Search Results

Aesthetic Body Contouring

The Vitruvian Liposaber™ consists of a control unit with an interconnecting cable to power and control a handpiece. The handpiece employs a motor intended to imitate the surgeons repetitive back and forth motions used during the liposuction procedure. The handpiece holds the cannula and the vacuum tubing. The handpiece is controlled by the user through the interaction with the control unit. The control unit controls the speed of the motor in the handpiece which provides the reciprocating motion of the cannula. The speed of the motor is variable between 3000 and 5000 RPM. The nominal speed is 4000 which can be adjusted using the controls on the handpiece between 3000 and 4000 RPM. Adjustments higher than 4000 must be performed through the user interface on the control unit.

The provided FDA 510(k) summary for the Vitruvian Liposaber pertains to a suction lipoplasty system, which is a physical device used for aesthetic body contouring. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data and comparison of technical specifications, rather than clinical studies involving human patients or AI performance metrics.

Therefore, the requested information regarding AI acceptance criteria, specific study designs (MRMC, standalone), human reader performance improvement, multi-expert ground truth establishment, training and test set sample sizes for AI, and adjudication methods is not applicable to this device and its 510(k) submission.

The document explicitly states: "No clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for years. The non-clinical testing details in this submission support the substantial equivalence of the device." This confirms that the approval is based on equivalence to existing, commonly understood devices, not on novel AI performance.

Below is a summary of the acceptance criteria and device performance as demonstrated in this 510(k) in the context of the device's technical specifications and non-clinical testing.

Acceptance Criteria and Reported Device Performance (Non-Clinical) for Vitruvian Liposaber™

The Vitruvian Liposaber™ is a physical medical device (suction lipoplasty system). Its acceptance criteria and performance are demonstrated through comparison to a predicate device and non-clinical testing, as opposed to AI performance metrics.

1. Table of Acceptance Criteria (as implied by comparison to predicate and non-clinical testing) and the Reported Device Performance:

Ask a specific question about this device

BRS Procedure Face Mask is a non-sterile, single use, disposable face mask intended to be worn to protect both healthcare personnel and patients from the transfer of microorganisms, blood and body fluids, and particulate material. This equipment is intended for the use in infection control practices to reduce the potential exposure to blood and fluids.

BRS Level 1 Procedure Face Mask (Model# 00850021617004)
BRS Level 2 Procedure Face Mask (Model# 00850021617196)
BRS Level 3 Procedure Face Mask (Model# 00850021617561)

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a surgical face mask (BRS Procedure Face Mask). It is a regulatory approval document and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Initial 510(k) clearance: Stating the device is substantially equivalent to legally marketed predicate devices.
• Regulatory compliance reminders: Information about general controls, specific regulations, registration, labeling, adverse event reporting, and quality systems.
• Indications for Use: Clearly defining the intended purpose of the BRS Procedure Face Mask.

Therefore, I cannot fulfill your request for information on acceptance criteria and a study from this document, as it does not contain that type of technical performance data.

Ask a specific question about this device

The Digital NeuroPort Biopotential Signal Processing System supports recording, processing, and display of biopotential signals from user-supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electroculography (EOG), and Evoked Potential (EP).

The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body.

The document describes the Digital NeuroPort Biopotential Signal Processing System, which is a physiological signal amplifier. The device's substantial equivalence to a predicate device (K090957, NeuroPort Biopotential Signal Processing System) is affirmed based on various performance data.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   Test / Characteristic	Acceptance Criteria	Reported Device Performance
   NeuroPlex E Functional Testing
   Mating	Screws down on pedestal and LED turns green	Pass
   Crosstalk	Isolation resistance of 1kΩ at 500 V DC	Pass
   Label Durability	IEC 60601-1:2005/A1:2012, Edition 3.1 7.1.3	Pass
   Digital Accuracy	Appropriate voltages for different filters (0.02-10 kHz Wide, 0.3-7.5 kHz Standard); Peak-to-peak of 500mV ±10%	Pass
   Input Impedance	≥10MΩ	Pass
   Impedance Measurement	820 ± 15% kOhms and 170 ± 15% kOhms	Pass
   Current Rating

Ask a specific question about this device

The Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

This document describes the FDA 510(k) clearance for Black Box Medical LLC's Pedicle Screw System (K201751). It does not contain information about acceptance criteria or a study proving the device meets those criteria.

