(26 days)
The Arthrex Univers Apex, Size 5 Stem is indicated for:
The Arthrex Univers Apex is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
The Arthrex Univers Apex, Size 5 Stem, subject to this submission, is a smaller version of the previously cleared Arthrex Univers Apex (K131633). It is a modular stem with fixed inclination angle design and is the identical size as the previously cleared Size 5 Univers II stems (K103466). The stem is machined of titanium alloy. The distal section of the stem has a conical design. The proximal section of the stem is rectangular in design and has a morse-taper for the mating of humeral heads. The stem's surface finish is textured for cemented or press-fit (non-cemented) implantation. The Arthrex Univers Apex, Size 5 Stem falls within the length range of the previously cleared Univers Apex stems (K131633).
The document is a 510(k) premarket notification for the Arthrex Univers Apex, Size 5 Stem, a shoulder prosthesis. This submission is a line extension to a previously cleared device. Therefore, the acceptance criteria and study described are not for a medical imaging AI/ML device but for a physical medical device (shoulder prosthesis).
The relevant sections for acceptance criteria and performance are found in the "Special 510(k): Arthrex Univers Apex, Size 5 Stem" section, specifically under "Substantial Equivalence Summary."
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Safety and Effectiveness Equivalence: The device should be substantially equivalent to predicate devices in intended use, design, size range, and material, with any differences not raising new questions of safety and effectiveness. | The device is a "smaller version of the previously cleared Arthrex Univers Apex (K131633)" and the "identical size as the previously cleared Size 5 Univers II stems (K103466)." The submission asserts: "An differences between the Arthrex Univers Apex, Size 5 Stem and the predicates are considered minor and do not raise questions concerning safety and effectiveness." |
| Mechanical Performance: The device's mechanical performance should be adequate for its intended use and equivalent to predicate devices. This implies meeting certain strength, durability, and functional requirements under simulated use conditions. | "The submitted in vitro testing (cyclic compression loading) The submitted mechanical testing data demonstrated that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Univers Apex, Size 5 Stem is adequate for their intended use." |
| Biocompatibility (implied): As a metal alloy implant, biocompatibility is a critical implicit criterion. While not explicitly detailed as "acceptance criteria," the use of "titanium alloy" (a commonly used and well-understood biomedical material) in a device found substantially equivalent implies that biocompatibility has been addressed through material selection and prior clearance of similar devices. | "The stem is machined of titanium alloy." The substantial equivalence claim based on material with predicate devices (which would have undergone biocompatibility assessment) serves as the performance evidence. |
| Design and Features: The design features should be consistent with the intended use and not introduce new safety or effectiveness concerns compared to predicate devices. This includes aspects like modularity, inclination angle, distal and proximal sections, and surface finish. | "It is a modular stem with fixed inclination angle design... The distal section of the stem has a conical design. The proximal section of the stem is rectangular in design and has a morse-taper for the mating of humeral heads. The stem's surface finish is textured for cemented or press-fit (non-cemented) implantation." These design features are compared to those of the predicate devices. |
| Length Range Compliance: The device length should fall within the range of previously cleared predicate devices or be justified. | "The Arthrex Univers Apex, Size 5 Stem falls within the length range of the previously cleared Univers Apex stems (K131633)." |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a mechanical performance study involving "in vitro testing (cyclic compression loading)." The document does not provide details of this study beyond its type.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the in vitro mechanical testing. For physical devices, "sample size" typically refers to the number of devices tested.
- Data Provenance: The testing was "in vitro," meaning it was conducted in a lab setting, not using human or animal subjects. No specific country of origin for the data is mentioned, but the manufacturer is based in Naples, FL, USA. The testing is assumed to be prospective in nature, as it's conducted to support a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a physical medical device (shoulder prosthesis) and not an AI/ML device requiring expert interpretation for ground truth. Mechanical testing relies on engineering standards and measurements, not expert consensus on diagnostic images.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as above. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in diagnostic studies, not for mechanical device testing.
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 information is not applicable. This is not an AI-assisted diagnostic device. The study involved mechanical testing of a shoulder implant, not human readers or AI assistance. The document explicitly states: "Clinical data and conclusions are not needed for this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the mechanical performance of the implant itself, which was assessed through in vitro testing.
7. The type of ground truth used:
For this device, the "ground truth" for proving its performance is mechanical testing data against established engineering standards and performance of predicate devices. This is based on quantifiable physical measurements of strength, durability, and other mechanical properties under simulated conditions.
8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of a physical device's mechanical testing in the way it is used for AI/ML models.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 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.”