(259 days)
The Rosch Thurmond Fallopian Tube Catheterization Set is intended to be used for through a uterine access device for fluoroscopic selective catheterization of the proximal fallopian tube(s) and injection of contrast medium in the evaluation of tubal patency.
The Fallopian Tube Catheterization Set is intended to be used through a uterine access device for fluoroscopic selective catheterization of the proximal fallopian tube(s) and injection of contrast medium in the evaluation of tubal patency.
The Fallopian Tube Catheterization Wire Guide with Platinum Tip is to be used through a dimensionally compatible (>0.018 inch inner diameter) uterine access device or selective salpingography catheter to assist in the evaluation of tubal patency.
This submission contains two catheter sets: the Rösch-Thurmond Fallopian Tube Catheterization Set and the Fallopian Tube Catheterization Set. The submission also includes the Fallopian Tube Catheterization Wire Guide with Platinum Tip, which is included in the Fallopian Tube Catheterization Set, and will also be sold separately.
Rösch-Thurmond Fallopian Tube Catheterization Set: This set contains a 31 cm, 9 Fr, Teflon introducing catheter; a 50 cm, 5.5 Fr, polyethylene, radiopaque, torque control catheter; and a 65 cm, 3 Fr, Teflon, radiopaque, injection catheter. The introducing catheter is designed with a check flow valve at the user end while the two other catheters have a standard luer lock adapter. The set also comes with three 90 cm long, stainless steel, accessory wire guides. Two of the wire guides are 0.035 inches in diameter and the other is 0.015 inches in diameter.
Fallopian Tube Catheterization Set: This set contains a 50 cm, 5.5 Fr, polyethylene, radiopaque torque control catheter, a 65 cm, 3.0 Fr nylon injection catheter with radiopaque tip, and two wire guides. The larger wire guide is stainless steel and has a diameter of 0.035 inches. The set also comes with a smaller wire guide which can be purchased in two variations; either the 0.015 inch diameter, 90 cm long, stainless steel Cope mandril wire guide, or the 0.018 inch diameter, 90 cm long, nitinol Cope mandril wire guide.
Fallopian Tube Catheterization Wire Guide with Platinum Tip: This wire guide is identical to the Nitinol Cope Mandril Wire Guide included in Fallopian Tube Catheterization Set, but can be purchased individually.
Both the Rösch-Thurmond Fallopian Tube Catheterization Set, the Fallopian Tube Catheterization Set, and the Fallopian Tube Catheterization Wire Guide with Platinum Tip are sterilized using ethylene oxide, packaged in Tyvek® polyethylene peel-open pouches, and have a shelf-life of three years. The devices are intended for one time use.
The provided text describes a 510(k) premarket notification for multiple fallopian tube catheterization devices. It details the device's indications for use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence. However, it does not contain information related to a study involving algorithm/AI performance, human readers, or the establishment of ground truth by experts in the context of imaging analysis.
The acceptance criteria and study described are for the physical properties and performance of the medical device itself (catheters and wire guides), not for an AI/algorithm-based diagnostic system. Therefore, I cannot extract the specific information requested in your prompt regarding AI/algorithm performance, expert-established ground truth, sample sizes for AI training/test sets, or MRMC studies.
The document discusses:
- Acceptance Criteria: These are generally derived from internal Cook procedures, industry standards (e.g., ISO, ASTM, JIS), and performance parameters (e.g., tensile strength greater than predetermined criterion, no leakage, no signs of fracture, comparable tip flexibility).
- Device Performance: Reported as meeting or exceeding these predetermined acceptance criteria for various tests (sterilization, biocompatibility, packaging integrity, and bench performance tests like tensile, torque response, liquid leakage, corrosion resistance, fracture, flex damage, radiopacity, and tip deflection).
Here's a breakdown of the information that is available in the document, framed as closely as possible to your request, but highlighting the absence of AI-related information:
Acceptance Criteria and Device Performance (for the physical medical device):
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance | Comments |
|---|---|---|---|
| Material & Sterilization | Sterilization Validation (ISO 11135-1:2007) | Met applicable design and performance requirements. | Standard validation. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation per ISO 10993) | Demonstrated no different questions of safety and effectiveness. | Standard biocompatibility tests. | |
| Packaging & Shelf-Life | Transportation Simulation (ASTM D4169-16) | Met applicable design and performance requirements. | Standard packaging integrity. |
| Package Integrity (Bubble Leak, Seal Strength per ASTM F2096, F88; Visual Inspection) | All predetermined acceptance criteria were met; No damage displayed. | Tested after real-time aging. | |
| Catheter Performance | Compatibility Testing | Demonstrated compatibility between components. | For components used together as stated in IFU. |
| Tensile Testing (Catheter hub to shaft and tip to shaft) | Peak load value was greater than the predetermined acceptance criterion. | Acceptance criterion per Cook's internal procedures and JIS T 3246:2011. | |
| Torque Response Testing (5.5 Fr catheter) | Catheter has an appropriate torque response per predetermined acceptance criteria. | - | |
| Liquid Leakage Test (5.5 Fr and 3 Fr catheters) | Fluid path catheter assembly did not leak under the predetermined injection pressure (38 kPa). | For catheters used for contrast injection. | |
| Wire Guide Performance | Corrosion Resistance (per BS EN ISO 11070:2014 Annex B) | Tensile properties did not degrade; Predetermined acceptance criterion was met. | - |
| Fracture Testing (per BS EN ISO 11070:2014 Annex F) | No signs of fracture observed in the region of interest. | - | |
| Tensile Test (per BS EN ISO 11070:2014 Annex H) | Peak load value was greater than or equal to the predetermined acceptance criterion. | - | |
| Resistance to Damage by Flex (per BS EN ISO 11070:2014 Annex G) | No signs of defects or damage after repeated flexing; Predetermined acceptance criterion was met. | - | |
| Imaging Compatibility | Radiopacity Evaluation | Subject device was determined to be radiopaque in a simulated clinical setting. | - |
| Tip Flexibility | Tip Deflection Testing | Tip flexibility between the subject and predicate devices was comparable. | - |
Regarding your specific points (and why they are not applicable to this document):
- A table of acceptance criteria and the reported device performance: This has been provided above, but note it is for a physical medical device, not an AI.
- Sample sizes used for the test set and the data provenance: Not applicable to an AI test set. The document refers to "representative testing" for many bench tests, but does not provide numerical sample sizes for each physical test. Data provenance is implied to be internal testing by Cook Incorporated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be related to the physical properties and performance of the device, established through standardized testing methodologies, not expert interpretation of medical images.
- Adjudication method for the test set: Not applicable. There is no "adjudication" for the physical performance tests of a device. The tests have predefined pass/fail criteria.
- 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, an MRMC study was not done. This document describes the clearance of a physical medical device (catheters, wire guides), not an AI algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. This document pertains to hardware.
- The type of ground truth used: For the physical device, the "ground truth" is established by the specifications, design requirements, and a battery of standardized physical, chemical, and biological tests (e.g., tensile strength, leakage, biocompatibility).
- The sample size for the training set: Not applicable. There is no AI training set mentioned.
- How the ground truth for the training set was established: Not applicable. There is no AI training set mentioned.
§ 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.