Search Results

The Soring MBC200/BCC140 devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures. Typical users of this system are trained medical professionals.

Soring MBC200/BCC140 device has 2 configurations. Depending on the unit variant, the user can choose from the following functions:

• . MBC200: Monopolar cutting and Coaqulation and Bipolar Coagulation
• . BCC140: Bipolar Cutting and Coagulation
  Electrosurgical devices are frequently used during surgical operations helping to prevent blood loss in hospital operating rooms or in outpatient procedures. Electrosurgery is performed using an Electrosurgical Generator (also referred to as Power Supply or Waveform Generator) and a handpiece including one or several electrodes, sometimes referred to as an RF Knife. Lower RF-voltages (below 150) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coaqulation. During the use of the Soring MBC200/BCC140 device, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts.

The provided 510(k) summary is for an electrosurgical cutting and coagulation device (Soring MBC200/BCC140), which is a hardware medical device. The information requested regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth is typically applicable to AI/ML-enabled devices or diagnostic devices that rely on complex algorithms and data analysis for performance claims.

For a device like the Soring MBC200/BCC140, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on engineering specifications, electrical safety, electromagnetic compatibility, and biocompatibility, as demonstrated through compliance with recognized consensus standards and internal (non-clinical) verification and validation testing.

Therefore, I cannot populate the requested table and answer many of the questions (2 through 9) in the manner typically expected for AI/ML or diagnostic devices. The 510(k) summary provided does not contain the type of clinical study data with patient samples, expert ground truth, or statistical power calculations that would be found in the approval for a device making diagnostic or predictive claims based on data analysis.

However, I can extract the relevant information regarding safety and performance criteria and the testing performed, reinterpreting some of the prompts to fit the context of this type of device.

Acceptance Criteria and Device Performance (Reinterpreted for a Hardware Electrosurgical Device)

Inapplicable or Not Provided Information

The following questions are not applicable or the information is not provided in the context of this 510(k) summary for a hardware electrosurgical device:

2. Sample sizes used for the test set and the data provenance: This device is not an AI/ML or diagnostic device that uses a "test set" of patient data in the conventional sense. Testing involved non-clinical engineering validation and verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML or diagnostic devices (e.g., expert consensus on image interpretation) is not relevant for proving the safe and effective operation of an electrosurgical unit.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic or interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" relates to objective engineering measurements (e.g., power output, safety limits, thermal effects on tissue models in a lab setting) and compliance with recognized standards, rather than clinical outcomes or pathology from patient data.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Approval Context:

The 510(k) for the Soring MBC200/BCC140 relies on demonstrating "substantial equivalence" to a predicate device (K024059) and compliance with established performance and safety standards. The "study" that proves the device meets the criteria consists of non-clinical verification and validation tests conducted against the enumerated international and national standards (e.g., ISO 10993-1, EN 60601-1-2, IEC 60601-1, EN 60601-2-2, EN ISO 14971). These tests ensure the device meets electrical safety, electromagnetic compatibility, biological compatibility, and specific performance requirements for electrosurgical equipment without raising new issues of safety or effectiveness. The standard approach for such devices does not involve clinical studies with patient data or expert read-outs in the same way an AI diagnostic algorithm would.

Ask a specific question about this device

The SONOCA Lipo is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring.

SONOCA Lipo™ is a modified version of the SONOCA 300 cleared by FDA under K992026 and can be used in two ways:

1. As an ultrasonic dissector / aspirator as in the SONOCA 300 to cut, irrigate, and suction at the surgical site and
2. As an alternative to conventional Lipectomy because it is a combination of a standard Lipectomy suction device and an Ultrasound assisted Lipectomy for the selective dissection of human fatty tissue.

The SONOCA Lipo™ can be trolley mounted or a desktop unit consisting of an ultrasonic generator, an infiltration pump and an aspiration pump. The nodular build of the electronic components allow the unit to function at a high capacity, totally free of electronic maintenance.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.

The documents are FDA 510(k) letters and summaries for the Soring GmbH Sonoca Lipo, an ultrasonic surgical instrument. They describe the device, its indications for use, and its substantial equivalence to predicate devices, but they do not contain any details regarding clinical or analytical performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.

