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The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of autologous tissue. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of adipose autologous tissue for aesthetic body contouring. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.

The Origins LipoHarvesting System consists of a reusable, closed loop tissue collection system comprised of a medical grade canister, a drain port and a lid intended to be used with a standard liposuction aspiration pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the collection canister via a port in the canister lid. The physician removes unwanted waste materials from the collection system via the drain port at the base. This process leaves fatty tissue that can be transferred to syringes for autologous fat re-injection.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Origins LipoHarvesting System:

Acceptance Criteria and Device Performance for Origins LipoHarvesting System (K120328)

Based on the provided 510(k) summary, the device is a suction lipoplasty system used for harvesting and transferring autologous adipose tissue. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance testing related to materials and basic functionality, rather than clinical efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not mention any studies involving a "test set" in the context of human or animal data. The performance testing described is limited to bench testing for material biocompatibility and general performance against pre-determined specifications. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature for a test set of data is not applicable/provided.

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

As there is no mention of a "test set" involving human or animal data needing a ground truth established by experts, this information is not applicable/provided in the summary. The studies described are primarily engineering and material conformance tests.

4. Adjudication Method for the Test Set

Not applicable, as there is no human or animal test set described.

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

No MRMC comparative effectiveness study was described or performed. The submission is for a physical device for tissue collection, not an imaging or diagnostic AI-powered device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Not applicable. The device does not contain an algorithm or software. It is a mechanical system.

7. The Type of Ground Truth Used

For the biocompatibility testing, the "ground truth" would be the standards themselves (ISO 10993-1: 2009). The material properties were tested against the requirements of this standard.

For the bench performance testing, the "ground truth" would be the predetermined specifications for the device's function.

8. The Sample Size for the Training Set

No training set is applicable or mentioned. The device is a physical system, not an AI or machine learning model.

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

Not applicable, as there is no training set.

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The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.
The Sound Surgical VentX 2.1 is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX 2.1 is designed to operate with the Sound Surgical VASER 2.1 or as a stand-alone system.
The Sound Surgical VASER 2.1 Lipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
The Sound Surgical VASER 2.1 Lipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues:

• Neurosurgery;
• Gastrointestinal and affiliated organ surgery;
• Urological surgery;
• Plastic and reconstructive surgery;
• General surgery
• Gynecological surgery:
• Thoracic surgery; and
• Laparoscopic surgery.

The Sound Surgical Technologies LLC (Sound) VASER 2.1 Lipo System (VASER 2.1) is an ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues.
The Sound VASER 2.1 is comprised of two (2) primary components: (1) the Sound VASER 2.1 Ultrasonic Amplifier; and (2) the VentX 2.1 Infiltration and Aspiration Console. Both the Sound VASER 2.1 Ultrasonic Amplifier and the Sound VentX 2.1 Infiltration and Aspiration Console are designed to operate independently, and may be sold or used separately, or together, as a system.
The VASER 2.1 Amplifier utilizes an ultrasonic surgical VASER Handpiece and Probe to fragment and emulsify the soft tissue. The VentX 2.1 Console utilizes sterile infiltration tubing, a handle and cannulae to infiltrate the tissue with fluids, and sterile suction tubing, a handle and cannulae to aspirate fluids and soft tissue.

This document describes the regulatory approval (510(k) clearance) for the "Sound Surgical Technologies LLC VASER 2.1 Lipo System." The approval is based on its substantial equivalence to a predicate device (Sound VASER System, K022051), rather than a study proving the device meets acceptance criteria in the sense of a clinical trial demonstrating efficacy against specific endpoints.

The performance testing detailed in the document focuses on compliance with recognized standards for medical device safety, sterility, biocompatibility, software, electrical safety, and electromagnetic compatibility. It does not present specific acceptance criteria with numerical targets for clinical performance or statistically derived device performance metrics.

Here's a breakdown of the information requested, based on the provided text, acknowledging that much of it is not applicable in the context of a 510(k) summary focused on substantial equivalence and compliance with general safety and performance standards:

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

Since this is a 510(k) submission based on substantial equivalence and compliance with established standards, explicit "acceptance criteria" for clinical performance (e.g., specific percentages for fragmentation, emulsification, or aspiration effectiveness) are not provided in the document. Instead, the "acceptance criteria" are implied by adherence to the cited industry standards. The "reported device performance" is a statement of compliance with these standards and the device's predetermined specifications.

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 provided in the document. The testing described (sterilization, shelf-life, biocompatibility, software, electrical safety, EMC, and bench performance) are laboratory and engineering tests, not clinical studies involving patient data or test sets in the typical sense for an AI/diagnostic device.

