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510(k) Data Aggregation
(88 days)
The CRYO-HIT™ 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 CRYO-HIT™ 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 CRYO-HIT™ System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.
The Galil Medical's Cryo-Hit™ System for Cryoanalgesia is a modification of Galil Medical LTD's cleared Cryo-Hit™ (K993965). The modified Cryo-Hit™ System is the exact same device as the Cryo-Hit™ except for the addition of the 4.5 mm surface probe.
The provided document is a 510(k) summary for the Galil Medical Cryo-Hit™ System, focusing on a modification for cryoanalgesia. It does not present specific acceptance criteria or a formal study designed to "prove the device meets acceptance criteria" in the way one would expect for a diagnostic or AI-driven medical device. Instead, it relies on demonstrating substantial equivalence to predicate devices and referencing existing medical literature and two clinical studies to support the safety and effectiveness of the device for cryoanalgesia.
Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone performance) are not applicable or explicitly stated in this type of regulatory submission for a simple device modification.
Below is an attempt to address the requested information based on what is available in the document, with explicit notes about what is not provided.
Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria
The Galil Medical Cryo-Hit™ System is a cryosurgical unit. The specific submission is for a modification focusing on its use for cryoanalgesia, with the addition of a 4.5 mm surface probe. The acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices by showing the modified device is as safe and effective for its intended use.
The study supporting this claim consists of reviewing existing medical literature on cryoanalgesia and presenting two recent clinical studies conducted using the Cryo-Hit™ system.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a cryosurgical unit modification and not a diagnostic device, explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.) are not defined. Instead, the "acceptance" is based on demonstrating safety and effectiveness compared to predicate devices for the specified indications. The reported device performance is described in terms of clinical outcomes, primarily pain reduction and absence of major complications.
| Feature / Outcome | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety | No new questions of safety compared to predicate devices. Absence of major complications. | Study 1 (Facet Joint): No major complications reported. Study 2 (Intercostal Cryoanalgesia): No major complications or serious side effects. No additional intervention needed. |
| Effectiveness (Pain Reduction - Facet Joint) | Comparable or improved pain relief to established cryoanalgesia methods. | Study 1: VAS score for 88% of patients with pure facet syndrome improved by an average of 72%. VAS score of 53% of patients with discopathy improved by 39%. Patients with spinal fusion had little improvement. Median analgesia period: 11.4 months. |
| Effectiveness (Pain Reduction - Post-Op Chest) | Comparable or improved pain relief for post-operative pain to established cryoanalgesia methods. | Study 2: 62% had a mean pain score < 4 (mild pain). 31% had a mean pain score between 4-7 (moderate pain). 7% had severe pain. Upon discharge, 32% had no pain, and 68% had only mild pain treatable with OTC drugs. None needed additional treatment. |
| Technological Characteristics (Cryoanalgesia) | Device function as a cryosurgical tool for cryoanalgesia, consistent with predicate devices and prior cleared device. | Cryo-Hit™ system used with Argon gas for freezing. Probes: 3mm blunt (Study 1), 4.5mm surface (Study 2). Monitoring: MRI (Study 1), Direct visualization of Nerve Bundle (Study 2). |
| Similarity to Predicate Devices (for Cryoanalgesia) | Same intended use, comparable indications, and no new questions of safety or effectiveness from modifications. | The Cryo-Hit™ for Cryoanalgesia has the same intended use as CRYO-HIT™ (K993965), Cryomedics Neurostat, and Spembly Lloyd Neurostat. The specific indications are a combination of these predicate devices. The device is the same as the cleared Cryo-Hit™ except for the additional 4.5 mm surface probe, which does not raise new safety or effectiveness concerns. Clinical data presented aims to demonstrate equivalence in safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document presents data from two clinical studies:
- Study 1 (Facet Joint Syndrome):
- Sample Size (Patients that received Cryoanalgesia): 48
- Data Provenance: Not explicitly stated, but the author is J.F. ROY et al., abstract for "THE ISMR 9(2001)". This suggests a European or international origin, possibly for a medical conference. This is a retrospective summary of clinical results.
- Study 2 (Intercostal Cryoanalgesia):
- Sample Size (Patients that received Cryoanalgesia): 28
- Data Provenance: Not explicitly stated, but the author is JD Fonger et al., "TO BE SUBMITTED FOR PUBLICATION". This is a retrospective summary of clinical results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the studies are clinical outcome studies, not studies requiring expert review of medical images or data for ground truth establishment. Patient pain scores (VAS) are self-reported outcomes.
4. Adjudication method for the test set
This information is not provided and is not applicable given the nature of the clinical outcome studies (patient-reported pain scores).
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, especially those incorporating AI. The Cryo-Hit™ is a surgical tool, and the studies presented focus on its clinical outcomes.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The Cryo-Hit™ is a physical medical device (cryosurgical unit) operated by a clinician, not an algorithm. Therefore, "standalone performance" in the context of an algorithm without human intervention is not relevant.
7. The type of ground truth used
The "ground truth" in these clinical studies is primarily based on:
- Patient-reported outcomes: Visual Analog Scale (VAS) scores for pain.
- Clinical observation: Assessment for complications by medical professionals.
- Absence of need for additional treatment.
This is considered outcomes data and clinical assessment by the treating physicians.
8. The sample size for the training set
This information is not applicable/not provided. The Cryo-Hit™ is a hardware device; thus, it does not have a "training set" in the context of machine learning algorithms. The development and design validation would rely on engineering principles, predicate device extensive history of use, and potentially bench testing, but not a data-driven training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as #8.
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