(28 days)
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the humeral head and/or glenoid;
- . rheumatoid arthritis;
- . correction of functional deformity:
- . humeral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This system is to be used for cemented applications
The purpose of this application is to include a new keeled and pegged glenoid for the Turon Shoulder System manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics relatable to AI/ML or diagnostic accuracy. Instead, the document is a 510(k) summary for a medical device (Turon e+ Glenoid) and the FDA's clearance letter.
However, based on the information provided regarding the device and its clearance, I can infer the "acceptance criteria" and "study" in a regulatory context, focusing on the equivalence to predicate devices, rather than performance metrics like sensitivity or specificity.
Here's an interpretation based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied Regulatory) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device has the same intended use and technological characteristics as predicate device, or if different, the differences do not raise new questions of safety and effectiveness. | "Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use." |
| Non-Clinical Performance: Device meets established standards and demonstrates performance for its intended use through bench testing. | "Testing included: cyclic displacement test, glenoid pull-out test, impact resistance, small punch testing, tensile testing, oxidation testing, biocompatibility, and cytotoxicity." |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices. | FDA determined the device is "substantially equivalent...to legally marketed predicate devices." This implies safety and effectiveness have been adequately addressed for regulatory clearance. |
| Indications for Use: Device indications align with predicate devices and accepted medical practice for joint replacement. | Indications for Use listed are consistent with those for shoulder joint prostheses. |
| Materials: Use of materials (UHMWPE and highly crossed-linked UHMWPE infused with Vitamin E) is safe and effective and comparable to predicate devices. | The device uses "both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E," which suggests these materials have been established as safe and effective in similar predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document explicitly states "Clinical Testing: None provided." The "test set" in this context refers to the non-clinical tests performed on the physical device, not patient data.
- Data Provenance: Not applicable for a traditional test set with patient data. Non-clinical testing results would be generated in a lab setting, presumably by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts and Qualifications: Not applicable. For non-clinical, bench-top testing, ground truth isn't established by medical experts in the same way it would be for a clinical trial or AI model. The "ground truth" for these tests are the established engineering and material science standards and methodologies which the device must meet.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication typically refers to expert review of clinical cases. For non-clinical testing, the results are compared directly against predefined specifications and standards.
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
- No MRMC study was done. This information is not relevant to this type of device (a physical implant) or the regulatory submission provided, which explicitly states "Clinical Testing: None provided."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical shoulder joint prosthesis, not an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for this device's non-clinical testing refers to established engineering specifications, material properties, and performance standards for a shoulder joint prosthesis (e.g., specific thresholds for cyclic displacement, pull-out strength, impact resistance, tensile strength, oxidation resistance, biocompatibility, and cytotoxicity). These are objective measurements against predefined limits.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical implant, not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical device.
§ 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.”