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/provided. The 510(k) summary does not describe any clinical studies where expert-established ground truth would be relevant. The "ground truth" for the various performance tests is defined by the technical standards (e.g., a sterile product tested to ISO 11137 standards, or an electrical safety test to IEC 60601-1).

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

This information is not applicable/provided. Adjudication methods are typically relevant for clinical studies or image interpretation studies, which are not detailed here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is relevant for AI-powered diagnostic or assistive devices, which this VASER 2.1 Lipo System is not. This is a surgical device.

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

This information is not applicable/provided. The device described is a physical surgical system, not an algorithm, and its performance inherently involves a human operator (surgeon).

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

The concept of "ground truth" in the context of this 510(k) submission refers to the established requirements and methods defined by the relevant international and national standards (e.g., ISO, IEC, UL, FDA guidance for software). For example, the ground truth for electrical safety is defined by the limits and test procedures in IEC 60601-1. For sterilization, it's achieving a specified sterility assurance level (SAL) as validated against ISO 11137.

8. The sample size for the training set

This information is not applicable/provided. As this is a physical medical device, not an AI or machine learning algorithm, there is no "training set."

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

This information is not applicable/provided for the same reason as point 8.

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The Sound Surgical Technologies LLC PowerX Lipo System is intended for the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

The Sound Surgical Technologies LLC (Sound) PowerX Lipo System (PowerX) consists of three major components: (1) an electronic Controller with software, (2) an electronic Handpiece, and (3) a reusable, sterilizable Cannula. The Handpiece is connected to the Controller and to an independent aspiration source. The Controller sends electronic signals to the Handpiece and thereby controls the motion of the cannula that is fitted to the distal end of the Handpiece. The Sound PowerX is a prescription device, and is intended for use by trained medical personnel.

The provided document is a 510(k) summary for the Sound Surgical Technologies LLC PowerX Lipo System. It describes the device, its intended use, and various performance tests conducted to demonstrate its safety and effectiveness. However, it does not include information about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic accuracy, which is typically what such a request implies.

The "Performance Testing" section states that "The Sound PowerX was tested for performance in accordance with its predetermined specifications as specified in Section 11, Device Description - Performance Specifications, of this submission. Test results indicate that the Sound PowerX complies with its predetermined specification." However, Section 11 is not provided in the snippet, so the specific performance specifications are unknown.

The document does provide information on acceptance criteria and testing for aspects like sterilization, biocompatibility, software validation, electrical safety, and electromagnetic compatibility. This is generally summarized as compliance with recognized standards.

Here's a breakdown of the information that can be extracted from the provided text, and significant gaps where information related to diagnostic accuracy would typically be found:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific performance specifications for the device's primary function (tissue/fluid removal) are not detailed in the provided excerpt beyond a general statement of compliance. The other "performance" criteria relate to general medical device safety and functionality.

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 provided in the document for any of the performance tests. The document refers to "test results" but does not detail the nature of these tests in terms of sample size or data provenance that would be typical for a diagnostic accuracy study.

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/not provided. The device is a "Suction lipoplasty system" meant for "removal of tissue or fluids," not a diagnostic device that relies on expert interpretation of output to establish ground truth.

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

This information is not applicable/not provided for the same reasons as point 3.

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/not provided. The device is not a diagnostic AI system, and therefore, MRMC studies and AI assistance metrics are not relevant to its evaluation as described.

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

This information is not applicable/not provided as it is not a diagnostic algorithm. The device itself is standalone in its mechanical/electronic function, but this question typically refers to the performance of a diagnostic algorithm in isolation.

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

This information is not applicable/not provided in the context of diagnostic "ground truth." The "ground truth" for the device's technical performance would be its ability to meet its engineering specifications (e.g., proper motor function, suction power, sterilization efficacy), which are implicitly based on established engineering principles and medical device standards.

8. The sample size for the training set

This information is not applicable/not provided. This question typically refers to the development of machine learning algorithms. The device's software is stated to be designed and developed "according to a robust software development process" and "rigorously verified and validated," implying standard software engineering practices rather than machine learning training sets.

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

This information is not applicable/not provided for the same reasons as point 8.

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The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

• Neurosurgery -
• Gastrointestinal and Affiliated Organ Surgery -
• Urological Surgery -
• Plastic and Reconstructive Surgery -
• General Surgery -
• -Orthopedic Surgery
• Gynecological Surgery -
• Thoracic Surgery -
• -Laparoscopic Surgery

The SoundVASER System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues.

