(45 days)
The ShangRing™ device is indicated for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.
The ShangRing is a sterile, single use, disposable circumcision device consisting of two concentric rings made from polycarbonate. The outer ring is formed from two semi-circular halves that are joined together on one end by a hinge, and by interlocking ratchets on the opposite end. The inner ring is lined with a soft silicone band. The ShangRing is available in 14 sizes with inner ring diameters ranging from 26mm to 40mm. A disposable sizing guide is provided to assist in selecting the appropriate size ShangRing. The ShangRing is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare practitioner everts the patient's foreskin over the inner ring and the outer ring halves are locked together, sandwiching the foreskin between the two rings which effectively prevents bleeding. Skin forward of the crush line is trimmed away. After the procedure, the ShangRing device remains on the patient for 7 days. After 7 days, the ShangRing is removed by the healthcare practitioner.
The provided text describes the ShangRing™ circumcision device and its regulatory submission. While it mentions clinical evaluations, it does not explicitly define acceptance criteria in a quantitative manner or provide a detailed study report that proves the device meets specific performance metrics in a structured way that would allow for the direct extraction of acceptance criteria and reported performance in a table format.
However, I can infer the "acceptance criteria" and "reported device performance" based on the general conclusions drawn from non-clinical and clinical tests as stated in the document.
Here's an attempt to extract and present the information requested, with necessary inferences and notations where direct data is absent:
Derived Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Inferred from study conclusions) |
|---|---|---|
| Biocompatibility | Must be biocompatible for prolonged contact with intact skin. | Confirmed to be biocompatible for its intended use according to ISO 10993-1 for a surface device in prolonged contact with intact skin. |
| Mechanical Strength | - Outer ring locking mechanism must not disengage during normal use conditions. |
- Device must remain in place on the patient (skin retention) when exposed to anticipated forces. | - Force required to pull apart the locking mechanism was determined.
- Force required to pull skin out of the ShangRing in the locked position was measured.
Conclusion: Possesses the required mechanical strength to prevent bleeding and remain attached to the foreskin for at least 7 days following closure of the locking ring. |
| Clinical Safety | - Infrequent adverse events. - Mild adverse events, requiring minimal management.
- Complication rates lower than conventional methods. | - Adverse events were infrequent.
- Adverse events were mild, requiring minimal management.
- Complication rates were lower than experienced with conventional methods.
Overall Conclusion: ShangRing™ is a safe means of performing circumcision. |
| Clinical Effectiveness | - Easily applied. - Short surgical procedure.
- No suturing required.
- Performs circumcision effectively. | - Easily applied in a short surgical procedure.
- No suturing required.
Overall Conclusion: ShangRing™ is an effective means of performing circumcision on adult males. The device achieves circumferential crushing of the foreskin. |
| Wear Duration | Device should remain on the patient for 7 days. | Mechanical testing and clinical studies support the device remaining attached for at least 7 days, allowing for effective crushing and subsequent removal. (Implicit in the "remains attached for at least 7 days" and "device remains on the patient for 7 days" statements). |
Here's the breakdown of the other requested information based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Approximately 3000 cases.
- Data Provenance: Clinical evaluations were conducted in China and Kenya. The text does not explicitly state whether these studies were retrospective or prospective, but clinical evaluations for device efficacy and safety are typically prospective.
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)
- The document mentions "clinical evaluations" and "clinical data" but does not specify the number of individual experts (e.g., surgeons, physicians) involved in establishing the ground truth or their specific qualifications (e.g., years of experience, specialization). It refers to healthcare practitioners performing the procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any specific adjudication method for establishing ground truth or evaluating outcomes in the clinical studies. It broadly states "clinical evaluations" and "clinical data collected confirms."
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, this is not applicable. The ShangRing™ is a physical surgical device (circumcision clamp), not an AI-assisted diagnostic or therapeutic tool for which MRMC comparative effectiveness studies (involving human readers improving with AI) would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, this is not applicable. The ShangRing™ is a physical surgical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The device's performance is inherently tied to its use by a human healthcare practitioner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the clinical studies appears to be based on clinical outcomes data (e.g., successful circumcision, absence/presence and severity of adverse events, complication rates, ease of application, duration of procedure, requirement for sutures). These outcomes would have been observed and recorded by the treating healthcare practitioners.
8. The sample size for the training set
- The concept of a "training set" typically applies to machine learning algorithms. Since the ShangRing™ is a physical medical device, there isn't a "training set" in that sense. The device's design and mechanical properties are refined through engineering and non-clinical testing, while clinical "training" for the device's efficacy and safety for human use relies on the reported clinical evaluations.
- If "training set" is interpreted as initial smaller clinical trials or studies that informed the final design and understanding before the reported "extensive clinical evaluations," the document does not provide details on such distinct phases or their sample sizes. The "approximately 3000 cases in these two countries" represents the cumulative clinical experience reported to demonstrate performance.
9. How the ground truth for the training set was established
- As above, the concept of a "training set" in the context of an AI/algorithm is not applicable here. For the clinical evaluations (which serve as the basis for understanding the device's performance and implicit "truth"), the ground truth was established through direct observation of clinical outcomes by medical professionals in China and Kenya. These outcomes included the successful completion of circumcision, the occurrence and nature of adverse events, and complication rates, as documented during standard clinical practice and research protocols.
§ 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.