(343 days)
The SIS Sinus Implant Stabilizer is intended to provide a fixed anchorage point to stabilize dental implants in the sinus region, enabling sinus augmentation and implantation to be carried out in one session.
The SIS Sinus Implant Stabilizer consists of a titanium plate provided with 3 large perforations for screw fixation of implants for premolars and first molars. It may be additionally secured in place with titanium microscrews and is provided in two sizes for use with different implant systems.
This appears to be a 510(k) premarket notification for a medical device called the "SIS Sinus Implant Stabilizer." This type of document is a submission to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
Unfortunately, the provided text does not contain specific acceptance criteria, detailed study designs, or performance metrics in the way you've outlined for a clinical study proving a device meets acceptance criteria. Instead, it states:
"Performance Data: Testing was performed to support substantial equivalence to the predicate devices. The SIS Sinus Implant Stabilizer met all specified design and performance requirements."
This is a general statement indicating that the device passed internal testing to support its substantial equivalence claim, rather than a detailed report of a study designed to evaluate its performance against pre-defined acceptance criteria with specific metrics.
Therefore, I cannot fill in the table or answer most of your detailed questions based solely on the provided text. The 510(k) summary typically doesn't include the granular details of performance testing or clinical studies unless they are novel or significant. The focus here is on demonstrating equivalence to existing predicate devices.
Here's what I can extract and state based on the provided text, and where information is missing:
Acceptance Criteria and Device Performance (Based on provided text)
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Mechanical Strength) | Reported Device Performance (Value/Range, Confidence Interval) | Basis for Acceptance (e.g., clinical need, predicate device performance) |
|---|---|---|
| General Statement of Meeting Requirements | Met all specified design and performance requirements. | Substantial equivalence to predicate devices (which implies similar safety and effectiveness). |
| Specific mechanical/biocompatibility criteria | Not detailed in this summary | Not detailed in this summary |
Detailed Study Information (Based on provided text)
-
A table of acceptance criteria and the reported device performance
- As noted above, the document only states that the device "met all specified design and performance requirements." It does not provide a table with specific quantitative acceptance criteria (e.g., specific tensile strength, fatigue life, or biocompatibility pass/fail criteria) nor detailed performance values.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified, but likely from Mondeal Medical Systems GmbH in Germany given their address.
- Retrospective/Prospective: Not specified.
-
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. This device is a physical implant. Performance testing would likely involve bench testing (mechanical, material, biocompatibility) rather than expert-established ground truth on a 'test set' in the context of diagnostic AI.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
-
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. This is a physical medical implant device, not an AI/diagnostic software.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical implant device, not an AI/diagnostic software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical sense for an AI/diagnostic device. Performance was assessed against design and performance requirements (e.g., mechanical properties, biocompatibility). The "ground truth" is that the device must meet these engineering and regulatory specifications.
-
The sample size for the training set
- Not Applicable. This is a physical medical implant device; it does not involve a "training set" in the context of machine learning.
-
How the ground truth for the training set was established
- Not Applicable. See point 8.
Conclusion based on provided text:
The provided 510(k) summary is for a physical medical implant (SIS Sinus Implant Stabilizer). The performance data section broadly states that "Testing was performed to support substantial equivalence to the predicate devices. The SIS Sinus Implant Stabilizer met all specified design and performance requirements." This indicates that the device underwent necessary engineering and possibly biological testing (e.g., biocompatibility) to demonstrate its safety and effectiveness, likely by meeting recognized standards and internal specifications similar to its predicate devices. However, the document does not elaborate on the specific acceptance criteria, quantitative results, or detailed study designs that would typically be found in a clinical study report for a diagnostic AI device.
{0}------------------------------------------------
JUL 3 0 2007
Image /page/0/Picture/1 description: The image shows a handwritten expression that appears to be a mathematical or symbolic notation. The expression includes the number 1, followed by a symbol that resembles a stylized '8' or a loop, and then the number 2. A horizontal line is drawn beneath the entire expression, possibly indicating a fraction or some other mathematical operation.
MONDEAL
MEDICAL SYSTEMS GMBH
Postfach 4741 78512 Tuttlingen Telefon (0 74 61) 9 33 20 Telefax (0 74 61) 9 33 28 mail@mondeal.de
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | July 24, 2006 |
|---|---|
| Submitter: | |
| Name: | Mondeal Medical Systems GmbH |
| Address: | Moltkestr. 3978532 TuttlingenGermany |
| Contact Person: | Ralph Duerr |
| Telephone: | +49.7461.933214 |
| Fax: | +49.7461.93328 |
| Product: | |
| Trade Name: | SIS Sinus Implant Stabilizer |
| Classification: | Class II |
| Common Name: | Bone Plate |
| Classification Name: | Endosseous Implant |
| Predicate Devices: | Synocta Prosthetics, K990342Mini Bone Plate System, K951392Micro Titanium Plate System, K951688Lin/Liou Orthodontic Mini Anchor System (LOMAS), K042345 & K050257 |
| Device Description: | The SIS Sinus Implant Stabilizer consists of a titanium plate provided with 3 large perforations for screw fixation of implants for premolars and first molars. It may be additionally secured in place with titanium microscrews and is provided in two sizes for use with different implant systems. |
| Intended Use: | The SIS Sinus Implant Stabilizer is intended to provide a fixed anchorage point to stabilize dental implants in the sinus region, enabling sinus augmentation and implantation to be carried out in one session. |
| Performance Data: | Testing was performed to support substantial equivalence to the predicate devices. The SIS Sinus Implant Stabilizer met all specified design and performance requirements. |
K17
{1}------------------------------------------------
K062 436 272
Image /page/1/Picture/1 description: The image shows the logo for MONDEAL MEDICAL SYSTEMS GMBH. The word "MONDEAL" is in large, white, sans-serif letters on a black background. Below the word "MONDEAL" is the phrase "MEDICAL SYSTEMS GMBH" in smaller, white, sans-serif letters.
Postfach 4741 78512 Tuttlingen Telefon (0 74 6 1 ) 9 33 20 Telefax (0 74 6 1) 9 33 28 mail@mondeal.de
Sterilization The SIS Sinus Implant Stabilizer is intended for single use and may be offered either sterile by gamma radiation or nonsterile for autoclave steam sterilization.
- Based upon the product technical information provided, Conclusion: intended use and performance information provided in this premarket notification, as well as similarity to legally marketed devices, Mondeal Medical Systems GmbH considers the SIS Sinus Implant Stabilizer to be substantially equivalent to the current legally marketed predicate devices.
{2}------------------------------------------------
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mondeal Medical Systems GmbH C/O Ms. Angelika Scherp Regulatory Affairs Consultant Business Support International Amstel 320-I 1017 AP Amsterdam THE NETHERLANDS
JUL 3 0 2007
Re: K062436
Trade/Device Name: SIS Sinus Implant Stabilizer Regulation Number: 21 CFR 872.4760 Regulation Name: Endosseous Dental Implant Accessories Regulatory Class: II Product Code: JEY Dated: July 4, 2007 Received: July 13, 2007
Dear Ms. Scherp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Ms. Scherp
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suite y. Michaud md
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
/7/
KD62436
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SIS Sinus Implant Stabilizer
!ndications for Use: The SIS Sinus Implant Stabilizer is intended to provide a fixed anchorage point to stabilize dental implants in the sinus region, enabling sinus augmentation and implantation to be carried out in one session.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Ruar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K062436
Page 1 of _
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.