Search Results
Found 11 results
510(k) Data Aggregation
(248 days)
MEDICON, E.G.
The Medicon Mogen Circumcision Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child.
The Medicon Mogen Circumcision Clamp is a stainless steel, reusable circumcision clamp consisting out of multiple components, including clamp and locking bar. For safety reasons the lock screw of the clamp is fixed with a spot welding point in order not to become loose. For safety reasons the clamp opens to a maximum of 2.5 mm, in order not to trap the glans and the edges of closing area are chamfered and rounded inside and outside to avoid injuries
The provided text describes a Medical Device: Medicon Mogen Circumcision Clamp, which is a reusable stainless steel instrument used to compress the foreskin of the penis during circumcision of a male infant or child.
Here's an analysis of the acceptance criteria and supporting study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Medicon Mogen Circumcision Clamp) |
|---|---|---|
| Material | Stainless Steel Standards | Complies with ASTM F 899-09 and ISO 7153-1 (Standard Specification for Stainless Steels for Surgical Instruments). |
| Corrosion Resistance | Corrosion Standards | Complies with ASTM F 1089-10 and ISO 13402 (Standard Specifications for resistance against corrosion and autoclaving of Surgical Instruments). All components are corrosion resistant. |
| Sterilization | Sterilization Validation | Sterilization validation performed (though non-sterile upon supply, intended for autoclave steam sterilization by user). Demonstrated substantial equivalence in sterilization. |
| Mechanical Performance | Mechanical Performance Testing | Performance testing mechanical characteristics performed. Jaws designed to separate to a maximum of 2.5 mm in open position. Locks with a defined closing force. Lock screw fixed with a spot welding point. Demonstrated substantial equivalence in mechanical performance. |
| Design/Safety | Design Features | Opens to a maximum of 2.5 mm (to not trap glans). Edges of closing area are chamfered and rounded inside and outside (to avoid injuries). Lock screw fixed with spot welding (not to become loose). |
| Intended Use | Consistent with Predicate | Identical to predicate device: "an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child." |
| Operating Principle | Consistent with Predicate | Identical to predicate device. |
Regarding the study that proves the device meets the acceptance criteria:
The document describes a non-clinical laboratory study comparing the Medicon Mogen Circumcision Clamp to a predicate device (T. S. Medical Circumcision Clamp, K033403) to establish substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "sample size" in the context of human subjects or a clinical test set. The testing performed was non-clinical laboratory testing on the device itself.
- Data Provenance: The data provenance is from non-clinical laboratory tests conducted on the Medicon Mogen Circumcision Clamp, likely at the manufacturer's facility or a contracted lab. The country of origin of the device manufacturer is Germany (MEDICON eG). This was a laboratory study, not a human study, so terms like "retrospective or prospective" are not directly applicable in the typical clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was a non-clinical laboratory study involving material and mechanical performance testing, not human-centered data requiring expert ground truth for diagnostic accuracy. Standards (ASTM, ISO) served as the "ground truth" for material and performance specifications.
4. Adjudication method for the test set
- Not applicable. As this was a non-clinical laboratory study, there was no adjudication method involving expert review of results in the traditional sense of a clinical outcome. Compliance with established engineering and material standards determined acceptance.
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 a medical instrument, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests was established by recognized international and national standards for surgical instruments and materials:
- ASTM F 899-09 (Standard Specification for Stainless Steels for Surgical Instruments)
- ISO 7153-1 (Surgical instruments — Metallic materials — Part 1: Stainless steel)
- ASTM F 1089-10 (Standard Specification for Wrought Stainless Steels for Surgical Instruments Used in the Body)
- ISO 13402 (Surgical instruments — General aspects including safety, marking and information provided by the manufacture)
8. The sample size for the training set
- Not applicable. This was not a machine learning or AI algorithm development; therefore, there was no "training set." The device itself was tested directly against established physical and material standards.
