(28 days)
The ALLY II UPS™ (Uterine Positioning System) 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 ALLY II UPS™ (Uterine Positioning System) attaches to the operating room table and enables the bed-side assistant to readily mount, hold, and position the manipulator during laparoscopic surgical procedures. The ALLY II UPS enables access and provides the ability to maneuver and maintain the manipulator in a desired position. The ALLY II UPS consists of the ALLY II UPS and a manipulator adapter with built-in sterile drape, known as the adapter drape.
The CooperSurgical ALLY II UPS is a non-patient contacting, electromechanical device that consists of a single, multi-segmented, articulated arm. The ALLY II UPS can be attached to the standard operating room bed rail, and a separate, sterile, disposable Adapter Drape that is used to attach a uterine manipulator to the ALLY II UPS. When unlocked, the flexible arm allows the attached manipulator to be positioned by the user. The arm can then be locked in the desired position by releasing a foot pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator.
The purpose of this submission is to gain clearance for minor modifications made to the ALL Y Uterine Positioning System to meet user needs and allow for user convenience. The overall functionality and interface of the ALLY II UPS for the user remains the same.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the ALLY II UPS™ (Uterine Positioning System). This type of document is for medical devices, not AI/ML algorithms. Therefore, the questions related to AI/ML specific aspects like training data, ground truth establishment, MRMC studies, and standalone algorithm performance are not applicable to this submission.
The acceptance criteria and performance data described in this document relate to the physical and mechanical performance of the revamped medical device compared to its predicate.
Here's an analysis based on the provided text, focusing on the device's acceptance criteria and proven performance:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a direct table of acceptance criteria with corresponding performance values for the ALLY II UPS™. Instead, it broadly states that "The ALLY II UPS met the pre-determined acceptance criteria for each intended output." It lists the types of tests performed.
Implied Acceptance Criteria and Performance (based on Section VII. Performance Data):
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Durability (Useful Life) | Device sustains intended function, material integrity, and performance over its expected lifespan. | "was performed" (details not provided, but implies met criteria given substantial equivalence conclusion) |
| Holding Force | Device can consistently and securely hold uterine manipulators in desired positions without slippage or movement beyond acceptable tolerances. | "was performed" (details not provided, but implies met criteria given substantial equivalence conclusion) |
| Range of Motion | Device can manipulate to designated 6 points of extension in anteverted hand position and designated 5 points of extension in retroverted hand position. | Subject device has "greater Range of Motion than the predicate" and met the specified extension points. |
| Link Soak | Materials of the flexible arm (17-4 stainless steel, PEEK inserts) maintain integrity and function after exposure to relevant cleaning/sterilization protocols. | "was performed" (details not provided, but implies met criteria given substantial equivalence conclusion) |
| Foot Pedal Cable Retention | The detachable foot pedal cable remains securely connected during use and does not pose a safety risk. | "Justification" submitted (details not provided, but implies met criteria given substantial equivalence conclusion) |
| Electrical Safety (IEC 60601-1) | Compliance with general requirements for basic safety and essential performance of medical electrical equipment. | Device is "compliant with the following standards: IEC 60601-1: 2005+AMD1:2012+AMD2:2020 CSV" |
| EMC (IEC 60601-1-2) | Compliance with requirements for electromagnetic compatibility for medical electrical equipment. | Device is "compliant with the following standards: IEC 60601-1-2: 2014" |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the sample size for any of the tests (Durability, Holding force, Range of motion, Link Soak, Foot Pedal Cable Retention).
- Data Provenance: The data provenance is internal testing performed by CooperSurgical, Inc. It is a prospective test in the sense that newly designed units of the ALLY II UPS™ were manufactured and then tested to demonstrate their performance. The country of origin for the testing is not explicitly stated but is implied to be within the company's operational context (likely US, given the FDA submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this is a mechanical device, not an AI/ML system that requires expert interpretation for ground truth. The "ground truth" for this device would be defined by engineering specifications and objective measurements (e.g., force in Newtons, angles in degrees, material integrity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device. Adjudication methods are typically used in clinical studies or for establishing ground truth from human interpretations (e.g., radiology reads). The performance of this device is assessed through engineering and mechanical testing against predefined specifications.
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 device is a mechanical uterine positioning system, not an AI-assisted diagnostic or therapeutic tool with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a purely mechanical device; there is no AI algorithm to test for "standalone" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by engineering specifications, mechanical measurements, and compliance with recognized standards. For example:
- Holding Force: Measured in units of force (e.g., Newtons or pounds) against a specified minimum.
- Range of Motion: Measured in degrees or specific positions achievable, defined by design.
- Durability: Performance over a specified number of cycles or operating hours.
- Material Integrity: Assessed through material science tests and visual inspection post-soak/cycle.
- Electrical Safety/EMC: Compliance verified against the specified IEC standards (60601-1 and 60601-1-2).
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As stated above, this is not an AI/ML device.
§ 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.