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510(k) Data Aggregation
(677 days)
adeor Medical AG
The Velocity Alpha™ Drill System is indicated for trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials.
Applications: Cutting, removing, shaping and sawing hard and soft tissue, bone, and bone replacement materials.
Areas of use: Neurosurgery and spinal surgery.
The Velocity Alpha™ Highspeed Surgical Drill System is an electric AC powered surgical motor drill system for rapid cutting, sawing, drilling and manipulation of soft tissue and bone.
The Subject Device has several components, such as an electric motor hand piece connected to and driven by an AC-powered control unit, a foot control unit (wired or wireless (Bluetooth)) and several adapters and nosepiece attachments, e.g. straight & angled nosepiece attachments, craniotome attachments, speed reducer attachments and sawing attachments.
The device has an optional irrigation pump that can supply irrigation through sterile tubing. Speed is variable from 1.000 RPM up to 80.000 RPM in order to adjust the speed to the surgeon's requirements. The direction of rotation can be pre-selected to the left and to the right.
The provided text describes the "Velocity Alpha Highspeed Surgical Drill System" and presents a summary of its substantial equivalence to a predicate device, including performance data. However, it does not contain a typical study design with acceptance criteria and results in the format implied by your request for "device performance" in relation to specific clinical outcomes or diagnostic accuracy.
The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance (510(k)). The "Performance data testing" section refers to engineering and functional tests rather than clinical studies or those involving expert review of diagnostic output.
Here's an analysis of the provided information based on your requested headings:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional (motor speed / torque analysis) | Torque was reached as specified | Pass |
| Temperature | Temperature was in compliance to specifications | Pass |
| Lifetime | The System functioned according to specifications | Pass |
| Noise level | The Noise level did not exceed the limit | Pass |
| Electrical Safety | Be aligned with IEC60601-1:2005 Electrical Safety | Pass |
| Electromagnetic Compatibility | Be aligned with IEC60601-1-2:2014 Electromagnetic compatibility | Pass |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify a "test set" in the context of clinical data, diagnostic images, or patient-specific results. The performance data presented are for the device itself (e.g., motor speed, temperature, electrical safety). Therefore, there is no information on sample size or data provenance in that regard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for the engineering performance tests (motor speed, temperature, etc.) would be established by technical specifications and validated measurement equipment, not by clinical experts.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication, as the tests performed are technical and do not involve subjective interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document does not describe any studies comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical drill system, not an AI algorithm or diagnostic tool. The performance tests are for the physical device's operation.
7. The Type of Ground Truth Used
The ground truth for the performance data testing was based on technical specifications and established international standards (e.g., IEC 60601-1, IEC 60601-1-2) which define acceptable limits for motor speed, torque, temperature, noise, electrical safety, and electromagnetic compatibility.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical/electrical surgical system and does not utilize a "training set" in the AI/machine learning sense.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The document describes a series of engineering and functional performance tests conducted on the Velocity Alpha Highspeed Surgical Drill System. These tests evaluated various technical aspects of the device, including:
- Motor speed and torque analysis: To confirm the motor performs within its specified range.
- Temperature analysis: To ensure the motor temperature remains within safe and specified limits during activity.
- Lifetime testing: To verify the system's durability and functionality over its expected operational lifespan.
- Noise level analysis: To confirm the noise generated by the device does not exceed specified limits.
- Electrical Safety testing: Conducted to ensure compliance with IEC 60601-1:2005, a standard for medical electrical equipment safety.
- Electromagnetic Compatibility (EMC) testing: Conducted to ensure compliance with IEC 60601-1-2:2014, a standard for EMC of medical electrical equipment.
- Wireless Foot Control testing: Included software verification/validation (IEC 62304:2006), EMC (IEC 60601-1-2:2007), and Electrical Safety (IEC 60601-1-1:2005) tests.
- Software Validation: Met requirements according to IEC 62304:2006.
- Biocompatibility testing: Performed on patient-contacting components (attachments/nosepieces) to meet ISO 10993 and EN ISO 10993-1 requirements.
Conclusion of the study: All tests "Passed," indicating that the device met its specified technical and safety acceptance criteria, demonstrating its substantial equivalence to the predicate device (Aesculap ELAN 4 Electro Motor System) based on technological characteristics, functionality, and intended use, without negative effects on safety or effectiveness. The document explicitly states "No clinical data is required for this device classification submission."
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(317 days)
Adeor Medical AG
The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600Vp.
The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
The types of surgery intended include:
- ENT
- Gynecology (except for use in female sterilization)
- Urology
- General surgery
- Neurosurgery
- Laryngeal Surgery
- Orthopedic Surgery
- Thoracic Surgery
The Adeor Medical AG Bipolar Forceps are electrosurgical instruments used to grasp, manipulate, cut or coagulate tissue. Bipolar forceps have various lengths and tip configurations, as well as irrigation and suction technologies. Both reusable and single-use forceps are available, with flat plug or two pin plug configurations. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of a high frequency generator and may be used only with bipolar coagulation current. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHz: maximum generator operating voltage 600Vn.
