(259 days)
The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
The device is intended for cemented fixation.
The Episealer Patellofemoral System is a patient-individualized arthroplasty device which replaces a damaged patellofemoral joint. The subject device consists of two components:
- . Episealer PF
- Patellar Component ●
The Episealer PF component is implanted centrally in the trochlear area of the distal femur. The Patellar Component is implanted on the backside of the patella and articulates with the Episealer PF.
The provided text describes a 510(k) premarket notification for the Episealer® Patellofemoral System, an orthopedic device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria.
As such, detailed information regarding acceptance criteria for a specific performance metric, and a study proving those criteria were met in the same way one would assess an AI/ML algorithm, is not available in this document.
However, I can extract the information that is present regarding performance testing, even though it's not structured around explicit acceptance criteria and corresponding performance metrics in the way you've requested for an AI model.
Here's an attempt to answer your request based on the provided text, highlighting what is included and what is explicitly not mentioned:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like "sensitivity", "specificity", "AUC", or "agreement" as would be seen for an AI/ML device. Instead, it describes general performance testing and analyses.
| Performance Aspect (Implied Criteria) | Reported Device Performance Statement |
|---|---|
| Wear (Criteria: Acceptable wear characteristics comparable to predicate/standard) | "Wear testing of the Episealer Patellofemoral System was performed." (No specific wear rates or comparison values are provided in this summary.) |
| Contact Area (Criteria: Appropriate load distribution/contact area) | "In addition, analyses of contact area... were conducted." (No specific contact area values or comparison values are provided in this summary.) |
| Cantilever Bending Strength (Criteria: Sufficient mechanical strength) | "...and cantilever bending strength were conducted." (No specific strength values or comparison values are provided in this summary.) |
| Component Placement Accuracy (Criteria: Accurate and proper component placement relative to pre-plan) | "A cadaver study was conducted to demonstrate that the components of the patient-matched Episealer Patellofemoral System can be accurately placed relative to the pre-planned position, with proper recession and engagement of the Episealer PF and Patellar components." (The statement indicates successful demonstration, but no quantitative metrics for "accuracy" or "proper recession/engagement" are provided.) |
| Overall Performance (Criteria: Performs as intended) | "The testing, engineering analyses, and cadaver study demonstrate the ability of the Episealer Patellofemoral System to perform as intended in the target population." (General conclusion of successful performance, without specific metrics.) |
Summary of Performance Testing:
The document states: "Performance Testing Summary: Wear testing of the Episealer Patellofemoral System was performed. In addition, analyses of contact area and cantilever bending strength were conducted. A cadaver study was conducted to demonstrate that the components of the patient-matched Episealer Patellofemoral System can be accurately placed relative to the pre-planned position, with proper recession and engagement of the Episealer PF and Patellar components. The testing, engineering analyses, and cadaver study demonstrate the ability of the Episealer Patellofemoral System to perform as intended in the target population."
This section indicates that the device underwent standard engineering and mechanical testing relevant to orthopedic implants, as well as a cadaver study to verify surgical placement. However, specific acceptance criteria (e.g., "wear rate must be less than X," "contact area must be within Y range") and the quantitative results against those criteria are not provided in this 510(k) summary. The conclusion is a qualitative statement: "demonstrate the ability... to perform as intended."
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 for Test Set: Not specified in the provided summary. The text only mentions "wear testing," "analyses of contact area and cantilever bending strength," and "A cadaver study." The number of cadavers or individual test repetitions is not given.
- Data Provenance: Not specified.
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)
This is not applicable in the context of this device. A medical device like the Episealer Patellofemoral System undergoes engineering, mechanical, and cadaveric testing, not evaluation against expert-defined "ground truth" labels in the way an AI/ML diagnostic tool would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of testing described (mechanical testing, cadaver study).
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 is an orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is an orthopedic implant, not an algorithm. The device itself is a standalone implant that is surgically placed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as used for AI/ML evaluation does not directly apply here. Instead, performance is assessed through:
- Engineering measurements (wear, contact area, bending strength) against industry standards or internal specifications.
- Cadaveric surgical validation, where the "truth" would be successful implantation according to surgical protocols and demonstration of intended function.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This is not an AI/ML device that requires a training set.
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December 23, 2022
Episurf Medical, Inc. % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs Mcra, LLC 803 7th St NW Washington, District of Columbia 20001
Re: K221048
Trade/Device Name: Episealer® Patellofemoral System Regulation Number: 21 CFR 888.3540 Regulation Name: Knee Joint Patellofemoral Polymer/Metal Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRR Dated: December 1, 2022 Received: December 1, 2022
Dear Hollace Rhodes:
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.
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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 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 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-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.
Ting Song -S
Ting Song, Ph.D. 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
Enclosure
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Indications for Use
510(k) Number (if known) K221048
Device Name
Episealer Patellofemoral System
Indications for Use (Describe)
The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
The device is intended for cemented fixation.
| 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
| Device Trade Name: | Episealer® Patellofemoral System |
|---|---|
| Manufacturer: | Episurf Operations, ABKarlavägen 60SE-114 49 StockholmSweden |
| Contact: | Ms. Hollace Saas RhodesVice President, Orthopedic Regulatory AffairsMCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Direct: (202) 552 5807Mobile: (240) 472 7464hrhodes@mcra.com |
| Prepared by: | MCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: 202.552.5800 |
| Date Prepared: | December 23, 2022 |
| Regulation: | 21 CFR 888.3540, Knee Joint Patellofemoral Polymer/MetalSemi-Constrained Cemented Prosthesis |
| Class: | II |
| Product Code: | KRR |
| Primary Predicate: | Arthrosurface Patello-Femoral Arthroplasty System (K060127) |
| Reference Devices: | Arthrosurface Patello-Femoral Arthroplasty System (K181280,K071413)Restoris Multi Compartmental Knee (MCK) (K172326) |
Indications For Use:
The Episealer Patellofemoral System is intended to be used in patients with osteoarthritis limited to the distal patellofemoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
The device is intended for cemented fixation.
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Device Description:
The Episealer Patellofemoral System is a patient-individualized arthroplasty device which replaces a damaged patellofemoral joint. The subject device consists of two components:
- . Episealer PF
- Patellar Component ●
The Episealer PF component is implanted centrally in the trochlear area of the distal femur. The Patellar Component is implanted on the backside of the patella and articulates with the Episealer PF.
Predicate and Reference Devices:
Predicate: Arthrosurface Patello-Femoral Arthroplasty System (K060127)
Reference Devices: Arthrosurface Patello-Femoral Arthroplasty System (K181280, K071413), and Restoris Multi Compartmental Knee (MCK) (K172326)
Performance Testing Summary:
Wear testing of the Episealer Patellofemoral System was performed. In addition, analyses of contact area and cantilever bending strength were conducted.
A cadaver study was conducted to demonstrate that the components of the patient-matched Episealer Patellofemoral System can be accurately placed relative to the pre-planned position, with proper recession and engagement of the Episealer PF and Patellar components.
The testing, engineering analyses, and cadaver study demonstrate the ability of the Episealer Patellofemoral System to perform as intended in the target population.
Substantial Equivalence:
The Episealer Patellofemoral System is equivalent to the predicate device, the Arthrosurface Patello-Femoral Arthroplasty System, with respect to intended use, materials, geometry, range of sizes, and method of fixation. Therefore, the substantial equivalence between these two devices has been established.
§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”