9. How the ground truth for the training set was established
- Not applicable. (See point 8. above). The "ground truth" for the acceptance criteria was based on compliance with industry standards, not a training set.
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(443 days)
MEDICON, E.G.
The Medicon FIXIT head rest system is designed to provide stabilization and rigid fixation of patient's skull during surgical operations. It is indicated for neurosurgical operative procedures.
The Medicon Fixit Head Rest System is made from one part, not 2 parts as the competitors systems. The Medicon clamp is designed to prevent closing by accident. The pistol handle with safety lock allows the surgeon a one-hand-use of the clamp. Furthermore, the movable parts are reduced to a minimum. The locking mechanism can be loaded with more than 90 kg.
There is a variety of pin holders available. The choice of pin holders very much depends on the preference of the surgeon, the clinical indication and the type of position of the skull.
The pins are made from Titanium and stainless steel and are delivered nonsterile. The pins are re-usable. At the pistol grip side there is a pressure indicator. By turning the screw the surgeon fixes the skull with a fineadjustment.
Hydraulicus allows via a foot pedal to open and close the connector between the head rest clamp and the operating table which enables the surgeon to manipulate the head rest and / or the patient's head manually and at the same time open and close the locking mechanism with the foot peal.
The base unit is connected to the operating table. As the base unit is equipped with a quick coupling, it may be adapted easily and fast to any operating table.
The provided text describes a 510(k) submission for the Medicon Fixit Headrest System, which is a device for neurosurgical head stabilization. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, rather than comprehensive de novo clinical studies to prove acceptance criteria based on specific performance metrics.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance data, or training set information.
Instead, the submission relies on the following for demonstrating safety and effectiveness:
1. Table of "Acceptance Criteria" (Implied) and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for novel performance metrics akin to a new drug or efficacy study are not defined. Instead, the "acceptance criteria" are implied by the performance and characteristics of the predicate devices. The "reported device performance" focuses on demonstrating similar functionality and safety characteristics.
| Acceptance Criteria (Implied by Predicate Devices) | Reported Medicon Fixit Headrest System Performance |
|---|---|
| Material Composition: Use of biocompatible and robust materials for patient contact. | Patient contact material for all Headrest Systems consists of titanium or stainless steel. Contact device are the skull pins. |
| Design and Functionality: Ability to provide stabilization and rigid fixation of the patient's skull; similar components (pins, holders, frame). | The Medicon Fixit Headrest System provides stabilization and rigid fixation of patient's skull during surgical operations. The design is very similar between the systems, consisting of skull pins, skull pin holder and Headrest frame. The Medicon design offers a quick lock, a variety of Skull pin holders, and a one-part Headrest frame (compared to two-part competitor systems). It prevents accidental closing, has a pistol handle with safety lock for one-hand use, and reduced movable parts. The locking mechanism can be loaded with more than 90 kg. A pressure indicator allows fine adjustment. Hydraulicus allows foot pedal operation for opening/closing connector between headrest clamp and operating table, enabling manual head manipulation and locking mechanism control. The base unit connects to operating tables with a quick coupling. |
| Safety: Does not raise new safety issues; robust locking mechanism. | The Medicon clamp is designed to prevent closing by accident. The pistol handle has a safety lock. The locking mechanism can be loaded with more than 90 kg. The submission asserts that "the Medicon FIXIT Headrest System is substantially equivalent to the commercially marketed predicate device and does not raise new issues of safety and effectiveness." and "The handling of the Medicon Fixit Headrest System is identical or substantially equivalent to the other commercially available headrest systems. The slight differences in design and size do not adversely affect the safety and effectiveness of this device." |
| Effectiveness: Ability to perform the intended use during neurosurgical operations. | "The Medicon FIXIT head rest system is designed to provide stabilization and rigid fixation of patient's skull during surgical operations. It is indicated for neurosurgical operative procedures." This is directly stated as the intended use, implying effectiveness in this role. |
| Compliance with Standards: Adherence to relevant quality management and medical device standards. | The Medicon's Fixit Headrest System is manufactured in accordance with the MDD 93/42 EEC, ISO, and German DIN Standards. Medicon e.G. has received EN ISO 13485 - 2003 certification. |
2. Sample size used for the test set and the data provenance
The document does not describe a test set or any specific study that involved a sample size of patients or data collected from patients. This is a 510(k) summary focused on engineering specifications and comparison to predicate devices, not clinical performance data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set involving ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable. No test set involving adjudication 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 a mechanical headrest system, not an AI-assisted diagnostic or therapeutic tool, so MRMC studies involving human readers and AI are irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm, so standalone performance in this context is irrelevant.
