gynecologic specialized manual instrument). Your questions (e.g., about test sets, ground truth, experts, MRMC studies, standalone algorithm performance, training sets) are typically relevant for software-as-a-medical-device (SaMD) or devices incorporating AI/ML, which analyze data (like images) to provide diagnostic or prognostic information.
• Nature of the Submission: This document is a 510(k) summary of safety and effectiveness, seeking clearance based on substantial equivalence to a predicate device. For physical devices, substantial equivalence is often established through manufacturing specifications, material biocompatibility, and functional bench testing.
• "Performance Data" Section: The text states, "Design verification performance test results demonstrate that the Glenveigh Vaginal Repair Balloon Catheter performs its intended use and is equivalent to the predicate device." This typically refers to engineering tests (e.g., burst pressure, inflation/deflation rates, material strength, biocompatibility), not clinical studies with human readers or AI algorithms evaluating data.

Therefore, based on the provided text, I cannot answer your specific questions relating to acceptance criteria and a study as typically understood for AI/ML-driven medical devices. The document does not contain information about:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or similar metrics. The "performance data" mentioned refers to functional equivalence testing.
2. Sample sizes for test sets or data provenance. No such clinical or dataset-based testing is described.
3. Number or qualifications of experts for ground truth. Not applicable in this context.
4. Adjudication method. Not applicable.
5. MRMC comparative effectiveness study. Not conducted for this type of device according to the document.
6. Standalone algorithm performance. No algorithm is described.
7. Type of ground truth used. Not applicable.
8. Training set size. No training set is applicable.
9. How ground truth for the training set was established. Not applicable.

Summary of what is available in the text related to "performance" and "acceptance":

• Device Function: "temporarily blocks the flow of fluids to assist in episiotomy/laceration repair."
• Performance Claim: Bench testing demonstrated the device is "functionally equivalent to predicate EpiStat/V-Stat Vaginal Tamponade Balloon, and that any minor differences do not affect safety or effectiveness."
• Biocompatibility: "materials that come in direct contact with the patient have a long history of use in medical use and are biocompatible according to ISO 10993."
• Conclusion: "Based on the performance testing, it can be concluded that the Glenveigh Vaginal Repair Balloon Catheter is equivalent to the predicate EpiStat/V-Stat Vaginal Tamponade Balloon with respect to intended use and technological characteristics."

The "acceptance criteria" for this device would likely be successful completion of these functional and biocompatibility tests, demonstrating equivalence to the predicate device, rather than diagnostic accuracy metrics.

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The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.

The Cook® Fetal Membrane Manipulator is used to atraumatically push and position emerging fetal membranes back through the cervical canal and into the uterus to facilitate a successful cervical cerclage procedure in order to prolong pregnancy to a successful delivery. The Cook® Fetal Membrane Manipulator is intended to be used as an adjunct to a cervical cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage. The Cook® Fetal Membrane Manipulator is comprised of a November polycarbonate dual lumen catheter with a silicone balloon. The balloon catheter assembly includes a Check-Flo-adapter. The device is provided sterile and intended for one-time use.

The provided text describes a medical device, the Cook® Fetal Membrane Manipulator, and its substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or the specifics of a study that proves the device meets those criteria.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The specific quantitative or qualitative acceptance criteria for biocompatibility, sterility, and performance are not detailed. For instance, what specific tests were performed for "biocompatibility" (e.g., cytotoxicity, irritation, sensitization), what were their acceptance limits, and what were the exact results? Similarly for sterility (e.g., SAL of 10^-6) and performance (e.g., balloon inflation pressure, catheter maneuverability, membrane repositioning effectiveness).

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified, but given the nature of the device (fetal membrane manipulator), these tests are likely conducted in a lab setting or in animal models, not human clinical trials for this type of 510(k). The document mentions "performance testing" which usually refers to bench testing.

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

• Number of Experts: Not applicable, as this is primarily a device performance and safety evaluation (biocompatibility, sterility, mechanical performance) rather than an interpretative diagnostic device requiring expert ground truth in the traditional sense.
• Qualifications of Experts: Not applicable for the reasons above.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The tests mentioned (biocompatibility, sterility, performance) would typically involve objective measurements against predefined standards rather than consensus-based adjudication.

