Search Results

The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO™ 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

The CARTO™ 3 EP Navigation System V8.0, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheter's location and intracardiac ECG signals and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using specialized mapping catheters and reference devices. The CARTO™ 3 System uses two distinct types of location technology – magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The CARTO™ 3 System V8.1 consists of the following hardware components:

• Patient Interface Unit (PIU)
• Workstation with Graphic User Interface (GUI)
• Wide-Screen monitors, keyboard, and mouse
• Intracardiac In Port
• Intracardiac Out Port
• Power Supply
• Patches Connection Box and Cables (PU)
• Pedals
• Location Pad (LP)
• Signal Processing Unit (SPU)

All hardware components of the CARTO™ 3 system V8.1 are the same as those found in the predicate device.

The provided FDA 510(k) clearance letter for the CARTO™ 3 EP Navigation System V8.1 does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device (CARTO™ 3 EP Navigation System V8.0) and outlines the V&V testing performed at a high level.

Specifically, the document does not report specific quantitative acceptance criteria or reported device performance metrics in a readily extractable table format. It states that "All tests were successfully completed and met the acceptance criteria" for various testing phases, but the acceptance criteria themselves are not provided. Similarly, actual performance metrics (e.g., accuracy values, false positive rates, etc.) are not listed.

Regarding the "study that proves the device meets the acceptance criteria," the document describes verification and validation testing, but this is not presented as a single, comprehensive "study" with a specific design (like an MRMC study or a standalone performance study) and reported results in the same way one might describe a clinical trial. Instead, it's a summary of different types of engineering and software testing.

Given these limitations, I will extract and infer information where possible based on the provided text, and explicitly state when information is not available in the document.

Overview of Device Acceptance and Performance (Based on Available Information)

The acceptance of the CARTO™ 3 EP Navigation System V8.1 is broadly based on the successful completion of various verification and validation (V&V) tests, ensuring the device meets its design specifications and performs as intended, especially with new features and existing functionalities. The primary "proof" of acceptance is the statement that "All tests were successfully completed and met the acceptance criteria," even if those criteria are not quantitatively detailed.

Since quantitative acceptance criteria and reported numerical performance are not explicitly provided, a table with specific metrics cannot be generated. The document focuses on conceptual and functional "acceptance."

Detailed Breakdown of Available Information:

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

Not explicitly provided in the document in a quantitative, tabular format.

The document states:

• "All tests were successfully completed and met the acceptance criteria" for "Proof of Design."
• "All system features were found to perform according to specifications and met the tests acceptance criteria" for "Functional verification."
• "All tests were successfully completed and met the acceptance criteria" for "Unit Tests."
• "All testing performed were successfully completed and met the acceptance criteria" for "Retrospective Validation Tests."
• "All test protocol steps were successfully completed and expected results were achieved" for "Animal Testing."

While these statements confirm the device met its internal acceptance criteria, the specific numerical values of these criteria (e.g., "accuracy > X mm," "sensitivity > Y%") and the actual measured performance values are not disclosed in this 510(k) letter.

Inferred Performance Claims:

• The device maintains "identical magnetic location sensor and ACL location accuracy" as the predicate device (V8.0). However, the specific accuracy values are not stated for either version.

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

• Test Set Sample Size: Not explicitly stated.
  • For "Retrospective Validation Tests," it mentions "clinical recorded data from historic EP procedures." The number of procedures or specific data points is not provided.
  • For "Animal Testing," it indicates "animal testing was conducted," but the number of animals or specific test cases is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated. The company Biosense Webster has facilities in Irvine, CA, USA, and Yokneam, Israel. The data could originate from clinical sites globally.
  • Retrospective or Prospective:
    • "Retrospective Validation Tests" explicitly used "clinical recorded data from historic EP procedures." This indicates retrospective data.
    • "Animal Testing" would be considered prospective in the context of controlled experimental animal studies.

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

Not explicitly stated. The document does not describe the process of establishing ground truth for any of the V&V tests, nor the involvement or qualifications of experts for this purpose.

