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The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).

The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device.

The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.

The provided document is a 510(k) summary for the Gynetech ManipulatOR and ManipulatOR PRO devices. It describes the devices, their intended use, and claims substantial equivalence to previously cleared predicate devices.

However, the document does not contain information about acceptance criteria, detailed study designs, specific device performance metrics, sample sizes for test or training sets, ground truth establishment, or expert involvement for a performance study.

Instead, the document primarily focuses on:

• Indications for Use: What the device is cleared to do.
• Technological Characteristics: How the device is similar to and different from its predicate, largely related to material changes (addition of colorants).
• Performance (mention only): A general statement that the devices were subjected to safety and performance testing for the initial 510(k) review and passed biocompatibility testing. It states this testing "demonstrated the functionality and safety of the device for its intended use."

Therefore, based solely on the provided text, I cannot complete the requested tables and information about acceptance criteria and a study proving device performance in detail.

The document states: "The ManipulatOR and ManipulatOR PRO were subjected to safety and performance testing by the manufacturer for the initial 510(k) review." and "The performance testing undertaken for the initial 510(k) review demonstrated the functionality and safety of the device for its intended use." This is a summary statement, not a detailed report of a performance study. No specific metrics like sensitivity, specificity, accuracy, or other quantitative performance measures are given.

In the context of 510(k) submissions, "performance testing" often refers to engineering and bench testing to ensure the device meets its design specifications and safety requirements, rather than a clinical study evaluating diagnostic accuracy or reader improvement. The described changes (colorants) are material changes, and the associated performance testing would likely be focused on biocompatibility and mechanical property verification, not a clinical study of efficacy.

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The InsufflatOR Needle™ is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide, to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Gynetech InsufflatOR Needle is a sterile disposable Veress needle which is available in 120mm or 150mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of gas flow. The most proximal end contains a male luer lock connector for connection to a CO2 gas line. The InsufflatOR Needle has applications in gynaecological laparoscopy and other laparoscopic procedures.

The provided document describes the Gynetech InsufflatOR Needle, a Veress needle for establishing pneumoperitoneum during laparoscopic procedures. The submission is for a 510(k) premarket notification, claiming substantial equivalence to a predicate device, the GeniCon Pneumo-Needle (K993625).

The document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device. The information provided relates to the substantial equivalence of a physical medical device (InsufflatOR Needle) to a predicate device, focusing on manufacturing specifications, sterilization methods, and basic performance tests relevant to its mechanical function.

Therefore, most of the requested information, which pertains to AI/ML device performance studies, ground truth establishment, sample sizes for training/test sets, expert qualifications, adjudication methods, and MRMC studies, is not present in the provided text.

Based on the available text, here's what can be extracted:

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

The document mentions that the InsufflatOR Needle was manufactured to the "same exact specifications as the predicate device by GeniCon." It also states, "All testing undertaken to demonstrate substantial equivalence of the requirements of its predetermined acceptance criteria and intended use." However, it does not explicitly list the specific acceptance criteria or the numerical performance results for most of these tests. It lists the types of tests performed.

2. Sample size used for the test set and the data provenance:
Not applicable as this is a physical device, not an AI/ML algorithm requiring a data test set in the traditional sense. The "test set" described refers to physical devices undergoing functional and sterility testing. The sample size for these specific physical tests is not mentioned. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood for AI/ML devices is not relevant here. The "ground truth" for this device would be its physical and functional specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of 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:
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 not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of AI/ML. For this physical device, the "ground truth" implicitly refers to the established engineering specifications and performance characteristics of the predicate device and relevant international standards (e.g., ISO for sterilization).

8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable.

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The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device. The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.

This document is a 510(k) summary for the Gynetech ManipulatOR and ManipulatOR PRO. It details the device's indications for use, its description, and a summary of performance and safety data, as well as a substantial equivalence discussion.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., "device must withstand N newtons of force"). Instead, it lists various performance tests and indicates that they were "successfully completed to confirm the subject device met the user requirements for the proposed intended use." The reported device performance is qualitative, confirming that the tests were passed.

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

The document does not specify the sample sizes for the various performance tests (e.g., number of devices tested for air leak, balloon integrity, etc.). The provenance of the data is from Gynetech Pty Ltd, an Australian company. The studies appear to be prospective bench testing and biocompatibility testing, conducted by the manufacturer to demonstrate device performance. This is not clinical data, but rather engineering and laboratory testing.

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

This information is not provided in the document. The performance data is derived from technical bench tests and biocompatibility testing, not from expert review of data that would require "ground truth" establishment in the traditional sense of clinical studies.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are bench tests and biocompatibility assessments, not clinical studies involving expert adjudication of findings.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes technical performance testing and biocompatibility assessment, not a clinical study involving human readers or AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study of an algorithm was not done. This device is a physical medical instrument, not an AI or software device. The listed studies focus on the physical and material performance of the uterine manipulator.

7. Type of Ground Truth Used

The "ground truth" for the performance studies described would be based on engineering specifications, material science standards (e.g., ISO 10993-1 for biocompatibility), and established test protocols to determine if the device meets its design requirements. This is not clinical "ground truth" like pathology or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, and the described studies are not machine learning or AI-based; therefore, there is no "training set."

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

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

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The McCartney Access Tube is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and as a template for dissection, while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopically assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

The McCartney Access Tube is a sterile, single use instrument consisting of a silicone rubber tube, a polypropylene body and a silicone rubber cap. The McCartney Access Tube is available in 35mm and 45mm diameters. The instrument is packaged with a stopcock that can be inserted on the cap in order to insufflate and desufflate the peritoneum along with minizing gas leakage. The cap has two valves for 5mm and 10mm minimally invasive instrument access. The distal end of the silicone rubber tube is beveled and has a textured surface for internal identification.

The provided document is a 510(k) Summary of Safety and Effectiveness Information for the McCartney Access Tube dated August 29, 2005. This type of regulatory submission is for medical devices and focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting performance acceptance criteria with detailed statistical analysis as is common for AI/ML-driven devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in this document, as it falls outside the scope of a traditional 510(k) for a non-AI/ML device.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, design, and materials, not on specific performance metrics or acceptance criteria for statistical-based outcomes.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data or study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, 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-driven device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No study requiring ground truth is described.
8. The sample size for the training set: Not applicable. This is not an AI-driven device, so there is no training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI-driven device, so there is no training set or associated ground truth.

Summary of Device Acceptance (from the provided document):

The acceptance of the McCartney Access Tube is based on the FDA's determination of substantial equivalence to a legally marketed predicate device (KOH Colpotomizer System, K954311). This means the FDA found that the new device is as safe and effective as the predicate device.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The "study" or evidence proving this equivalence relies on:

• Comparison of Intended Use: The McCartney Access Tube has a "similar intended use" to the predicate device.
• Comparison of Technological Characteristics: While the McCartney Access Tube has a "different design and constructed of different materials" from the predicate, the 510(k) process concludes that these differences do not raise new questions of safety or effectiveness. The document itself does not detail specific performance characteristics or comparison points other than stating similarity in intended use. It's implicit that the manufacturer provided sufficient information (e.g., bench testing, material safety data) to convince the FDA that the new design/materials do not alter its fundamental safety and effectiveness in its intended application.

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