(207 days)
Anchorsure is indicated for attaching suture to ligaments of the pelvic floor.
Anchorsure is a suture kit that consists of monofilament polypropylene suture, an anchor, an anchoring handle, and a surgical needle.
The ANCHORSURE device is a suture kit used for attaching sutures to ligaments of the pelvic floor. The submission evaluates the device against its predicate, the GYNECARE PROLENE FASTENER SYSTEM (K042603).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ANCHORSURE device are based on demonstrating that it meets established performance requirements and standards. The reported device performance is that it "meets the established performance requirements and standards."
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization | Ethylene oxide residuals within limits, Ethylene chlorohydrins residuals within limits, Sterility assurance level (SAL) determination met. | Meets established requirements and standards. |
| Packaging | Accelerated Aging Study results confirm package integrity and shelf stability. | Meets established requirements and standards. |
| Biocompatibility | Biocompatibility requirements met (supported by prior device testing). | Meets established requirements and standards (via K102815 support). |
| Mechanical Tests | Suture strength per USP 881, Anchor strength, Suture diameter per USP 861, Pullout strength of the anchor, Tensile strength of the suture-anchor interface per USP 871. | Meets established requirements and standards. |
Note: The document states that "Results of verification testing indicate that the product meets the established performance requirements and standards." Specific numerical acceptance values are not provided in this summary but are implied by adherence to standards like USP.
Study Details
Based on the provided information, the studies conducted are performance tests primarily focused on the physical and material properties of the device, rather than a clinical study evaluating human outcomes or an AI-driven analysis.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for each test. The sample sizes would be determined by the specific protocols for each performance test (e.g., number of sutures tested for strength, number of anchors for pullout strength).
- Data Provenance: The tests are likely performed in a laboratory setting by the manufacturer, Neomedic International, S.L., located in Spain, or by a contract testing facility. This is an in vitro evaluation, not involving human subjects or real-world clinical data. Therefore, the concept of "country of origin of the data" in a clinical sense, or "retrospective/prospective," is not directly applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. For these performance tests, "ground truth" is established by adherence to recognized national and international standards and test methods (e.g., USP standards for materials and mechanical properties, ISO standards for sterilization and biocompatibility). The expertise lies in performing the tests according to these standards and interpreting the results against the specified criteria. There isn't a "ground truth" established by human experts in the context of clinical interpretation or diagnosis.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image-based evaluations where multiple human readers assess a case. For physical performance tests, the results are typically quantitative measurements that are compared directly to pre-defined numerical or qualitative acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not relevant here as this is a physical device undergoing performance testing, not a diagnostic or AI-assisted system that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI-enabled device or an algorithm. It's a physical surgical tool.
7. The Type of Ground Truth Used:
- For sterilization, packaging, and mechanical tests, the ground truth is established by adherence to industry-recognized standards and test methods (e.g., USP, ISO).
- For biocompatibility, the ground truth was "biocompatibility testing completed on the Surelift Prolapse System (K102815) was used to support the biocompatibility of Anchorsure." This means the biocompatibility of the materials used in Anchorsure was confirmed by previous, cleared testing of a similar device using the same materials, ensuring compliance with relevant biocompatibility standards.
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not a machine learning model or an AI algorithm.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. (See point 8).
In summary, the ANCHORSURE device underwent rigorous laboratory-based performance testing against established industry standards for sterilization, packaging, biocompatibility, and mechanical properties. The aim was to demonstrate that the device's physical and material characteristics meet the necessary safety and effectiveness requirements, rather than evaluating its performance in a clinical setting with human readers or AI algorithms.
§ 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.