This submission is a declaration of substantial equivalence to a predicate device (Stowe Pedicle Screw System, K181554) and explicitly states: "Performance data is not included in this submission. The design changes being included for review are the same changes implemented and approved under K181554. No additional changes have been made for this submission that would require additional performance testing."

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this document indicates that such information was not part of this specific 510(k) submission (K201751). The clearance is based on substantial equivalence to a previously cleared device.

Ask a specific question about this device

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (

Cortical Electrode (Per FDA Classification)

This document is a Traditional 510(k) Summary for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids). It asserts substantial equivalence to a predicate device (AD-TECH Subdural Cortical Electrodes) rather than claiming specific performance criteria and a study to meet them. Therefore, the requested information on acceptance criteria and a study proving the device meets them cannot be directly extracted as it would for a claim of new performance.

However, I can interpret the document's content to provide related information about the device's safety and effectiveness testing where it implicitly establishes "acceptance criteria" through conformance to recognized standards and successful test results.

Here's a breakdown of the available information, structured to align as closely as possible with your request:

Acceptance Criteria and Device Performance (Indirectly Derived from Safety and Performance Testing)

The document focuses on demonstrating substantial equivalence to a predicate device, which means proving the new device is as safe and effective as the legally marketed predicate. The "acceptance criteria" are generally implied to be compliance with relevant standards and successful completion of various tests, demonstrating that the device performs as intended and does not raise new questions of safety or efficacy.

Ask a specific question about this device

The FUSE Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The FUSE Pedicle Screw System consists of longitudinal rods and polyaxial screws. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

This document is a 510(k) premarket notification for the FUSE Pedicle Screw System and does not contain information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document states: "Performance data is not included in this submission. The design changes being included for review do not present a new worst-case configuration that would require additional performance testing." This indicates that the submission relies on the substantial equivalence to a predicate device (ACME Talon Pedicle Screw System, K071824) rather than new performance studies for the FUSE Pedicle Screw System itself.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

The Stowe Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The STOWE Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

Here's a breakdown of the requested information based on the provided text:

Important Note: The provided document is an FDA 510(k) clearance letter for a medical device (Stowe Pedicle Screw System), not a study report for an AI/ML powered device. Therefore, much of the requested information regarding acceptance criteria, performance studies, expert involvement, and ground truth for an AI/ML device is not present in this document. The document describes a traditional medical device and its substantial equivalence to a predicate device.

Acceptance Criteria and Study Information (Based on the Provided Document)

As this document pertains to a traditional medical device (spinal pedicle screw system) and not an AI/ML-powered one, the concepts of "acceptance criteria" and "study" as they relate to AI/ML performance (e.g., sensitivity, specificity, F1-score) are not applicable.

Instead, for this type of medical device, "acceptance criteria" would refer to demonstrating substantial equivalence to a previously cleared predicate device, typically through comparisons of:

• Intended Use
• Indications for Use
• Technological Characteristics (design, materials, dimensions)
• Performance (mechanical, biocompatibility, sterilization, etc. if changes warrant new testing)

The "study" that proves the device meets these criteria is a comparative analysis against the predicate device, often supported by engineering analysis, materials testing, and sometimes bench testing or animal studies if there are significant design changes. However, the document explicitly states:

"Performance data is not included in this submission. The design changes being included for review do not present a new worst-case configuration that would require additional performance testing."

This indicates that the "study" for this particular 510(k) relied primarily on the technical characteristics and equivalence to the predicate device rather than new, extensive performance data.

