(141 days)
The Probe Holder System is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
The Intuitive Surgical Probe Holder System is used to mount, position and hold in position uterine manipulators used in laparoscopic surgical procedures. The Probe Holder System can be mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time. Use of the Probe Holder System frees operating room staff for other activities and reduces fatigue associated with manually maintaining a device in position during surgical procedures. The Probe Holder System consists of two attachment mechanisms: one at its distal terminus for mounting the system to the operating room table and the other at the proximal terminus for securely grasping a surgical device. The mechanism at the distal terminus consists of jointed links, a crossbar and rail clamps while that at the proximal end is a simple mechanism for affixing detachable sterile adaptors that securely grasp a surgical device in the desired position. A handle and foot pedal actuated-mechanism facilitates rapid and secure intra-operative re-positioning of the device by the surgeon as needed. The Probe Holder System remains external to the patient's body at all times and is covered intra-operatively by sterile draping.
The provided text describes a 510(k) summary for the Intuitive Surgical Probe Holder System, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, or human-in-the-loop studies.
However, based on the document's nature for a medical device (a mechanical holder), we can infer the type of "acceptance criteria" and "performance data" that would be relevant for such a device in this context. The document explicitly states that design analysis and testing were conducted to confirm that basic functional characteristics are substantially equivalent to predicate devices and that design output meets design input requirements.
Given the information provided and interpreting the request in the context of this specific regulatory submission for a non-AI/software device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria or reported performance values. Instead, it indicates a qualitative assessment of substantial equivalence. For a device like a probe holder, typical "acceptance criteria" would relate to mechanical stability, secure holding, ease of positioning, compatibility with accessories, and durability.
| Acceptance Criteria (Inferred for a Mechanical Holder) | Reported Device Performance (as stated in submission) |
|---|---|
| Securely mounts and holds uterine manipulators | "Design analysis and testing has been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited." |
| Allows for stable positioning during laparoscopic procedures | "The Probe Holder System can be mounted to standard operating room tables and locked in position allowing surgical devices to be securely held in position for long periods of time." |
| Facilitates intra-operative repositioning by the surgeon | "A handle and foot pedal actuated-mechanism facilitates rapid and secure intra-operative re-positioning of the device by the surgeon as needed." |
| Compatible with standard operating room tables and surgical devices | "The Probe Holder System consists of two attachment mechanisms: one at its distal terminus for mounting the system to the operating room table and the other at the proximal terminus for securely grasping a surgical device." |
| Material safety and biocompatibility (where applicable) | Not explicitly detailed, but implied by "design analysis and testing... to meet design input requirements." |
| Durability and reliability under intended use conditions | Not explicitly detailed, but implied by "design analysis and testing... to meet design input requirements." |
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 any sample sizes for tests or the provenance of data. The "testing" mentioned refers to internal design validation and verification, which is typical for mechanical devices seeking 510(k) clearance based on substantial equivalence.
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)
This section is not applicable as the device is a mechanical holder, not an AI or diagnostic device that requires expert-established ground truth for its performance assessment in a clinical context. The "ground truth" for a mechanical device is its functional performance according to engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the device is a mechanical holder. Adjudication methods are typically used in studies involving subjective interpretations (e.g., radiology reads) to establish consensus ground truth.
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 MRMC study was done or is relevant for this mechanical device. This type of study is specific to AI/CAD systems that assist human operators in tasks like image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a mechanical holder and does not involve an "algorithm" or standalone AI performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this mechanical device is its engineering specifications and functional requirements (e.g., holding force, range of motion, stability, compatibility). These are established through design inputs and verified through engineering tests.
8. The sample size for the training set
This section is not applicable as there is no "training set" for a mechanical device like this. Training sets are used for machine learning models.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this 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.