7. The type of ground truth used
Not applicable. No ground truth based on pathology, outcomes data, or expert consensus from clinical cases is mentioned or required for this type of submission focused on substantial equivalence of a mechanical device. The "ground truth" for this submission would essentially be the validated performance and safety of the predicate devices.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a mechanical device.
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(201 days)
MEDICON, E.G.
The Medicon Stern-a-Fix Sternal Closure System is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
The Medicon Stern-a-Fix Stermal Closure System consists of titanium plates and 2.4 mm locking and standard bone screws, as well as 2.7 mm emergency screws. All 2.4 mm screws are self- drilling, i.e., a predrilled hole is not required, but may be used if desired. Screws are provided in lengths from 7-15 mm.
The plates are affixed to the sternum using the screws. They include thinner horizontal sections to facilitate quick re-entry.
The provided text describes a medical device, the Medicon Stern-a-Fix Sternal Closure System, and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any AI/software performance.
Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices. The "study" mentioned is a comparative fixation strength study against cerclage wire.
Here's an analysis based on the information provided, explicitly stating where information is missing for your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fixation Strength: | "Significantly greater stability was recorded for the Medicon Stern-a-Fix sternal closure system in all regions of the sternum, particularly at the xyphoid" compared to cerclage wire. |
| (Specific quantitative thresholds for "significantly greater stability" are NOT provided.) | (No specific numerical performance metrics are provided for the Stern-a-Fix system itself beyond the comparative statement.) |
| Biocompatibility: | (Not explicitly mentioned, but implied by material (titanium) and regulatory class. Detailed acceptance criteria and performance data are not in this summary.) |
| Mechanical Properties (e.g., fatigue, tensile strength of components): | (Not explicitly mentioned. These would typically be part of a comprehensive device submission but are not detailed in this summary.) |
| Clinical Outcomes (e.g., reoperation rate, infection rate): | (Not mentioned. The study referenced is a biomechanical comparison, not a clinical outcomes study.) |
| Intended Use Equivalence: | "The Medicon Stern-a-Fix Sternal Closure System is the same as the predicate devices in indicated use, method of rigid bone fixation, operating principle and materials." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document references a study by "Dasika et al" titled "Lower Sternal Reinforcement Improves the Stability of Sternal Closure." However, the sample size for this study is not provided in the given text.
- Data Provenance: Not specified. It's unclear if the study was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" here relates to biomechanical fixation strength, not diagnostic interpretations from experts. The study likely involved physical testing or simulations, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. This refers to expert consensus in diagnostic studies, which is not what was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This document does not describe a MRMC study or any study where human readers' performance with/without AI assistance was evaluated. The device is a surgical implant, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not applicable. The device is a physical surgical implant, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for the comparison was biomechanical fixation strength (stability) in a model of a sternum, rather than expert consensus, pathology, or outcomes data. This would typically involve objective measurements from mechanical testing.
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI algorithm that requires a training set. The term "training set" is generally used in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no AI algorithm or training set for this physical device.
