Search Results

XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures.

XSense Cryoablation System with CryoProbes 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 fibroadenomas, prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

XSense Cryoablation System with CryoProbes may be used with an imaging device such as an ultrasound to provide realtime visualization of the cryosurgical procedure.

The system has the following specific indications:

• · Urology Ablate prostate tissue in cases of prostate cancer and benign prostatic 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. Palliation of the skin. Destruction of warts or lesions.
• · Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
• · ENT (Ear, Nose, and Throat) - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth.
• · General Surgery - Ablation of breast fibroadenomas, leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of the oral cavity, rectum, and skin.
• · Thoracic Surgery - Ablation of arrhythmic cardiac tissue and cancerous lesions.
• · Proctology - Ablation of benign or malignant growths of the anus and rectum and hemorrhoids.

The XSense Cryoablation System with CryoProbes is operated in conjunction with an imaging system, such as ultrasound, to provide real-time visualization of the cryosurgical procedure, used in a professional healthcare environment for cryotherapy according to IceCure Medical's technology. The device technology is based on the delivery of the lowtemperature cryogen under pressure from the internal dewar to the CryoProbe's tip, enabling it to reach very low temperature, due to the thermal energy transfer principle that occurs as a result of phase transfer from liquid to gas of nitrogen at the tip of the CryoProbe, and thus freeze and destroy the treated tissue that the CryoProbe comes in contact with.

The XSense Cryoablation System with CryoProbes is the next generation of its predicatethe already cleared ProSense™ Cryoablation System (K183213) and is part of the IceCure family of cryoablation products. The XSense Cryoablation System with CryoProbes operates in the same manner as the previous design of the ProSense™ Cryoablation System. The XSense Cryoablation System will include the following additional accessories: (1) CryoProbes that are available in two configurations, (2) an external 25 liters dewar with a supporting cart, (3) an Introducer, and (4) a Holder.

The system is comprised of three main subsystems: XSense (console), CryoProbes, External dewar. Optional accessories: Introducer, Holder.

The provided text is a 510(k) Summary for the XSense Cryoablation System with CryoProbes. It compares the subject device to a predicate device (ProSense™ Cryoablation System) to demonstrate substantial equivalence, rather than providing a performance study of an AI/ML powered device.

Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Details on sample size, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance.
• Information on ground truth establishment or training set details relevant to AI/ML.

The provided text focuses on the device's intended use, technological characteristics, and safety and effectiveness relative to a traditional medical device predicate, not an AI-powered one.

Ask a specific question about this device

The ISOLIS cryoprobes, used with the Cryocare Systems, are intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The systems are designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, tumors, skin lesions, and warts.

In addition, the systems are intended for use in the following indications:

General Surgery

• Destruction of warts or lesions
• Palliation of tumors of the oral cavity, rectum and skin
• Ablation of breast fibroadenomas
• Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions

Urology

• Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia

Gynecology

• Ablation of malignant neoplasia or benign dysplasia of the female genitalia
  Oncology
• Ablation of cancerous or malignant tissue
• Ablation of benign tumors
• Palliative intervention

Neurology

• Freezing of nerve tissue in pain management/cryoanalgesia
  Dermatology
• Ablation or freezing of skin cancers and other cutaneous disorders
  Proctology
• Ablation of benign or malignant growths of the anus or rectum
• Ablation of hemorrhoids
  Thoracic Surgery
• Ablation of cancerous lesions

The ISOLIS cryoprobe is a single use, disposable device designed for use with CryoCare® Systems. ISOLIS cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The refrigerative and warming capability is limited to the distal end of the probe shaft that is comprised of stainless steel and is designed with a pointed tip to facilitate cryoprobe insertion and placement.

This document is a 510(k) Premarket Notification for the ISOLIS Cryoprobe, which aims to demonstrate substantial equivalence to a predicate device (CRYOCARE TOUCH™ System and Accessories, K201588). The document primarily focuses on explaining the device, its intended use, and comparing its technical characteristics to the predicate. It does not contain a study designed to prove the device meets specific acceptance criteria in the way one might expect for an AI/ML-driven device or a device requiring clinical performance validation against metrics like sensitivity/specificity.

