(100 days)
A circumcision clamp is used in a circumcision procedure to compress the foreskin of the penis during circumcision of a male infant or child.
The Surgical Design Gomco Circumcision Clamp is a disposable medical device that is constructed of Chrome Plated Brass. The device will be sold Non Sterile for further processing(i.e. Packaging and Sterilization) by the Final Distributors. We do not intend to sell these devices to the end users.
This document is a 510(k) summary for the Surgical Design Circumcision Clamp, which is a medical device. As such, it does not contain the typical information associated with studies proving a device meets acceptance criteria for an AI/ML or diagnostic device. The device in question is a physical surgical clamp, not a software or AI-driven system.
Based on the provided text, here's an analysis of the information related to acceptance criteria and "studies":
The document does not describe acceptance criteria in the typical quantitative or performance-based sense that would be expected for a diagnostic or AI device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device.
The "study" conducted to prove the device meets these criteria is a comparison to a predicate device, rather than a clinical trial or performance study.
Here's a breakdown based on your requested information, highlighting where the document's nature prevents providing the specific details you've asked for:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Material: Chrome-Plated Brass | Same as predicate |
| Design: Gomco-Style Circumcision Clamp | Same as predicate |
| Intended Use: Used in medical procedure to compress foreskin during circumcision of male infant or child | Intended for infant and child circumcision (Predicate: Infant Circumcision) |
| Re-use: No, disposable | Same as predicate |
| Sizes Available: (Specific sizes listed) | Extra Small: 1.1 CM |
| Newborn: 1.3 CM | |
| Infant: 1.45 CM | |
| Child : 1.6 CM (Predicate did not have "Child" size) | |
| Sterility: Non-Sterile (for further processing) | Non-Sterile (Predicate: Sterile) |
Note: The acceptance criteria here are derived from the characteristics of the predicate device. The "performance" is simply confirming that the new device shares these characteristics or has acceptable differences.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable. No test set in the traditional sense was used. The evaluation centered on comparing the physical characteristics and intended use of the new device against an existing, legally marketed predicate device.
- Data provenance: Not applicable. No "data" was collected from a test set of patients or images. The information comes from the physical specifications of the new device and the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "ground truth" to establish for a test set of diagnoses or observations, as this is a physical medical device (a clamp). The regulatory review for substantial equivalence is conducted by FDA personnel.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication was used. The determination of substantial equivalence is a regulatory decision made by the FDA.
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
- Not applicable. This is not a diagnostic device or an AI-powered system. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical, manual surgical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this type of device, the "ground truth" for regulatory approval is essentially the established safety and effectiveness of the legally marketed predicate device (Centurion® CirClamp™). The new device demonstrates substantial equivalence if it performs similarly and raises no new questions of safety or effectiveness.
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
In Summary:
This document is a 510(k) premarket notification for a physical medical device. The "study" described is a demonstration of substantial equivalence to a predicate device, which is a common regulatory pathway for many medical devices. It explicitly states:
- "Non Clinical testing was not performed"
- "Clinical testing was not performed"
The document aims to show that the Surgical Design Circumcision Clamp is "identical in material, design and intended use" to a previously cleared device, with minor differences (larger size available, non-sterile packaging) that do not raise new questions of safety or effectiveness. The FDA's letter confirms that they have reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.
§ 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.