Search Results

Vega Triple Wave Applicator (755nm/ 810nm/ 1064nm)
Indications for use of the Triple Wave Applicator, Includes:
The Super Hair Removal (SHR) mode is intended for the temporary reduction of hair.

Vega 810nm Applicator:
Indications for use of the 810nm Applicator, Includes:
The Hair Removal (HR) and Super Hair Removal (SHR) modes are intended for the permanent reduction of hair regrowth, defined as a stable and long-term reduction in the number of hairs that regrow, measured at 6, 9, and 12 months after completing a treatment regimen. It is suitable for use on all skin types (Fitzpatrick I-VI), including tanned skin, when using the HR and SHR mode.

VEGA is a high-power laser therapy device with electromagnetic emission in the infrared spectrum, designed for long-lasting hair removal on all skin types. Laser energy can be transferred to the treatment area via an 810nm or triple wave (755, 810, 1065nm) handpiece.

N/A

Ask a specific question about this device

The VEGA Knee System is indicated for use in reconstruction of the diseased by ostearthritis, theumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for aon-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The VEGA Knee is designed for use with bone cement.

The Columbus Total Knee System is indicated for use in reconstruction of the diseased by osteoarthritis, theumatord arthritis, post-traumatic arthritis, the need to revise failed arthroplasties where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for and on non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The Columbus Knee is designed for use with bone cement.

All Poly Tibia posterior stabilizing and cruciate retaining implants are a line extension to the VEGA Knee System® and Columbus Total Knee System, respectively. The posterior stabilizing version is being introduced to the VEGA Knee System® and the cruciate retaining, deep dish version is being introduced to the Columbus Total Knee System. The subject implants are available with an optional centralizer.

VEGA Knee System® is a semi-constrained cemented prosthesis with a posterior stabilized (PS) design. Columbus Total Knee System includes both cruciate retaining and posterior stabilizing variants of the femoral, tibial and meniscal components.

For both knee systems, the femoral component, tibial plateau and extension stems are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo), available with an optional Zirconium nitride (ZrN) coating. The tibial gliding surface (insert), patella and All Poly Tibia are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The optional centralizer, designed to be used with the All Poly Tibia is made of polymethyl methacrylate (PMMA). The patella and All Poly Tibia incorporate X-ray markers. The materials of the X-ray markers in the patella are wrought stainless steel and the All Poly Tibia X-ray markers consist of a titanium peg and a tantalum ball. The tibial plug is made of PEEK.

VEGA and Columbus Knee Systems are made up of numerous components available in various sizes. The VEGA Knee System® is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateaus (CR/PS and CRA/PSA) and augments.

VEGA and Columbus components are sterile and intended for single use only.

The provided document is a 510(k) premarket notification for the VEGA Knee System® and Columbus Total Knee System, specifically regarding the introduction of All Poly Tibia posterior stabilizing and cruciate retaining implants with an optional centralizer. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, the document does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.

Instead, it focuses on demonstrating substantial equivalence to predicate devices by addressing technological characteristics and manufacturing processes. The "Performance Data" section briefly mentions:

• A risk analysis.
• Biomechanical testing.
• A comparison evaluation of wear.
• Biocompatibility of X-ray markers.
• Validation and verification of new instruments.

The conclusion of this section is that these analyses "raised no new issues of safety and efficacy for the design modifications described herein." This indicates that the intent was to show that the new components did not negatively impact the established safety and efficacy of the existing systems, rather than to present new acceptance criteria or a study demonstrating achievement of those criteria.

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory approval through substantial equivalence, not on quantifiable performance acceptance criteria and a study demonstrating their achievement.

Ask a specific question about this device

The VEGA Knee System is indicated for use in reconstruction of the diseased by ostearthritis, theumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties where pain, deformity or dysfunction persist and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The VEGA Knee System is designed for use with bone cement.

VEGA Knee System is a semi-constrained cemented prosthesis with a posterior stabilized (PS) design. The femoral component, tibial plateau, extension stems and obturators are manufactured from Cobalt Chromium Molybdenum allov (CoCrMo), with an optional Zirconium nitride (ZrN) coating. The tibial gliding surfaces (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The tibial plug is made of PEEK.