4. Adjudication method for the test set

Not explicitly stated. Given that expert involvement for ground truth is not detailed, an adjudication method is also not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No, an MRMC comparative effectiveness study was NOT done or reported. The document focuses on demonstrating substantial equivalence through technical V&V testing and software feature improvements, not on comparative effectiveness with human readers. The CARTO™ 3 System is a navigation system, not an AI for image interpretation that typically undergoes MRMC studies.

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

Yes, aspects of standalone performance were evaluated, though not explicitly labeled as such.

• "Proof of Design" and "Unit Tests" would inherently involve evaluating the device's (or its software components') performance against design specifications in a standalone manner, without direct human-in-the-loop interaction beyond setup and execution of the tests.
• The statement "identical magnetic location sensor and ACL location accuracy" implies a standalone assessment of the system's core navigational accuracy.

However, specific quantitative metrics for this standalone performance (e.g., location accuracy in mm, precision, etc.) are not provided.

7. The type of ground truth used

Not explicitly stated for specific tests.

Inferred types of ground truth based on the nature of the device and tests:

• Engineering Specifications/Reference Standards: For "Proof of Design," "Functional verification," and "Unit Tests," the ground truth would likely be defined by internal engineering design specifications, simulated environments, and established reference measurements. For accuracy testing of location, highly precise physical measurement systems or phantoms would be used as ground truth.
• Retrospective Clinical Data: For "Retrospective Validation Tests," ground truth would presumably come from existing clinical records of "historic EP procedures," although how this ground truth was established within those records (e.g., confirmed diagnoses, procedural outcomes, expert review) is not detailed.
• Direct Observation/Measurement in Animal Models: For "Animal Testing," ground truth would be based on direct measurements and observations within the animal during the simulated procedures.

8. The sample size for the training set

Not applicable/Not mentioned. The CARTO™ 3 System is described as a navigation system with improved software features (e.g., catheter support, legacy feature enhancements). It is not presented as an AI/ML model that undergoes a distinct "training set" development phase in the typical sense of deep learning models requiring large datasets for training. The changes appear to be more in line with traditional software development and feature integration.

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

Not applicable/Not mentioned (as it's not described as an AI/ML system with a training set).

Summary of Limitations of the Document for this Request:

The provided FDA 510(k) clearance letter serves its purpose of demonstrating substantial equivalence based on the provided V&V testing summary. However, it is not a detailed technical report or clinical study publication that would typically include the specific quantitative acceptance criteria, full performance metrics, detailed sample sizes, expert qualifications, or ground truth methodologies you are requesting for a comprehensive analysis of a device's proven performance. The document implies successful adherence to internal specifications without detailing those specifications or the resultant performance values.

Ask a specific question about this device

Ask a specific question about this device

The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The panaSIa SI Fusion device is a threaded, expandable device, designed to stabilize the sacroiliac joint by piercing the adjacent cortical bone when expanded. The device has large fenestrations to allow for uninterrupted graft contact across the SI joint space. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy.

The provided FDA 510(k) clearance letter for the "panaSIa SI Fusion System" describes a medical device, specifically a smooth or threaded metallic bone fixation fastener, intended for sacroiliac (SI) joint fusion.

Based on the provided document, the acceptance criteria and the study proving the device meets these criteria are limited in detail. This is typical for a 510(k) clearance for this type of device, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than extensive clinical studies or AI algorithm performance validation.

Here's an analysis of the provided information, addressing your points where possible, and noting where information is not present in the document.

Overview of Device and Clearance Type

The panaSIa SI Fusion System is a physical implant (a threaded, expandable device made of titanium grade alloy) used for sacroiliac joint fusion. The FDA clearance is a 510(k), which means the manufacturer demonstrated the device is substantially equivalent to legally marketed predicate devices. This type of clearance typically relies on non-clinical testing (e.g., mechanical performance) and comparison of design, materials, and indications for use, rather than extensive human clinical trials or complex AI performance metrics.

