(238 days)
The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only.
The Exeter® Hip is indicated for:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The currently marketed Exeter® Hip Stem is equivalent to the stainless steel hip stem with a V40™ trunnion approved via K011623. The Exeter® Hip Stem continues to be manufactured from the same design, the same materials, and the same manufacturing process.
The provided document describes a 510(k) premarket notification for the "Exeter® Hip Stem" (K110290), a femoral component for total hip arthroplasty. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel effectiveness or safety through clinical trials. As such, the information you've requested regarding acceptance criteria and a study to prove the device meets those criteria, particularly in the context of AI/software performance metrics, does not directly apply to this type of medical device submission.
The "acceptance criteria" for a 510(k) are typically met by demonstrating that the new device has the same intended use, technological characteristics, and performs as well as (or better than) a legally marketed predicate device, without raising different questions of safety and effectiveness. The "study" proving this for a traditional orthopedic implant usually involves non-clinical (bench) testing, rather than human clinical trials or AI performance evaluations with ground truth.
However, I can extract the relevant information presented in the document pertaining to the equivalence demonstration and non-clinical testing.
Here's a breakdown based on the document, addressing your questions where applicable to a traditional hardware medical device 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are implied by the performance of the predicate device and relevant ISO/ASTM standards for hip implants. The device needs to demonstrate comparable mechanical integrity and biocompatibility.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Mechanical integrity (Axial Pull-off strength) comparable to predicate & standards. | Testing conducted for new compatibilities: Axial Pull-off testing performed. (Specific values not reported in summary, but indicated as acceptable for equivalence) |
| Mechanical integrity (Axial fatigue & post-fatigue ultimate compression) comparable to predicate & standards (ISO 7206-10). | Testing conducted for new compatibilities: Axial fatigue & post fatigue ultimate compression testing (according to ISO 7206-10) performed. (Specific values not reported in summary) |
| Mechanical integrity (Ultimate compression on new and "damaged/used" tapers) comparable to predicate & standards (ISO 7206-6). | Testing conducted for new compatibilities: Ultimate compression testing on both new and "damaged or used" femoral stem tapers (per ISO 7206-6) performed. (Specific values not reported in summary) |
| Resistance to galvanic corrosion (ASTM G 71-81) when combined with new materials. | Testing conducted for new compatibilities: Galvanic corrosion testing (according to ASTM G 71-81) conducted for cobalt chrome alloy heads and titanium alloy sleeves with stainless steel stems. (Results implicitly acceptable for equivalence) |
| Fretting characteristics comparable to predicate when combined with new materials. | Testing conducted for new compatibilities: Fretting evaluated as compared to the predicate device. (Results implicitly acceptable for equivalence) |
| Maintains original design, materials, and manufacturing process for the core stem. | Confirmed: "The Exeter® Hip Stem continues to be manufactured from the same design, the same materials, and the same manufacturing process." |
| Compatibility established with specified femoral heads (V40™ cobalt chrome alloy, Universal Taper Biolox® Delta Ceramic with titanium alloy sleeve). | Confirmed: Testing performed to support this additional compatibility. |
Explanation: In a 510(k) for an orthopedic implant, "acceptance criteria" are less about a single numerical threshold and more about demonstrating that the new device configuration (here, new head compatibilities) performs equivalently to the existing cleared device and predicate devices under relevant standard tests, and does not introduce new safety concerns. The "reported device performance" refers to the non-clinical tests performed to support this equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the summary document. For mechanical testing of medical devices, sample sizes are typically determined by statistical rationale to ensure confidence in the results, but these specifics are not provided in the public summary. These are bench tests, not clinical data sets.
- Data Provenance: The data is derived from non-clinical (bench) testing performed by the manufacturer, Howmedica Osteonics Corp. Country of origin for data generation is not explicitly stated but would typically be in a controlled laboratory environment conforming to regulatory standards (e.g., in the US or a region with equivalent standards). The testing is prospective in the sense that it was specifically conducted for this 510(k) submission to establish new compatibilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this 510(k). "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for clinical studies, particularly for AI/software devices. For a traditional orthopedic implant's non-clinical testing, the "ground truth" is typically defined by engineering specifications, validated test methods (e.g., ISO, ASTM standards), and established material properties, interpreted by qualified engineers and scientists. No external "experts" in the sense of clinical reviewers are used to establish ground truth for these bench tests; the data speaks for itself against the standards.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers or experts when establishing ground truth for diagnostic accuracy in clinical evaluations, particularly for AI. For non-clinical bench testing, the results are quantitative and directly measured against predefined acceptance criteria or predicate device performance; there's no need for multi-reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is used to assess the change in human reader performance (e.g., diagnostic accuracy) when aided by an AI algorithm. This 510(k) is for a physical orthopedic implant, not an AI software device. Therefore, no MRMC study was performed, and there is no "effect size of how much human readers improve with AI vs without AI assistance."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This question is applicable to AI/software as a medical device (SaMD) where the algorithm performs a function independently. The Exeter® Hip Stem is a physical implant; thus, no standalone algorithm performance was evaluated.
7. The Type of Ground Truth Used
The "ground truth" for this submission's non-clinical testing is based on:
- Validated engineering standards: Primarily ISO (e.g., ISO 7206-10, ISO 7206-6) and ASTM (e.g., ASTM G 71-81) for mechanical testing and material compatibility.
- Performance of the predicate device: The established safety and effectiveness profile of the already-marketed Exeter V40 Hip System (K011623) and other listed predicate devices (e.g., Meridian TMZF Femoral Hip Stem - K972228, V40™ taper cobalt chrome alloy femoral heads, Universal Taper Biolox® Delta Ceramic heads with titanium alloy adaptor sleeve) serves as the benchmark for equivalence.