VEGA Knee System is made up of numerous components available in various sizes. The VEGA Knee System is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateaus (CR/PS and CRA/PSA) and augments.

All components are sterile and intended for single use only.

This document is a 510(k) premarket notification for the VEGA Knee System. It does not contain information about the acceptance criteria or a study proving that a device (in the context of an AI/ML device) meets acceptance criteria. Instead, it discusses the regulatory process for a knee replacement system.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to previously cleared medical devices based on design, materials, and intended use, rather than presenting a performance study with acceptance criteria in the way you've described for AI/ML devices.

Ask a specific question about this device

The VEGA Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain. deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee ioint.

The VEGA Knee System is designed for use with bone cement.

The VEGA Knee System is a semi-constrained cemented prosthesis with a Posterior Stabilization (PS) design. The femoral component, tibial plateau and extension stem are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo) with a Zirconium nitride (ZrN) coating. The tibial "gliding surfaces" (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and the tibial plug is made of PEEK. The system is made up of numerous components available in various sizes. The VEGA Knee System is compatible with Aesculap Columbus cruciate retaining/posterior stabilizing tibial plateau and augments (CRA/PSA). All components are sterile and for single use only.

Here's an analysis of the provided FDA 510(k) summary for the VEGA Knee System, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for VEGA Knee System (K140452)

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission (K140452) is for a line extension, specifically the addition of optional compatible Aesculap Columbus CRA/PSA tibial plateau and augments to the existing VEGA Knee System.

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or in-vitro study with a specific number of units. The assessment was a geometrical worse-case comparison, which would involve analyzing the designs and dimensions of the components rather than testing a "sample size" of physical devices.
• Data Provenance: The data is based on the design specifications and geometrical properties of the existing VEGA Knee System (cleared under K101281 and K121879) and the Columbus CRA/PSA components (previously cleared in 510(K) K053390, K071220 and K120955). This is considered retrospective in the sense that it relies on previously designed and cleared components rather than newly generated test data from a prospective study. The country of origin is not explicitly stated for the designs, but the company is US-based.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given the nature of the "geometrical worse-case comparison," these would likely be engineering experts with expertise in orthopedic implant design, tolerancing, and biomechanics.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "study" was a geometrical comparison, not a clinical trial requiring adjudication of patient outcomes or expert consensus on clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, which is not applicable to an orthopedic implant line extension.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: No, a standalone algorithm performance study was not done. This type of study is relevant for AI/ML algorithms, which is not applicable to this physical implant device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is based on engineering design principles, dimensional compatibility, and risk analysis methodologies. The "truth" is whether the combined components fit together without creating new risks or compromising the function of the knee system. This is an engineering/design-based ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This submission does not involve an AI/ML algorithm that requires a training set. The "fundamental scientific technology and materials" for the VEGA system are established.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device. The underlying design principles and performance of the predicate devices (VEGA and Columbus components) were established through their respective 510(k) clearances, which would have involved various mechanical testing, biocompatibility, and design verification activities.

Ask a specific question about this device

The VEGA Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

The VEGA Knee System is designed for use with bone cement.

The VEGA Knee System is a semi-constrained cemented prosthesis with a Posterior Stabilization (PS) design. The femoral component, tibial plateau and extension stem are manufactured from Cobalt Chromium Molybdenum alloy (CoCrMo) with a Zirconium nitride (ZrN) coating. The tibial "gliding surfaces" (inserts) and patella are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and the tibial plug is made of PEEK. The system is made up of numerous components available in various sizes. All components are sterile and for single use only.

The provided document is a 510(k) summary for the VEGA Knee System, specifically addressing a modification to the wrench size for 10mm extension stems. This document is a premarket notification for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a study with human subjects.

Therefore, many of the requested data points (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable to this type of submission for this particular device modification. The submission focuses on mechanical testing to ensure the modification does not negatively impact the device's performance compared to the predicate.