Acceptance Criteria and Study Details (Based on Provided Document)

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission (510(k) for a physical implant), the "acceptance criteria" are not explicitly quantifiable metrics like sensitivity/specificity for an AI algorithm. Instead, they are typically the successful fulfillment of recognized standards and comparative performance to predicates.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "cadaver testing," which refers to ex vivo testing of the device. However, it does not specify the sample size (i.e., number of cadavers or test specimens from cadavers) used for this testing.
• Data Provenance: The document does not specify the country of origin of the cadaver data or whether the testing was retrospective or prospective. Given it's cadaver testing, it's inherently a controlled, ex vivo experimental setup rather than a patient-based retrospective/prospective study.

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

• This information is not applicable/not provided in this type of 510(k) submission. The "ground truth" for a physical implant's mechanical performance is typically established by engineering standards (like ASTM F3574) and direct measurement, not by expert consensus on image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical imaging studies or clinical trials where human interpretation or consensus is required. This information is not applicable/not provided for a mechanical device performance test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers (e.g., radiologists interpreting images). This device is a physical implant; therefore, no MRMC study was done or is relevant for this submission.

6. Standalone (Algorithm Only) Performance Study

• This refers to the performance of an AI algorithm alone, without human intervention. Since this is a physical medical device and not an AI algorithm, a standalone algorithm performance study was not conducted or is not relevant.

7. Type of Ground Truth Used

• For the non-clinical performance testing:
  • Mechanical Standards: Adherence to established engineering standards (ASTM F3574 for static and dynamic vertical shear testing).
  • Comparative Performance: The performance of the device was directly compared against a predicate device in cadaver models. While not explicitly stated as "ground truth," the predicate device's known performance serves as the benchmark against which the new device is measured.
  • No clinical outcomes or pathology ground truth was used for this 510(k) clearance, as it is based on substantial equivalence through non-clinical testing.

8. Sample Size for the Training Set

• This device is not an AI algorithm, so there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and prior device designs, but not through a formalized data training set as seen in AI development.

9. How the Ground Truth for the Training Set Was Established

• As there is no AI "training set," this question is not applicable.

In summary, the provided FDA 510(k) clearance letter details a non-AI medical device (an SI joint fusion implant). The "acceptance criteria" and "study" proving these criteria are primarily based on:

• Substantial equivalence to legally marketed predicate devices in terms of intended use, principles of operation, design, and materials.
• Non-clinical performance testing, specifically:
  • Adherence to ASTM F3574 for static and dynamic vertical shear testing.
  • Comparative cadaver testing against an additional predicate device.

The document does not delve into the detailed quantitative results of these tests (e.g., exact maximum shear force sustained), sample sizes of cadavers, or the specific methods of ground truth establishment beyond relying on industry standards and direct comparison. This level of detail for non-clinical testing is typically found within the full 510(k) submission, not the public-facing clearance letter.

Ask a specific question about this device

The piezoelectric surgical system is indicated for: osteotomies, osteoplasties, drilling and shaping of hard tissue. Including:

• Otolaryngology,
• Maxillofacial surgery,
• hand- & foot-surgery and
• plastic & reconstructive surgery.

The new device, the "Piezomed Pro", is an ultrasonic surgical modular system which has to be connected to W&H's AMADEO device (K213221). The new device is an ultrasonic surgical system whose basic function is the conversion of electrical energy into mechanical vibration.

In addition, a physiological saline solution is pumped to the treatment site with a displacement pump, depending on the treatment.

Using a control unit with electronics, the user can change several operating parameters within predefined limits:

• oscillation amplitude, 5 to 100% in steps of 5 (100 % corresponds to max. power)
• coolant flow rate via pump speed control; 5 to 100% in steps of 5 (100% corresponds to max. water quantity)

The device is activated or deactivated via a foot control.