The information provided describes a design and performance validation process rather than a clinical study with human subjects, ground truth adjudication, or statistical metrics like AUC, sensitivity, or specificity commonly associated with AI/ML device performance. The "acceptance criteria" here are implicitly related to the device's functional and performance characteristics mirroring or improving upon the predicate device within established safety and effectiveness parameters.

Here's an attempt to structure the available information relevant to your request, with significant caveats that much of the information you've asked for (e.g., sample size for AI, number of experts for ground truth, MRMC study, effects of AI assistance) is not applicable or not present in this type of premarket notification for a physical medical device like a cryoprobe.

Device: ISOLIS Cryoprobe (K230271)

Type of Device: Cryosurgical Unit And Accessories (Product Code: GEH)

Summary of Acceptance Criteria and Device Performance (Based on Bench Testing and Comparison to Predicate):

• Handle Construction & Materials: Heat shrink (polyolefin or PVDF) covering a stainless-steel vacuum handle (Predicate: Plastic ABS injection molded handle). Rationale: Smaller, slimmer handle and provides better improved insulation.
• Heat Exchanger: Copper-nickel alloy finned tubing coiled around a stainless-steel mandrel (Predicate: Copper screw-type cryostat). Rationale: Increases surface area for thermal exchange, maximizing freeze performance.
• Accessories: Two Return Hose Clips added to the Return Hose. Rationale: Added as an optional feature to aid in stability of the Return Hose and probe, especially during CT imaging. |
  | Usability | Successfully passed usability evaluations. |
  | Packaging & Sterilization| Successfully passed packaging tests. Sterilization method (Gamma Irradiation) and Single-Use, Sterile, Disposable status are the same as the predicate. |
  | Biocompatibility | Successfully passed biocompatibility evaluations (10993-1, Externally communicating medical device with tissue/bone/dentin contact with limited duration (≤24 hours)). Same as predicate. |
  | Risk Profile | Verified that the differences between the subject and predicate devices did not alter the overall risk profile. |

Study Details (Relevant to a physical device without AI/ML component):

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a "sample size" in the context of patient data or clinical images. The testing described is bench testing of the physical device variants. The document lists 4 variants of the ISOLIS Cryoprobe (PC-2.1E, PC-2.1S, PC-2.1EL, PC-2.1SL). It is implied that these variants, or representative samples thereof, were subjected to the described bench tests.
   • Data Provenance: Not applicable in the context of clinical data. The "data" comes from engineering bench tests conducted by Varian Medical Systems, Inc. (located in Austin, TX, USA). The testing is non-clinical.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable. "Ground truth" in the context of this device's performance refers to the objective physical measurements obtained during bench testing (e.g., isotherm size, temperature profiles) and engineering design specifications. These are established through validated measurement methods and engineering principles, not expert consensus on medical images or clinical outcomes.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert labeling of data, typically in AI/ML performance studies or clinical trials involving subjective assessments. This document describes objective bench testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This device is a physical cryoprobe, not an AI/ML-driven diagnostic tool. MRMC studies are used to evaluate human reader performance, often with and without AI assistance. This type of study is not relevant for this device.
   • Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

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

   • No. This device does not contain an "algorithm" in the sense of AI/ML. Its function is based on physical principles (Joule-Thomson Effect). The performance evaluation is based on the physical properties and functional output of the probe itself.

6. The type of ground truth used:

   • The "ground truth" for this device's performance testing is based on objective physical measurements and engineering specifications. For example, the "size of isotherm" is a measurable physical property of the cryoprobe's freezing capability, measured directly during bench testing under controlled conditions. "Temperature-time history" is also a direct physical measurement.

7. The sample size for the training set:

   • Not applicable. This document describes a physical medical device, not an AI/ML model for which a "training set" would be relevant.

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

   • Not applicable. As there is no AI/ML model or training set, this question is not relevant.

