(79 days)
The CooperSurgical Infrared Coagulator ("IRC") is intended for coagulative necrosis of tissue. It is indicated for the treatment of genital condylomas (condyloma accuminata) and general warts.
The Cooper IRC delivers short pulses of visible and infrared light through a small contact tip applicator that is applied to the tissue. This light causes thermal coagulation that results in tissue necrosis. The user sets the pulse duration control knob depending on the depth of the tissue necrosis required. The depth of coagulation is directly related to the pulse length delivered to a given area of tissue. The area(s) to be treated may be locally anesthetized at the physician's discretion. Contact photocoagulation requires direct contact of the entire optical window of the disposable contact tip. The physician applies light mechanical pressure to the optical window against the tissue to be treated before depressing the activation trigger of the hand piece. To achieve coagulation, the user depresses the activation trigger. A built-in digital timer deactivates the lamp automatically according to the pulse duration setting preselected by the physician. If the desired treatment site is larger than the optical window, the physician may use overlapping exposures until the entire lesion is coagulated, waiting at least five seconds between exposures. The CooperSurgical IRC consists of the following main components: (1) a control unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip.
The provided text describes a 510(k) premarket notification for the CooperSurgical Infrared Coagulator. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria, a specific study design to prove acceptance criteria, or most of the requested information about sample sizes, ground truth establishment, or expert involvement for the current device.
However, the document does state that the safety and effectiveness are based on:
- Redfield IRC's premarket clearances for the treatment of hemorrhoids and chronic rhinitis, and for tattoo removal.
- The long history of use of lasers for the treatment of genital condylomas and general warts.
- Two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts.
Without the actual study reports for these "two recent clinical studies," it's impossible to extract the specific acceptance criteria and detailed study information as requested. The available document only provides a high-level summary of the basis for substantial equivalence.
Therefore, most of the requested information cannot be filled from the provided text.
Here's an attempt to answer what can be inferred from the document, with caveats:
1. Table of Acceptance Criteria and Reported Device Performance
- The document does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage of lesion clearance, a recurrence rate threshold, or a specific safety metric) for the CooperSurgical Infrared Coagulator or its performance in the context of acceptance criteria.
- It states that "two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts" were performed.
- Inference: The "acceptance criteria" for the CooperSurgical IRC was likely demonstrating equivalence (non-inferiority) to the established safety and efficacy profiles of the predicate devices for the new indicated uses (genital condylomas and general warts), rather than meeting predefined numerical thresholds reported in this summary. The performance would then be interpreted as "equivalent to predicate devices."
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Equivalence in safety and effectiveness to predicate devices | Demonstrated equivalence to predicate devices |
| for treatment of genital condylomas and general warts. | for the treatment of genital condylomas and |
| general warts, based on two clinical studies. |
2. Sample size used for the test set and the data provenance
- The document mentions "two recent clinical studies," but does not provide any details on the sample size used for the test set (patients/cases) or the data provenance (e.g., country of origin, retrospective or prospective nature) for these studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not specify the number or qualifications of experts used to establish ground truth in the clinical studies. Given the context (treatment of condylomas and warts), it is highly probable that clinicians (e.g., dermatologists, gynecologists, urologists) would have been involved in diagnosing and assessing treatment outcomes, but no details are provided.
4. Adjudication method for the test set
- The document does not describe any adjudication method used in the clinical studies.
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
- This device is an infrared coagulator, not an AI-powered diagnostic or treatment assistance tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a hardware medical device for tissue coagulation, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "two recent clinical studies," the ground truth for efficacy would likely be based on clinical assessment of lesion clearance/resolution and possibly recurrence rates as determined by treating physicians (outcomes data). For safety, it would involve monitoring adverse events. The document does not explicitly state the type of ground truth beyond "demonstrating that the IRC is equivalent."
8. The sample size for the training set
- As this is a hardware device cleared based on substantial equivalence and clinical studies, rather than an AI/ML algorithm requiring a training set, the concept of a "training set" in the AI sense is not applicable here. The design and parameters of the device were developed through engineering and pre-clinical testing, not a "training set" of data.
9. How the ground truth for the training set was established
- Again, as this is not an AI/ML device, the concept of establishing ground truth for a training set is not applicable. Device design is typically based on engineering principles, material science, and pre-clinical/bench testing, as well as prior knowledge from predicate devices.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).