The provided FDA 510(k) clearance letter for the Piezomed Pro describes a surgical device (an ultrasonic surgical modular system), not a diagnostic AI device. Therefore, the information typically requested regarding acceptance criteria and performance studies for an AI/ML-enabled diagnostic device (such as accuracy, sensitivity, specificity, sample sizes, ground truth establishment, expert adjudication, MRMC studies) is not present in this document.

This document focuses on proving substantial equivalence for a physical medical device based on:

• Intended Use/Indications for Use: The Piezomed Pro is indicated for osteotomies, osteoplasties, drilling, and shaping of hard tissue in various surgical specialties. This is shown to be identical to the predicate device.
• Technological Characteristics: The device's operating principle (conversion of electrical energy into mechanical vibration), frequency, operating mode, electrical classification, and components are compared to predicate and reference devices, demonstrating similarity.
• Performance Data: This section details non-clinical testing for biocompatibility, electromagnetic compatibility, electrical safety, reprocessing validation, and general performance/functional testing (e.g., life-time, falling, vibration tests).
• Software and Cybersecurity: Compliance with relevant standards and guidance documents for software development and cybersecurity is stated.

Therefore, based on the provided text, it's not possible to extract the information required for an AI/ML diagnostic device performance study. The questions provided in the prompt are geared towards evaluating the performance of an AI algorithm against a ground truth, which is not the subject of this 510(k) submission for the Piezomed Pro.

If this were an AI/ML diagnostic device, the "Performance Data" section would describe clinical study results, including metrics like sensitivity, specificity, AUC, and details about the test set, ground truth, and reader studies. Since it's a surgical tool, the performance data relates to its physical and functional safety and effectiveness, rather than diagnostic accuracy.

Ask a specific question about this device

The Testa™ TP Pivoting Spacer System with TiCell® Nano Advanced Surface Technology is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Testa™ TP Pivoting Spacer System is to be used with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Testa™ TP Pivoting Spacer System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Testa™ TP Pivoting Spacer System consists of new interbody implants that are provided sterile and intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The system is provided in a range of sizes to accommodate the anatomic needs for range of patients and is designed with a central graft window to accommodate graft material. The implant features TiCell® Nano Advanced Surface Technology, a proprietary etched surface with micro and nano-scale features, on the superior and inferior latticed surfaces. This is intended to help with resistance to migration and to facilitate fusion. The components of the implant are fabricated from Titanium-6 Aluminum-4 Vanadium ELI (Ti-6Al-4V ELI) conforming to ASTM F3001 and ASTM F136.

The provided document, an FDA 510(k) Clearance Letter for the Testa TP Pivoting Spacer System, does not contain information regarding an AI/ML-based device. Instead, it describes a traditional medical device: an intervertebral body fusion device.

Therefore, many of the requests in your prompt, which are specific to the regulatory approval process for AI/ML medical devices (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone AI performance, and AI ground truth establishment), cannot be answered from this document.

The document states: "Nonclinical testing was performed on the Testa™ TP Pivoting Spacer System to support substantial equivalence to the predicate device. The following testing was performed: Static and dynamic axial compression testing per ASTM F2077, Static and dynamic compression shear testing per ASTM F2077, Subsidence testing per ASTM F2267, Particulate and wear analysis per ASTM F1877. Clinical testing is not applicable." This indicates that the device was evaluated through bench testing and mechanical performance standards, not through AI/ML performance metrics or studies involving human readers or expert consensus on AI outputs.

Summary based on the provided document:

Since the device is a physical medical implant (intervertebral body fusion device) and not an AI/ML software, the requested information on AI-specific acceptance criteria and study methods is not applicable and is not present in the provided FDA 510(k) clearance letter. The document focuses on demonstrating physical and mechanical substantial equivalence to predicate devices through non-clinical bench testing.

Ask a specific question about this device

• Red light: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Red+Blue light: Treatment of mild to moderate inflammatory acne.

The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.