Conclusion from the Document:

The manufacturer concluded that the ISOLIS Cryoprobe is substantially equivalent to the predicate device (Slimline probes) based on:

• Successful completion of comprehensive bench testing (functional, electrical safety, performance, physical, usability, packaging, bioburden, gamma sterilization adoption, and biocompatibility).
• Demonstration that the device meets established design criteria.
• Confirmation that the differences in design and performance (e.g., improved isotherm size, sharper tip, better handle insulation) do not alter the overall risk profile.
• The fact that the indications for use and principle of operation are identical to the predicate device.
• The isotherm and temperature-time history data are similar to (or improved upon) the predicate device.

Ask a specific question about this device

The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, oncology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications:

General Surgery

• · Destruction of warts or lesions
• · Palliation of tumors of the oral cavity, rectum and skin
• · Ablation of breast fibroadenomas
• Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions

Urology
· Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia

Gynecology
· Ablation of malignant neoplasia or benign dysplasia of the female genitalia

Oncology

• · Ablation of cancerous or malignant tissue
• Ablation of benign tumors
• · Palliative intervention

Neurology

• · Freezing of nerve tissue in pain management/cryoanalgesia
  Dermatology
  · Ablation or freezing of skin cancers and other cutaneous disorders

Proctology

• Ablation of benign or malignant growths of the anus or rectum
• · Ablation of hemorrhoids

Thoracic Surgery
· Ablation of cancerous lesions

The CRYOCARE TOUCH™ System and accessories are a cryotherapy delivery system that is used to freeze/ablate tissue by the application of extreme cold temperatures.

The CRYOCARE TOUCH System is a standalone surgical system consists of a compact, easyto-operate console and associated accessories that include Endocare™ Cryoprobe devices to deliver cold temperatures to the therapeutic tissue and Endocare TempProbe™ Devices to monitor temperatures in the surrounding tissue. The system utilizes the Joule-Thomson effect and inert argon and helium gases to provide cryotherapy and is comprised of the following:

• . CRYOCARE TOUCH Control Console
• 15-inch LCD Touchscreen Monitor with folding Monitor Arm
• Side Handles to facilitate mobility ●
• Wheels with wheel locks
• . Power Supply
• . Argon Port, Regulator, and Supply Line
• . Helium Port, Regulator, and Supply Line
• . Cryoprobe Interface with eight (8) cryoprobe connections
• . TempProbe Interface with eight (8) TempProbe connections
• Alarm Audio Output on Back Panel
• . Remote Keypad

The CRYOCARE TOUCH system software manages the therapy delivered to the patient by the Endocare cryoprobes. The cryoprobes are designed to deliver cold temperatures for cryotherapy using highpressure argon gas circulated through the cryoprobe. Active tissue thawing is achieved by circulating helium gas through the cryoprobe. The refrigerative and warming capacity is limited to the distal end of the probe shaft.

The provided text describes a 510(k) premarket notification for the CRYOCARE TOUCH™ System and Accessories. This document mainly addresses the substantial equivalence of the new device to a predicate device (Cryocare CS™ Surgical System), detailing changes in user interface and accessories, and providing general statements about performance testing.

However, the document does not contain the detailed information required to answer all parts of your request, especially regarding acceptance criteria for an AI/algorithm's performance and the specific studies that prove it meets these criteria at a statistical level. This is because the CRYOCARE TOUCH™ System is a cryosurgical unit, a hardware medical device with associated software to manage its operation, rather than an AI/algorithm for diagnostic or prognostic purposes.

The "software" mentioned in the document relates to controlling the cryosurgical unit, managing displays, and responding to alarms, rather than an AI performing an analytical task that would require a test set, ground truth experts, MRMC studies, or training/validation data in the context of machine learning.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training sets, are not applicable or not present in this document for an AI/algorithm-based device.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

1. Table of acceptance criteria and reported device performance:

The document lists performance specifications and mentions that testing demonstrated conformance. However, it does not provide a quantitative table of acceptance criteria alongside the specific measured performance values for each criterion. The criteria are described qualitatively.