The "Performance Data" section in {5} only states that the device has been designed and tested to pass various voluntary safety and EMC standards (e.g., UL 2601-1, EN 60601-1, IEC 950). This refers to compliance with engineering and electrical safety standards, not an evaluation of its clinical efficacy or diagnostic performance against acceptance criteria.

Ask a specific question about this device

The devices are intended to cut and or coagulate soft biological tissue with gas-enhanced coagulation during general surgical procedures.

During the use of RF surgery devices, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts. Lower RF-voltages (below 150veff) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coagulation.

Cold plasma technology using Helium gas is a very gentle method for coagulating or dissecting specific types of tissue. In contrast to conventional RF surgery, the penetration depth related to tissue damage and the electrical strain on the patient are significantly reduced (no electrical current flowing through the patient). The significantly lower peak current value (as compared to conventional spray coagulation) results in far less damage to tissue lavers immediately beneath the treatment area because constant sine-shaped currents are used.

The provided text is a 510(k) summary for the Soring GmbH CPC™ devices, an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the device itself against specific metrics.

Here's an analysis based on the information provided, highlighting what is present and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific, quantified acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) are provided in this document for the Soring GmbH CPC™ devices. The "Performance Data" section merely states that the devices use "standard data communications controls to detect errors" and comply with various electrical safety and electromagnetic compatibility standards. These are general compliance statements, not specific performance metrics against an intended clinical task.

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

This information is not provided. The document does not describe a clinical or performance test set for evaluating the device's efficacy or safety against clinical outcomes. The performance data mentioned refers to compliance with electrical and safety standards, not a study involving human or animal subjects for clinical performance.

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

This information is not provided. Since there is no described performance test set requiring ground truth, there's no mention of experts or their qualifications.

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

This information is not provided. There is no described performance test set that would require an adjudication method.

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 Soring GmbH CPC™ device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device type.

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

This information is not applicable/not provided. This device is a surgical instrument and requires human operation. It is not an algorithm, so a "standalone" algorithmic performance study is not relevant.

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

This information is not provided. As there's no described performance study for efficacy or clinical outcomes, there's no mention of ground truth types.

8. The sample size for the training set:

This information is not applicable/not provided. The device is an electrosurgical unit, not a machine learning or AI model that requires a training set.

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

This information is not applicable/not provided. As above, no training set is relevant to this type of device.

Summary of the Study and Why it Meets Acceptance Criteria (as per the document):

The "study" described in the 510(k) summary is not a clinical performance study in the way one might typically expect for a diagnostic or AI device. Instead, the "study" is a demonstration of substantial equivalence to a predicate device based on:

• Identical Indications for Use: Both the Soring GmbH CPC™ devices and the predicate devices (Söring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, MBC) are "intended to cut and or coagulate soft biological tissue with gas-enhanced coagulation during general surgical procedures."
• Similar Technology: While the Soring GmbH CPC™ devices introduce "Cold plasma technology using Helium gas," the document emphasizes its function as an "Electrosurgical conductive gas coagulation" device, which aligns with the predicate's classification (Electrosurgical, Cutting & Coagulation & Accessories). The key difference highlighted is the gentler method and reduced side effects (lower penetration depth, reduced electrical strain on patient, less damage to underlying tissue) due to constant sine-shaped currents.
• Compliance with Recognized Standards: The devices comply with a list of international and industry standards for electrical safety and electromagnetic compatibility (IEC 950, CISPR 22, IEC-801-2, IEC-801-3, IEEE 1003.1, IEC 601-1, IEC 601-2-2). These standards serve as the de facto "acceptance criteria" for the safety and foundational performance aspects of such medical devices.
• No Control of Life-Sustaining Functions: Both the new and predicate devices "do not control any life sustaining functions or services," which simplifies the regulatory assessment by reducing the perceived risk level.

Conclusion stated in the document: "Based on the information supplied in this 510(k), we conclude that the subject devices are safe, effective, and substantially equivalent to the predicate devices."

The acceptance criteria for this 510(k) submission are implicitly met by demonstrating that the device:

1. Has the same intended use as a legally marketed predicate device.
2. Has similar technological characteristics.
3. Complies with relevant electrical and safety standards.
4. Does not raise new questions of safety or effectiveness.

The "study" that proves the device meets these (implied) acceptance criteria is the comparison to the predicate device and the declaration of compliance with the listed safety standards. The FDA's letter concurs with this determination of substantial equivalence, allowing the device to be marketed.