The LED LIGHT MASK adopts light emitting diodes (LED) in the red (635nm ± 5nm) + blue (425 ± 5nm) and red-blue (635nm + 425nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect (i.e. treatment of wrinkles and mild to moderate acne. The LED LIGHT MASK adopts the form of a mask that contains 64 LEDs on the inner surface of the main unit. A wired controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). The subject device operates in three treatment modes. One mode emits red light, one mode emits blue light, and the third mode emits red-blue light (i.e. mixed light). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, the user must wear the product before turning it on, then the built-in eye mask of the face mask can block the radiation of LED light to the eyes during each treatment.

The provided FDA 510(k) clearance letter for the LED Light Mask (A093) does not contain any information about acceptance criteria or specific study results proving the device meets these criteria in a performance study with human subjects, AI, or expert adjudication.

The document focuses on:

• Substantial Equivalence: It asserts that the device is substantially equivalent to a predicate device (LED Light Therapy Mask, Model(s): RB-008G/RB-008GB/RB-008J/RB-008JB, K243423).
• Non-Clinical Performance Testing: It lists various safety and performance standards (Biocompatibility, Electrical Safety, Software Verification and Validation) that the device complies with.
• Claim of No Clinical Testing Needed: Section 11.0 explicitly states, "Clinical testing is not needed for this device." This means there was no de novo clinical trial or performance study conducted to establish clinical efficacy for wrinkles or acne beyond demonstrating functional safety and equivalence to a previously cleared device.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These elements are typically part of a clinical performance study (often required for devices claiming new indications or significant technological differences), which the manufacturer declared was "not needed" and was therefore not submitted or reviewed by the FDA for this particular 510(k) clearance. The clearance is based on similarity to a predicate device and compliance with relevant safety and performance standards.

Ask a specific question about this device

When used with pedicle screw fixation systems, the Annex® 2 Adjacent Level System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Annex® 2 Adjacent Level System can be linked to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods of the following systems: CapSure®, Sniper® or Salvo® Spine Systems.

The Annex® 2 Adjacent Level System consists of a selection of non-sterile, single-use locking screws, adjacent level devices, and connectors for attachment to an existing pedicle spinal fixation construct to extend a rigid spinal construct. The Annex® 2 Adjacent Level System components are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing between existing screw and rod hardware. The implant components of this system are manufactured from titanium (ASTM F67)), titanium alloy (Ti-6Al-4V ELI (ASTM F136)), and cobalt-chromium (CoCr (ASTM F1537)).

The provided FDA 510(k) clearance letter pertains to a medical device, the Annex® 2 Adjacent Level System, which is a physical implant, not an AI/ML-driven software device. Therefore, the information requested regarding acceptance criteria and study design for AI/ML performance metrics (such as test set size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

The document discusses non-clinical testing to support substantial equivalence for a physical medical implant. Here's a summary of the relevant information from the provided document:

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

The document mentions that non-clinical testing was performed, but it does not explicitly state specific pass/fail acceptance criteria or quantitative performance results in the provided text. It generally concludes that the device is "substantially equivalent" based on these tests.

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

• Sample size: Not specified in the document.
• Data provenance: Not applicable in the context of clinical data for a physical implant. The testing described is non-clinical mechanical testing.

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

This information is not applicable as the study involved non-clinical mechanical testing of a physical device, not expert interpretation of AI/ML output.

4. Adjudication method for the test set:

Not applicable as the study involved non-clinical mechanical testing of a physical device, not subjective interpretation requiring adjudication.

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, as this is a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be established by standardized testing methods and material properties, rather than expert consensus, pathology, or outcomes data. The document states testing was performed "per ASTM F1717," indicating adherence to a recognized standard for spinal implant testing.

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.

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

Not applicable, as this is a physical medical device, not an AI/ML system.

In summary, the provided document is a 510(k) clearance letter for a physical orthopedic implant system. The study mentioned (non-clinical testing per ASTM F1717) focuses on establishing mechanical and material equivalence to predicate devices, not on AI/ML performance metrics.