Summary of Device and Evidence:
The Medicon Stern-a-Fix Sternal Closure System is a physical metallic bone fixation appliance. Its regulatory clearance is based on substantial equivalence to existing predicate devices for its intended use (stabilization and fixation of anterior chest wall fractures). The primary "proof" cited in this 510(k) summary regarding performance is a biomechanical comparison study ("Dasika et al") which found that the Stern-a-Fix system provided "significantly greater stability" than cerclage wire for sternal closure. This study is primarily focused on the physical performance (fixation strength) of the device, and not on diagnostic accuracy, AI performance, or clinical outcomes as might be seen for software or diagnostic devices.
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(111 days)
MEDICON, E.G.
The Medicon IMF Orion Screws are intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla, mandible or both.
The MEDICON IMF-Orion Screws are available in different lengths. Threadlengths within the range of 10.0, 12.0, 14.0 mm and 16.0 mm. The diameter of the shafts is 2.0 mm. The head shape is in a diameter of 4.0 mm. It is grooved for fastening of wires and rubber bands. For a self-retaining fit to the blade the top is tapered inner hexagonal. The screws are manufactured of Ti6Al-4V according to ASTM F 136-02a. The MEDICON IMF-Orion Screws provide temporary occlusal and fracture stabilization which can be achieved within a matter of minutes. These screws may be applied prior to or after exposure of the fracture.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies.
It is important to note that the provided document is a 510(k) premarket notification for a medical device (MEDICON IMF-Orion Screws). For such devices, particularly those claiming substantial equivalence, the focus is often on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices, rather than establishing new acceptance criteria through novel clinical studies with specific performance metrics akin to diagnostic AI.
The document primarily relies on comparisons to predicate devices and literature references rather than reporting specific performance metrics from a dedicated study against pre-defined acceptance criteria.
Acceptance Criteria and Study Details for MEDICON IMF-Orion Screws
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "acceptance criteria" are implied by the substantial equivalence criteria to predicate devices and the favorable safety and effectiveness profile reported in the cited literature. The device performance is primarily described in terms of its characteristics and consistency with known safe and effective practices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Serve as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures. | Yes. The MEDICON IMF-Orion Screws have the same intended use as predicate devices. (Page 2, 2.7 & Page 3, 2.13) |
| Material Composition: Manufactured from biocompatible and strong material suitable for bone implantation. | Ti6Al4V according to ASTM F 136-02a. This is identical to several predicate devices, with one predicate using 316-L, though the document emphasizes the primary material. (Page 1, 2.6 & Page 3, 2.13) |
| Design Characteristics: Functional screw design (e.g., self-tapping/self-drilling, appropriate thread lengths, head shape for gripping). | Various lengths (10, 12, 14, 16 mm). Diameter of shafts: 2.0 mm. Head diameter: 4.0 mm, grooved for wires/rubber bands, tapered inner hexagonal. Self-retaining fit to the blade. Self-tapping & self-drilling function. These characteristics are described as very similar to SE (Substantially Equivalent) devices, with slight differences in size and specific thread functions not adversely affecting safety/effectiveness. (Page 1, 2.6 & Page 2, 2.9 & Page 3, 2.13) |
| Sterilization Method: Effective sterilization validated to appropriate standards. | Steam Sterilization to SAL of 10^-6. Specific cycle: 3 times pre-vacuum, 132° C, holding time 4 minutes (full cycle), drying time 10 minutes. Validated according to ISO 14937:2000. This is consistent with predicate devices. (Page 3, 2.13) |
| Safety and Effectiveness: Demonstrate comparable safety and effectiveness to predicate devices. | Clinical results of the MEDICON IMF-Orion Screws made out of Titanium Alloy (Ti6Al4V) and manufactured after ASTM F136-02a have shown their safety and effectiveness. This is supported by three cited literary references. "The results of design validation and clinical testing raise no new issues of safety and effectiveness." (Page 2, 2.10 & 2.12) The differences in design and size do not adversely affect safety and effectiveness. (Page 2, 2.12) |
| Compliance with Industry Standards: Adherence to relevant manufacturing, packaging, and sterilization standards. | Certifies compliance with required ISO/EN/ASTM and other device-related standards. (Page 2, 2.11) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of a prospective clinical trial with a defined number of subjects. The document refers to "clinical results of the MEDICON IMF-Orion Screws" but does not quantify the number of patients or cases.