The "ground truth" is not clinical outcomes, pathology, or expert consensus in this context, but rather adherence to engineering principles and demonstrated physical performance.
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train machine learning models. This 510(k) does not involve machine learning or AI; it's for a physical medical implant.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8. No training set was used or established.
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SEP 2 7 2011
| Sponsor | Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430 |
|---|---|
| For Information contact: | Valerie GiambancoHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201)-831-6275Fax: (201)-831-3275 |
| Proprietary Name: | Exeter® Hip Stem |
| Common Name: | Artificial Hip Replacement Components - Femoral Stem |
| Classification Name and Reference: | 21 CFR 888.3350 Hip joint metal/polymer semi-constrainedcemented prosthesis |
| Regulatory Class: | Class II |
| Product Codes: | JDI |
| Predicate Device: | Exeter V40 Hip System |
| Date Prepared: | September 20, 2011 |
510(k) Summary of Safety and Effectiveness
Description:
The currently marketed Exeter® Hip Stem is equivalent to the stainless steel hip stem with a V40™ trunnion approved via K011623. The Exeter® Hip Stem continues to be manufactured from the same design, the same materials, and the same manufacturing process.
Intended Use:
The Exeter® hip is intended for use in total hip arthroplasty. They are intended for cemented use only. The Exeter® hip is provided sterile for single-use.
The Exeter® Femoral Stems are currently cleared for use with femoral heads manufactured from Zirconia, alumina ceramic, Biolox® delta ceramic, and stainless steel. The purpose of this 510(k) is that the Exeter® stems will now be marketed as compatible with Howmedica Osteonics' V40™ cobalt chrome alloy femoral heads and Universal Taper Biolox® Delta Ceramic heads when using a titanium alloy sleeve. Thus, Exeter® stem size range cleared in K011623 will be compatible with V40™ Taper femoral heads manufactured frome alloy, alumina ceramic, Biolox® delta ceramic (Zirconia toughened), and stainless steel and a Universal Taper femoral heads manufactured from Biolox® delta ceramic only when using a titanium alloy adaptor sleeve.
Indications:
The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only .
The Exeter® Hip is indicated for:
lot 2.
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- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ●
- rheumatoid arthritis; .
- correction of functional deformity; .
- revision procedures where other treatments or devices have failed; and .
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
Substantial Equivalence:
The Exeter® hip stem continues to be manufactured from the same material via the same process and same design as the Exeter® hips that were cleared in K011623. The Exeter® Hip Stems are substantially equivalent to other commercially available hip arthroplasty systems in regards to indications for use design, materials, and operational principles. The femoral head compatibility of the Exeter Hip Stem is substantially equivalent to Meridian TMZF Femoral Hip Stem that was cleared via K972228 . The following devices are examples of predicate systems currently cleared for use that will now be intend for compatible usage with the Exeter® stems: Howmedica Osteonics' V40™ taper cobalt chrome alloy femoral heads (K993601, K022077, K061434, K010757) and Universal Taper Biolox® Delta Ceramic heads with a titanium alloy adaptor sleeve (K070885).
Summary of Technologies: The technological characteristics (material, design, sizes, and operational principles) of the Exeter® V40™ Hip Stem are similar or identical to the predicate devices.
Summary of Non-Clinical Testing and Evaluation:
Testing has been performed to demonstrate equivalence of the subject device intended use compared to its predicate device intended use. Additional testing was conducted on the cobalt chrome alloy and Universal taper Biolox® delta ceramic femoral heads with the corresponding titanium alloy sleeves when used with Exeter® stainless steel femoral stems.
New testing to support this additional compatibility for the Exeter® Femoral Stem with cobalt chrome femoral heads includes an Axial Pull-off testing.
New testing to support this additional compatibility for the Exeter® Femoral Stem with the Universal taper Biolox® delta ceramic femoral heads with titanium sleeve includes Axial fatigue & post fatigue ultimate compression testing (according to ISO 7206-10), Axial pull-off testing (according to ISO 7206-10) and ultimate compression testing on both new and "damaged or used" femoral stem tapers (per ISO 7206-6).
For both the cobalt chrome alloy heads and titanium alloy sleeves when used with stainless steel Exeter Stems, testing for galvanic corrosion (according to ASTM G 71-81) was conducted and fretting was evaluated as compared to the predicate device.
Clinical Testing
None provided as a basis for substantial equivalence
Conclusion
The Exeter® V40™ Hip Stem is substantially equivalent to the predicate devices identified in this premarket notification
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W 066-G609 Silver Spring, MD 20093-0002
Howmedica Osteonies Corp. % Ms. Valerie Giambanco 325 Corporate Drive Regulatory Affairs Specialist Mahwah, New Jersey 07430
SEP 2 7 2011
Re: K110290
Trade/Device Name: The Exeter® V40 hip stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: HDI Dated: August 16, 2011 Received: August 17, 2011
Dear Ms. Giambanco:
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 is 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Valerie Giambanco
forth in the quality svstems (QS) regulation (2) 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.html 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/Safetv/ReportalProblem/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 vours.
Ernst Keith
C, 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
510(k) Number (if known): K110290
Indications for Use:
The Exeter® V40™ hip stem is intended for use in total hip replacement. It is intended for cemented use only.
The Exeter® Hip is indicated for:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- rheumatoid arthritis; ●
- correction of functional deformity; .
- revision procedures where other treatments or devices have failed; and .
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Michael lulus for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110290
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.