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

• Sample Size: Not specified in the document. The testing described is bench testing and verification/validation activities for a hardware device and its control software. It's not a "test set" in the context of an AI model evaluated on a dataset of patient data.
• Data Provenance: Not applicable in the context of patient data samples for AI. The "data" refers to measurements and observations from engineering tests, not clinical patient data. The document explicitly states "No animal studies or clinical tests have been included in this pre-market submission."

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

This is not applicable. Ground truth experts are typically used for assessing the performance of diagnostic or prognostic AI models against clinical data (e.g., radiologist reads vs. AI reads). This document describes a cryosurgical device, not an AI for image analysis or diagnosis. The "ground truth" for this device would be established by physical measurements and engineering specifications, not by human experts interpreting clinical cases.

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

This is not applicable. Adjudication methods are used to resolve disagreements among human experts when establishing ground truth for AI model evaluation.

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 applicable. MRMC studies are performed to demonstrate the clinical utility of AI tools by comparing human performance with and without AI assistance. The CRYOCARE TOUCH™ System is a surgical device, not an AI assistant for diagnostic reading or interpretation. The document explicitly states, "No animal studies or clinical tests have been included in this pre-market submission."

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

This is not applicable. This question pertains to the performance of an AI algorithm independently of human interaction. The software in the CRYOCARE TOUCH™ System controls the hardware and provides user interface functions; it is not a standalone "algorithm" in the AI sense.

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

The "ground truth" for this device's performance is based on engineering specifications, physical measurements, and adherence to recognized standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility). For example, the accuracy of temperature readings would be verified against calibrated measurement devices, not expert consensus on pathology slides.

8. The sample size for the training set:

This is not applicable. The device's software is a control system for a medical device, not a machine learning model that requires a "training set" of data in the AI sense.

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

This is not applicable. See the explanation for point 8.

Ask a specific question about this device

Indications for Use statement for the ERBECRYO 2 cryosurgical unit:
"The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization of tissue by the application of extreme cold."

Indications for Use statement for the Erbe Flexible Cryoprobes:
"The Erbe Flexible Cryoprobes are intended for palliative devitalization) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies."

The ERBECRYO® 2 Unit and Accessories are manufactured with various metals, plastics, silicone, adhesive, etc. The system consists of connecting hoses, an adapter, a switching valve (optional for using two gas cylinders), the Unit, electrical cables, the footswitch, and the flexible cryoprobes. The ERBECRYO® 2 unit is a standalone unit that can be placed on a table top or secured on a cart. The Cryosurgical Unit has a monochromatic display that provides operational information. The display is surrounded by buttons allowing for user interface (e.g., set the effect, select a program, etc.). Default settings are also displayed per the cryoprobe that is attached. The Cryorugical Unit is connected to an electrical power source, a carbon dioxide (CO2) source, the footswitch and a flexible cryoprobe. The Cryosurgical Unit displays errors and/or emits audio alarms to alert users of malfunctions or user errors. Typically, a cryoprobe is placed down the working channel of an endoscope (e.g., bronchoscope, etc.) that can accommodate the dimensional attributes (i.e., outer diameter and length) of the probe. Upon activation via the pedal of the footswitch, the Unit delivers the regulated flow of the CO2 to the tip of the flexible cryoprobe. Through the Joule-Thomson Effect and in the presence of moisture, an ice is formed and surrounding tissue is cooled. The extreme cold is used for cryoadhesion and/or devitalization (i.e., the destruction) of target tissue (Note: The smaller 1.1mm single use cryoprobes have an oversheath so that tissue frozen to the tip can be removed through the endoscope without having to remove the scope from the patient.). The Unit and all of the Accessories, except for the single use flexible cryprobes, are supplied non-sterile and are reusable. The single use cryoprobes are provided sterile and are single patient use.

