(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."
§ 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.”