Here's an attempt to populate the table and answer the questions based on the document's context:

1. Table of Acceptance Criteria and 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)

• Sample Size: Not applicable. This is not a study involving patient data or an algorithm's test set. The "test set" here would refer to the device itself and its components, and the "testing" would be engineering analysis or bench testing. No specific sample sizes for such testing are detailed beyond the statement that no additional performance testing was required.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. For this type of device submission, "ground truth" as it relates to clinical outcomes or image interpretation (which would require experts) is not the primary focus of the 510(k) for substantial equivalence. The expertise involved would be in engineering, materials science, and regulatory affairs to assess the device's design and compare it to the predicate.
• Qualifications of Experts: Not specified in the document, but would typically involve engineers and regulatory professionals at the manufacturing company and the FDA.

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

• Adjudication Method: Not applicable. This term usually refers to resolving discrepancies in expert labeling or diagnoses for AI training/testing. For a traditional device, substantial equivalence is determined by regulatory review based on presented data 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

• MRMC Study: No. This type of study is relevant for AI-powered devices affecting human interpretation.

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

• Standalone Performance: No. This is not an AI algorithm.

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

• Type of Ground Truth: For this type of device, the "ground truth" for demonstrating safety and effectiveness is largely established by:
  • Regulatory standards: Adherence to material specifications (e.g., ASTM F136).
  • Predicate device's established safety and effectiveness: The historical performance and clearance of the ACME Talon Pedicle Screw System (K071824) serve as the benchmark.
  • Engineering principles and biomechanical testing (if performed): To ensure the device performs as intended under expected loads. However, the document explicitly states no additional performance testing was needed for this submission.

8. The sample size for the training set

• Sample Size: Not applicable. This is not an AI/ML device requiring a training set.

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

• Ground Truth Establishment: Not applicable. This is not an AI/ML device requiring a training set.

Ask a specific question about this device

Aesthetic body contouring. This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional.

The B89055 Vitruvian Infiltration Pump is intended to be used for aesthetic body contouring. Normal use includes general tumescent infiltration. It has a self-adjusting power converter which works with either 100V or 240V currents, and includes a pneumatic foot-switch and selfadjusting tubing guide to prevent tubing slippage during operation. It has a fully adjustable flow rate between 0 mL/min and 475 mL/min.

The Vitruvian Infiltration Pump is a pre-assembled device consisting of:

• Housing: ABS Plastic
• Power Operation: 100-240VAC, 50-60Hz, 1.8-1.0A
• Head: 3 roller peristaltic action
• Control: Knob used to set mL/min
• Display: LED
• Foot Switch: Air Powered ON/OFF
• Power Cord: Yes

The infiltration pump does not contact the patient.

This document is an FDA 510(k) premarket notification for the Vitruvian Infiltration Pump, which is a medical device. The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing indications for use, technological characteristics, and performance data to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vitruvian Infiltration Pump are primarily demonstrated through compliance with electrical safety standards and performance testing related to its function, particularly flow rate calibration. The document states compliance with general design and safety standards, and specifically mentions performance testing for flow rate.

It's important to note that for a 510(k), the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate, which often involves showing the new device performs as intended and meets relevant safety standards, rather than defining specific statistical endpoints for a comparative clinical study against a disease state.

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

The document does not specify a separate "test set" in the context of clinical data for algorithmic performance or diagnostic accuracy. The performance testing mentioned is for the device's functional characteristics (e.g., electrical safety, flow rate calibration). The data provenance for this functional testing is stated as "Performed at Manufacturing Facility." No patient-specific data or country of origin for such data is provided, as it is not a study involving patient outcomes or diagnostic outputs.

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

Not applicable. This is not a study assessing diagnostic accuracy or requiring expert-derived ground truth. The "ground truth" for the performance testing cited (electrical safety, flow rate calibration) would be the established engineering standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study involving diagnostic accuracy and expert adjudication. The "adjudication" for the performance tests would be whether the device passed or failed the specified standard's requirements.

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. The Vitruvian Infiltration Pump is an infiltration pump for aesthetic body contouring; it is not an AI-powered diagnostic or interpretive device that would involve human readers.

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

Not applicable. The Vitruvian Infiltration Pump is a medical device, not a standalone algorithm.