- Data Provenance: The device is German (Medicon eG, Tuttlingen, GERMANY D-78532). The clinical evidence cited is from "German Literature" (OP-Journal 2003, Die FAMI-Schraube...) and "Literature Addenbrooke's NHS" (UK). This suggests data originating from Germany and the UK. The studies appear to be retrospective literature reviews rather than new prospective trials for this specific submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified. The document relies on published clinical literature.
- Qualifications of Experts: The literature cited would have been authored by medical professionals (surgeons, oral and maxillofacial surgeons, etc.) based on their clinical experience and observations. However, their specific qualifications (e.g., years of experience, subspecialty) are not detailed in this 510(k) submission.
4. Adjudication Method for the Test Set
- No explicit adjudication method is mentioned, as this is not a study involving expert consensus on cases. The evidence is derived from existing clinical literature, where the "ground truth" would be established by the standard clinical diagnostic and outcome assessment practices described within those publications.
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
- No, an MRMC comparative effectiveness study was not done. This device is a surgical implant, not an AI-powered diagnostic tool. Therefore, a study of "human readers improving with AI" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone performance study (algorithm only) was not done. This device is a physical surgical screw, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" is based on clinical outcomes reported in medical literature concerning the safety and effectiveness of similar IMF screws, specifically those made of Ti6Al4V according to ASTM F136-02a. This implies successful temporary fixation, bone stabilization, and absence of adverse events as assessed by clinical professionals in real-world settings over time.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve an AI algorithm with a distinct "training set." The assessment is based on existing predicate device performance and published clinical experience with similar materials and designs.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, there is no ground truth established for one.
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(86 days)
MEDICON, E.G.
The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.
The Medicon 2.4 Mandibular Reconstruction Plating System includes titanium plates, titanium alloy Star*Grip screws, templates and accompanying instruments and accessories. Plates are 2.5 mm thick and include flat and preformed straight, angled, and full mandible configurations in lengths from 6 screw holes to 29 screw holes. Plates can accept 2.4 mm diameter locking screws or standard, non-locking 2.4 mm and 2.7 mm diameter bone screws. All screws are self-tapping. The 2.7 mm diameter screws can also be used as emergency screws.
The device is supplied non-sterile and must be sterilized prior to use. Moist heat sterilization is recommended.
Instruments and accessories available are: screwdrivers, screw holding forceps, twist drills, drill guide, cheek retractor with drill guide and trocar, plate bender, plate bending forceps, plate bending pliers, cutting lever, plate holding forceps, plate cutting forceps, tap, templates, storage and sterilization trays for implants and instruments.
This looks like documentation for a medical device (a mandibular reconstruction plating system) and not an AI/ML powered medical device. Therefore, the concepts of "acceptance criteria," "study," "sample size," "ground truth," "expert consensus," "training set," and "MRMC comparative effectiveness study" are not applicable in the context of AI/ML.
The provided document, K043297, is a 510(k) summary for the Medicon 2.4 Mandibular Reconstruction Plating System. It details the device description, intended use, and claims substantial equivalence to a previously cleared device (K951689). The FDA's review confirms this substantial equivalence.
Instead of an AI/ML study, the document focuses on regulatory compliance for a physical medical device. The "acceptance criteria" here would be established by the FDA's regulatory framework for medical devices, specifically demonstrating substantial equivalence to a predicate device.
Key points from the document relevant to its clearance:
- Device Description: The system includes titanium plates, titanium alloy Star*Grip screws, templates, and instruments. Plates are 2.5 mm thick, come in various configurations, and accept 2.4 mm or 2.7 mm screws. The device is supplied non-sterile.
