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INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: · prolonged second stage - · suspicion of immediate or potential fetal compromise - · shortening of the second stage for maternal benefit

Instrumed obstetrical forceps are instruments designed to aid in the delivery of the fetus. Many different types of forceps have been described and developed. Generally, forceps consist of 2 mirror image metal instruments that are manoeuvred to cradle the fetal head and are articulated, after which traction is applied to effect delivery. Forceps have 4 major components, as follows: - Blades: The blades grasp the fetus. Each blade has a curve to fit around the fetal head. The . blades are oval or elliptical and can be fenestrated (with a hole in the middle) or solid. Many blades are also curved in a plane 90° from the cephalic curve to fit the maternal pelvic curve). - Shanks: The shanks connect the blades to the handles and provide the length of the device. They . are either parallel or crossing. - Lock: The lock is the articulation between the shanks. Many different types have been designed. . - Handles: The handles are where the operator holds the device and applies traction to the fetal . head. The surgeon chooses the obstetrical/gynaecological forceps based on the anatomy of the site and the type desired, based on the type of the surgical procedure. Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel. The instruments are offered in non-sterile condition.

The provided text describes a 510(k) submission for Instrumed Obstetrical Forceps. It details the device's description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the content provided, the acceptance criteria and the study proving the device meets them are articulated in terms of equivalence to predicate devices, rather than specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a test set or data provenance in the context of clinical studies with human participants. The evaluation relies on non-clinical and bench testing to demonstrate similarity to predicate devices. Therefore, traditional "sample size" for a clinical test set is not applicable here.

• Sample Size for Test Set: Not applicable as no human clinical test set is described. The evaluation is primarily based on non-clinical and bench testing of the device itself and comparison to predicate devices.
• Data Provenance: Not explicitly stated as the evaluation focuses on the physical device and its properties, materials, and design in comparison to existing devices.

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

This information is not provided in the document. Given that the submission is for substantial equivalence based on non-clinical and bench testing and comparison to predicate devices, there's no mention of a ground truth established by medical experts for a test set of patient data.

4. Adjudication Method for the Test Set

This information is not provided in the document. As no human clinical test set requiring expert ground truth or adjudication is described, this section is not applicable.

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 conducted or described in this submission. The device is a surgical instrument (forceps), and its evaluation is based on material properties, design, and functional similarity to already marketed predicate devices, not on the interpretation of medical images by multiple readers.

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

This question is not applicable as the device is a manual surgical instrument, not an algorithm or AI system. Its performance inherently involves a human operator (the surgeon).

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly established by the known safety and effectiveness of the predicate devices and the standards for material properties (e.g., ASTM F 899-09 for stainless steel). The claim is that the Instrumed Obstetrical Forceps functions equivalently to these well-established devices and uses appropriate materials, thus achieving safety and effectiveness.

• Implicit Ground Truth: Safety and effectiveness of legally marketed predicate devices and compliance with material standards.

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of an algorithm or AI system that requires a "training set."

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

This information is not applicable as there is no mention of an algorithm or AI system that requires a "training set" or its associated ground truth establishment.

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The Dimeda Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate vaginal delivery, provided that the cervix is fully dilated and the fetal head is positioned appropriately in the vagina. Use of the forceps is indicated for:

• 0 prolonged second stage
• 0 suspicion of immediate or potential fetal compromise
• shortening of the second stage for maternal benefit 0

The Dimeda Obstetrical Forceps is a surgical medical device for medical procedure to grasp the fetal head when it is in the vagina and bring about delivery by traction and guidance without causing injury to the mother or baby. The forceps consists of two arms which are movable. The device is manufactured from surgical stainless steel.

This submission for Dimeda Obstetrical Forceps (K092827) is a 510(k) premarket notification, which establishes substantial equivalence to previously cleared devices. It does not present a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial or performance study for a novel device would. Instead, it relies on demonstrating equivalence in intended use, design, materials, and performance to predicate devices already on the market.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or cannot be extracted from this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission for a traditional surgical instrument, there are no explicit "acceptance criteria" for novel performance features or quantitative reported device performance in the document. The acceptance criterion is the determination of "substantial equivalence" to the predicate devices, implying that the Dimeda Obstetrical Forceps perform as safely and effectively as the predicates.

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

• Sample Size: Not applicable. No specific test set with a defined sample size for performance evaluation is mentioned in the document. The submission relies on comparative data and market history.
• Data Provenance: The statement "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures" refers to retrospective market data from Europe.

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

Not applicable. No ground truth establishment by experts for a specific test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more typical for diagnostic imaging AI systems, not generally for surgical instruments demonstrating substantial equivalence.

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

Not applicable. This device is a manual surgical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

Not applicable in the usual sense of a diagnostic or algorithmic device. The "ground truth" for demonstrating safety and effectiveness relies on:

• Predicate Device Performance: The established safety and efficacy of the legally marketed predicate devices (K013747 - Tekno-Medical Obstetrical Forceps and K951529 - V. MUELLER Obstetrical (OB) Forceps).
• Market History: The lack of device failures over many years of use in Europe.

8. The Sample Size for the Training Set

Not applicable. This device is a manual surgical instrument and does not involve a training set for an algorithm.

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

Not applicable.

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tekno-medical obstetrical forceps are used for helping delivering the baby. The forceps is consisting of two parts and you are introducing every part from the forceps(blades) seperately into the vagina.

The Obstetrical forceps consist of two parts. Each of these two parts is introduced from the forceps (blades) seperately into the vagina.

This document is a 510(k) premarket notification decision letter from the FDA regarding "Techno-Medical Obstetrical Forceps." It communicates that the device is substantially equivalent to legally marketed predicate devices.

This type of document (a 510(k) clearance letter for a physical medical device like obstetrical forceps) typically does not contain the detailed information about acceptance criteria and a specific study proving device performance as would be found for a software-as-a-medical-device (SaMD) or AI-based device.

For a physical device like obstetrical forceps, "acceptance criteria" generally refer to design specifications, material properties, sterilization methods, and manufacturing quality control, rather than performance metrics like sensitivity, specificity, or AUC as seen in diagnostic algorithms. The "study" would typically involve biocompatibility testing, mechanical testing (e.g., tensile strength, fatigue), and potentially cadaveric or animal studies for safety and function, rather than human subject clinical trials focused on diagnostic accuracy.

Therefore, based solely on the provided text, I cannot extract the information required for your specific prompt. The document indicates that the device is "substantially equivalent" to predicate devices, meaning its safety and effectiveness are considered comparable to devices already on the market, but it does not detail the specific studies and acceptance criteria that led to this determination in the way you've outlined for an AI/software product.

Here's a breakdown of why each specific point you requested cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document only states the device is "substantially equivalent."
2. Sample size used for the test set and the data provenance: Not applicable/not present. This is a physical device, and the focus is on equivalence, not diagnostic test performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present. Ground truth as typically defined for AI/diagnostic algorithms is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not present.
8. The sample size for the training set: Not applicable/not present. This is a physical device.
9. How the ground truth for the training set was established: Not applicable/not present.

To find the kind of information you are looking for (acceptance criteria and detailed study results), you would need to examine the actual 510(k) submission document (if publicly available) which would contain engineering specifications, test reports, and comparisons to predicate devices, but these would not be structured in the same way as studies for an AI/SaMD product.

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