(90 days)
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Mako System is indicated for use in surgical shoulder procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a patient imaging databased model of the anatomy. These procedures include:
-
· Reverse Shoulder Arthroplasty (primary joint replacement)
The implants compatible with the system are: -
· Aequalis PerFORM Reversed Glenoid (cementless)
-
· Aequalis PerFORM + Reversed Glenoid (cementless)
The Mako System with the subject Mako Shoulder Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning application, and tools and accessories. The Mako System uses patient CT data to assist the physician with presurgical implant placement planning and intraoperative tracking of the patient's scapula.
The system's architecture is designed to support reverse shoulder procedures. With application-specific hardware and software, the system provides haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning, implant placement, and interpretive/intraoperative navigation of the patient's anatomy.
Once configured for a specific application, the Mako robotic arm can serve as the surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.
Here's a breakdown of the acceptance criteria and study information for the Mako Shoulder Application (1.0), based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests but does not explicitly state numerical acceptance criteria or quantifiable performance metrics for these tests. The conclusions broadly state that performance testing demonstrates equivalence and that the device is safe and effective.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality is robust and performs as intended. | Software Functional Testing: Successfully completed, implying the software operates correctly. |
| Cutting system demonstrates adequate accuracy. | Cutting System Accuracy: Successfully completed, implying the cutting system meets its design specifications for precision. |
| Device is reliable in its operation. | Reliability: Successfully completed, indicating the system maintains consistent performance over time. |
| Software meets performance specifications. | Software Performance Verification: Successfully completed, confirming the software's performance aligns with its design requirements. |
| Overall system operates effectively as a cohesive unit. | System Testing: Successfully completed, demonstrating integrated functionality. |
| Device is safe and effective for its indicated cadaveric use. | Cadaveric Design Validation: Successfully completed, demonstrating the device's efficacy and safety in a simulated surgical environment prior to human use. |
| The device as a whole meets all design and performance requirements. | Summative Evaluation: Successfully completed, indicating the final product met all specified requirements and is deemed suitable for its intended use. |
| The device is substantially equivalent to the predicate device. | Overall Conclusion: "Performance testing demonstrates that the characteristics of the subject Mako Shoulder Application are equivalent to the characteristics of the predicate device. The subject device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes (e.g., number of cases, number of cadavers) used for the software functional testing, cutting system accuracy, reliability, software performance verification, system testing, cadaveric design validation, or summative evaluation.
The data provenance is from non-clinical performance testing, primarily involving software and hardware evaluations, and cadaveric design validation. There is no mention of human clinical data or its provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth for any of the performance tests. The testing appears to be primarily engineering and design validation based, rather than clinical ground truth establishment. For the cadaveric design validation, it's plausible that surgeons or surgical experts were involved, but this isn't explicitly stated, nor are their qualifications.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1, none). This type of adjudication is typically used in studies involving human interpretation or subjective assessments, which are not detailed in this section of the submission. The performance testing described suggests objective measurements and validations against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described. Such studies are typically conducted to evaluate the impact of AI or assisted devices on human reader performance in areas like diagnostic imaging. This submission focuses on the safety and effectiveness of a surgical guidance system through engineering and cadaveric validation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The performance testing described (Software Functional Testing, Cutting System Accuracy, Reliability, Software Performance Verification, System Testing) constitutes standalone testing of the algorithm and hardware components. The "Cadaveric Design Validation" also tests the system's performance, albeit in a simulated surgical environment where a "human-in-the-loop" (the surgeon operating the system) is inherent to its use. However, the initial listed tests would primarily assess the underlying algorithmic and mechanical performance without necessarily measuring full human interaction.
7. The Type of Ground Truth Used
The ground truth for the various tests would be based on:
- Design Specifications/Requirements: For software functional testing, reliability, and software performance verification, the ground truth is adherence to predefined engineering and functional specifications.
- Physical Measurements/Engineering Standards: For cutting system accuracy, ground truth would be precise measurements against known physical standards or benchmarks.
- Anatomical Accuracy/Surgical Goals: For cadaveric design validation, the ground truth would relate to the accurate execution of the pre-planned surgical procedure on the cadaveric specimen, evaluated against anatomical landmarks and surgical objectives.
There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth in this document.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. The Mako Shoulder Application uses patient CT data for pre-operative planning and intraoperative guidance, but the document does not discuss how the underlying algorithms were "trained" using specific datasets, nor the size of any such training data. The mention of BLUEPRINT (K232265) for the preoperative workflow implies use of an established planning software, but details about its training data are not provided in this 510(k) summary.
