(78 days)
Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
Galil Medical Cryoablation Systems have the following specific indications:
- Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
- . Oncology (ablation of cancerous or malignant tissue and benign turnors, and palliative intervention)
- . Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell turnors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
- Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) .
- . General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
- . ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)
- . Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions)
- . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
The IceRod Plus 17G Cryoablation Needles are sterile, single use, disposable components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. They are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IceRod Plus needles are available in two configurations, straight and angled 90°. Each 17-gauge (17G) disposable cryoablation needle has a sharp cutting tip, a shaft, a color-coded handle, a gas tube, and a connector. Additionally, each needle exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceRod Plus needles differ from the predicate device in that they contain an inner vacuum insulated tube to provide additional shaft insulation during a cryoablation procedure.
The provided text describes a 510(k) summary for the "IceRod Plus 17G Cryoablation Needles" and a letter from the FDA. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance metrics as might be found for novel devices or software.
Based on the information provided, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding device performance data in the typical sense of a clinical trial or performance study for a diagnostic device. Instead, it describes various types of testing conducted to ensure the device meets specifications and is substantially equivalent to predicate devices. The "reported device performance" is a general statement that the device met these specifications, rather than a specific metric.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional Testing | Adherence to specified dimensions for the needles (e.g., length, diameter, markings every 5mm). | "Test results demonstrated that the IceRod Plus needles meet defined specifications." |
| Functional Testing | Proper operation of the device as intended for cryoablation (e.g., gas flow, freezing/thawing application). | "Test results demonstrated that the IceRod Plus needles meet defined specifications." |
| Freezing Performance | Ability to achieve and maintain appropriate cold temperatures for tissue destruction. | "Test results demonstrated that the IceRod Plus needles meet defined specifications." |
| Stability | Maintenance of performance over time and under various conditions. | "Test results demonstrated that the IceRod Plus needles meet defined specifications." |
| Biocompatibility | Compliance with ISO 10993 standards for biological evaluation of medical devices. | "Additionally, the needles meet the biocompatibility requirements outlined in ISO 10993." |
| Overall Safety and Effectiveness | Not raising any new safety or effectiveness issues compared to predicate devices. | "Test results demonstrated that the IceRod Plus needles meet defined specifications and do not raise any new safety or effectiveness issues." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for the testing set beyond implying that "performance testing was conducted on the IceRod Plus Cryoablation Needles" (plural, suggesting more than one, but not a defined number). There is no information provided about the data provenance (e.g., country of origin, retrospective or prospective) for these performance tests. This typically involves in-house laboratory testing rather than human subject data for this type of device.
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)
This information is not applicable to the type of device and testing described. The "ground truth" for cryoablation needles would be their physical and functional characteristics (e.g., dimensions, temperature output, biocompatibility), which are evaluated against engineering specifications and international standards, not typically established by clinical experts in the way ground truth is for diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human reviewers independently assess data and resolve discrepancies, typically for diagnostic or clinical outcome measures. The testing described for the IceRod Plus is product performance testing against engineering and regulatory standards.
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
There is no indication that an MRMC comparative effectiveness study was conducted, nor is this type of study typically expected for a cryoablation needle. MRMC studies primarily evaluate the impact of a diagnostic AI system on human reader performance. The IceRod Plus is a medical device (a needle) used by a clinician during a procedure, not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The IceRod Plus is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing mentioned (dimensional, functional, freezing performance, stability, biocompatibility) would be defined by engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and in-house requirements. It is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but rather from measurable physical and performance characteristics.
8. The sample size for the training set
This information is not applicable. The IceRod Plus 17G Cryoablation Needle is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.