Ask a specific question about this device

EMS is used for:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

TENS is used for:

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain

EVE Synergy has Synergy handpiece (1EA), Pro handpiece (2EA), Micro cable, Tip (Ball type, T type, COMB type) and Power adaptor & cable.

EVE Synergy has Synergy mode and Pro mode.

Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃.

Pro mode has low frequency function that uses the Pro handpiece with tip.

It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the EVE Synergy (EVE-20M) device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a comparative effectiveness study involving AI assistance or human-in-the-loop performance.

Therefore, many of the requested details regarding acceptance criteria for AI performance, specific study designs (MRMC, standalone), ground truth establishment for AI training/test sets, and sample sizes for these, are not present in this type of regulatory submission. This document primarily describes the physical and electrical characteristics of the device and compares them to predicate devices, along with standard electrical safety, EMC, and software validation testing.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

The document does not present "acceptance criteria" in the traditional sense of a specific performance metric (like accuracy, sensitivity, specificity) for a clinical outcome or an AI model's performance. Instead, it demonstrates compliance with safety and performance standards and similarity to predicate devices.

The "acceptance criteria" are implicitly met by showing:

• Compliance with various IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304) for electrical safety, EMC, and software.
• The device's technical specifications (e.g., output voltage, current, pulse width, frequency, power density) are comparable to or within the safe limits established by the predicate devices.

Table of Performance (extracted from comparison tables):

Ask a specific question about this device

The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

The GORE® Tri-Lobe Balloon Catheter is a compliant, tri-lobed polyurethane balloon catheter. The lobed design of the balloon catheter is designed for inflation without complete blockage of aortic blood flow. The three polyurethane balloons are mounted on the leading end of a multi-lumen catheter shaft. Radiopaque markers indicate the balloon edges. Each of the three inflation lumens is in communication with one of the balloons. The inflation port is in communication with all of the inflation lumens and is affixed with a luer lock. The guidewire lumen allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the guidewire lumen is affixed with a flushing/guidewire port with a luer lock, used for flushing the guidewire lumen. A Tuohy-Borst valve is integrated into the trailing end of the guidewire lumen.

The GORE® Tri-Lobe Balloon Catheter is available in two sizes. The smaller balloon can be inflated to diameters of 16 mm to 32 mm and the larger balloon can be inflated to diameters of 26 mm to 48 mm.

The provided FDA 510(k) clearance letter and associated summary pertain to a medical device, the GORE® Tri-Lobe Balloon Catheter, not an AI/ML-driven software device. Therefore, the information typically requested for AI/ML device acceptance criteria and study design (such as confidence intervals for performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or ground truth establishment) is not applicable or present in this document.

The document describes the device's technical characteristics, indications for use, and summaries of performance testing and clinical data to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the relevant information provided, structured to highlight what is and isn't applicable to your request:

Acceptance Criteria and Device Performance (Not Applicable as per AI/ML context)

While the document details performance testing, it doesn't present a table of quantitative acceptance criteria and corresponding reported device performance values in the way one would for an AI/ML device (e.g., Sensitivity, Specificity thresholds). Instead, safety and effectiveness are demonstrated through various tests and clinical observations.

Table 1. Technological Characteristics (This is a comparison of intended balloon diameters and inflation volumes, not performance metrics like accuracy or sensitivity for an AI/ML device.)

Key observations for performance (qualitative as per the document):

• Clinical Outcomes (Day 0 Adverse Events): Among the 44 subjects with known GORE® Tri-Lobe Balloon Catheter use in the Aortic Arch substudy:
  • Zero (0) Adverse Events of Aortic Rupture, Aortic Dissection, Balloon Related Mortality, and Type III Endoleak.
  • One (1) reported Type I Endoleak at Day 0.
• Conclusion: The device is deemed "substantially equivalent" to its predicate based on bench, pre-clinical, and clinical testing. The changes did not raise new concerns related to safety or effectiveness.