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

• MRMC Study Done: No, this type of study is typically for evaluating the effectiveness of diagnostic devices or AI algorithms where human interpretation is involved. This device is an instrument for a surgical procedure.
• Effect Size of Human Readers Improvement: Not applicable.

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

• Standalone Study Done: Not applicable. This is a medical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable in the context of expert-derived ground truth. For the reported tests, the "ground truth" would be established scientific standards and methods for assessing biocompatibility (e.g., ISO 10993 series), sterility (e.g., USP or ISO 11137/17665), and engineering performance (e.g., specified mechanical properties, leak tests, etc.).

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning context. Its development and validation are based on engineering principles, materials science, and established medical device testing protocols.

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

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of what the document does state regarding acceptance criteria and studies:

The 510(k) summary states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration established and recognized international standards. Testing results were well within the acceptance criteria. Testing data and information is included in this submission."

This indicates that standard, established protocols were followed for these critical safety and performance aspects. However, the specific details of these protocols, the exact acceptance criteria, and the measured results are not provided in the publicly available summary. Such details would typically be contained within the full 510(k) submission document to the FDA.

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

The Bakri Postpartum Balloon is designed to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Postpartum Balloon is an inflatable tamponade balloon designed and proven to be affective in reducing and controlling postpartum bleeding. The construction of the Bakri Postpartum Balloon is silicone rubber. Biocompatibility testing has shown the materials to meet the test requirements. Bench testing has proven the products durability during simulated use. The Bakri Postpartum Balloon is provided sterile in peel open pouches and is intended for one time use.

The provided text describes a 510(k) premarket notification for the Bakri Postpartum Balloon. The core of this submission is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested sections (2-9 relating to study details) are not explicitly present in the provided documentation, as a different regulatory pathway was taken.

Here's a breakdown of the information that can be extracted and an explanation for the missing elements based on the nature of a 510(k) submission based on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Performance Goal: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device, specifically the SOS Bakri Tamponade Balloon Set (K013597).

Reported Device Performance:

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

This information is not provided as this submission relies on demonstrating substantial equivalence to a predicate device, not on a clinical trial with a "test set" for performance evaluation in the way requested. The "testing, gathered data, and the history of the predicate device" refer to the existing data for the already cleared predicate.

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)

This information is not provided for the same reasons as above. No specific "test set" with expert-established ground truth was part of this 510(k) for the new device.

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

This information is not provided as no specific clinical "test set" requiring adjudication for ground truth was used in this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a manual obstetric-gynecologic instrument (balloon), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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 or AI.

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

The "ground truth" for the current device's safety and effectiveness is primarily established through demonstration of substantial equivalence to an already legally marketed and cleared predicate device (SOS Bakri Tamponade Balloon Set K013597). This implies that the predicate device's safety and effectiveness (likely supported by historical data, clinical experience, and potentially older, pre-market clearance studies not detailed here) serves as the basis. The current submission highlights:

• "testing, gathered data, and the history of the predicate device... proves that the Bakri Postpartum Balloon is a safe and effective device."
• Biocompatibility testing results for the specific materials.
• Bench testing for durability.

8. The sample size for the training set

This information is not provided. As this is a 510(k) submission for a physical medical device based on substantial equivalence, there is no "training set" in the context of machine learning or AI.

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

This information is not provided. No "training set" in the context of machine learning or AI was used. The "ground truth" for the device's overall claims relies on its demonstrated equivalence to the predicate and the predicate's established track record.

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EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge of fluids from the vagina in order to assist with the episiotomy repair procedure.

V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.

EpiStat is an inflatable balloon tamponade device designed to provide a safe and effective method of temporarily tamponading the vagina to assist with post partum episiotomy repair. EpiStat is provided sterile in peel-open packages and intended for onetime use.

V-Stat is an inflatable balloon tamponade device designed to provide a safe and effective method of achieving haemostatic control by direct or indirect compression of vaginal tissues as a result of the inflation of a balloon using air. V-Stat is provided sterile in peelopen packages and intended for one-time use.

