(63 days)
The ACUTE Innovations® Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.
The ACUTE Innovations® Modular RibLoc System consists of plates and screws for fractures, fusions, and osteotomies. The plates are pre-contoured to minimize bending which is done intraoperatively. Instrumentation is supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium or titanium alloy.
The provided text describes a 510(k) summary for the ACUTE Innovations Modular RibLoc Fixation System. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo performance characteristics through extensive clinical studies.
Therefore, much of the information requested, such as specific acceptance criteria and detailed study designs involving human subjects, AI assistance, or pathology-based ground truth, is not typically found in a 510(k) summary for a device like a bone fixation system. Instead, the evaluation relies heavily on preclinical testing and comparison to existing devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states: "The non-clinical tests performed by the company include an analysis of strength of the ACUTE Innovations® Modular RibLoc plates. The results of the performed tests demonstrate that the ACUTE Innovations® Modular RibLoc System is substantially equivalent to legally marketed predicate devices."
This implies that the acceptance criteria are related to mechanical strength and performance and that the device's performance met those criteria by demonstrating substantial equivalence to predicate devices. However, specific numerical acceptance criteria (e.g., "withstanding X N of force for Y cycles") and corresponding reported performance values are not explicitly detailed in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the preclinical testing.
- Data Provenance: The preclinical testing was performed by "the company" (ACUTE Innovations, LLC), suggesting it was internal testing. The origin country is likely the USA, where the company is located. It would be considered prospective for the purposes of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or not provided for this type of preclinical testing. Ground truth for mechanical strength tests typically comes from engineering measurements and relevant industry standards, not expert medical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for preclinical mechanical testing.
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 rib fixation system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the preclinical testing mentioned, the "ground truth" would be established by engineering standards and measurements of mechanical properties (e.g., strength, fatigue life) compared against established performance benchmarks for similar predicate devices.
8. The sample size for the training set:
This is not applicable, as there is no machine learning or AI component described that would require a "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above. If there were a training set, the ground truth establishment method would depend on the specific task (e.g., expert annotation for image recognition, lab results for predictive models).
Summary of what is known based on the provided text:
- Acceptance Criteria (Implied): Substantial equivalence in mechanical strength and performance to predicate devices (MedXpert STRATOS, ACUTE Innovations® RibLoc System, ACUTE Innovations Sternal Fixation System).
- Study Proving Acceptance: "Preclinical Testing" which included "an analysis of strength of the ACUTE Innovations® Modular RibLoc plates."
- Device Performance: The tests "demonstrate that the ACUTE Innovations® Modular RibLoc System is substantially equivalent to legally marketed predicate devices."
The 510(k) pathway is designed to demonstrate that a new device is as safe and effective as (substantially equivalent to) a legally marketed predicate device, often relying on non-clinical data for devices like bone fixation systems. It does not typically require the extensive clinical trials or AI-specific validation metrics that would be associated with software as a medical device or novel therapeutic approaches.
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K113318 '1/2
JAN 1 2 2012
5. 510(k) Summary
| Device Trade Name: | ACUTE Innovations Modular RibLoc Fixation System |
|---|---|
| Manufacturer: | ACUTE Innovations, LLC21421 NW Jacobson Road, Suite 700Hillsboro OR, 20005 |
| Contact: | Ms. Mariah KnightRegulatory & Quality Manager503.686.7200 |
| Date Prepared: | November 9, 2011 |
| Classifications: | 21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories |
| and | |
| 21 CFR 888.3040, Smooth or threaded metallic bone fixationfasteners | |
| Class: | II |
| Product Codes: | HRS and HWC |
Indications for Use:
The ACUTE Innovations® Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.
Device Description:
The ACUTE Innovations® Modular RibLoc System consists of plates and screws for fractures, fusions, and osteotomies. The plates are pre-contoured to minimize bending which is done intraoperatively. Instrumentation is supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium or titanium alloy.
Predicate Devices:
Comparative information presented in the 510(k) supports the substantial equivalence of the ACUTE Innovations® Modular RibLoc System to the following predicate devices: MedXpert STRATOS (K073556); ACUTE Innovations® RibLoc System (K051410); and ACUTE Innovations Sternal Fixation System (K101170).
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Substantial Equivalence:
The components of the Acute Innovations® Modular RibLoc System are substantially equivalent to the identified predicates with respect to its indications for use, geometry, available sizes, materials, methods of fixation to bone, and performance.
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Preclinical Testing:
The non-clinical tests performed by the company include an analysis of strength of the ACUTE Innovations® Modular RibLoc plates. The results of the performed tests demonstrate that the ACUTE Innovations® Modular RibLoc System is substantially equivalent to legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 2 2012
ACUTE Innovations, LLC % Ms. Mariah Knight 21421 NW Jacobson Road, Suite 700 Hillsboro, OR 97124
Re: K113318 Trade/Device Name: ACUTE Innovations Modular RibLoc Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: November 9; 2011 Received: November 10, 2011
Dear Ms. Knight:
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 (reporting of medical
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Page 2 - Ms. Mariah Knight
device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
N.N.B., 1/13/12
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 4.
510(k) Number (if known): _K || 3 3 | 8
Device Name: ACUTE Innovations® Modular RibLoc System
The ACUTE Innovations® Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.
Prescription Use र्भ (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabethe PR
Co (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113318
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.