The provided text describes a 510(k) premarket notification for the ERBECRYO 2 Cryosurgical Unit and Accessories (K190651), comparing it to a legally marketed predicate device (K151041). The document primarily focuses on demonstrating substantial equivalence rather than a clinical study establishing acceptance criteria for a new AI/software device. There is no mention of an AI/software component in this submission.

Therefore, many of the requested categories are not applicable to the information provided. The document describes a medical device (cryosurgical unit and cryoprobes) and its physical and performance characteristics, along with various standard tests to ensure its safety and effectiveness relative to a predicate device.

However, I can extract the relevant information where applicable and indicate "Not applicable" for items that are not present or relevant to this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/software device and the submission focuses on substantial equivalence to a predicate, the "acceptance criteria" are generally compliance with recognized standards and demonstration that new features (like different cryoprobe dimensions or sterile single-use probes) do not raise new safety or effectiveness concerns. The performance reported relates to the cryosurgical function and material properties.

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 for Test Set: Not specified in terms of clinical trial patient numbers or image counts, as this is primarily a device safety and performance submission based on bench testing, ex-vivo, and in-vivo (animal) studies, and literature review.
  • Biocompatibility: "Erbe Flexible cryoprobes" tested. Specific number of probes or samples not given.
  • Sterilization Validation: "Mixed load sterilization cycle" validated. Specific number of samples not given.
  • Shelf Life Validation: "Sterilized samples" tested. Specific number of samples not given.
  • Performance Testing (Freezing, Biopsy Weight, In-vivo): "Comparative ex vivo tissue testing on three different tissues (bovine liver, porcine kidney and porcine lung)" and "animal testing in an in vivo porcine lung model" were conducted. Specific numbers of tissue samples or animals not given.
• Data Provenance:
  • Biocompatibility, Sterilization, Shelf Life, and Performance Testing were conducted by Erbe Elektromedizin GmbH, based in Germany. The specific testing facilities are not mentioned.
  • For the "removal of blood clots" indication, "peer-reviewed real world evidence (literature and published case reports)" were provided. This implies a retrospective review of existing published data globally.

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

• This is not applicable as there is no "ground truth" established by experts in the context of an AI/software device. The data is physical measurements, biological evaluations, and performance characteristics compared to a predicate device and existing literature.

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

• Not applicable, as there is no expert review or adjudication method described for establishing ground truth for an AI/software output. The testing methodologies are based on laboratory measurements and comparisons.

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 a submission for a physical cryosurgical unit and cryoprobes, not an AI or software device. No human reader studies with or without AI assistance were performed.

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

• Not applicable. This device does not involve an algorithm or AI.

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

• The "ground truth" in this context refers to the established scientific and engineering principles for device performance, safety standards, and comparative data against a legally marketed predicate device.
  • Benchmarking/Comparative Data: Performance as measured against the predicate device (e.g., freezing performance, biopsy weight).
  • Standard Compliance: Adherence to international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for shelf life, IEC 60601 series for electrical safety).
  • Animal Model Data: In-vivo performance (porcine lung model).
  • Literature Review: Real-world evidence from peer-reviewed literature and published case reports for specific indications (e.g., removal of blood clots).
  • Laboratory Procedures: Sterility, shelf-life, and biocompatibility testing results.

8. The sample size for the training set

• Not applicable. This is not an AI/software device, so there is no training set.

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

• Not applicable. As there is no training set for an AI/software device.

Ask a specific question about this device

The CryoStar™ System is a cryoanalgesia device intended for use in blocking pain by temporarily ablating the peripheral nerves.

The CryoStar™ system consists of a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. A console is used to house and control the supply of gas to the cryoprobe and to provide an electrical nerve location device. A footswitch completes the system. A convenience procedure kit for probe placement is also provided as a single use disposable.

In the CryoStar™ system, compressed nitrous oxide or carbon dioxide is directed to the tip of the cryoprobe where it is allowed to expand through a fine annular space. The expansion of the gas to near atmospheric pressure causes cooling by the loule Thompson effect. The design of the cryoprobes is such that the warmer incoming gas maintains the outer stem of the cryoprobe above freezing temperatures to prevent freezing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the CryoStar™ console facilitates the location of the peripheral nerve prior to freezing. Freezing of the nerve fibers creates a block which prevents the conduction of pain. The effect is usually non-permanent, and a repeat of the treatment may be necessary to deal with long term pain.