Ask a specific question about this device

The devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures.

The Soring GmbH MBC™ Series is a monopolar and bi-polar RF surgical device for cutting and coagulation. RF Surgery is the use of high frequency alternating electrical current (frequency higher then 300 kHz) with the purpose of alteration or destruction of cells and for cutting tissue. The Soring GmbH MBC™ Series is used for tissue removal and cauterization in connection with mechanical operation techniques. The tissue cauterization and cutting effects are accomplished by a combination of heating through the electrical resistance offered by the biological tissue and through the heating of the electrode. Heat production is mainly a result of the fact that biological tissue acts as an electrical resistor for frequencies normally used during RF surgery and that as an electrical resistor biological tissue heats up when electric currents flow through. The amount of heat developed is therefore dependent on the current and the resistance of the conductor (the biological tissue) put up by the patient. From an electrical point of view, the patient is the conductor. As a result, in a closed current loop of metallic conductors and biological tissue of equal cross sectional area the biological tissue heats up significantly more. As can be seen in the table below, different biological tissue types offer a wide range of electrical resistance and thus are affected differently by the applied RF signal. The Soring GmbH MBC™ Series internal circuitry automatically senses the resistivity and adjusts the RF signal accordingly for the best results.

This 510(k) summary describes an electrosurgical device, not an AI/ML powered medical device. Therefore, much of the requested information (e.g., sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies) is not applicable to this submission.

However, I can extract the acceptance criteria and the stated "performance data" as presented for this type of medical device submission.

Acceptance Criteria and Reported Device Performance

Note: This submission focuses on compliance with established electrical safety and electromagnetic compatibility standards, which are germane to electrosurgical devices. There are no performance metrics related to diagnostic accuracy, sensitivity, specificity, or other measures typically associated with AI/ML driven devices.

Non-Applicable Information for this Device (Electrosurgical Device)

The following information is not present or not relevant to this 510(k) submission for an electrosurgical device, as it pertains to AI/ML powered medical devices:

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 not AI/ML based.
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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. There is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance is adherence to electrical and safety standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The SONOCA 180/190 is an instrument intended for selected ultrasound dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.

SONOCA 180 & 190 is a desktop unit that controls ultrasonic handpieces used in general surgery, vascular surgery, and dermatological surgery.

general bargery, vacual carget case; technologically derived from the Sonoca 300 family of units (K992026) with the same general modules (hardware and software).

During the use of this ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue and is a supplementary tool for the selective dissection of human tissue.

The provided text describes the regulatory filing for the Sonoca 180/190 ultrasonic surgical instrument, focusing on its substantial equivalence to a predicate device (Sonoca 300). However, the document does not contain the detailed performance study information typically found in an AI/Software as a Medical Device (SaMD) submission. The performance data section refers to compliance with general safety and electromagnetic compatibility standards for the device itself (hardware and software controls for error detection), not to the clinical performance of an AI algorithm in the way a diagnostic AI would be evaluated.

Therefore, many of the requested items cannot be answered from the provided text.

Here's what can be extracted and what cannot:

Acceptance Criteria and Reported Device Performance

Study Details (Information Not Available in the Provided Text for AI/SaMD Context)

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

   • Not provided. The document focuses on regulatory compliance of a hardware device with software controls, not an AI algorithm evaluated on a test set of data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. This is not an AI/diagnostic device that generates specific outputs requiring expert adjudication for ground truth.

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

   • Not applicable/Not provided. No adjudication of AI output against expert ground truth is described.

4. 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/Not provided. This is a surgical instrument, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable/Not provided. "Standalone" performance in the context of AI refers to the algorithm's diagnostic accuracy without human involvement. This document describes a surgical instrument, not an AI algorithm with such a function. The "software controls to detect errors" are part of the device's basic functionality, not an AI a standalone AI.

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

   • Not applicable/Not provided. No ground truth in the context of AI performance evaluation is mentioned. The "ground truth" for this device's performance would be its adherence to established safety and functional standards.

7. The sample size for the training set:

   • Not applicable/Not provided. This device is not described as having an AI component that undergoes a training phase with a dataset.

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

   • Not applicable/Not provided. As there's no mention of a training set for an AI component, this information is not relevant or provided.

