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510(k) Data Aggregation
(239 days)
The drive unit for surgical transmission instruments is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery
The AMADEO is an electrical drive unit, including motor, attachments and accessories, for surgical transmission attachments which is indicated for: drilling, cutting, sawing, screwing (for placement) of osteosynthesis screws, implants and plates, in soft and hard tissue. The foreseen areas of application will be: ENT (ear, nose, throat) surgery and Maxillofacial surgery. The basic function is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. Depending on the treatment, a physiological saline solution is pumped to the treatment site by a displacement pump. A single-use sterile disposable irrigation tubing set is supplied within the scope of delivery and offered as an accessory. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation/deactivation of the motor and for changing parameters e.g. program, pump state and motor direction.
This document is a 510(k) Premarket Notification from the FDA for the medical device AMADEO, an electrical drive unit for surgical transmission instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device, the NSK Primado2.
The document does not contain an acceptance criteria table or a study proving the device meets specific performance acceptance criteria in the manner one might expect for a new AI/software device submission. This is because the device, AMADEO, is an electro-mechanical surgical drill system, not an AI or software-only diagnostic device. The evaluation focuses on demonstrating its safety and effectiveness are substantially equivalent to a previously cleared device.
Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not explicitly detailed in the provided text as they would be for an AI diagnostic device.
However, based on the principle of the 510(k) submission, we can infer the "acceptance criteria" is that the device performs as intended and is as safe and effective as the predicate device. The "study that proves the device meets the acceptance criteria" is the entirety of the non-clinical testing performed to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit "acceptance criteria" in the form of performance metrics (like sensitivity, specificity, accuracy) are not provided, as this is an electro-mechanical device, not an AI diagnostic. The "acceptance" is substantial equivalence to the predicate. The performance data and technological characteristics are compared against the predicate device.
| Characteristic | Acceptance Criteria (Equivalent to Predicate) | Reported Device Performance (AMADEO) |
|---|---|---|
| Indications for Use | Equivalent to Primado2 | Drive unit for surgical transmission instruments indicated for drilling, milling, cutting, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery. (Note: Excludes neurological indications, which is noted as not impacting substantial equivalence). |
| Regulation Number | Identical to Primado2 (874.4850) | 874.4850 |
| Secondary Reg. Number | Identical to Primado2 (872.4120) | 872.4120 |
| Class | Identical to Primado2 (Class II) | II |
| Product Code | Equivalent to Primado2 | ERL, DZI (Predicate also includes GEY, HWE, HBC, DZJ, HBE, GFF, EQJ, but the core ERL, DZI are shared for the applicable uses). |
| Regulation Generic Name | Identical to Primado2 | Drill, Surgical, Ent (Electric or Pneumatic) Including Handpiece |
| Sterility | Equivalent to Primado2 (Provided non-sterile) | Provided non-sterile |
| Use | Equivalent to Primado2 (Rx only) | Rx only |
| Basic Functions | Equivalent to Primado2 | Conversion of electrical energy into mechanical rotary motion. Physiological saline solution pumped to treatment site via displacement pump. Control unit with electronics allows user to change motor speed, torque, and coolant flow rate. |
| Mains Voltage/Frequency | Identical to Primado2 (120V, 50-60 Hz) | 120 V, 50-60 Hz |
| Operating Mode | Equivalent to Primado2 | Intermittent duty S3 (load time max. 3min / rest time min. 5min). (Predicate is "intermittent duty (load/rest depending on motors used)"). |
| Foot Control | Equivalent to Primado2 | Wireless and wired options. (Predicate is wired only, but adding wireless is generally acceptable as an enhancement, not a fundamental difference in safety/effectiveness if properly validated). |
| Biocompatibility | Compliance with ISO 10993 standards | Evaluation performed according to ISO 10993-1, -10, -11, -12, -17, -18, and -23. |
| Electrical Safety/EMC | Compliance with IEC 60601 standards | In compliance with IEC 60601-1 and IEC 60601-1-2. |