The CryoStar™ console has been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. The pedestal of the console provides a convenient small footprint mobile base for the system, and houses up to four gas tanks. A simple footswitch completes the system.

This 510(k) premarket notification for the CryoStar™ system is a substantial equivalence submission, not a de novo submission. Therefore, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way one might expect for a novel device undergoing a rigorous performance evaluation.

Here's why and what information can be gleaned from the provided text:

• Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and either the same technological characteristics or, if different technological characteristics, that those differences do not raise new questions of safety or effectiveness.
• Focus on Predicate Devices: The document primarily focuses on comparing the CryoStar™ system to existing, legally marketed predicate devices (Spembly Lloyd Neurostat, Cryomedics Neurostat, Wallach Painblocker WA5000). The argument for safety and effectiveness is built on the proven track record and characteristics of these predecessors.
• Lack of De Novo Performance Study Details: Since the device is considered substantially equivalent, there isn't a need for a new, extensive clinical or performance study to establish novel acceptance criteria or prove its efficacy from scratch. The FDA simply acknowledges that it's equivalent to devices already on the market.

Based on the provided text, the following information is either not present or not applicable in the context of a 510(k) substantial equivalence submission:

1. Table of acceptance criteria and reported device performance: Not provided because this is a substantial equivalence claim, not a de novo approval requiring new performance benchmarks.
2. Sample size for the test set and data provenance: No specific test set or study data is presented, as the claim is based on equivalence to existing devices.
3. Number of experts used to establish ground truth and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this submission for the reasons stated above.
6. Standalone (algorithm-only) performance: Not applicable, as this is a medical device, not a standalone algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

What the document does provide pertinent to the request (though not in the requested format):

• Intended Use: The CryoStar™ system is a cryoanalgesia device intended for use in blocking pain by temporarily ablating the peripheral nerves. This is a crucial "acceptance criterion" in the sense that the device must fulfill this purpose, and its equivalence to predicates implicitly suggests it does.
• Device Description and Principle of Operation: The document describes how the device works (Joule Thompson effect to freeze nerves, nerve stimulator for location) and its components. This implies that the device functions as intended, similar to the predicate devices.
• Safety and Effectiveness: The submission explicitly states: "There are now new issues of safety of [or] effectiveness raised by the subject device." This is the core claim of substantial equivalence, meaning no new risks or concerns are identified compared to the predicate devices.
• Predicate Devices: The specific predicate devices are listed (K781302 Spembly Lloyd Neurostat, K831963 Cryomedics Neurostat, K854334 Wallach Painblocker WA5000). The "proof" of meeting criteria relies on the regulatory approval and established performance of these devices.

In summary, this 510(k) submission successfully argued for substantial equivalence, meaning the FDA agreed it was similar enough to already-approved devices that no new, detailed performance studies or elaborate acceptance criteria (beyond those implicitly met by the predicates) were necessary.

Ask a specific question about this device

To destroy tissue during surgical procedures by applying extreme cold.

The CryoProbe™ is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold gas (N2O). The device is based on direct application of nitrous oxide in the liquid phase to the selected area. The N2O gas is delivered to the treatment site at -89° C to effect cellular destruction.

The hand-held device is shaped like a pencil to afford maximum user control and comfort. An N2O gas cylinder, commercially available, is held within the pencil body. The gas cylinder is punctured at its intended nozzle by the CryoProbe™ gas guidance tube and retained by the safety valve (handle) until treatment begins. The gas flow is controlled by the microapplicators, high or low flow. This flow rate is selectable when a gas cylinder is installed by selecting the appropriate microapplicator for the assembly.

The CryoProbe™ is designed for safety, performance, and convenience for the user. The design is confirmed by Risk Analysis and actual market usage in the European market. Over 3,000 units are in distribution and use with no adverse effects reported.

