(143 days)
The DELTA XTEND Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previous failed joint replacement and/or;
• Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND Reverse Shoulder. Porous-coated epiphysis are indicated for use in total shoulder replacement only.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cemented or cementless use.
All other metallic components are intended for cemented use only.
The DELTA XTEND Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws used for reverse shoulder arthroplasty. The humeral spacer can be added between the epiphysis and the humeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.
This document is a 510(k) Premarket Notification for the DELTA XTEND™ Reverse Shoulder System, a medical device (shoulder prosthesis). It describes the non-clinical performance testing conducted to demonstrate substantial equivalence to legally marketed predicate devices.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" refers to engineering and material performance tests, not a study involving human-in-the-loop AI or diagnostic performance.
Here's an analysis of the provided text in relation to your questions, framed for a medical device rather than an AI/diagnostic system:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values for the device. Instead, it lists the types of non-clinical tests performed to demonstrate safety and efficacy and asserts that the device was "determined as substantially equivalent."
Here's what can be inferred/extracted:
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Fatigue Analysis | Device withstands fatigue loads representative of its intended use and service life (comparable to predicate devices). | Met requirements, supported substantial equivalence. |
| Tolerance Analysis | Manufacturing tolerances ensure proper fit, function, and interchangeability of components within design specifications. | Met requirements, supported substantial equivalence. |
| Epiphysis Comparison and | Design and material characteristics suitable for intended use and comparable to predicate devices. | Met requirements, supported substantial equivalence. |
| Design Justification | ||
| Range of Motion Analysis | Device allows for a functional range of motion, comparable to predicate devices and physiological limits. | Met requirements, supported substantial equivalence. |
| Biocompatibility Study | Materials are biocompatible and do not elicit adverse biological responses (e.g., cytotoxicity, sensitization, irritation). | Materials are biocompatible, supported substantial equivalence. |
| Bacterial Endotoxin Testing | Meets specified limits for bacterial endotoxin (ANSI AAMI ST-72:2011). | The proposed devices meet the requirement of bacterial endotoxin testing. |
| MRI Compatibility Testing | Device is safe for use in an MRI environment, indicating specific field strengths, SAR limits, and artifact characteristics. | Testing conducted in support of adding MRI compatibility language to labeling. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Sizes: The document does not specify the sample sizes (e.g., number of implants or test specimens) used for each non-clinical test (Fatigue Analysis, Biocompatibility, etc.).
- Data Provenance: The data provenance is from non-clinical laboratory testing of the device components. The specific country of origin of these tests is not stated, but the manufacturer "DePuy (Ireland)" is based in Ireland. These are prospective tests performed on newly manufactured devices or components to demonstrate performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device submission.
- Ground Truth: For a shoulder prosthesis, "ground truth" for performance is established through engineering principles, material science, and regulatory standards (e.g., ISO, ASTM standards for implant testing). It's based on objective measurements rather than expert consensus on individual cases.
- Experts: While engineers, material scientists, and regulatory experts would have designed and overseen these tests, the document does not specify their number or qualifications as it would for, say, a clinical diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers (e.g., radiologists) interpret images and their interpretations need to be reconciled for ground truth establishment. For mechanical device testing, results are objective measurements from laboratory equipment and are compared against predetermined engineering specifications.
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 question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where the performance of human readers, potentially aided by AI, is being evaluated. This submission is for a mechanical medical implant, not a diagnostic imaging device or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm in this medical device. The "standalone performance" for this device would be its mechanical performance in a laboratory setting, which is what the non-clinical tests assessed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance is based on:
- Engineering and material science principles: Adherence to established mechanical, physical, and chemical properties required for an implantable device.
- Regulatory standards: Compliance with international and national standards for implantable medical devices (e.g., for fatigue, biocompatibility, endotoxin levels).
- Comparison to predicate devices: The "ground truth" of performance is largely the established safe and effective performance of previously cleared, substantially equivalent devices.
8. The sample size for the training set
This question is not applicable. This device is a mechanical implant; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
February 24, 2020
DePuy (Ireland) % Ashley Goncalo Project Manager - Regulatory Affairs Depuy Orthopaedics, Inc 325 Paramount Drive RAYNHAM MA 02767
Re: K192855
Trade/Device Name: DELTA XTEND™ Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: January 23, 2020 Received: January 24, 2020
Dear Ashley Goncalo:
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
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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
Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192855
Device Name DELTA XTEND™ Reverse Shoulder System
Indications for Use (Describe)
The DELTA XTEND Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
· a previous failed joint replacement and/or;
· Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND Reverse Shoulder. Porous-coated epiphysis are indicated for use in total shoulder replacement only.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cemented or cementless use.
All other metallic components are intended for cemented use only.
