(116 days)
The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.
The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament.
The provided text describes the Saffron™ Fixation System, a medical device for attaching sutures to pelvic floor ligaments. The document does not contain information about acceptance criteria for a study or a study proving the device meets these criteria in the context of an AI/ML powered device.
Instead, the document details a 510(k) premarket notification for a traditional medical device, focusing on demonstrating substantial equivalence to a predicate device based on non-clinical performance data (biocompatibility, mechanical/performance testing, sterilization, and packaging).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets these criteria, as the input document does not pertain to an AI/ML powered device or a clinical study with detailed acceptance criteria of that nature.
Here's why the provided text cannot answer your questions and what it does contain:
- No mention of AI or ML: The Saffron™ Fixation System is a mechanical device, not an AI/ML powered device. Therefore, questions about "human readers improve with AI vs without AI assistance" or "standalone (algorithm only without human-in-the-loop performance)" are irrelevant.
- No clinical study for effectiveness: The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This means there's no clinical trial data to establish effectiveness in a human population.
- Focus on Substantial Equivalence via Non-Clinical Data: The FDA clearance for this device is based on demonstrating that it is "substantially equivalent" to an existing legally marketed device (predicate device). This is primarily achieved through showing similar technological characteristics and non-clinical performance data (e.g., strength, material safety, sterility) rather than a clinical effectiveness study against predefined acceptance criteria.
- "Acceptance Criteria" in this context refers to regulatory compliance: The "acceptance criteria" for this device are broadly the standards and test results that show it meets its intended function safely and effectively, and is comparable to the predicate device, as outlined in the various ISO standards and FDA guidances cited. They are not framed as specific performance metrics from a clinical study.
- Ground Truth: For a traditional mechanical device like this, "ground truth" for training or testing isn't applicable in the same way it is for AI. Performance is assessed through engineering tests (e.g., tensile strength, penetration force).
If you were expecting information on an AI/ML powered device, please provide a different document.
§ 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.