Here's the information that can be extracted from the provided text, alongside an explanation of why other points are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Explanation: For this type of modification (wrench size for extension stems), the "acceptance criteria" are implied to be that the modified component, when subjected to mechanical testing, performs comparably to the previously cleared design. The document doesn't specify numerical thresholds for success, but rather a qualitative comparison.

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

• Sample Size: Not specified. The document states "Mechanical testing... was performed," but does not provide the number of samples or specimens tested.
• Data Provenance: The testing was performed internally by the manufacturer (Aesculap Implant Systems, LLC). The nature of the testing is "mechanical testing," implying laboratory-based testing rather than clinical data from a country of origin.
• Retrospective/Prospective: Not applicable. Mechanical testing is a laboratory-based evaluation of physical properties, not a study involving patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This was mechanical testing of a physical component (extension stem), not an evaluation of a diagnosis or outcome that would require expert human judgment or "ground truth."

4. Adjudication Method

• Not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. This type of study investigates human reader performance (e.g., radiologists, pathologists) often in the context of diagnostic AI. The submission is for a knee implant modification and involves mechanical testing.

6. If a Standalone (Algorithm Only) Performance Study was Done

• Not applicable. This is a medical device (knee implant), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for mechanical testing is typically established by engineering specifications, material properties, and comparison to the performance of the predicate device under similar testing conditions. It's not "expert consensus," "pathology," or "outcomes data" in the traditional sense for diagnostic or prognostic studies. The implied ground truth is the established performance of the original VEGA Knee System (K101281) through its own mechanical testing.

8. The Sample Size for the Training Set

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

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

• Not applicable for the same reasons as #8.

Study that Proves the Device Meets the Acceptance Criteria:

The document states: "Mechanical testing of the Aesculap Implant Systems VEGA 10mm extension stems was performed as a result of the risk assessment. The results were found to be similar to the legally marketed VEGA Knee System."

This "mechanical testing" is the study referenced. No further details are provided in this summary regarding the specific tests conducted (e.g., fatigue testing, static strength testing), the number of samples, or the quantitative results. The conclusion provided is that the performance was "similar" to the predicate device, indicating it met the implicit acceptance criterion of not degrading performance due to the modification.

Ask a specific question about this device

The VEGA CPAP System/Heated Humidifier, models CP-03 delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. The device is intended for use in the home or hospital/institutional environment on adult patients.

The VEGA CPAP System/Heated Humidifier, models CP-03 is a smaller and lighter AC -powered, micro processor-controlled, and blower-based system that generates positive airway pressure from 3 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface(mask). The CPAP device may also be used with VEGA Heated Humidifier that has been designed to be compatible with the CPAP and controlled from the CPAP. The basic functional and performance characteristics of the VEGA CPAP System/Heated Humidifier are completely similar to the predicate device, the Respironics REMstar Plus CPAP System/REMstar Heated Humidifier(K010263).

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of a medical device's performance characteristics or clinical outcomes. Instead, it describes a 510(k) summary for a CPAP system and heated humidifier, focusing on its substantial equivalence to a predicate device, technical specifications, and non-clinical verification activities.

Specifically:

• The document mentions "Performance Compliance Test for CPAP according to ISO 17510-1" and "Performance Compliance Test for heated humidifier according to ISO 17510-1" as non-clinical tests conducted by the manufacturer. However, it does not specify what the acceptance criteria for these tests were (e.g., specific pressure accuracy ranges, flow rate tolerances, temperature stability) nor does it report the device's performance against any such criteria.
• It explicitly states: "No any Clinical Test is conducted for the VEGA CPAP System/Heated Humidifier." This means there is no clinical study to demonstrate effectiveness or patient outcomes, which would typically be associated with acceptance criteria for device performance in a clinical setting.
• The document primarily relies on "substantial equivalence" to a predicate device (Respironics REMstar Plus CPAP System/REMstar Heated Humidifier, K010263) based on similar intended use and technological characteristics, and verification/validation tests for electrical safety and EMC.