| 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
As required by 21 CFR 807.92 and 21 CFR 807.93
| Submission Information | ||
|---|---|---|
| Sponsor Name | DePuy (Ireland) | |
| Sponsor Address | Loughbeg, Ringaskiddy Co. Cork Ireland | |
| Sponsor EstablishmentRegistration Number | 9616671 | |
| 510(k) Contact | Ashley GoncaloDePuy SynthesRegulatory Project Manager | Phone: 508.977.3907Email: agoncalo@its.jnj.com |
| Date prepared | 10/2/2019 | |
| Device Information | ||
| Trade or proprietary name | DELTA XTEND™ Reverse Shoulder System | |
| Common or usual name | Shoulder Prosthesis | |
| Classification name | Shoulder joint metal/polymer semi-constrained cementedprosthesis | |
| Class, regulation | Class II, 21 CFR 888.3660 | |
| Product Code | PHX, KWS | |
| Classification panel | Orthopedics panel | |
| Legally marketeddevice(s) to whichequivalence is claimed | Predicates: DePuy Synthes GLOBAL UNITE Platform ShoulderSystem (K170748) and DELTA XTEND Reverse ShoulderSystem (K071379, K120174)Reference Device: Tornier Aequalis™ Ascend™ Flex ShoulderSystem (K122698) | |
| Reason for 510(k)submission | Line extension to DELTA XTEND Reverse Shoulder System toadd additional epiphysis device components. Additionally, thissubmission supports the addition of MRI compatibility languageto the labeling for the currently marketed, FDA cleared, DELTAXTEND Reverse Shoulder System and GLOBAL UNITEPlatform Shoulder System. | |
| Device description | The DELTA XTEND Reverse Shoulder System consists ofhumeral stem, modular epiphysis, humeral spacer, humeral cup,glenosphere, metaglene and metaglene screws used for reverseshoulder arthroplasty. The humeral spacer can be added betweenthe epiphysis and the humeral cup if necessary. Humeral head canbe used in hemi-shoulder arthroplasty in place of the humeral cupand glenoid components. | |
| Intended use of the device | The DELTA XTEND Reverse Shoulder prosthesis is intended foruse in total or hemi-shoulder arthroplasty procedures in patientswith non-functional rotator cuffs, with or without bone cement. | |
| Indications for use | The DELTA XTEND Prosthesis is indicated for use in treatmentof a grossly deficient rotator cuff joint with:• severe arthropathy and/or;• a previous failed joint replacement and/or;• Fracture-dislocations of the proximal humerus where thearticular surface is severely communited, separated from its bloodsupply or where the surgeon's experience indicates thatalternative methods of treatment are unsatisfactory | |
| The patient's joint must be anatomically and structurally suited toreceive the selected implant(s), and a functional deltoid muscle isnecessary to use the device. | ||
| DELTA XTEND hemi-shoulder replacement is also indicated forhemi-arthroplasty if the glenoid is fractured intraoperatively or forthe revision of a previously failed DELTA XTEND ReverseShoulder. Porous-coated epiphysis are indicated for use in totalshoulder replacement only. | ||
| The metaglene component is HA coated and is intended forcementless use with the addition of screws for fixation. Themodular humeral stem is HA coated and is intended forcementless use. The HA coated humeral epiphysis is intended forcementless use. The porous-coated epiphysis is intended forcemented or cementless use. | ||
| All other metallic components are intended for cemented useonly. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE | ||||
|---|---|---|---|---|
| PREDICATE DEVICES | ||||
| Characteristic | Subject Device:Epiphysis Device -DELTA XTENDTMReverse ShoulderSystem | Primary PredicateDevice:Epiphysis Device -DePuy SynthesGLOBAL UNITEPlatform ShoulderSystem (reverseconfiguration)(K170748) | Predicate Device:Epiphysis Device -DELTA XTENDTMReverse ShoulderSystem (K071379,K120174) | Reference Device:Epiphysis Device -Tornier AequalisTMAscendTM FlexShoulder System(reverse configuration)(K122698) |
| Intended Use | Reverse shoulderarthroplasty | Reverse shoulderarthroplasty | Reverse shoulderarthroplasty | Reverse shoulderarthroplasty |
| Material | ||||
| Epiphysis Component | Titanium alloy withPorocoat® porous-coating | Titanium alloy withPorocoat® porous-coating | Titanium alloy withhydroxyapatite coating | Titanium alloy withtitanium plasma spraycoating |
| Screw Component | Titanium alloy | Titanium alloy | Titanium alloy | N/A |
| Design | ||||
| Modularity | Epiphysis componentinterfaces with stemcomponent via male-female boss and screw | Epiphysis componentinterfaces with stemcomponent via male-female boss and screw | Epiphysis componentinterfaces with stemcomponent via male-female boss and screw | Stem component(unified epiphysis anddiaphysis) interfaceswith reversed traycomponent |
| Neck Shaft Angle | 145° and 155° | 155° | 155° | 145° |
| Epiphysis Sizes | Size 1 and 2 (incentered, eccentric leftand eccentric rightversions) | Size 1 (in centered,eccentric left andeccentric right versions) | Size 1 and 2 (incentered, eccentric leftand eccentric rightversions) | N/A |
| PERFORMANCE DATA | ||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | ||||
| The proposed Epiphysis Device of the DELTA XTEND Reverse Shoulder System was determined as substantially equivalent interms of safety and efficacy with the predicate devices as demonstrated by the following: | ||||
| Fatigue Analysis Tolerance Analysis Epiphysis Comparison and Design Justification Range of Motion Analysis Biocompatibility Study | ||||
| The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72:2011.Additionally, MRI testing was conducted in support of adding MRI compatibility language for the currently marketed shoulderplatforms, with which the proposed devices are compatible – the existing DELTA XTEND Reverse Shoulder System and GLOBALUNITE Shoulder System. | ||||
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCEAND/OR OF CLINICAL INFORMATION | ||||
| No clinical tests were conducted to demonstrate substantial equivalence. | ||||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | ||||
| The proposed epiphysis device of the DELTA XTEND Reverse Shoulder System is substantially equivalent to the epiphysis devicesof the predicate DePuy Synthes GLOBAL UNITE Platform Shoulder System and predicate DELTA XTEND Reverse ShoulderSystem. |
Traditional 510(k) – DELTA XTEND Reverse Shoulder System
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§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid 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. 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)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(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,” and
(vii) 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”