- Intended Use: Used for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts in emergency and non-emergency situations.
- Substantial Equivalence: The Medicon 2.4 Mandibular Reconstruction Plating System is substantially equivalent to the Medicon Titanium Mandibular Reconstruction System (K951689) with modifications in plate material, thickness, screw holes, and expanded product lines for plates, screws, and instruments.
The FDA's letter (pages 2-3) confirms the substantial equivalence determination, allowing the device to be marketed. This regulatory process does not involve the type of acceptance criteria or studies typically associated with AI/ML device performance.
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(77 days)
MEDICON, E.G.
The Medicon VIPAIR high speed system is specially designed for cutting and drilling of cranial and spinal bones in the Neurology. Thanks to a wide variety of working attachments and tools, the Medicon pneumatic high speed system "VIP AIR" can be also used in the ENT and Orthopaedics.
The Medicon VIPAIR pneumatic high speed system is specially designed for cutting and drilling of cranial and spinal bones. This system combines security and precision in an ergonomic design. The latest technology allows a reduction of the noise level to a minimum. The System consists of a small handpiece motor, a motor air tube, a foot control, a wall air tube, various hand pieces, craniotoms , burs, drills and cutters. The system components connect to each other via a safety coupling mechanism.
The provided document is a 510(k) Summary for the Medicon VIPAIR Pneumatic High Speed System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those specific criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, human reader studies, and training data is not present.
However, I can extract information related to the comparison with predicate devices, which serves as a form of "acceptance criteria" in the context of 510(k) submissions, as the device must be shown to be substantially equivalent.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
In a 510(k) submission, "acceptance criteria" are typically defined by demonstrating substantial equivalence to existing legally marketed predicate devices. The performance is assessed by comparing key characteristics.
| Characteristic / "Acceptance Criteria" | Medicon VIPAIR System Performance / Comparison |
|---|---|
| Intended Use | YES (Used for same clinical applications as predicates in Neurology, ENT, Orthopaedics) |
| Methods of Sterilization / Sterility Status | YES (Steam Sterilization (DIN 58953-9); non-sterile upon delivery, requiring user reprocessing) |
| Material (Patient Contact) | YES (Surgical stainless steel, as per DIN ISO 7153-1) |
| Motor (Operation) | YES (Pneumatic power source, foot pedal control for speed) |
| Motor (Speed - RPM) | 100,000 RPM (Comparable to predicates ranging from 80,000 to 95,000 RPM) |
| Pressure (Operating PSI) | 90-120 PSI (Comparable to predicates ranging from ~20 to 150 PSI) |
| Handpieces and Accessories | YES (Includes straight and curved handpieces, craniotoms, burs, drills, and cutters, similar to predicates) |
| Industry Standards (MDD 93/42 EEC) | YES (Class IIA product, CE Certificate) |
| Company Certification (ISO 9001:2000 or EN ISO 13485-2003) | YES |
| German Medical Product Law (MPG) | YES |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A): This document describes a 510(k) submission focused on substantial equivalence to predicate devices, not a clinical study with a "test set" in the traditional sense of evaluating a novel algorithm or diagnostic performance. Instead, it relies on comparative analysis of technical specifications and intended use against existing devices. There is no mention of a "test set" or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A): As explained above, there is no "test set" or "ground truth" to be established by experts in the context of this 510(k) submission. The evaluation is based on comparing device specifications and regulatory compliance.
4. Adjudication method for the test set:
- Not applicable (N/A): No test set or expert adjudication 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:
- No, not done: This is a pneumatic surgical drill system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and not described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, not done: This is medical hardware (a pneumatic drill system), not a standalone algorithm.