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

For the performance testing mentioned (IEC standards, flow rate calibration), the ground truth is established by the technical specifications and requirements of those international and national standards. For example, a flow rate calibration would involve comparing the pump's output to accurately measured fluid volumes over time, with the "ground truth" being the true measured flow rate.

8. The sample size for the training set

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

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

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

Ask a specific question about this device

The IDSS-ForceTriad Control Module is designed for integration in the IDSS(Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.

The IDSS ForceTriad Control Module is an additional function to the IDSS, which is an integrated operating room system controlling video displays, observation cameras, audio video equipment, teleconferencing and the routing of video and images from multiple sources to multiple destinations via a touch screen interface. With the IDSS ForceTriad Control Module, operation room staff is able to control the ForceTriad setup from the touch panel location rather than using the ForceTriad unit itself.

The provided FDA 510(k) summary (K153205) describes the IDSS-ForceTriad Control Module. This device is an accessory that enables remote control of the Covidien ForceTriad Energy Platform within an Integrated Digital Surgical Suite (IDSS). The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to showcase the performance of an AI/ML algorithm that interprets medical images or data.

Therefore, many of the requested criteria regarding AI/ML performance studies, such as effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable to this document.

Here's an analysis of the provided information, focusing on the context of a medical device accessory and its validation:

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 applicable. This device is a control module, not a diagnostic or AI image analysis system that would typically use a "test set" of medical images or patient data. The testing is focused on software functionality and risk management.

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. As noted above, this is a control module, not an AI/ML system requiring expert-adjudicated ground truth for medical data.

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

Not applicable. This is not an AI/ML system requiring adjudication of medical cases.

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 filing concerns a control module for an energy platform, not an AI-assisted diagnostic or imaging device. There is no mention of human readers or AI assistance in the context of clinical interpretation.

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

Not applicable. This is not an AI algorithm. Its function is to remotely control an existing medical device.

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

For the software validation and risk analysis, the "ground truth" would be related to the correct and expected functionality of the software according to its design specifications, user requirements, and safety standards (e.g., ISO 14971:2007). This is established through internal design documents, functional specifications, and compliance with regulatory standards, rather than clinical outcomes or expert consensus on medical findings.

8. The sample size for the training set

Not applicable. This is not an AI device that involves a "training set" in the machine learning sense.

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

Not applicable. This is not an AI device.

Ask a specific question about this device

Aesthetic body contouring.

The Vitruvian Aspirator is a pre-assembled device consisting of:

• . Housing: Powder Coated Steel
• . Vacuum Pump: Dual ½ hp dual voltage rocking piston motor with Maximum Suction flow rate of 125PSI, 6.4 cfm, 27.5in HG(711 mm of Hg)
• . Vacuum Meter Display: The device displays the vacuum levels digitally. The software does not control the unit in any way and does not accept any input.
• . Power Operations: 120/230 volt 50/60hz
• . Control: Pressure control valve located on the face of the device with rotary control knob with both LED numerical and Color Graphic LED display
• . Footswitch: Dual activated air powered
• IV Pole .
• . Filter: Bacterial filter having a pore size of 0.3 microns or less.

The provided document describes a 510(k) submission for the "Vitruvian Ultimate Aspirator." This product is a suction lipoplasty system, which is a medical device and not an AI/ML software device. Therefore, the questions related to AI/ML specific aspects like training data, inference, expert adjudication, etc., are not applicable.

Here's the information derived from the document regarding the acceptance criteria and performance testing for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on compliance with recognized medical device standards and functional performance testing. The reported performance indicates compliance with these criteria.

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

The document does not specify a "test set" in the context of data for AI/ML. Instead, performance testing was conducted on the physical device itself. The provenance of this testing is indicated as the "Manufacturing Facility."

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

Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This is not an AI/ML device 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. This is a physical medical device, not an AI assistance tool for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the functional aspects, the "ground truth" or reference for performance is established by the specified industry standards (e.g., IEC 60601 series) and the functional specifications of the predicate device. For the vacuum display calibration, the "acceptable criteria range" serves as the ground truth.

8. The sample size for the training set

Not applicable. 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.

Ask a specific question about this device