| Reprocessing Validation | Per FDA Guidance Document | Validation provided per FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Cleaning/disinfection for control unit/foot controller, cleaning/sterilization for motor cable/handpieces. |
| Bench Testing | Meets device specifications | Functional testing performed to test application, settings, features, and touchscreen per device specifications requirements. |
| Software Verification | Compliance with IEC 62304 and FDA Guidance | Verification according to IEC 62304 and FDA Guidance Document for Software Contained in Medical Device; necessary software documentation for moderate level of concern provided. |
2. Sample Size for the Test Set and Data Provenance
Not applicable in the typical sense for an AI/software diagnostic. The "test set" here refers to the physical device and components undergoing bench testing, biocompatibility, electrical safety, and reprocessing validation. The provenance of this would be internal laboratory testing by the manufacturer. No patient data is involved in these types of tests for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of electro-mechanical device submission. Ground truth, in this context, would be established by engineering standards, validated test methods, and industry-accepted protocols for safety and performance (e.g., precise measurements, material analyses).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation or similar diagnostic tasks, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks. The AMADEO is a surgical drill and does not involve AI assistance for human readers/interpreters in a diagnostic context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is relevant for AI diagnostic algorithms. The AMADEO is a physical surgical device. Its software controls the device's functions, but it's not a standalone diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" for the AMADEO's performance comes from:
- Engineering Specifications and Standards: The device's design, operational parameters (e.g., motor speed, torque), electrical safety, and electromagnetic compatibility are validated against established engineering specifications and international standards (e.g., IEC 60601-1, IEC 60601-1-2).
- Biocompatibility Standards: Materials in contact with the patient are tested against ISO 10993 standards.
- Reprocessing Protocols: The ability to clean and sterilize/disinfect reusable components is validated against FDA guidance and established cleaning protocols.
- Functional Bench Testing: Verification that the device performs its intended functions (e.g., touchscreen responsiveness, motor control) according to its own design specifications.
8. Sample Size for the Training Set
Not applicable. There is no AI model being trained with a training set for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
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(87 days)
Oral Surgery Contra is for oral surgery. This device is driven by an electronic micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.
The Ti-Max Series Oral Surgery Contra handpieces, X-SG93L, X-SG93 and X-SG25L, are contra-angle handpieces that are intended for use by a clinician in a healthcare facility/hospital setting for oral surgery and preparation for dental implant operation. The subject handpieces are available in two options: 1) fiber optic glass (X-SG93L and X-SG25L) or 2) non-optic (X-SG93). The Oral Surgery Contra handpieces are driven by a micromotor, thereby rotating surgical burs at different transmission gear ratios, to cut the maxillary/mandibular bone during oral surgery and preparation for dental implant surgery. The maximum rotational speeds of the handpieces are as follows: 120,000 min-1 for the X-SG93L and X-SG93 models; 40,000 min-1 for the X-SG25L model. The maximum rotation speed depends on the transmission gear ratios as follows:
| Model | Transmission gear ratio | Maximum speed |
|---|---|---|
| X-SG93L | 1:3 Increasing | 120,000 min-1 |
| X-SG93 | 1:3 Increasing | 120,000 min-1 |
| X-SG25L | 1:1 Direct Drive | 40,000 min-1 |
| The handpieces are manufactured using titanium and stainless steel and feature a push-button chuck mechanism. They are designed for use with surgical motors with an ISO 3964 (EN ISO 3964) type coupling system. The handpieces are designed for use with surgical burs, as follows: |
- X-SG93L and X-SG93: ISO 1797 Type 3 FG burs (φ1.59 - 1.6 mm)
- X-SG25L: ISO 1797 Type 1 CA burs (φ2.334 - 2.35 mm).
The Oral Surgery Contra handpieces are a prescription-only device.
This document describes a 510(k) premarket notification for the "Oral Surgery Contra" device. It is a submission for substantial equivalence based on comparisons to predicate and reference devices, and no clinical studies were conducted that prove device meets acceptance criteria.
