(219 days)
OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
OPS™ Insight is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patient-specific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and prosthetic impingement detection.
The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPS™ Insight is a closed platform. Please refer to the Instructions for Use for compatible implant systems.
The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria, specifically in the format requested. The document is a 510(k) summary for the OPS™ Insight device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed technical report of performance validation.
Here's what can be extracted and what is missing based on your request:
What can be extracted:
- Non-Clinical Testing: "Non-clinical testing was performed to assess the usability and performance of OPS™ Insight software device to demonstrate that the device functions as intended. Software verification and validation testing was conducted according ISO 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
- Clinical Testing: "Clinical testing was not necessary for this Traditional 510(k)."
Information Missing from the provided text:
- Table of acceptance criteria and reported device performance: This detailed information is not present in the 510(k) summary. The summary only states that non-clinical testing was done to show the device "functions as intended" but does not quantify performance against specific criteria.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not necessary for this Traditional 510(k)," which implies no human reader studies (MRMC) were conducted for this submission.
- Standalone (algorithm-only) performance: While non-clinical testing for "performance" was mentioned, the specific metrics, acceptance criteria, and results for standalone algorithmic performance are not detailed.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Summary of available information:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated or tabulated. The general statement is that non-clinical testing demonstrated the device "functions as intended."
- Study Type: Non-clinical verification and validation testing in accordance with ISO 62304 and FDA guidance for software in medical devices. No clinical testing was deemed necessary.
- Ground Truth: Not detailed.
- Sample Sizes/Expert Details: Not detailed for either test or training sets.
- Human-AI Comparative Effectiveness: No clinical study involved, thus no human-AI comparison.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size and a blue square behind it.
May 1, 2020
Corin USA % Ms. Martina Cecconi Regulatory and Clinical Affairs Team Leader Corin (Australia) 17 Bridge Street Sydney, New South Wales 2073 AUSTRALIA
Re: K192656
Trade/Device Name: Optimized Positioning System (OPS™) Insight Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, LZO, MEH, PLW, LWJ Dated: March 30, 2020 Received: March 31, 2020
Dear Ms. Cecconi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Optimized Positioning System (OPSTM) Insight
Indications for Use (Describe)
OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) SUMMARY
| 1. Applicant/Sponsor: | Corin USA Limited |
|---|---|
| Distributor | 12750 Citrus Park LaneSuite 120Tampa, Florida 33625 |
| Establishment Registration No.: 1056629 | |
| 2. Manufacturer: | Optimized Ortho Pty Ltd |
| 17 Bridge Street | |
| Pymble NSW | |
| 2073 Australia | |
| Establishment Registration No: 3012916784 | |
| 3. Contact Person: | Crissy Tomarelli |
| Regulatory and Quality Director | |
| Corin Australia | |
| 1 61 2 94977400 | |
| crissy.tomarelli@coringroup.com | |
| Lucinda Gerber | |
| Global Regulatory Affairs Manager | |
| Corin USA Limited |
-
- Date: 30th March 2020
-
- Trade Name: Optimized Positioning System (OPSTM) Insight
1 (772) 321-2478
-
- Common Name: OPS™ Insight
-
- Classification Product Code(s): LLZ
8. Classification Name:
21 CFR 892.2050 – Picture archiving and communications
{4}------------------------------------------------
9. Substantially Equivalent (predicate) device(s):
10. De vice Description:
OPS™ Insight is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patient-specific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and prosthetic impingement detection.
The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPS™ Insight is a closed platform. Please refer to the Instructions for Use for compatible implant systems.
11. Indications for Use / Intended Purpose:
OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
12. Summary of Technologies/Substantial Equivalence:
The device comparison showed that the subject device is substantially equivalent to the predicate OneFIT Medical hipEOS (K173390), Corin OPS™ Plan (K171847, K183038) and Corin OPS™ FHA (K190834). The subject device and predicate devices. OneFIT Medical hipEOS (K173390), Corin OPS™ Plan (K171847, K183038)and Corin OPS™ FHA (K190834) have similar indications for use, technological characteristics and principles of operation, with all utilizing imaging scans to generate an end plan. The predicate OneFIT Medical hipEOS (K173390) outputs similar biomechanical measurements including those relating to leg length,
offset and femoral version, cup orientation (cup inclination & anteversion)
{5}------------------------------------------------
to the subject device. The predicate Corin OPS™ Plan (K171847, K183038) provide the same biomechanical measurements including those relating to leg length, offset and femoral version and the predicate and the subject device, and the Corin OPS™ FHA (K190834) performs the same functional analysis of the pelvic parameters and cup orientation calculation during flexion and extension as the subject device.
The end user for the subject and all predicate devices are trained medical professionals and the subject and predicate devices do not have contact with the patient.
The subject device differs from the predicate OneFIT Medical hipEOS (K173390) in the input imaging used and in that the subject device is used for total hip replacement while the predicate can be used for pre-operative planning for lower limb (including hip) and spine. The predicate device does not provide a functional analysis of the pelvic parameters or cup orientation calculation during flexion and extension,
The subject device differs from the predicates OPS™ Plan (K171847, K183038) and Corin OPS™ FHA (K190834) in that, for the predicate devices, the Surgeon cannot actively interact with, alter or change the surgical pre-plan.
The differences between the subject device and its predicate devices raise no new issues in terms of safety or effectiveness. Therefore, based on these similarities, Corin believes that the OPSTM Insight is substantially equivalent to the predicate devices.
Compatible Devices
OPS™ Insight can be used with the following implant systems:
Trinity acetabular system (K093472, K103120, K110087 (K111481, K122305, K130343, K170359) MetaFix (K082525, K121439, K130634, K131952, K15338, K162942) TriFit TS (K153772, K121563) TriFit CF (K173880) TaperFit (K153725, K142761) MiniHip, ( K131986, K11046,K083312) Paragon (K123782) MobiliT Cup (K191831)
{6}------------------------------------------------
13. Non-Clinical Testing:
Non-clinical testing was performed to assess the usability and performance of OPS™ Insight software device to demonstrate that the device functions as intended. Software verification and validation testing was conducted according ISO 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'
14. Clinical Testing:
Clinical testing was not necessary for this Traditional 510(k).
Conclusion: 15.
The subject device has similar intended uses, technological characteristics, and principles of operation as its predicate devices. The differences between the subject device and its predicates raise no new issues in terms of safety or effectiveness.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).