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The SeedNet 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 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 may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide realtime visualization of the cryosurgical procedure.

The SeedNet System is a cryosurgical unit with argon-cooled probes. The modified SeedNet System includes cryoneedles and cryoprobes of different sizes, shapes, or made of different materials, a remote MRI Compatible Mobile Distribution Panel (MDP) for the MRI compatible system, functional features added to the software to indicate the user when no signal is detected from specific temperature sensors or thermocouples, a New General Use Template for use with the IceRod Cryoneedles, and IceRod Prostate and Renal Kits. The trade names CryoThera, Cryo-Hit, and SeedNet/SeedNetGold are associated with the system.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Galil Medical LTD. SeedNet System.

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) summaries primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting de novo clinical trial data with acceptance criteria for novel performance. Therefore, the information typically found in a clinical study report regarding specific acceptance criteria and detailed performance metrics might be limited or absent, as is the case here.

This submission argues for substantial equivalence primarily based on technological characteristics, mode of operation, performance characteristics, and intended use being similar to existing cleared devices. The "performance data" mentioned refers to design verification testing, not a clinical study to prove efficacy against specific, pre-defined acceptance criteria.

Acceptance Criteria and Device Performance

Based on the provided text, there are no explicitly stated quantitative acceptance criteria for a study designed to prove the device's performance against specific metrics of diagnostic accuracy (like sensitivity, specificity, accuracy) that are commonly seen in AI/diagnostic device submissions.

The document's "Performance Data & Substantial Equivalence" section emphasizes the modified SeedNet System's equivalence to predicate devices and outlines a "comprehensive testing process as part of the design verification process," including electrical, mechanical, and biocompatibility testing. This type of testing ensures the device functions as intended and safely, but it does not evaluate its diagnostic or therapeutic efficacy against a defined clinical "ground truth" with statistical measures.

The core argument for clearance is substantial equivalence. The "performance" being evaluated implicitly is that the modified device performs comparably to the predicate devices in its intended use, which is cryogenic tissue destruction.

Table of Acceptance Criteria and Reported Device Performance

• Ability to perform cryogenic destruction of tissue.
• Safety (electrical, mechanical, biocompatibility). | - "The modified SeedNet System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SeedNet System."
• "The modified SeedNet System and its modified accessories were subjected to a comprehensive testing process as part of the design verification process. This included electrical, mechanical and biocompatibility testing."
• "The modified SeedNet System does not raise any new safety and/or effectiveness issues." |
  | Specific Indications for Use:
• Effective ablation for prostate tissue, cancerous/malignant tissue, skin lesions, etc. (as per predicate device's established efficacy). | - The modified device retains the same indications for use as the predicate SeedNet System, implying that its ability to perform these functions is considered equivalent. |

Study Information

Given the nature of a 510(k) summary for a cryosurgical unit, the "study" referred to is a series of engineering verification and validation tests, not a clinical trial in the sense of evaluating diagnostic or therapeutic efficacy with patient data. Therefore, many of the requested points below (e.g., sample size for test sets, ground truth, experts for ground truth, MRMC studies) are not applicable or not detailed in this document.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable in the context of a clinical test set from patient data. The "test set" would refer to the device units and components undergoing design verification. No specific numerical sample size for components or systems is provided, nor is patient data involved.
   • Data Provenance: Not applicable for clinical data. The testing is internal design verification and validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as there is no mention of "ground truth" being established by experts for clinical performance in this submission. The "ground truth" for electrical, mechanical, and biocompatibility testing would be adherence to engineering specifications and relevant standards, verified by qualified engineers and testers.

3. Adjudication method for the test set:

   • Not applicable. There's no mention of an adjudication process for clinical outcomes, as this is not a clinical efficacy study.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a cryosurgical unit, not an AI-assisted diagnostic or imaging interpretation tool. There are no "human readers" or AI in the context of improving interpretation.

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

   • Not applicable. This is a hardware cryosurgical system, not a standalone algorithm.

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

   • For the design verification testing mentioned, the "ground truth" would be adherence to defined engineering specifications, industry standards, and regulatory requirements (e.g., for electrical safety, mechanical integrity, biocompatibility). It is not clinical "ground truth" like pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable. This device does not involve AI or machine learning models that require a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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