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SA10 Portable Controller is intended to provide power to drive SanAgile™ Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired.

SanAgile™ Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures.

The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button.

The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller consists of two interdependent devices: portable controller (Cat. # SA10) and single patient use dissector (Cat. #s SASD14, SASD23, SASD36 and SASD45). The SA10 Portable Controller is a compact portable generator and provides power to drive the dissectors for dissection, coagulation, and cutting tissues in open or laparoscopic procedures.

The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller is intended to be used by qualified medical professionals trained in the techniques and surgical procedures, such as surgeons and nurses, in hospital operation rooms. SA10 Portable Controller is also intended to be maintained by trained service or biomedical engineers and validated for cleaning and disinfection between surgeries. The Advanced Dissector is integrated with a transducer for single use; therefore, no dissector-transducer assembly is required prior to surgery.

Based on the provided 510(k) Clearance Letter, the device is the SanAgile™ Ultrasonic Surgery Advanced Portable Controller and Dissectors. This document outlines the regulatory clearance and states that no clinical data was necessary to determine the substantial equivalence of this device.

Therefore, there is no information in this document regarding:

• Acceptance criteria for performance based on clinical data.
• A study that proves the device meets the acceptance criteria through clinical performance.
• Sample sizes used for test sets.
• Number of experts used to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used (expert consensus, pathology, outcomes data).
• Sample sizes for training sets.
• How ground truth for training sets was established.

The "Non-Clinical Performance Data" section lists various non-clinical tests performed, such as biocompatibility, electrical safety, EMC, software verification and validation, dimensional verification, sterilization validation, shelf-life testing, transportation testing, ex vivo burst pressure study, and acute and chronic animal studies. These tests confirmed that the device met design inputs and performance specifications, supporting its safety and effectiveness relative to the predicate device.

In summary, the provided FDA 510(k) clearance letter for the SanAgile™ Ultrasonic Surgery Advanced Portable Controller and Dissectors does not contain the specific information requested about acceptance criteria and study data for an AI/software device, because it explicitly states that no clinical data was necessary for its substantial equivalence determination. The clearance was based on similarity to predicate devices and non-clinical performance data.

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The device is intended for use in surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.

This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside

The provided text is a 510(k) summary for the DMETEC SmarThor Ultrasonic Surgery device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria, performance metrics, and detailed study design as might be done for a novel device or AI/software.

Therefore, the following information is extracted or inferred based on the nature of a 510(k) submission for this type of device (an ultrasonic bone-cutting instrument).

Here's a breakdown of the information based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (EMS Piezon Master Surgery). The performance is reported by comparing the specifications of the SmarThor to the predicate device.

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

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. No specific "test set" of cases or patients was used for evaluating performance in the way an AI/software study would. The evaluation is based on non-clinical bench testing and comparison of specifications to a predicate device, as well as biocompatibility testing on biological samples.
• Data Provenance:
  • Non-clinical tests (biocompatibility, electrical safety, EMC, software validation): These tests would have been performed by DMETEC CO., LTD. in Korea (country of origin). These are "prospective" tests conducted specifically for this submission.

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

• Not applicable. This 510(k) does not involve expert-established ground truths for performance evaluation in the way a diagnostic AI would. The "ground truth" for compliance with standards (e.g., biocompatibility) is defined by the standard itself, and the comparison to the predicate relies on published specifications and post-market experience.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical "test set" requiring adjudication by experts.

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

• No, an MRMC study was not done. This device is a physical instrument, and its 510(k) submission relies on demonstrating substantial equivalence through technical specifications, non-clinical bench testing, and comparison with a predicate device, not through a comparative effectiveness study involving human readers and interpretations.

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

• Not applicable. This is a medical device (ultrasonic surgery instrument), not an AI algorithm. Its performance is inherent in its physical and electrical characteristics.

7. The Type of Ground Truth Used

• For non-clinical tests (biocompatibility, electrical safety, EMC): The ground truth is established by the requirements and methodologies defined in the cited international standards (e.g., ISO 10993-5:2009, IEC 60601-1, IEC 60601-1-2).
• For comparison to the predicate: The ground truth is the published technical specifications and intended use of the legally marketed predicate device (EMS Piezon Master Surgery), as well as its established safety and effectiveness through "post-market experience."

