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The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.

The Uterine ElevatOR PRO with OccludOR Balloon™ is a sterile, single-use medical device used to manipulate the uterus and cervix in surgical and diagnostic procedures. The device includes an insulated and anatomically designed stainless steel shaft with an intrauterine balloon and reference graduations (centimetres) at the proximal [to patient] end and an external handle at the distal end. The intrauterine balloon is inflated with air using a standard syringe (not included). The device has a vaginal cup that is pushed along the shaft to support a green cervical cup. The cervical cup provides a guide for colpotomy. There are four sizes of cervical cups available, 32mm, 37mm, and 40mm, which correspond to the different model numbers. A locking assembly secures the position of the vaginal cup and therefore the cervical cup. Sites for suturing are located on the cervical cup. An Occluder Balloon further reduces leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.

This is a 510(k) premarket notification for a medical device called the "Uterine ElevatOR PRO with OccludOR Balloon™", not an AI/ML device. Therefore, the request for acceptance criteria and study details related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable.

The document describes performance data for a physical medical device, which includes:

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

The document broadly states that "In all testing, the subject device met the pre-specified acceptance criteria." However, it does not provide a specific table detailing each acceptance criterion and the corresponding reported device performance. It lists the types of tests conducted:

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 any of the tests, nor does it provide information on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in full study reports, not a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable, as this is a physical medical device and not an AI/ML device relying on "ground truth" derived from expert consensus. The "truth" for this device's performance is determined by meeting physical and biological specifications through various standard engineering and biocompatibility tests.

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

Not applicable for a physical medical device as 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, as this is a physical medical device and not an AI/ML device involving human readers or AI assistance.

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 without an algorithm component.

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

Not applicable for a physical medical device. The "ground truth" here is adherence to engineering specifications and biocompatibility standards.

8. The sample size for the training set:

Not applicable, as this is a physical medical device and not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set or AI/ML model for this physical medical device.

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The use of the DUMI ManipulatOR is indicated in diagnostic laparoscopy, mini laparotomy, fertility exams, and salpingoplastic procedures where manipulation of the uterus is required.

The DUMI ManipulatOR is a sterile, single use, disposable medical device designed for the intra-operative manipulation of both the anteverted and retroverted uterus as well as facilitating simple and effective dye studies. The device includes an anatomically designed balloon at the distal end that is injected with air by syringe through the luer connector of inflation valve. The three-way hub can accommodate fluid and can be used for dye studies.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines various tests conducted to demonstrate the safety and effectiveness of the DUMI ManipulatOR, primarily by establishing substantial equivalence to a predicate device. The acceptance criteria are generally "successfully met predetermined acceptance criteria" or demonstrating performance "at least the same as the predicate device." Specific numerical criteria are not always explicitly stated in this summary, but the types of tests and their successful outcome are.

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

The document does not explicitly state specific sample sizes for each individual test. However, it references several standards that typically dictate sample size requirements for testing and quality control:

• ISO 2859-1:1999: "Sampling procedures for inspection by attribute - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection." This standard would have guided the sample sizes for attribute inspection tests.
• ASTM F3172-15: "Design verification device size and sample selection for Endovascular devices." While the DUMI ManipulatOR is not an endovascular device, this standard indicates that sample size selection for design verification was a considered aspect of the testing strategy.

Given the nature of the device (uterine manipulator) and the tests performed (physical, mechanical, biocompatibility, sterilization, packaging), the data would be prospective as the tests were conducted specifically for this submission.

The provenance of the data is not explicitly stated per test but is implied to be from testing labs associated with The O.R. Company Pty Ltd, an Australian company with offices in Australia, North America, and Hong Kong. The testing was conducted to meet international and US FDA standards.

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 tests described are primarily objective, quantitative engineering, microbiological, and chemical tests. Clinical expert "ground truth" (e.g., radiologists, pathologists) is typically relevant for diagnostic devices or AI algorithms that interpret medical data. For a manual surgical instrument, the "ground truth" for performance is established through defined acceptance criteria in engineering standards, material science, and regulatory guidelines.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are usually relevant in clinical trials or studies where human interpretation or consensus is required to establish a gold standard for disease presence or other clinical outcomes. The tests performed for the DUMI ManipulatOR are laboratory-based and objective, with outcomes determined by measurement against predetermined standards.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this device. The DUMI ManipulatOR is a manual surgical instrument, not an AI-powered diagnostic or assistive tool for image interpretation. Therefore, there is no concept of "human readers" or "AI assistance" in its evaluation.

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

No, a standalone algorithm-only performance assessment was not done. The DUMI ManipulatOR is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:

• Engineering and Material Standards: Defined specifications and performance limits derived from international and national standards (e.g., ISO, ASTM).
• Predicate Device Equivalence: The performance of the predicate device (Panpac Uterine Manipulator Injector, Model UMI 4.5) serves as a benchmark for comparison in several performance tests. The new device must perform "at least the same as" the predicate.
• Regulatory Requirements: Compliance with quality management systems (ISO 13485, 21 CFR 820), risk management (ISO 14971), and biocompatibility guidelines (ISO 10993 series).

8. The Sample Size for the Training Set:

This information is not applicable. The DUMI ManipulatOR is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The device itself is manufactured, and its performance is verified through testing.

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

This information is not applicable as there is no "training set" for this type of device.

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