This FDA 510(k) summary for the "Adeor Medical nxt Non-stick Bipolar Forceps" focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.
Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this document does not contain data related to these aspects for an AI/ML product.
The document primarily discusses the physical characteristics, intended use, and non-clinical testing (electrical safety, wear, function (drop testing)) of surgical forceps, comparing them to legally marketed predicate devices to establish substantial equivalence.
The information provided in the document is about a traditional medical device (bipolar forceps), not an AI/ML device.
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(465 days)
ADEOR MEDICAL AG
HiCut™ Highspeed Instruments are surgical burs indicated for trephination, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and biomaterials in Orthopedic Surgery, Neurological and Spinal Surgery, Plastic and Maxillofacial Surgery, Arthroscopy, Sternotomy and General Surgery.
The HiCut™ Highspeed Instrument is a sterile packed, single-use cutting device with numerous tip designs and various lengths. The rear end is designed to fit in various commonly marketed surgical motor drill systems. The tip designs are similar to the commonly used tip designs.
The HiCut™ Highspeed Instrument is classified Class II (USA) (Class IIa in EU) per CFR, Part 882.4310. The HiCut™ Highspeed Instruments are simple powered burs to be inserted in pneumatic or electric powered motor drill devices.
The provided document is a 510(k) summary for a surgical bur, the HiCut™ Highspeed Instrument. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel effectiveness through clinical studies with specific performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, and AI performance metrics is not applicable to this document.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance:
This device is a surgical bur, a mechanical device. The "acceptance criteria" and "reported device performance" in this context refer to the successful completion of non-clinical performance testing confirming that the device is safe and performs as intended, demonstrating substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria (Non-clinical Performance Testing) | Reported Device Performance (Conclusion) |
|---|---|
| Biocompatibility: Evaluated in compliance with ISO 10993. | Based on the selected materials and the provided evaluation, sufficient biocompatibility can be assumed. |
| Sterility: Method of radiation complies with ISO 11137-1, 2, and 3. | The sterilization process is validated and ensures the sterility of the device throughout the shelf life and transport. |
| Sterility Assurance Level (SAL): Specific to radiation sterilization. | The sterilization process is validated and ensures the sterility of the device throughout the shelf life and transport. (Implicitly met as part of overall sterility validation). |
| Packaging Integrity: Testing to ensure packaging maintains device sterility (integrity of sealed seam according to ISO 11607) and is not adversely affected by aging (10-year artificial aging test in accordance with ASTM F 1980) or transport (drop and vibration test based on ISO13355 and ASTM D 5276-98). | The compliance with these criteria is ensured for at least the duration of shelf life. |
| Parameter Comparison (Substantial Equivalence): Comparison of geometrical conditions and critical values of the subject device and predicate devices. Materials, design, and mechanical constitution. | It can be stated that the subject devices have an equivalent rear end design, which ensures a secure fit into the corresponding drill chucks. Further qualification criteria of the subject device such as materials, design, and mechanical constitution exceed the same results as the predicate devices. Thus, the substantial equivalence and therefore, the safety and effectiveness of the subject device can be established. |
| Overall Safety and Effectiveness: Based on non-clinical tests and comparison to predicates. | The subject device is as safe, as effective, and performs as well as the predicate devices. The Highspeed Instruments proved to be substantially equivalent. The subject device described in this submission performs as intended and raises no new safety or effectiveness issues. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "Samples for each system of both the subject and predicate devices were compared" for parameter comparison. It does not specify an exact number of samples. For biocompatibility, sterility, and packaging tests, standard industrial testing protocols would have been followed, likely using a sufficient number of samples as required by the relevant ISO and ASTM standards.
- Data Provenance: The studies are non-clinical (laboratory/bench testing) and were conducted by the manufacturer, adeor Medical AG, a German company ("Kirchplatz 1, 82049 Pullach, Germany"). The document indicates the device is marketed in the European Union, suggesting testing would adhere to international standards commonly accepted in both the EU and USA. This is prospective testing related to device manufacturing.
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 is not applicable. The product is a surgical bur, a mechanical instrument. "Ground truth" in this context is established through objective performance metrics derived from laboratory testing, adherence to international standards (ISO, ASTM), and comparison to the physical and material characteristics of predicate devices, rather than through subjective expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no subjective assessment requiring adjudication. The tests (biocompatibility, sterility, mechanical parameter comparison) are objective, laboratory-based analyses against defined 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
This is not applicable. This device is a mechanical surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a mechanical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence for this type of device is:
- Objective Test Results: Data from standardized laboratory tests (e.g., biocompatibility according to ISO 10993, sterility according to ISO 11137, packaging integrity according to ISO 11607 and ASTM F 1980).
- Engineering and Material Specifications: Directly comparing the materials, design specifications, and mechanical performance characteristics of the subject device to those of the predicate devices.
- Adherence to Standards: Compliance with recognized international standards indicates that the device meets established safety and performance benchmarks.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set."
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