8. The Sample Size for the Training Set

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

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

• Not applicable.

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A device intended for use surgical procedure Including osteotomy, osteoplasty, Periodontal surgery and implantation

This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside

Here's an analysis of the provided text regarding the acceptance criteria and study for the DMETEC Ultrasonic Surgery Machine:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (EMS Piezon Master Surgery) rather than defining explicit, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly met by showing that the DMETEC device is "similar in functions and efficiency" and has "similar specification and performance" to the predicate.

Here's a table comparing the DMETEC device's reported performance against the predicate, which serves as the de facto "acceptance criteria" through substantial equivalence:

Note: The differences, particularly in supply voltage and output power, are acknowledged, but the submission argues for substantial equivalence based on the overall functional similarity and safety.

Study Information

The document does not describe a classic clinical study with an explicit test set and detailed performance metrics as one might expect for novel technology. Instead, it relies on demonstrating substantial equivalence through non-clinical testing and comparison to post-market experience of the predicate device.

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

   • No specific sample size for a clinical "test set" is mentioned in the context of device performance evaluation.
   • Data provenance: The document mentions "post market experience" of the predicate device. This suggests retrospective data from the market performance of the EMS Piezon Master Surgery. No specific country of origin is mentioned for this "post market experience."

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

   • Not applicable. There is no mention of a defined "test set" requiring expert ground truth establishment for clinical performance.

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

   • Not applicable, as no clinical test set requiring adjudication 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. This device is a surgical instrument, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers" improving with/without AI are not relevant.

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

   • Not applicable. This is a physical surgical instrument, not an algorithm.

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

   • The "ground truth" for substantial equivalence appears to be derived from documented performance and safety records of the predicate device (EMS Piezon Master Surgery), as well as compliance with recognized standards (IEC 60601-1, ISO 10993). For biocompatibility, lab tests (in vitro cytotoxicity, skin sensitization, oral mucosa irritation) served as the basis for assessing safety.

7. The sample size for the training set:

   • Not applicable. As this isn't an AI/machine learning device, there is no "training set."

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

   • Not applicable, for the same reason as above.

Summary of Non-Clinical Tests Conducted:

• Biocompatibility Tests:
  • In vitro cytotoxicity test (ISO 10993-5 criteria: evaluated as Grade 0, no cell lysis or toxicity).
  • Skin sensitization test (scores were zero, 0% sensitization rates at 24 hours).
  • Oral mucosa irritation test (no mortality, no body weight changes, no differences between saline and test group).
• Electric Safety and Electromagnetic Compatibility:
  • Tested according to EN 60601-1 and IEC 60601-1-2. Device met the requirements.
• Software Validation:
  • A software validation report indicated the device "performs as it should" and is substantially equivalent.

Overall Conclusion of Studies:

The manufacturer concludes that the DMETEC Ultrasonic Surgery Machine (Surgy Star, AIC Surgery) is substantially equivalent to the predicate device based on:

• Similar intended use.
• Similar specifications and performance, despite some numerical differences (e.g., output power).
• Successful completion of non-clinical tests (biocompatibility, electrical safety, electromagnetic compatibility, software validation) demonstrating safety.
• Comparison to the post-market experience of the predicate device to infer similar functions and efficiency.

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The ARTeotomy Ultrasonic surgery system (OP1) uses piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal soft tissue trauma. The system is supplied with sharp, smoothing and blunt insert tips for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Piezo tips come in various shapes and forms (BS-OTI, BS-OT3, BS-OT5 etc.) and are designed to generate a vibrating frequency of 26-32 kHz

The ARTeotomy Ultrasonic Surgery System (OM1) uses magnetostrictive ultrasonic technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The system is supplied with sharp, smoothing and blunt insert for dental oral surgery use, including implantology, periodontal surgery and surgical orthodontics. Inserts come in various shapes and forms (ART-AS, ART-LH, ART-LV etc.) and are designed to generate a vibrating frequency of 24.5 kHz.

Not Found

I am sorry, but the provided text is a 510(k) summary letter from the FDA to Bonart Company, Limited, regarding their Bonart-ARTeotomy Ultrasonic Surgery System. It details the FDA's determination of substantial equivalence for the device based on its indications for use.

This document does not contain any information about acceptance criteria, device performance tables, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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Ask a specific question about this device