(60 days)
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion.
Specific indications for use include:
- Flexible flat feet in children and adolescence,
- Progression medial talus protrusion,
- Loss of longitudinal arch,
- Pain along the tibialis posterior,
- Age > 6 years, after conservative treatment did not result in a flat foot correction,
- Age < 13 years, while the deformity may be corrected manually.
The MC-Subtalar™ II screws are partly threaded, cannulated and self-tapping screws. They are designed to be implanted into the calcaneus bone of the foot for subtalar extra-articular arthroeresis. A hexagonal shaped shaft end allows easy adjustment while operation. The screws are made of X2CrNiMo 18-15-3 stainless steel and are also available made of Ti6Al4V titanium alloy. The MC-Subtalar™ II is offered in sizes of 25 mm, 30 mm and 35 mm and with different head diameter of 6 mm, 8 mm and 10 mm to meet the specific anatomical requirements for various age groups.
The provided text is a 510(k) premarket notification for a medical device called MC-Subtalar™ II. This document describes the device, its indications for use, and its equivalence to legally marketed predicate devices. However, it explicitly states: "Clinical Data were not needed for these devices to show substantial equivalence."
Therefore, based on the provided text, a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or analytical performance study with specific acceptance criteria related to accuracy, sensitivity, or specificity, and human reader performance against an AI, was not performed or required for this 510(k) submission.
The "acceptance criteria" and "device performance" described are mechanical and biomechanical in nature, rather than diagnostic or clinical effectiveness outcomes that would involve complex statistical analyses of sensitivity, specificity, or reader studies.
Here's a breakdown of what is available in the document regarding the device's assessment:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it describes mechanical and biomechanical testing.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties | Passed tests in accordance with ASTM F543-13. |
| Durability (worst-case scenario) | Successfully passed 10^6 load cycles in biomechanical tests. |
| Overall Performance vs. Predicate | Mechanically as good as or better than the predicate devices. |
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 for Test Set: Not explicitly stated in terms of patient data. The "test set" refers to the physical devices subjected to mechanical and biomechanical testing. The number of devices tested is not specified, but such tests typically involve a statistically relevant number of samples to ensure robust results.
- Data Provenance: The tests were conducted by Merete Medical GmbH, a German company (Alt-Lankwitz 102, 12247 Berlin, Germany). The origin of the data (i.e., the conditions under which the mechanical tests were performed) would be laboratory-based and controlled, rather than patient data from a specific country or collected retrospectively/prospectively.
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 question is not applicable. The "ground truth" here is based on engineering standards (ASTM F543-13) and mechanical testing results, not expert interpretation of medical images or clinical outcomes. The evaluation relies on standardized physical tests and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or expert consensus for ground truth establishment. For mechanical testing, the results are objectively measured against pre-defined engineering specifications.
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 (Subtalar Arthroereisis Implant), not an AI-driven diagnostic or image analysis tool. There is no "human reader" component in its assessment for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on:
- Adherence to engineering standards (ASTM F543-13).
- Mechanical and biomechanical test results demonstrating the physical properties (e.g., strength, durability) of the implant.
8. The sample size for the training set
This is not applicable as there is no "training set" for an algorithm. The device is a physical implant.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set" for an algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Merete Medical GmbH % Mr. Matthias Möllmann Senior Vice President Merete Technologies Incorporated One Lincoln Center 18W140 Butterfield Road Oakbrook Terrace, Illinois 60181
April 29, 2016
Re: K160548
Trade/Device Name: MC-Subtalar™ II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 23, 2016 Received: February 29, 2016
Dear Mr. Möllmann:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device
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related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160548
Device Name MC-Subtalar™ II
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion.
Specific indications for use include:
- · Flexible flat feet in children and adolescence,
- · Progression medial talus protrusion,
- · Loss of longitudinal arch,
- · Pain along the tibialis posterior,
- · Age > 6 years, after conservative treatment did not result in a flat foot correction,
- · Age < 13 years, while the deformity may be corrected manually.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Merete. The logo consists of two interlocking circles inside of a larger circle on the left. To the right of the circle is the word "merete" in a dark blue, sans-serif font, with a registered trademark symbol in the upper right corner.
510(k) Summary of Safety and Effectiveness Information as required by 21 CFR 807.92
| Date Prepared: | 25th April 2016 |
|---|---|
| Submitted by: | Merete Medical GmbHAlt-Lankwitz 10212247 Berlin, Germany |
| Contact Person: | Matthias MöllmannMerete Technologies, Inc. (MTI)One Lincoln Centre18W140 Butterfiled Road, 15th FloorOakbrook Terrace, IL 60181Phone: 630-613-7181 |
| Device Name: | MC-SubtalarTM II |
| Common Name: | Subtalar Arthroereisis Implant |
| Classification Names: | Smooth or threaded metallic bone fixation fastener - 888.3040 |
| Device Product Code: | HWC |
| Proposed Regulatory Class: | Class II |
Legally marketed Devices to which substantial Equivalence is claimed:
K133035 Pellegrin Calcaneus Stop Screw, Normed Medizin-Technik GmbH
Reference devices:
| K111834 | Disco Subtalar Implant, Trilliant Surgical LTD |
|---|---|
| K152187 | Foot surgery screws, Merete Medical GmbH |
Device Description:
The MC-Subtalar™ II screws are partly threaded, cannulated and self-tapping screws. They are designed to be implanted into the calcaneus bone of the foot for subtalar extra-articular arthroeresis. A hexagonal shaped shaft end allows easy adjustment while operation. The screws are made of X2CrNiMo 18-15-3 stainless steel and are also available made of Ti6Al4V titanium alloy. The MC-Subtalar™ II is offered in sizes of 25 mm, 30 mm and 35 mm and with different head diameter of 6 mm, 8 mm and 10 mm to meet the specific anatomical requirements for various age groups.
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Image /page/4/Picture/0 description: The image shows the Merete logo. The logo consists of two interlocking circles inside of a larger circle on the left, followed by the word "merete" in a serif font. There is a registered trademark symbol to the right of the word.
Indications for use
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion.
Specific indications for use include:
- Flexible flat feet in children and adolescence,
- Progression medial talus protrusion,
- . Loss of longitudinal arch,
- Pain along the tibialis posterior,
- . Age > 6 years, after conservative treatment did not result in a flat foot correction,
- Age < 13 years, while the deformity may be corrected manually.
Comparison of technological characteristics with the predicate devices:
In order to demonstrate that the MC-Subtalar™ II has the mechanical properties necessary to perform as well or better than the predicate devices, Merete has conducted mechanical analysis and functional wort case tests. This tests have been performed in accordance with ASTM F543-13. Additionally a biomechanical tests has been performed to evaluate the durability of the MC-Subtalar™ II screws with 106 load cycles in a worst-case scenario. The MC-Subtalar™ II screws have successfully passed the tests and have hereby been proven to be mechanically as good as or better than the predicate devices. Differences in sterilization method and material have been addressed by pointing out to reference devices using the same methods/ materials.
Clinical Data were not needed for these devices to show substantial equivalence.
Substantial Equivalence:
The MC-Subtalar™ II have passed all defined criteria, have performed as well or better than the predicate device and are therefore considered substantially equivalent to the cleared predicate device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.