(257 days)
Circumcision of foreskin of males from infant to adult by circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
The Male Circumcision Kits: RAPIDECLAMP™ is a surgical procedure purposely for circumcision which using a set of clamps that involves partial or complete removal of the foreskin (prepuce) of the penis. This device was designed technologically using molding process to replace the conventional method. It was designed specifically to promote faster circumcision process, prevent severe bleeding with less pain. It contains a set of clamp with a protective shield, RAPIDECLAMP™ measuring plate, and a blade or scissor. This device known as RAPIDECLAMP™ is made up of Polycarbonate (PC) and Acrylonitrile butadiene styrene (ABS). Generally, RAPIDECLAMP™ consists of Guide Ring, Spike Body-Front and Rear, Anti-Slip Ring, Locking Cover, and Protective Shield.
The provided document describes the Male Circumcision Kits: RAPIDECLAMP™. This is a medical device, and the information focuses on its substantial equivalence to predicate devices for FDA clearance, rather than a detailed efficacy study with acceptance criteria and performance metrics in the typical sense of AI/software devices.
However, I can extract information related to the device's performance based on the clinical and non-clinical tests mentioned, and present them in a format that addresses your request where applicable. It's important to note that this is not a software/AI device, so many of your requested points (like data provenance, number of experts for ground truth, MRMC studies, standalone performance for an algorithm, training set details) are not directly applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a physical medical device seeking substantial equivalence, specific numerical 'acceptance criteria' for efficacy in the way one would see for an AI diagnostic tool (e.g., sensitivity > X%, specificity > Y%) are not explicitly stated in this document. Instead, the "acceptance criteria" are implied by demonstrating that the device is "safe and effective" and "substantially equivalent" to predicate devices. The performance is reported in terms of general clinical outcomes.
| Criteria (Implied) | Reported Device Performance (RAPIDECLAMP™) |
|---|---|
| Safety | - Meets all safety requirements (implied by non-clinical and clinical tests). |
- Biocompatibility: Compliant with ISO 10993 (cytotoxicity, sensitization, and irritation requirements).
- Locking Test: Confirmed that the circumcision clamp is secured properly.
- Force and break tests performed on the device. |
| Effectiveness (Clinical Outcome) | - Easily applied in a short surgical procedure. - No suturing required.
- Safe and effective means of performing circumcision on adult males.
- Designed to promote faster circumcision process, prevent severe bleeding with less pain. (Claimed design goal) |
| Substantial Equivalence | - Substantially equivalent in clamping method, sterility, single use, no use of suture, and intended use to the predicate devices (Smart Klamp® and Shang Ring™). - Differences in design do not raise new issues of safety and effectiveness. |
| Materials | - Materials (Polycarbonate and ABS) meet biocompatibility requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Clinical test were conducted" and "The clinical data collected confirms that the RAPIDECLAMP is a safe and effective means of performing circumcision on adult males." However, the exact number of patients enrolled in the clinical study is not provided in this summary.
- Data Provenance: The clinical tests were conducted in Malaysia at:
- Ar-Raudhah Clinic
- JB Specialist
- Retrospective/Prospective: Not explicitly stated, but clinical tests conducted at specific clinics typically imply a prospective study for device evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as this is a physical medical device, not an AI or software diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for a surgical device's effectiveness would be observed clinical outcomes and safety profiles in patients, assessed by the medical practitioners conducting the procedures.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/software device requiring expert consensus on interpretations, there's no "adjudication method" in the context of resolving disagreements among experts. Clinical safety and effectiveness would be judged by treating physicians and potentially by independent review boards or regulatory bodies based on the aggregate clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. An MRMC study is relevant for evaluating diagnostic performance of imaging systems or AI algorithms by comparing multiple readers' interpretations of cases. This device is a surgical clamp, not an interpretation tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical surgical instrument and inherently involves a human operator (a medical doctor). The concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the assessment of this device's safety and effectiveness is based on clinical outcomes data gathered from the patients on whom the device was used. This would include observations related to:
- Ease of application and surgical procedure time.
- Prevention of severe bleeding and reported pain levels.
- Post-procedure healing and absence of complications.
- Overall assessment of safety and effectiveness by the medical professionals involved.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical surgical 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.