7. The type of ground truth used:
- Not applicable (N/A): No "ground truth" as typically defined in diagnostic studies (e.g., pathology, outcomes data, expert consensus) is used here. The "truth" for this 510(k) submission is the existence and regulatory status of predicate devices with similar characteristics and the device's conformance to established industry standards and its own specifications.
8. The sample size for the training set:
- Not applicable (N/A): This document does not describe the development or evaluation of an algorithm or AI model, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable (N/A): As there is no training set, this information is not relevant or provided.
In summary: The provided document is a regulatory submission for a pneumatic surgical drill, demonstrating substantial equivalence to existing devices. It is not a study evaluating acceptance criteria for a novel diagnostic or AI-powered medical device. Therefore, many of the requested details about studies, sample sizes, ground truth establishment, and expert involvement are not pertinent to this specific document or type of device.
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(72 days)
MEDICON, E.G.
The Aarhus Anchorage System is intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
The Aarhus Anchorage System consists of 9.6 mm to 12.2 mm in length, non-sterile, single-use titanium screws designed to aid in dental movement by providing a rigid skeletal fixation point. The "self-drilling" thread design allows for easy insertion and removal - with the use of the system`s Grip Screwdriver Replaceable F Aarhus Screw Octagonal and Blades.
This is a 510(k) summary for the Aarhus Anchorage System. A 510(k) is a premarket submission made to 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 process does not typically involve detailed clinical studies with acceptance criteria as would be found in a PMA. Instead, it relies on demonstrating equivalence to existing devices.
Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, or clinical performance data against specific metrics.
The document focuses on:
- Device Description: The Aarhus Anchorage System consists of non-sterile, single-use titanium screws (9.6 mm to 12.2 mm long) designed to aid in dental movement by providing a rigid skeletal fixation point.
- Intended Use: To serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after treatment.
- Substantial Equivalence Claim: The device claims substantial equivalence to:
- Medicon eG, Micro Titanium Plate System (for material)
- KLS Martin L.P., Ortho Anchorage System (for application and function)
In summary, a 510(k) notification does not typically present a study with acceptance criteria in the manner you've outlined. The FDA's determination of "substantial equivalence" is the primary "acceptance criterion" for a 510(k) device.
If this were a different type of submission (e.g., a PMA, or a more recent 510(k) for a novel device that requires performance data), then the detailed study information would be present. Based only on the provided text, I cannot answer the specific points about acceptance criteria and study details.
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(128 days)
MEDICON, E.G.
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(128 days)
MEDICON, E.G.
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(168 days)
MEDICON, E.G.
The Servotronic EC 100 System is intended to be used for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures including maxillofacial surgery, ENT surgery, orthopedic surgery, plastic surgery, dental surgery and neurosurgery.
The Servotronic EC 100 System's primary components are: (1) a control unit with irrigation pump; (2) a micromotor; (3) a foot switch for remote control; and (4) various hand pieces and tools. The hand pieces to be used with the Servotronic EC 100 System include the following: (1) Sachse Micro Oscillating Saw; (2) Sachse Micro Osseoscalpel Saw; (3) Micro Compass Saw; (4) Steinhauser Mucotome; (5) Micro Sagittal Saw; and (6) Hauenstein Angular Screwing Instrument.
The Servotronic EC 100 requires an AC current of 110V or 230/240V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is connected to the back of the control unit. The Servotronic EC 100 has integrated safety and monitoring functions for excess temperature, current limitations within the main supply circuit and within the motor electronics, and a speed-dependent stop used during a change of direction.
This 510(k) submission for the Servotronic EC 100 provides a summary of its characteristics and states its substantial equivalence to a predicate device, but it does not include any acceptance criteria or the results of a study designed to prove the device meets such criteria.
The document is a premarket notification (510(k)) which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study against predefined acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from this document. The sections you asked for, such as sample size, ground truth, expert qualifications, and specific study types (MRMC, standalone), are typically found in clinical or performance testing reports, which are not part of this 510(k) summary.
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