(56 days)
The Ally Uterine Positioning System™ (UPS) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
The Advincula Delineator™ Adapter Drape for the Ally Uterine Positioning System™ UPS is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
The CooperSurgical Ally Uterine Positioning System™ (UPS) consists of a single, multi- segmented, articulating arm that attaches to a standard operating room bed rail, and a separate, sterile, disposable Ally UPS Adapter Drape that is used to attach a uterine manipulator to the Ally UPS. When unlocked, the articulation of the arm allows the attached manipulator to be positioned by the user. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator. The arm is then locked in the desired position by releasing a food pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm.
The Ally UPS is not intended for patient contact. The Adapter Drape for the Ally UPS is single- use and sterilized by ethylene oxide. The Ally UPS Adapter Drape secures either the Cooper Surgical RUMI II Uterine Manipulator Handle, or the Advincula Arch Uterine Manipulator Handle, to the distal end of the Ally UPS arm. The purpose of this submission is to gain clearance to add the new Advincula Delineator™ Adapter Drape to the system, which allows the Ally UPS to be used with the CooperSurgical Advincula Delineator™ Uterine Manipulator.
This document describes a 510(k) premarket notification for the CooperSurgical Ally Uterine Positioning System™ (UPS), specifically an update to include the Advincula Delineator™ Adapter Drape. This is a medical device, and the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance or AI effectiveness.
Therefore, many of the requested categories for AI-related studies (like MRMC, human-in-the-loop, training set details) are not applicable here. The document details non-clinical performance testing for a physical device.
Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance |
|---|---|
| Adapter Pull-off Force | Maintained specifications (specific values not provided in this summary, but implies it met predetermined thresholds). |
| Drape Pull-off Force | Maintained specifications (specific values not provided in this summary, but implies it met predetermined thresholds). |
| Handle Push Force | Maintained specifications (specific values not provided in this summary, but implies it met predetermined thresholds). |
| Sterilization Validation | Advincula Delineator™ Adapter Drape meets appropriate ethylene oxide and ethylene chlorohydrin residual levels per ANSVAAMI/ISO 10993-7:2008(R)2012, and achieved a Sterility Assurance Level (SAL) of 10-6 per ISO 11135-1:2007 and ISO 11135-2:2008. |
| Shelf Life (Stability Testing) | Advincula Delineator™ Adapter Drape maintained its specifications for the duration of its shelf life as demonstrated by stability testing in accordance with ASTM F1980-07. |
| Electrical Safety & Performance | Ally UPS is in compliance with IEC 60601-1 CORR 1 & 2 2007 and IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for each specific test (e.g., number of adapters tested for pull-off force). This is common for this type of summary, where the focus is on the type of test and the outcome rather than the granular details of the test execution (which would be in a full test report).
The data provenance is from non-clinical performance testing conducted by CooperSurgical, Inc. The document does not specify country of origin for the data; it's assumed to be part of the manufacturer's internal testing process. The testing is prospective in the sense that it was conducted specifically to evaluate the modified device before market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. This is a physical medical device, not an AI or diagnostic tool where human experts establish ground truth. The "ground truth" here is determined by engineering specifications, safety standards, and performance metrics measured in laboratory settings.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of human-interpreted data.
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 done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of this device submission. The document explicitly states: "Clinical testing was not required to support the conclusion of substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on:
- Engineering Specifications and Performance Metrics: Pre-defined thresholds for forces (pull-off, push), material properties, and functionality.
- International Standards: Compliance with standards like ISO 11135, ISO 10993, ASTM F1980, and IEC 60601 for sterilization, shelf life, and electrical safety. These standards themselves are established through expert consensus and scientific validation.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. 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. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.