Study Details (Interpreted for a medical device rather than AI/ML)

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

   • Test Set (Clinical Data): 77 total subjects were treated for lesions of the aortic arch in the GORE® TAG® Thoracic Branch Endoprosthesis Clinical Trial (G130120). Of these, 44 subjects (57.1%) had known use of the GORE® Tri-Lobe Balloon Catheter during the index procedure.
   • Data Provenance: The study was a "prospective, non-randomized, multicenter study." The country of origin is not explicitly stated but implied to be related to FDA clearance (likely US-based).
   • Retrospective/Prospective: Prospective.

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

   • This is not applicable as this is a medical device study, not an AI/ML performance evaluation requiring expert labeling for ground truth. Clinical outcomes and observations from medical professionals involved in the trial serve as the "ground truth" for device safety and performance here.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of AI/ML ground truth adjudication. Clinical adverse events and outcomes were reported and presumably reviewed as part of the clinical trial protocol.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This document describes the performance of a physical medical device.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

   • Not applicable as this is not an algorithm. The device's performance is inherently linked to its use by medical professionals in a clinical setting ("human-in-the-loop" in a very different sense).

6. The Type of Ground Truth Used:

   • Clinical Outcomes/Events: The "ground truth" for the device's safety and effectiveness was established through direct observation of clinical adverse events (e.g., Aortic Rupture, Aortic Dissection, Type I Endoleak) and the device's ability to facilitate dilatation of endoprostheses during the clinical trial. Bench and In Vivo Animal Testing also contributed to this "ground truth" indirectly by demonstrating physical properties and performance.

7. The Sample Size for the Training Set:

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

8. How the Ground Truth for the Training Set was Established:

   • Not applicable.

In summary, the provided document is a 510(k) clearance letter for a physical medical device. As such, the standard criteria and study designs relevant to AI/ML device performance evaluation (e.g., sensitivity, specificity, expert adjudication, MRMC studies, training/test sets) are not found within this content.

Ask a specific question about this device

The Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment.

The Mask is to be used by adults weighing ≥ 30 kg whom positive airway pressure (CPAP or bi-level system) has been prescribed.

WiZARD 520 Full Face Mask's cushion and frame provide a secure interface between the mask and the patient's face and the flexible cushion improves seal. A series of vents on the elbow, serve as an exhalation vent to purge the exhaled carbon dioxide from the mask. The mask is designed to maintain a continuous airflow to minimize the amount of CO2 rebreathed by the patient. The mask features a wider visibility design that ensures a clear line of sight. It also includes a fabric frame equipped with 3D-shaped headgear for enhanced comfort and stability.

WiZARD 520 Full Face Mask is intended for connection to a positive air pressure source such as CPAP or bi-level for the treatment of Obstructive Sleep Apnea. WiZARD 520 Full Face Mask can be linked to the CPAP or bi-level system's standard 22 mm breathing tube using a swivel hose, flexible tube, and tubing connector. Various sizes (small, medium, and large) are offered to ensure adequate fit over the extended patient population.

The provided text is an FDA 510(k) clearance letter for the WiZARD 520 Full Face Mask. This document describes the substantial equivalence of the new device to a predicate device, focusing on its physical and functional characteristics. It does not describe a study proving the device meets acceptance criteria related to an AI/Machine Learning model, nor does it provide information relevant to a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or the establishment of ground truth by expert consensus.

The clearance is for a physical medical device (a CPAP mask), not a software or AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria for an AI model," "sample size for test/training sets," "number of experts for ground truth," "adjudication method," "MRMC study," or "standalone algorithm performance" are not applicable to this document.

The document discusses performance tests that are standard for a physical medical device, such as CO2 rebreathing, pressure-flow characteristics, resistance to flow, anti-asphyxia valve operating pressures, and sound levels. These are engineering and physiological performance metrics, not metrics for an AI's diagnostic accuracy or expert agreement.

Therefore, I cannot fulfill your request using the provided input, as the input material does not contain the type of information you've asked for. It's crucial to understand that a 510(k) for a physical medical device like a CPAP mask does not involve AI development or validation processes.

Ask a specific question about this device