Therefore, I cannot provide the requested table or answer most of the questions because the necessary information (acceptance criteria, reported performance against those criteria, details of a performance study, sample sizes, ground truth, expert qualifications, etc.) is not present in the provided 510(k) summary.

In summary, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial or a detailed performance validation report would.

Ask a specific question about this device

The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a device used to remove fluids from airway or respiratory support system and infectious materials from wounds.

The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a portable AC powered suction pump. It consists of a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, and suction tube. The device is designed and manufactured to comply with IEC 60601-1. IEC 60601-1-2, and ISO 10079-1.

The provided text describes the 510(k) premarket notification for the "VEGA Medical Suction Equipment, model SU-01/SU-DC01." However, it does not include information about acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/algorithm-based devices with performance metrics like sensitivity, specificity, etc.

Instead, this submission is for a medical suction pump, which is a hardware device. The "acceptance criteria" and "study" described are about demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for such hardware.

Here's a breakdown based on the provided text, addressing your points where applicable for this type of device:

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

The document does not explicitly present a table of acceptance criteria for performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, acceptance criteria are inferred from the compliance with international standards and comparison to the predicate device.

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

This information is not applicable in the context of this 510(k) submission for a medical suction pump. The "tests" mentioned are compliance tests against engineering standards, not performance evaluations on a patient "test set" with data in the way AI/software devices are evaluated.

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)

This information is not applicable. Ground truth, as typically discussed for medical AI/imaging, is not relevant for the compliance testing of a hardware medical suction pump. Compliance is against defined engineering standards.

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

This information is not applicable. Adjudication methods are used in scenarios where human interpretation or consensus is required to establish ground truth from complex medical data (e.g., images, clinical records). This is not the case for a hardware device's compliance testing.

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 information is not applicable. This type of study investigates the impact of AI on human reader performance, which is not relevant for a standalone medical suction device. The submission explicitly states: "No particular Clinical Test was conducted for VEGA Medical Suction Equipment."

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

This information is not applicable. This device is a physical medical suction equipment, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

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

This information is not applicable. The "truth" for this device's evaluation is compliance with established engineering and safety standards (ISO 10079-1, IEC 60601-1, IEC 60601-1-2) and demonstration of substantial equivalence to a predicate device based on its design and specifications.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a hardware device, not a machine learning model.

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

This information is not applicable. As there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device

The Vega™ SPAN™ Spinous Process Plate System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, or degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies). The device is intended for use with bone graft material and is not intended for stand-alone use.

The Vega™ SPAN™ Spinous Process Plate System consists of plates of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating post-operatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct. System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

The provided text describes the regulatory clearance for the Vega™ SPAN™ Spinous Process Plate System, not an AI/ML powered medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment) is not applicable or available in the given document.

The document focuses on demonstrating substantial equivalence to predicate devices through a 510(k) submission, primarily relying on mechanical testing and comparison of technological characteristics.

Here's the relevant information based on the provided text, aligned with the spirit of your request regarding device performance and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This device’s clearance was based on mechanical testing, not a test set of data with human subjects or images requiring "data provenance" in the context of an AI/ML device. The "test set" here refers to the physical devices undergoing mechanical tests. The specific number of devices tested is not detailed in this summary, but mechanical testing typically involves a statistically significant number of samples to demonstrate consistency.

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

• Not Applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or classifications. For this device, "ground truth" relates to the performance standards defined by ASTM F1717 for mechanical properties, which are established engineering standards, not expert clinical consensus.

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

• Not Applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation or clinical outcomes. This study involved mechanical testing against established standards.

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. An MRMC study was not conducted as this is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

• Not Applicable. This is not an algorithm-only device. The "standalone" performance here refers to the device's mechanical integrity as tested in a laboratory setting. The results of these tests demonstrated the device meets mechanical performance criteria as defined by ASTM F1717.

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

• For the mechanical testing, the "ground truth" was established engineering standards, specifically ASTM F1717, which define acceptable static and dynamic compression and torsion performance for spinal implant devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense.

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

• Not Applicable. As above, no training set was used.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device