(216 days)
The DePuy Synthes DELTA XTEND™ Shoulder 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 comminuted, 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 either HA coated or porous-coated and is intended for cementless use with the addition of screws for fixation. Central screws can only be used with the porous-coated metaglenes and are required to be used with porous-coating augmented metaglenes.
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 cementless use.
All other metallic components are intended for cemented use only.
The DELTA XTEND Reverse Shoulder System consists of humeral stems, modular epiphysis, humeral spacers, humeral cups, glenospheres, metaglenes and metaglene screws used for reverse shoulder arthroplasty. Humeral heads can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.
The metaglenes are available in various design configurations including standard and augmented designs. The metaglenes allow for the placement of a central screw down the center of the post. A separate collet component is inserted into the metaglene post to receive the locking screw of the glenospheres.
The provided text describes a 510(k) premarket notification for a medical device, the DELTA XTEND Reverse Shoulder System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study or AI-driven performance metrics.
Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set details for AI/algorithm performance are not applicable to this 510(k) submission.
This submission is for a mechanical medical device (shoulder prosthesis), not a diagnostic or AI-based device that would typically undergo studies with the kind of performance metrics and ground truth establishment outlined in the request. The "Performance Data" section lists various mechanical tests (e.g., Pullout Evaluation, Fatigue Evaluation, Micromotion Evaluation), which are standard for orthopedic implants to demonstrate their physical properties and durability, ensuring they are comparable to existing, legally marketed devices.
Here's why the queried information is not present in the provided text:
- Acceptance Criteria & Reported Performance Table: The document doesn't provide numerical acceptance criteria for clinical performance (like sensitivity/specificity for a diagnostic device) or reported performance against such criteria. Instead, it demonstrates equivalence through design, materials, and mechanical testing.
- Sample Size & Data Provenance (for test/training sets): These are relevant for clinical trials or AI model validation datasets. For a 510(k) for a mechanical implant, the "sample size" would refer to the number of devices or test specimens used in engineering bench testing, not patient data for algorithm training/testing. Such detailed numbers are typically found in the full technical reports submitted to FDA, not in the summary document.
- Expert Ground Truth, Adjudication, MRMC, Standalone Performance: These concepts are specific to diagnostic devices, especially those involving image interpretation or AI algorithms where human readers' performance is augmented or replaced. They are not applicable to the evaluation of a shoulder prosthesis itself.
- Type of Ground Truth: For this device, the "ground truth" would be established through engineering specifications, material science, biomechanical principles, and the established performance of predicate devices. There wouldn't be "expert consensus" or "pathology" in the sense of diagnosing a condition; rather, it refers to engineering and clinical consensus on mechanical properties and surgical outcomes.
- Training Set Sample Size & Ground Truth Establishment: Again, these are AI/machine learning terms and do not apply to this type of device submission.
In summary, the provided document is a regulatory submission for a physical implant, not an AI/diagnostic device. The "study" referenced in the document (under "Performance Data") refers to benchtop mechanical and material testing, performed to demonstrate that the device is as safe and effective as its predicate devices, rather than a clinical study evaluating diagnostic accuracy or human performance improvement.
§ 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.”