The provided text is a 510(k) summary for the SoundVASER System, which outlines its substantial equivalence to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria.

Therefore, the document does not contain information on acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a test or training set.

The document explicitly states: "The SoundVASER System is similar with regard to design, operation, materials, methods of sterilization, and intended use to the predicate devices indicated above. Therefore, no new safety or efficacy issues are created and the SoundVASER System is substantially equivalent to the predicate devices." This highlights that the submission relies on demonstrating substantial equivalence to already approved devices rather than presenting new performance data against acceptance criteria.

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The SoundVASER Dissection System (Dissection Tips and Handpiece for The SoundVaser System) is indicated for use in when cutting and coagulation of soft tissues is desired, including bleeding control with minimal thermal injury.

The SoundVASER Dissection System is comprised of an ultrasonic surgical handpiece and associated dissection tips. The ultrasonic surgical handpiece converts electrical energy supplied by the SoundVASER ultrasonic generator into vibratory motion. The vibratory motion is applied to the dissection tip that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip cuts and coagulates contacted soft tissues.

This document describes a 510(k) submission for the SoundVASER Dissection System. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not require clinical studies with acceptance criteria in the way a PMA (Premarket Approval) submission would.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document focuses on:

• Predicate Devices: Identifying existing devices with similar technical design and operation that have already been cleared by the FDA.
• Device Description: Explaining how the SoundVASER Dissection System works (ultrasonic surgical handpiece and dissection tips for cutting and coagulation of soft tissues).
• Intended Use: Stating the purpose of the device.
• Summary of Technological Characteristics: Arguing that the device is substantially equivalent to predicate devices based on design, operation, materials, sterilization, and intended use, thus creating no new safety or efficacy issues.

In summary, this document is a substantial equivalence claim, not a report of a study designed to meet specific performance acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or clinical study outcomes because that information is not present in the provided text.

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The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, and Laparoscopic Surgery.

The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues. The suction and irrigation functions may be performed simultaneously or independently.

The provided document is a 510(k) summary for the SoundVASER System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not present in this document.

Here's an analysis based on the information available in the provided text:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This 510(k) summary does not define specific performance acceptance criteria for the SoundVASER System. The focus of the submission is to demonstrate "substantial equivalence" to existing predicate devices, implying that if it is equivalent, it implicitly meets the safety and effectiveness standards of those devices. No quantitative performance metrics are provided.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. No specific test set or study data is presented for performance evaluation.
• Data Provenance: Not applicable. No study data is provided.

3. Number of Experts and Qualifications for Establishing Ground Truth (Test Set)

• Number of Experts: Not applicable. No test set requiring expert ground truth is mentioned.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. No test set or expert evaluation requiring adjudication is mentioned.

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

• MRMC Study Done?: No. This document does not describe an MRMC study.
• Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study Done?: No. The SoundVASER System is a surgical instrument, not an AI algorithm. Its performance is related to its mechanical and ultrasonic properties, not an algorithm's standalone accuracy.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The document does not describe a study involving ground truth. The substantial equivalence argument relies on the inherent characteristics of the device and its similarity to already-approved devices, rather than a comparison to a "ground truth" derived from patient data or expert consensus.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. The SoundVASER System is a physical medical device, not an AI model that requires a training set.

9. How Ground Truth for Training Set Was Established

• How Established: Not applicable.

Summary from the Document:

The 510(k) summary for the SoundVASER System primarily aims to demonstrate substantial equivalence to predicate devices (Valleylab Inc., CUSA Excel Ultrasonic Surgical Aspirator System and CUSA Lap Accessory). It achieves this by highlighting:

• Similar Technical Design and Operation: The device is described as an ultrasonic generator, surgical handpiece with a probe, and a suction/irrigation subsystem, similar to existing devices.
• Similar Intended Use: Fragmentation, emulsification, and aspiration of soft tissue in various surgical specialties (Neurosurgery, Gastrointestinal, Urological, Plastic/Reconstructive, General, Orthopedic, Gynecological, Thoracic, and Laparoscopic Surgery).
• Similar Technological Characteristics: Design, operation, materials, methods of sterilization, and intended use are stated to be similar, leading to the conclusion that "no new safety or efficacy issues are created."

Conclusion:

This 510(k) submission is a regulatory document focused on proving equivalence rather than a detailed scientific study with defined acceptance criteria and performance metrics. It does not contain the information required to populate the requested table or answer most of the detailed questions about study design, sample sizes, expert involvement, or ground truth.

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