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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, 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 tumors, and palliative intervention
• Dermatology Ablation or freezing of skin cancers and other cutaneous disorders
Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal 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, recurrent cancerous lesions, ablation of breast fibroadenomas
• 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

Galil Medical's predicate IceSphere needles and Galil's proposed IceSphere needles are sterile, single use, disposable devices used in conjunction with Gali! Medical's cleared cryoablation systems (SeedNet, SeedNet Gold; Presice; Visual-ICE) for cryoablative destruction of tissue during surgical procedures. The needles have a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. Galil's predicate and proposed iceSphere needles are available in 2 handle configurations: straight and 90°. The needles contain shaft markings to aid the physician in needle placement.

Galil is requesting clearance of the proposed vacuum insulated IceSphere needles. The vacuum insulated modification represents a one-for-one component exchange within the internal non-patient contacting lumen of the cryoablation needle shaft.

The provided text is a 510(k) summary for the Galil Medical IceSphere Cryoablation Needle. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information regarding traditional acceptance criteria, a test set with ground truth, or details of a study with human readers or standalone AI performance.

Instead, the performance data discussed pertains to engineering verification testing to demonstrate that the modified device (with vacuum insulation) meets design specifications compared to the predicate non-insulated device.

Therefore, many of the requested fields cannot be filled based on the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "The insulated IceSphere successfully passed all the design properties testing in accordance with the established acceptance criteria compared to the non-insulated IceSphere predicate. Test results demonstrated that the proposed insulated IceSphere needles meet defined specifications and do not raise any new safety or effectiveness issues as compared to the predicate."

This implies that the acceptance criteria were defined as the modified device performing equivalently to the predicate device in design properties testing. Specific numerical acceptance criteria or performance metrics are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes engineering verification tests on the device itself, not a clinical study on patient data. Therefore, typical "test set" and "data provenance" as applied to AI/diagnostic devices are not applicable and not provided.

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 is not a diagnostic device or a study requiring expert readers for ground truth. This information is not applicable and not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not a diagnostic device or a study requiring adjudication. This information is not applicable and not provided.

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 is not a diagnostic device or a study involving human readers or AI assistance. This information is not applicable and not provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an algorithm or AI device. This information is not applicable and not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given this is an engineering verification of a physical medical device (cryoablation needle), the "ground truth" would be objective engineering measurements and comparisons to design specifications and the predicate device's measured performance. No clinical "ground truth" like pathology or outcomes data is relevant for the reported testing. This information is not applicable in the traditional sense of diagnostic AI.

8. The sample size for the training set

This document does not describe the development of an AI algorithm with a training set. This information is not applicable and not provided.

9. How the ground truth for the training set was established

This document does not describe the development of an AI algorithm with a training set. This information is not applicable and not provided.

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The SeedNet™ System (SeedNet Gold™ System) is intended for cryogenic destruction of tissue during surgical procedures. It 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. The SeedNet™ System (SeedNet Gold™ System) has 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 tumors and palliative intervention) Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors 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.) ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions.) Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids) The SeedNet™ System (SeedNet Gold™ System) may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

Galil Medical's SeedNet™ System with the SmartWarmer is a modification of Galil Medical LTD's cleared SeedNet™ System (K021261). The SeedNet™ System is the exact same device as the SeedNet™ except for the substitution of the SmartWarmer™ for Gaymar's warmer and Barnant's pump as the device's transurethral warmer ("TUW") accessory.

The provided text describes the Galil Medical SeedNet™ System, a cryosurgical unit. However, it does not contain specific acceptance criteria or an explicit study detailing performance outcomes against such criteria in a quantifiable manner as you've requested.

The document is a 510(k) summary for a medical device modification, focusing on demonstrating substantial equivalence to a predicate device. The core of its performance testing section states:

"Bench testing demonstrated that the SeedNet with modified TUW is at least as safe and effective as the cleared TUW in maintaining the urethra temperature during cryosurgical procedures."

This statement confirms that testing was done to ensure the modified device (SeedNet with SmartWarmer) performs at least as well as the previously cleared device (SeedNet with Gaymar/Barnant warmer) in maintaining urethra temperature.

Given the information, I cannot fill out the detailed table and answer all questions as requested. Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific quantitative thresholds (e.g., "temperature variation within X degrees Celsius," "maintains Y minimum temperature for Z duration") are not provided in this document. The criteria are implicitly tied to the performance of the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. "Bench testing" is mentioned, implying a controlled lab environment, but the number of tests or samples is not given.
• Data Provenance: Not specified. Origin of data (e.g., country) is not mentioned. The study is described as "Bench testing," which is typically a prospective design in a controlled environment, not retrospective clinical data.

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)

• Not Applicable. This type of information is relevant for studies involving human interpretation (e.g., image analysis). Since the testing described is "bench testing" for a cryosurgical unit's temperature regulation, expert consensus on "ground truth" in this context is not relevant. The ground truth would be physical measurements of temperature.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 3.

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 an AI/software device or an imaging device requiring human reader interpretation. It is a cryosurgical unit.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device, not an algorithm. The "bench testing" performed is inherently "standalone" in the sense that it's testing the device's physical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the bench testing would be physical measurements of temperature during simulated cryosurgical procedures, compared against predefined target temperatures or the performance of the predicate device.

8. The sample size for the training set

• Not Applicable. This device, as described, is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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