Here's an analysis based on the provided text:
No clinical studies were performed. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the Oral Surgery Contra." Therefore, there is no information in the provided text regarding acceptance criteria for device performance based on clinical outcomes, nor any study proving the device meets such criteria through clinical data.
The "Summary of Performance Testing" section mentions "verification/validation testing to internal functional specifications" and conformance to various ISO standards (AAMI/ANSI/ISO 17665-1:2006 for sterilization, ISO 14457:2012 for handpieces and motors, and AAMI/ANSI/ISO 10993-1: 2018 for biocompatibility). These are bench tests and evaluations, not clinical studies involving patients or expert review of clinical images/data.
Therefore, since no clinical study was performed, the following requested information cannot be provided from the text:
- A table of acceptance criteria and the reported device performance: Not applicable for clinical performance.
- Sample sized used for the test set and the data provenance: Not applicable as there was no test set from a clinical study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 mechanical handpiece, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a mechanical handpiece, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes a regulatory submission relying on substantial equivalence to predicate devices and bench testing, rather than novel clinical performance studies.
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(405 days)
Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
The Osstell Beacon is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell Beacon is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement tip on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the implant and is derived from the resonance frequency value obtained from the Smartpeg.
The provided document, a 510(k) summary for the Osstell Beacon device, does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. The document focuses on demonstrating substantial equivalence to a predicate device (Osstell ISQ K082523) by detailing technological characteristics rather than presenting a performance study with acceptance criteria.
However, based on the nonclinical testing section, it can be inferred that performance testing was conducted to confirm compliance to design specifications. Since the document claims the "Beacon performs as intended" and lists "Accuracy: ±2 ISQ units" under its specifications, we can reasonably extrapolate this accuracy as an implicit acceptance criterion.
Here's a breakdown of the requested information, with disclaimers about missing details:
1. Table of Acceptance Criteria and Reported Device Performance
Given the information, an explicit table of acceptance criteria and a detailed performance study are not provided in this 510(k) summary. However, an inferred acceptance criterion for accuracy exists:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy: ±2 ISQ units | Accuracy: ±2 ISQ units |
Note: This is an inferred acceptance criterion based on the device's stated accuracy in its specifications and the claim that performance testing confirmed compliance to design specifications. The document does not explicitly state this as an acceptance criterion from a study protocol.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Performance testing was conducted to confirm compliance to the design specifications." However, it does not provide any specific sample size for a test set or details about the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for any test set. The device likely provides direct measurements rather than relying on expert interpretation for its core function.
4. Adjudication Method for the Test Set
Since no involvement of experts in establishing ground truth or a test set is explicitly described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document states: "Clinical studies were not required to validate the modifications in the Osstell Beacon." This implies that no MRMC comparative effectiveness study was conducted. The device is a measurement tool, and the submission focuses on its equivalence to a predicate device rather than human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document indicates that "Performance testing was conducted to confirm compliance to the design specifications." The device operates as an "Implant Stability Analyzer" that provides an "Implant Stability Quotient (ISQ)" value directly. This implies a standalone performance evaluation of the algorithm's ability to accurately measure the resonance frequency and calculate the ISQ value. The "Accuracy: ±2 ISQ units" is a standalone performance metric.
7. Type of Ground Truth Used
The type of ground truth used for the performance testing is not explicitly stated but can be inferred as a reference measurement of resonance frequency or implant stability against which the device's calculated ISQ value would be compared. For a measurement device, this typically involves using a highly accurate, calibrated system or a known physical property (e.g., a standard with a known resonance frequency).
8. Sample Size for the Training Set
The document focuses on substantial equivalence and nonclinical testing. It does not mention any training set size because the device's underlying technology (Resonance Frequency Analysis and ISQ software algorithm) is based on established physical principles and is inherited from its predicate device (Osstell ISQ K082523), rather than requiring a machine learning model that needs a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set being used in the context of machine learning, there is no information on how its ground truth might have been established. The device relies on a physical measurement and algorithm, not a trainable model.
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