The EpiStat & V-Stat Vaginal Tamponade Balloon is a Class I and Class II medical device, respectively, and its premarket notification 510(k) summary does not contain the level of detail typically found in studies for AI/ML-powered devices. The provided document concerns a traditional medical device (tamponade balloons) seeking substantial equivalence to existing predicate devices, rather than a novel AI/ML application. Therefore, many of the requested categories related to AI/ML device studies, such as ground truth, expert adjudication, MRMC studies, and training set details, are not applicable or cannot be extracted from this document.

However, based on the provided text, here's what can be gathered regarding acceptance criteria and performance for the EpiStat & V-Stat Vaginal Tamponade Balloon:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify sample sizes for the performance tests (burst strength, tensile strength, leak testing, etc.).
• The data provenance is not specified. The tests are described as "Performance Testing" which implies an in-house or contracted laboratory setting, rather than clinical data from human subjects.

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)

• This information is not applicable and not provided in the document. The "ground truth" for a mechanical device is typically established by engineering specifications and objective physical measurements rather than expert human interpretation.

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

• This information is not applicable and not provided in the document. Adjudication methods are relevant for subjective assessments, particularly in clinical studies or image interpretation, which are not described here.

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 and not provided. An MRMC study is relevant for AI/ML image interpretation or diagnostic tools, which this device is not.

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

• This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm.

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

• For the performance tests, the "ground truth" is based on objective engineering and manufacturing specifications and established industry standards (e.g., ISO 10993-1 for biocompatibility). There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's physical and biological performance attributes.

8. The sample size for the training set

• This information is not applicable and not provided. The device is a physical tamponade balloon, not an AI/ML system requiring a training set.

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

• This information is not applicable and not provided for the reasons stated above.

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The Tamponade Uterine Balloon Catheter Set is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted. The device is one time use and is supplied sterile. "Use of this device is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted."

The Tamponade Uterine Balloon Catheter Set is intended for use in reducing and controlling post-partum uterine bleeding. The materials of the Tamponade Uterine Balloon Catheter are all silicone. Biocompatability testing has shown the materials to meet the test requirements.

The provided text is a 510(k) Premarket Notification for the Tamponade Uterine Balloon Catheter Set. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and device performance metrics in the way one would describe a diagnostic AI device or a novel therapeutic.

Therefore, much of the requested information cannot be directly extracted from this document. This submission is for a physical medical device, not an AI software.

Here's the information that can be extracted or inferred, and explanations for what cannot:

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

This information is not present in the provided 510(k) document. A 510(k) for a device like this primarily demonstrates substantial equivalence to predicate devices, focusing on materials, design, indications for use, and manufacturing processes, rather than presenting specific quantitative performance criteria and results like sensitivity, specificity, or precision. The "acceptance criteria" for a 510(k) are typically regulatory in nature (e.g., meeting biocompatibility standards, sterilization validation, etc.), not performance metrics of the device against a defined clinical outcome.

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

This information is not present. The document does not describe a clinical test set in the traditional sense. Substantial equivalence for this type of device is usually established through comparison to legally marketed predicate devices and validation of manufacturing and material properties, not a clinical trial with a defined test set of patients.

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)

This information is not applicable/not present. As there is no described clinical test set with ground truth establishment, this detail is not relevant to this 510(k) submission.

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

This information is not applicable/not present.

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/not present. This is a physical uterine balloon catheter, not an AI-assisted diagnostic or therapeutic device.

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

This information is not applicable/not present.

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

This information is not applicable/not present.

8. The sample size for the training set

This information is not applicable/not present. This is a physical device, not an AI algorithm requiring a training set.

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

This information is not applicable/not present.

Summary of Extracted Information:

The 510(k) document primarily describes the device, its intended use, and its substantial equivalence to predicate devices. It states:

• Device Name: Tamponade Uterine Balloon Catheter Set
• Intended Use: To provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted.
• Predicate Devices: Mentor U-Stasis balloons and the Balloon Uterine Stent manufactured by Cook OB/GYN®.
• Basis for Substantial Equivalence: Indications for use, design, materials of construction, manufacturing process controls, Quality Assurance Program, packaging, and sterilization procedures similar to currently marketed devices. The materials are all silicone, and biocompatibility testing showed they meet requirements.

