(431 days)
The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
The Konig Mogen Clamp consists of an arm with a locking mechanism in order facilitate compression on the foreskin. The locking mechanism consists of a lock connected to a lock bar using a pin. The clamp is fixed with a spot welding point, which allows for a maximum opening of 2.5 mm. The edges of the closing area are chamfered and rounded to avoid tissue injury.
The Konig Mogen Clamp is a reusable instrument that is provided non-sterilyzed by the user. The Konig Mogen Clamp will be validated for use in pre-vacuum steam sterilization.
The provided text describes a 510(k) premarket notification for a medical device called the Konig Mogen Clamp. This submission is for demonstrating substantial equivalence to a predicate device, not for establishing clinical efficacy or safety from scratch through the rigorous testing typically performed for novel devices or AI/software as a medical device (SaMD).
Therefore, the document does not contain the information requested about acceptance criteria, study details (sample size, data provenance, expert ground truthing, MRMC studies, standalone performance, training set details) that would be relevant for an AI/SaMD device.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing for physical performance, biocompatibility, and cleaning/sterilization validation, as detailed in the "Summary of Non-Clinical Testing" section.
Here's a breakdown based on the provided document, highlighting why most of the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a summary of non-clinical tests. The "Acceptance Criteria" for this type of device are typically met by passing standard international and ASTM (American Society for Testing and Materials) tests for surgical instruments. The "Reported Device Performance" is stated as "Test articles met the acceptance criteria" and "The Konig Mogen Clamp was non-toxic," and "No growth at the end of the incubation period." Specific numerical results or detailed acceptance ranges are not provided in this summary.
| Study | Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity | ||
| ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances | Must demonstrate non-toxicity and allowable limits for leachable substances as per ISO 10993 standards. | "The Konig Mogen Clamp was non-toxic." (Implies compliance with ISO 10993) | |
| Cleaning & Sterilization | ISO 17665-1:2006 Moist Heat - Req. for the development, validation, and routine control of a sterilization process for medical devices. | ||
| ISO 15883-2:2006 Req. and tests for washer-disinfectors employing thermal disinfection for surgical instruments (Used for the cleaning and thermal disinfection for reusable surgical instruments) | |||
| ANSI/AAMI ST79: 2017 Guide to steam sterilization and sterility assurance in health care facilities | Must be effectively cleaned and sterilized to achieve sterility assurance level (SAL). No microbial growth after sterilization. | "No growth at the end of the incubation period." (Confirms successful sterilization to required standards) | |
| Performance Testing | Custom Grip Test | ||
| ASTM E322-12 Standard Test Method For Analysis Of Low-Alloy Steels And Cast Irons By Wavelength Dispersive X-Ray Fluorescence Spectrometry | |||
| ASTM F1089-10 Standard Test Method for Corrosion of Surgical Instruments | |||
| ASTM E18 - 20 Standard Test Methods for Rockwell Hardness of Metallic Materials | Material composition, grip force, corrosion resistance, and hardness must meet specified ASTM standards for surgical instruments to ensure durability and proper function. | "Test articles met the acceptance criteria." (Confirms compliance with specified ASTM standards and custom grip test requirements, although specific values are not provided) |
2. Sample size used for the test set and the data provenance:
This document describes non-clinical bench testing for a physical surgical instrument. The "test set" would refer to the number of physical clamps subjected to the various physical, chemical, and sterilization tests. The document does not specify the exact number of units tested.
- Sample Size: Not specified for non-clinical tests. Medical device bench testing for performance and cleaning/sterilization typically involves a representative sample size of devices, often in the range of 3-30 units, depending on the test and statistical considerations.
- Data Provenance: Not applicable in the sense of patient data. The tests are performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in the context of this device's testing refers to objective measurements against engineering standards (e.g., material composition, hardness, successful sterilization, resistance to corrosion) rather than expert interpretation of patient data. These tests are performed by technicians or engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This refers to establishing consensus among human readers for diagnostic tasks, which is not relevant for this type of device's non-clinical testing.
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 type of study is relevant for AI or diagnostic imaging devices that assist human readers. The Konig Mogen Clamp is a manual surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This refers to the performance of an AI algorithm, not a manual surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's non-clinical testing is based on:
- Pre-defined engineering specifications and ASTM/ISO standard requirements (e.g., chemical composition, hardness values, corrosion resistance, maximum opening, sterilization success).
- Objective measurements obtained through laboratory testing (e.g., spectral analysis for material, physical force measurements, microbial growth assays).
8. The sample size for the training set:
Not applicable. This device is a mechanical instrument, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, for the same reason as #8.
In summary: The provided FDA 510(k) clearance document details the substantial equivalence of a manual surgical instrument and, therefore, focuses on non-clinical performance, safety (biocompatibility), and sterilization validation against established industry standards. It does not involve the types of clinical studies, AI performance metrics, or ground truth establishment relevant for an AI/SaMD device that the questions are implicitly structured to address.
§ 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.