Summary of Device and Performance Context:

The Sonoca 180/190 is an ultrasonic surgical instrument. Its "performance data" refers to its compliance with a list of regulatory and safety standards (e.g., IEC, CISPR, IEEE, DIN EN) and its functional equivalence to a predicate device (Sonoca 300) in terms of using "similar software controls to detect errors" and functioning as an ultrasonic dissector. This is a traditional medical device submission, not an AI/SaMD submission, which is why the requested details about AI performance studies are missing.

Ask a specific question about this device

The devices are intended to cut and or coagulate (soft) biological tissue with gas enhanced coagulation in ARCO models, e.g. during general surgical procedures.

ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 are an upgraded version of the ARCO MBC, ARCO MC, MBC 500 as described in K954171.

During the use of RF surgery devices, power is transmitted via an electrode in the contact zone to tissue. The active electrode then cuts or coagulates (depending upon its design and adjusted power form) the tissue. The inert gas coagulation uses an ionized beam of an inert gas (argon) to transmit the electrical energy to the tissue to achieve a coagulation effect.

The provided text is a 510(k) Summary of Safety & Effectiveness for electrosurgical devices (Soring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600). It describes an upgrade to existing devices and asserts substantial equivalence to a predicate device.

However, the document does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML-based medical devices or comparative effectiveness studies involving human readers.

The "Performance Data" section solely lists compliance with various electrical safety and electromagnetic compatibility standards, which are general safety and performance standards for medical electrical equipment, not specific clinical performance metrics related to diagnostic accuracy, a typical focus of the provided questions. It also mentions that the devices do not control life-sustaining functions.

Therefore, many of the requested details cannot be extracted from this document, as it pertains to traditional medical device approval based on substantial equivalence and adherence to general safety standards, rather than a clinical performance study with specific acceptance criteria and ground truth.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical test set or data provenance in the context of device performance. The approval is based on compliance with electrical safety standards and substantial equivalence to a predicate 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)
Not applicable. No clinical ground truth was established for a test set in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method is described.

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 device is an electrosurgical unit, not an AI-assisted diagnostic 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 traditional medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is compliance with established electrical and safety standards, and the functional characteristics of an electrosurgical device as demonstrated through engineering testing and comparison to a predicate, not clinical outcomes or expert consensus on diagnosis.

8. The sample size for the training set
Not applicable. There is no training set for an algorithm mentioned.

9. How the ground truth for the training set was established
Not applicable. No training set is involved.

Ask a specific question about this device

The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.

SONOCA 300 is an upgraded version of the SONOCA III having K9942095.

During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.

The SONOCA 300 is not an alternative to conventional surgery but a supplementary tool for the selective dissection of human tissue.

Where as the scalpel and other methods of cutting are basically limited to cutting tissue. The SONOCA 300 can be used to cut, irrigate, and suction at the surgical site.

The provided text describes a 510(k) premarket notification for a medical device called Sonoca 300, an ultrasonic surgical instrument. However, the document does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics, sample sizes for test or training sets, ground truth establishment, or details about expert involvement.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Sonoca III) by confirming the modified device's intended use has not changed and that it complies with various electrical and medical device safety standards.

Therefore, I cannot fulfill all parts of your request with the provided input. Below, I will present the information that is available based on the given text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics for the Sonoca 300. Instead, its acceptance is based on compliance with established safety and compatibility standards, and its substantial equivalence to a predicate device.

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

Not applicable. The document does not describe a performance study with a test set of data. The evaluation is based on compliance with standards and comparison to a predicate device.

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set.

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

Not applicable. The document does not describe a study involving adjudication for a test set.

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 device is an ultrasonic surgical instrument, not an AI-assisted diagnostic tool involving human "readers."

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

Not applicable. This information is relevant for AI/software devices. The Sonoca 300 is a hardware surgical instrument.

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

Not applicable. The "ground truth" for this device's regulatory acceptance is its compliance with established safety and performance standards and its substantial equivalence to a legally marketed predicate device, rather than a clinical ground truth established for diagnostic accuracy.

8. The sample size for the training set

Not applicable. The document does not describe a study with a training set for an algorithm or model.

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

Not applicable. The document does not describe a study with a training set for an algorithm or model.

Ask a specific question about this device