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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.

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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The CRYO-HIT™ System for MRI 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, 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 for MRI, like the already cleared 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 ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)

Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)

The CRYO-HIT™ System for MRI may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to locate the target tissue, ensure correct placement of the probes and monitor the size of the iceball. The MRI or ultrasound device provides real-time visualization of the cryosurgical procedure.

The CRYO-HIT™ system for MRI is the exact same device as Galil Medical LTD's cleared System (K991517) except for the following technological modification: (1)- the additional MRI kit and (2) the availability of more probe types: 2 mm probe, surface probe, and disk shaped probe (The probes cleared for use with the modified CRYO-HIT™ System under K991272 include the same 2 mm probes, surface and disk shape probes, proposed for use with the CRYO-HIT™ for MRI).

The provided text describes the CRYO-HIT™ System for MRI and its indications for use, but it does not contain specific information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

The document is a 510(k) summary and a subsequent correction letter from the FDA, focusing on substantial equivalence to a predicate device (CRYO-HIT™ 200 System, K991517) based on similar intended use, principle of operation, and technological characteristics. It highlights the modifications (MRI kit and additional probe types) that distinguish the new device from the predicate.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, and sample sizes as this information is not present in the provided text.

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The CRYO-HITTM 200 System, like the already cleared CRYO-HITTM 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, 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, tumor, lesions and warts.

In addition the CRYO-HIT™ 200 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, ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)

General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangilomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)

Thoracic surgery (ablation of arrhythmic cardiac tissue and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or rectum and ablation of hemorrhoids)

The CRYO-HIT™ 200 System is the exact same device as Galil Medical LTD's cleared CRYO-HIT™ System (K980913) except for the following tochnological modifications: (1) Additional accessories are made available (1.5 mm probe, multiprobe distribution panel). (2) disposable probes are added as an option; (3) an additional method of controlling the freeze process is offered; and (4) minor changes to the software that are necessary for the display of the screen information have been made: and (5) the probes are available in chrome-coated brass and the flexible hose is available in two additional materials.

The provided text describes the Galil Medical CRYO-HIT™ 200 System, a cryosurgical tool, and its substantial equivalence to previously cleared devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details typically found in a study proving device meet acceptance criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

To answer your request, I would need a document that describes:

1. Specific performance metrics (e.g., cooling rate, minimum temperature achieved, ice ball size, tissue necrosis depth).
2. Pre-defined acceptance criteria for these metrics.
3. A study protocol and results demonstrating how the CRYO-HIT™ 200 achieved these criteria.
4. Details on the study design, including sample sizes, data provenance, ground truth methods, and expert involvement.

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The modified CRYO-HIT™ System, like the already cleared CRYO-HIT™ System is intended for cryogene as a cryosurgical tool in the fields of general surgery, dermatology, neurology, thoracic surgery, ENT, general surgery, oncology, and urology, and urology, The system is designed to gynecology, oncology, proctorogy, and aronegy of temperatures including prostate and kidney tissue, liver metastascs, turnors, skin lesions, and warts.

In addition the modified CRYO-HIT™ System has the following specific indications:

Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hynernlasia "BPH")

Oncology (ablation of cancerous or malignant tissue, and ablation of benign tumors, and palliative intervention)

Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)

Gynecology (ablation of malignant neoplasia or benign dysplasia of the fomale genitalia)

General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)

Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)

Proctology (ablation of benign or malignant growths of the anus or recturn, and ablation of hemorrhoids)

The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe got a available in each model (1-probe, 2-probe, 3-probe, 4-probe, 5-probe, 5-probe, 7-probe and 8-probe configurations) and the number of temperature sensor ports, to meet the needs of different customers.

The probes that can be used in the different configurations are exactly the same. The modified CRYO-HIT™ System is the exact same device as Galil Medical I.TD's cleared CRYO-HIT™ System (K980913) except for the following technological modifications: (1) Additional probes are made available; (2) single use probes are added as an option; (3) a foot pedal is added as an operating option; (4) the number of probes and external thermocouples is more varied; (5) the modified CRYO-HIT™ System allows an additional method of controlling the freeze process; and (6) minor changes to the software that are necessary for the display of the screen informations

The provided document is a 510(k) summary for the Galil Medical CRYO-HIT™ System, which is a cryosurgical unit. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer the specific questions posed.

Therefore, I cannot provide the requested information from the given text.

The information includes:

• Company Name: Galil Medical Ltd.
• Trade/Proprietary Name: CRYO-HIT™ System
• Classification Name: CRYOSURGICAL UNIT
• Predicate Devices: ENDOcare CRYO-HIT™ System
• Indications for Use: Cryogenic destruction of tissue during surgical procedures in various fields (general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology). Specifically for ablating prostate and kidney tissue, liver metastases, tumors, skin lesions, warts, and other specified conditions.
• Device Description: Multiple models with varying numbers of probe ports (1-8), but same performance, technology, and intended use. Modified version includes additional probes, single-use probes option, foot pedal, more varied probe/thermocouple numbers, an additional freeze process control method, and minor software changes.
• Claim of Substantial Equivalence to previously cleared CRYO-HIT™ System (K980913) and ENDOcare system.
• FDA 510(k) clearance letter (K991272) dated February 21, 2008 (correcting a previous letter from July 12, 1999).

To answer the questions, information on clinical or non-clinical performance testing would be necessary, which is not present in this 510(k) summary. Usually, a 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed study results as an IDE or PMA submission would.

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CRYO-HIT™ 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, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissue.

CRYO-HIT™ is a cryosurgical system that consists of:

• 1, a structural enclosure (The CRYO-HIT™ system is housed in a rack assembly mounted on four cater wheels for ease of transport),
• 2. a power control panel,
• 3. a computer and control assembly,
• 4, a gas supply system: Argon (cooling) and Helium (thawing) gas reservoirs,
• 5. a gas distribution system (valve assembly ),
• 6. Accessories: cryoprobes (named galil-eo probes), temperature sensors and a remote control unit.
     The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe ports available in each model (3-probe, 5-probe, 7-probes and 8-probe configurations) and the number of temperature sensor ports ( to meet the needs of different customers).
     The probes used for the 3-probe, 7-probes and 8-probe configurations are exactly the same.

This is a 510(k) premarket notification for a medical device (CRYO-HIT™ System) and as such does not contain a study section with acceptance criteria and a description of a study to prove the device meets those criteria. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical performance studies with acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on establishing the substantial equivalence of the CRYO-HIT™ system to existing cryosurgical devices based on intended use, technology, and operating principles.

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