9. How the Ground Truth for the Training Set was Established
As no training set is discussed or specified in this document, there is no information on how its ground truth was established.
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November 7, 2024
MAKO Surgical Corp. Anne Edwards Principal Regulatory Affairs Specialist 3365 Enterprise Avenue Weston, Florida 33331
Re: K242373
Trade/Device Name: Mako Shoulder Application (1.0) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 9, 2024 Received: August 9, 2024
Dear Anne Edwards:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
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assistance/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,
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242373
Device Name Mako Shoulder Application (1.0)
Indications for Use (Describe)
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Mako System is indicated for use in surgical shoulder procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a patient imaging databased model of the anatomy. These procedures include:
-
· Reverse Shoulder Arthroplasty (primary joint replacement)
The implants compatible with the system are: -
· Aequalis PerFORM Reversed Glenoid (cementless)
-
· Aequalis PerFORM + Reversed Glenoid (cementless)
| 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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K242373 - 510(k) SUMMARY
| Sponsor: | Mako Surgical Corp.3365 Enterprise AveWeston, FL 33331 |
|---|---|
| Contact Person: | Anne EdwardsPrincipal Regulatory Affairs SpecialistAnne.Edwards@stryker.com505-221-0267 |
| Date Prepared: | November 6, 2024 |
| Proprietary Name: | Mako Shoulder Application |
| Common Name: | Mako Shoulder Application |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR Section 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |
Substantial Equivalence Claimed To:
The subject device, the Mako Shoulder Application, is substantially equivalent to the predicate device, Mako Partial Knee Application, cleared via K172301.
In addition, the subject device, the Mako Shoulder Application is substantially equivalent to the following reference devices:
Device Modifications that are the subject of this submission are as follows:
Software Changes:
Addition of the Mako Shoulder Application for Reverse Shoulder Arthroplasty (Glenoid). Use of BLUEPRINT (K232265) for the preoperative workflow and creation of a treatment plan.
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Hardware Changes:
End Effector tracking (replaces base array for robotic arm tracking) Mako Shoulder Instrument tray New Shoulder Specific instrumentation
Implants compatible with Mako Shoulder Application 1.0:
Aequalis PerFORM Reversed Glenoid (K183696) Aequalis PerFORM + Reversed Glenoid (K183696)
Description:
The Mako System with the subject Mako Shoulder Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning application, and tools and accessories. The Mako System uses patient CT data to assist the physician with presurgical implant placement planning and intraoperative tracking of the patient's scapula.
The system's architecture is designed to support reverse shoulder procedures. With application-specific hardware and software, the system provides haptic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning, implant placement, and interpretive/intraoperative navigation of the patient's anatomy.
Once configured for a specific application, the Mako robotic arm can serve as the surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.
Summary of Technological Characteristics Compared to Predicate Device:
| TechnologicalCharacteristics | Mako Shoulder Application | Mako Partial Knee Application -K172301 |
|---|---|---|
| Major Components | Robotic Arm, Guidance Module,Camera Stand, cutting system, genericuser laptop for pre-operativeplanning. | Robotic Arm, Guidance Module,Camera Stand, cutting system,preoperative planning laptop. |
| Tools/accessories | Various reusable and disposableinstruments | Various reusable and disposableinstruments |
| Image Use | CT | CT |
The technological characteristics of the Mako Shoulder Application compared to the predicate device are listed below:
Intended Use
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Image /page/6/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is written in all lowercase letters.
The Mako System is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Indications for Use
The Mako System is indicated for use in surgical shoulder procedures in which the use of stereotactic surgery may be appropriate and where reference to rigid anatomical bonv structures can be identified relative to a patient imaging data-based model of the anatomy. These procedures include:
• Reverse Shoulder Arthroplasty (primarv joint replacement)
The implants compatible with the system are:
- · Aequalis PerFORM Reversed Glenoid (cementless)
- Aequalis PerFORM + Reversed Glenoid (cementless)
Performance Data – The modified Mako System with the subject Mako Shoulder Application has been evaluated through the following non-clinical performance testing:
- Software Functional Testing ●
- Cutting System Accuracy ●
- Reliability
- Software Performance Verification
- System Testing
- Cadaveric Design Validation
- Summative Evaluation
Conclusions:
The hardware and software of the subject Mako System with Mako Shoulder Application uses equivalent technology to the hardware and software of the predicate Mako System with Mako Partial Knee Application. The software modifications do not impact the intended use or the fundamental technology of the device. Furthermore, performance testing demonstrates that the characteristics of the subject Mako Shoulder Application are equivalent to the characteristics of the predicate device. The subject device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, performance testing supports a determination of substantial equivalence.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).