This document describes the CryoProbe™, a hand-held cryosurgical instrument. The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on detailed performance studies with acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them based on the provided text.

Here's why and what's missing:

• Acceptance Criteria: Acceptance criteria are specific, measurable thresholds that a device must meet to be considered safe and effective. These are typically defined before testing. The document states "The CryoProbe™ is designed for safety, performance, and convenience for the user. The design is confirmed by Risk Analysis and actual market usage in the European market. Over 3,000 units are in distribution and use with no adverse effects reported." This is a general statement about design intent and post-market experience, not a set of measurable acceptance criteria.
• Study Details: The document mentions "Risk Analysis and actual market usage," but these are not described as formal studies with methodologies, sample sizes, ground truth establishment, or specific performance metrics that would allow for a table of acceptance criteria vs. reported performance.

To provide the information you've requested (table, sample size, ground truth, MRMC, etc.), there would need to be a detailed report on specific performance testing (e.g., consistency of temperature, cryolesion size, safety mechanisms, etc.) with pre-defined success/failure thresholds. This level of detail is typically found in design verification and validation documents, which are usually not part of a public 510(k) summary in this format.

Ask a specific question about this device

The Heartport™ Maze System: Cryoprobe Set is intended for use in minimally invasive cardiac surgery procedures, including the surgical treatment of cardiac arrhythmias. The cryoprobes are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis. The Set includes probes of varied tip shapes to optimize access to the treatment site.

The Heartport™ Maze System: Cryoprobe Set is specifically designed for introduction and use via a trocar or incision in minimally invasive cardiac surgery procedures. The Set includes probes of varied tip shapes to optimize access to the treatment site.

The provided text is a 510(k) summary for a medical device called the "Heartport™ Maze System: Cryoprobe Set." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is important to note that a 510(k) submission generally does not include studies demonstrating the device meets specific acceptance criteria in the way a clinical trial for a novel drug or a de novo device might. Instead, it focuses on demonstrating substantial equivalence to existing devices. Therefore, the information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and detailed ground truth provenance is not typically found within a 510(k) summary.

The document states that the device meets applicable sections of ASTM F 882-84, which is a standard for cryosurgical medical instruments. This is the closest it comes to "acceptance criteria" and "device performance" in the traditional sense you're asking for.

Here's an attempt to answer your questions based only on the provided text, with the understanding that many of your specific points are not addressed by this type of regulatory submission:

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

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

• Not provided. 510(k) summaries do not typically detail specific clinical or non-clinical test sets with sample sizes in this manner, beyond referencing compliance with standards. The "Performance" section for "Non-Clinical Test Results" only states that it meets a particular ASTM standard.

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/Not provided. This type of detail relates to clinical studies and ground truth establishment, which are not part of this 510(k) summary.

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

• Not applicable/Not provided. This is not relevant to a 510(k) submission for substantial equivalence.

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. This device is a cryoprobe, not an AI-assisted diagnostic tool.

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

• No. This device is a physical cryosurgical instrument for performing procedures, not an algorithm.

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

• Not applicable/Not provided. For the non-clinical performance test, "ground truth" would be defined by the standards and test methods within ASTM F 882-84. The document does not elaborate on this.

8. The sample size for the training set

• Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

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

• Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in the 510(k) summary is a non-clinical evaluation to demonstrate that the Heartport™ Maze System: Cryoprobe Set is "substantially equivalent" to predicate devices (Frigitronics® CCS-200 Cardiac Cryosurgical System and Spembly Medical Cardiac Cryounit and Cryoprobes).

• Performance: The device confirmed compliance with applicable sections of the ASTM F 882-84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments. No specific test results or metrics are included, only the statement of compliance.
• Biocompatibility: The materials used were evaluated and confirmed to have "established biocompatibility," likely based on their similarity to materials in the predicate devices.

This submission focuses on regulatory substantial equivalence rather than detailed clinical effectiveness data or specific performance metrics typical of studies for novel devices or algorithmic tools.

Ask a specific question about this device