The document does not contain the specific performance "acceptance criteria" and detailed study results typical for an AI software or a novel clinical intervention requiring extensive performance validation. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

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An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance.

The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of Pelvic organ prolapse/vaginal prolapse and is equivalent to the currently employed procedure, which is performed with the Deschamps™ device, distributed by BEI Medical Systems Corporation.

The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of vaginal prolapse.

The UroGyn DND 202™ device is a surgical tool, consisting of a plastic thimble connected to an operating box. The thimble element of the device contains a surgical needle and a cartridge preloaded with suture material.

The DND 202™ is mounted on the surgeon's index finger and controlled externally. DND 202™ allows the surgeon to operate guided by palpation only. The device is used to anchor the suture material to dense connective tissue at the hipbone during Bladder Neck Suspension for the treatment of Urinary Incontinence or Pelvic Organ Prolapse. The vaginal mucosa is open through surgical incision and the surgeon's finger, with the thimble of the DND 202 mounted on it, is placed through the incision to palpate the desired anatomical structure. The device is then operated externally by the other hand causing the projection of the surgical needle into the tissue. The needle reaches the opposite side of the device and retrieves the suture material from the cartridge. A reverse motion of the needle with the suture material hooked at the tip of the needle retracts the needle back into its housing. The surgeon remove his hand with the device out of the vagina, release the suture material from the needle and ends up with two ends of the suture material anchored to the target connective tissue and ready for tying.

This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The provided text is a 510(k) summary for the UroGyn DND 202™ Manual Urological Digital Needle Driver, which describes the device, its intended use, and indicates that the FDA found it substantially equivalent to a predicate device.

Specifically, the document states:

• No acceptance criteria or device performance data are reported.
• No study methodology, sample sizes, ground truthing, or adjudication methods are described.
• The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.

The "Conclusions" section in {2} states: "From UroGyn's experience we believe that the UroGyn design offers an equally effective alternative to the DND 101™ device and/or the Deschamps™ device for the treatment of female vaginal prolapse. Furthermore, as a minimally invasive procedure, we also believe that it presents equal safety to the patient and surgeon." This is a belief statement based on experience, not reported data from a formal study with acceptance criteria.

The 510(k) review process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trial data with specific acceptance criteria as might be seen for novel technologies or higher-risk devices.

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This instrument will be used to cut and clamp the umbilical cord in normal and abnormal deliveries. The instrument will cut and clamp both mother's side and baby's side of the univilical cord, simultaneously.

Not Found

This document is an FDA 510(k) clearance letter for a medical device called "Dr. Jahanger's Cutter (Umbilical Cord Cutter/Clamp)", dated October 29, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria.

Here's why and what information is missing:

• Type of Document: This is an FDA clearance letter, which confirms that a device has been found substantially equivalent to a predicate device. It is not a study report or a summary of device performance testing.
• Purpose of 510(k): The 510(k) pathway for medical device clearance primarily relies on demonstrating substantial equivalence to a device already on the market (the "predicate device"). While some performance data might be submitted, the full details of clinical studies, acceptance criteria, and ground truth establishment are typically not included or summarized in the clearance letter itself.
• Specific Device: The device is a mechanical "Umbilical Cord Cutter/Clamp." For such a device, performance criteria would likely revolve around mechanical integrity, cutting efficiency, clamping effectiveness to prevent blood loss, biocompatibility of materials, and sterilization validation. These are engineering and performance specifications, not often clinical efficacy metrics in the same way an AI diagnostic would have.

Therefore, I cannot provide the requested table and study details because the provided document does not contain that information.

To answer your request, I would need a different type of document, such as:

• A clinical study report for the device.
• A premarket approval (PMA) application summary (which requires more extensive clinical data than a 510(k)).
• A detailed technical file or design history file from the manufacturer.

The provided text only includes the device name, its intended use (to cut and clamp the umbilical cord), and the FDA's determination of substantial equivalence. It does not elaborate on the specific tests, acceptance criteria, or the methodology of any studies conducted to demonstrate its performance.

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