(61 days)
The POLARSTEMTM femoral stems with Ti/HA are indicated for:
- · Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
- · Fracture or avascular necrosis of the femoral head.
- · Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The POLARSTEMIM with Ti/HA is intended for single use only and is to be implanted without bone cement.
The Subject Device is a reusable tool intended to be used with the hip implant POLARSTEM™ Collared (Standard and Lateral) and POLARSTEM™ Valgus Femoral Stem with Ti/HA. The Subject Device is used to prepare the bony bed of the proximal femur to allow implantation of the implant POLARSTEM™ in the femoral bone. The Subject Device is designed to be clipped onto the trial rasp to guide the calcar reamer/planer when preparing the proximal femur for a collared POLARSTEM™ and to define the physical stop of the calcar reamer or planer.
The provided text describes a 510(k) premarket notification for a medical device called the POLARSTEM™ Calcar Reamer Guide. This document asserts substantial equivalence to a predicate device and includes a section on performance testing. However, it does not provide a specific table of acceptance criteria or detailed results of a study as typically outlined for AI/ML device performance.
Instead, the performance testing section broadly states:
"To further support a determination of substantial equivalence, functional testing was conducted on the Subject Device to evaluate its usability, safety, and effectiveness with regard to the associated implants, reference materials and combinable medical devices. Testing demonstrated that the Subject Device met or exceed the performance testing of the Predicate Device."
This statement indicates that the device's performance was evaluated against the predicate, but it doesn't quantify specific metrics or provide a direct comparison table.
Given the information provided, I cannot fully answer your request for acceptance criteria and a study that proves the device meets those criteria in the typical format for AI/ML device evaluations. The details you requested (sample size, provenance, expert qualifications, etc.) are not present in this regulatory document.
However, I can extract the available information regarding performance testing and present it in a modified format based on what is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Regulatory Description) | Reported Device Performance |
|---|---|
| Usability, Safety, and Effectiveness with regard to associated implants, reference materials, and combinable medical devices (equivalent to or better than the Predicate Device). | "Testing demonstrated that the Subject Device met or exceed the performance testing of the Predicate Device." |
| Functionality in preparing the bony bed of the proximal femur for POLARSTEM™ implants. | Demonstrated through cadaver/Sawbone surgery. |
| Guidance of the calcar reamer/planer when preparing the proximal femur for a collared POLARSTEM™. | Demonstrated through cadaver/Sawbone surgery. |
| Defining the physical stop of the calcar reamer or planer. | Demonstrated through cadaver/Sawbone surgery. |
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: Not specified. The document mentions "cadaver/Sawbone surgery" but does not quantify the number of cadavers or Sawbones used.
- Data Provenance: Not specified, beyond the mention of "cadaver/Sawbone surgery." It's typically considered prospective simulation.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document implies surgical assessment during the cadaver/Sawbone testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a mechanical surgical guide, not an AI/ML diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth appears to be based on successful surgical preparation and implantation, as assessed during cadaver/Sawbone surgery. This likely involves qualitative and quantitative assessments by the surgical team of the fit and proper preparation achieved using the guide.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a mechanical device, not an AI/ML system that undergoes training.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable. This is a mechanical device, not an AI/ML system that undergoes training.
Summary of Device and Performance Testing Context:
The POLARSTEM™ Calcar Reamer Guide is a mechanical accessory tool used in hip replacement surgery. Its purpose is to guide a calcar reamer/planer and define its physical stop during the preparation of the femoral bone. This 510(k) submission seeks to demonstrate substantial equivalence to a previously cleared predicate device. The "performance testing" described is functional testing comparing the subject device's usability, safety, and effectiveness to that of the predicate device, primarily through simulated surgical use (cadaver/Sawbone surgery). The document explicitly states that the subject device "met or exceed the performance testing of the Predicate Device," but it does not provide specific metrics or acceptance thresholds in a detailed, quantifiable manner as one would expect for an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 19, 2021
Smith & Nephew, Inc. Pamela Hopkins Regulatory Affairs Specialist II 1450 East Brooks Rd Memphis, Tennessee 38116
Re: K211548
Trade/Device Name: POLARSTEM Calcar Reamer Guide Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, KWY, LWJ, MEH Dated: May 17, 2021 Received: May 19, 2021
Dear Pamela Hopkins:
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
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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 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,
Limin Sun, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K211548
Device Name POLARSTEM™ Calcar Reamer Guide
Indications for Use (Describe)
The POLARSTEMTM femoral stems with Ti/HA are indicated for:
- · Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
- · Fracture or avascular necrosis of the femoral head.
- · Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The POLARSTEMIM with Ti/HA is intended for single use only and is to be implanted without bone cement.
| 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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510(k) Summary
| Submitted by: | Smith & Nephew, Inc.1450 East Brooks RoadMemphis, Tennessee 38116 |
|---|---|
| Revision Date: | July 16, 2021 |
| Contact Person: | Pamela Hopkins, Regulatory Affairs Specialist IIT (901) 399-5471M (901) 427-7303 |
| Name of Device: | POLARSTEM™ Calcar Reamer Guide, an accessory tool thatis part of the POLARSTEM™ Collared (Standard and Lateral)and POLARSTEM™ Valgus Femoral Stem with Ti/HA. |
| Common Name: | Total Hip Joint, Femoral Component |
| Device Classification Name andReference: | 21 CFR 888.3353 - Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Nonporous Uncemented Prosthesis21 CFR 888.3390 - Hip joint femoral (hemi-hip)metal/polymer cemented or uncemented prosthesis21 CFR 888.3360 - Hip joint femoral (hemi-hip)metallic cemented or uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LZO, KWY, LWJ, MEH |
| Predicate Device: | POLARSTEM™ Calcar Reamer Guide, an accessory toolincluded in K143739 which cleared the POLARSTEM™Collared (Standard and Lateral) and POLARSTEM™Valgus Femoral Stem with Ti/HA system |
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Device Description
The Subject Device is a reusable tool intended to be used with the hip implant POLARSTEM™ Collared (Standard and Lateral) and POLARSTEM™ Valgus Femoral Stem with Ti/HA. The Subject Device is used to prepare the bony bed of the proximal femur to allow implantation of the implant POLARSTEM™ in the femoral bone. The Subject Device is designed to be clipped onto the trial rasp to guide the calcar reamer/planer when preparing the proximal femur for a collared POLARSTEM™ and to define the physical stop of the calcar reamer or planer.
Indications for Use
The POLARSTEM™ femoral stems with Ti/HA are indicated for:
- Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
- Fracture or avascular necrosis of the femoral head.
- · Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The POLARSTEM™ with Ti/HA is intended for single use only and is to be implanted without bone cement.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the Subject Device is substantially equivalent to the Predicate Device with regards to indications for use, material, and performance characteristics.
When compared to the Predicate Device, the Subject Device is nearly identical to the predicate instrument, with the exception of the distance between the hook and the rasp. The Subject Device has an improved hook design to reduce the risk of interference of material (bone debris) by adding additional clearance between the hook and the rasp.
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Substantial Equivalence Information
The materials and indications for use for the Subject Device are identical to the Predicate Device. The minor design difference between the Subject Device and the Predicate Device (i.e. the distance between the hook and the rasp) do not raise any new or different questions of safety and effectiveness. Therefore, the Subject Device is substantially equivalent to the Predicate Device.
Performance Testing
To further support a determination of substantial equivalence, functional testing was conducted on the Subject Device to evaluate its performance. The principal test method used was cadaver/Sawbone surgery to evaluate the Subject Device's usability, safety, and effectiveness with regard to the associated implants, reference materials and combinable medical devices. Testing demonstrated that the Subject Device met or exceed the performance testing of the Predicate Device.
Conclusion
The subject Calcar Reamer Guide is identical in function, intended use, and materials to the Predicate Device. The minor design difference between the Subject Device and the Predicate Device do not raise any new or different questions of safety and effectiveness. Therefore, the subject Calcar Reamer Guide is substantially equivalent to the legally marketed Predicate Device.
N/A