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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:

• Irritation per ISO 10993-10:2010
• Sensitization per ISO 10993-5:2010
• Acute Systemic toxicity per ISO 10993-11:2017
• Pyrogenicity per ISO 10993-11 and USP | "The subject device is considered externally communicating device & surface contact device that may come in contact with tissue and breached or compromised surface respectively for a duration of less than 24 hours."
  "met the pre-specified acceptance criteria." |
  | Performance & Mechanical | - Intrauterine balloon integrity & concentric inspection
• Intrauterine balloon inflation stability test for a defined time period.
• Intrauterine balloon burst test
• Intrauterine balloon fatigue test
• Intrauterine balloon adhesion strength test
• OccludOR balloon outer diameter inspection & leakage free test
• OccludOR balloon deflation time test
• OccludOR balloon capacity test- reliability/safety
• OccludOR balloon fatigue durability test
• OccludOR balloon burst test
• Vaginal cup air leakage test
• Cervical cup temperature test
• Air inflation valve test
• Dye-injection port compliance & leakage test
• Thumb screw strength test
• Locking force test of vaginal cup
• Ease of movement of vaginal cup along the shaft
• Cervical cup detachment force test
• Cervical cup stopper adhesion strength test
• Device tensile strength
• Handle joint strength
• Tip deflection
• Ultrasonic welding strength | "In all testing, the subject device met the pre-specified acceptance criteria." |

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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