(122 days)
The AltiVate Anatomic™ Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
- · Rheumatoid and other inflammatory arthritis
- · Correction of functional deformity, including fracture malunion
- Humeral head fracture
- · Revision of other devices if sufficient bone stock remains
The AltiVate Anatomic™ Shoulder System is a hemiarthroplasty shoulder replacement for patients with a functional deltoid muscle suffering from pain and dysfunction due to:
· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural head and/or glenoid, and post traumatic arthritis
- · Rheumatoid and other inflammatory arthritis
- · Correction of functional deformity, including fracture malunion
- · Humeral head fracture
- Rotator cuff tear arthropathy
- · Revision of other devices if sufficient bone stock remains
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.
Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.
The AltiVate Anatomic™ Shoulder System consists of four primary components: humeral stem, neck, head and glenoid. Components are offered for use for either primary or revision surgery applications, in a hemi or total shoulder application.
The proximal body of the stem is rectangular in cross-sectional geometry and tapers proximal to distal. The distal stem is cylindrical. Anterior and posterior fins are located on the proximal body to help provide rotational stability. The anterior and posterior fins have suture holes to allow reattachment of soft tissue and bone fragments in the case of humeral head fracture.
The humeral neck has two male Morse type tapers that differ in size to prevent incorrect installation. The smaller Morse type taper interfaces with the female Morse type taper in the humeral stem, while the larger Morse type taper interfaces with the female Morse type taper in the humeral head.
The humeral heads are available in standard and offset configurations. In the offset configuration, the male Morse type taper on the humeral heads is offset from the center that makes it possible to orient the head in asymmetric positions on the symmetric stem, thus allowing the surgeon to intraoperatively select the position of the humeral head to recreate the anatomy of the individual patient.
The glenoid components are fabricated from vitamin E ultra-high molecular weight polyethylene and ultra-high molecular weight polyethylene. The articulating surface has a radius of curvature greater than the corresponding humeral head. This allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted.
This document (K162024) is a 510(k) premarket notification for a medical device called the AltiVate Anatomic™ Shoulder System, a shoulder joint replacement. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance acceptance criteria through the kind of studies you describe in the input.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present or applicable in this regulatory document.
Here's a breakdown based on the information provided and the nature of a 510(k) submission:
-
A table of acceptance criteria and the reported device performance:
A formal table like this is not included in this document. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and presents results from non-clinical mechanical testing to ensure performance under expected conditions. The acceptance "criteria" are implicitly tied to the performance of the predicate devices and the relevant ASTM/ISO standards followed for mechanical testing. -
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
For the non-clinical mechanical testing mentioned ("Rocking Horse, Stem/Head Fatigue and Humeral Head Disassociation"), the document does not specify sample sizes or data provenance directly. This is common for summaries of mechanical tests where standard test methods (e.g., ASTM F2028 for 'Rocking Horse' or similar fatigue standards) would dictate sample sizes. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. The document describes a medical device, not an AI or diagnostic device that requires expert-established ground truth for performance evaluation in the way you've outlined. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is a medical device submission, not a study evaluating human reader performance or algorithm output. -
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:
Not applicable. This is a medical device (shoulder implant), not an AI-assisted diagnostic tool. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (shoulder implant), not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of an AI or diagnostic device's ground truth. For the device itself, its functional "ground truth" would be its mechanical integrity and biocompatibility, demonstrated through material testing, mechanical load testing, and clinical use (post-market, as no clinical study was required for this 510(k)). -
The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model. -
How the ground truth for the training set was established:
Not applicable. This is a medical device, not a machine learning model.
Summary based on available information for K162024:
- Acceptance Criteria/Performance: The submission implies that the device "meets acceptance criteria" by demonstrating substantial equivalence to predicate devices and by successfully undergoing non-clinical mechanical testing.
- Non-Clinical Mechanical Testing: "Rocking Horse, Stem/Head Fatigue and Humeral Head Disassociation" tests were performed.
- Results: "All testing has determined that the device is substantially equivalent to the predicate devices."
- Endotoxin Assessment: Bacterial endotoxin testing was conducted and met expected limits.
- Study That Proves Device Meets Criteria: The non-clinical mechanical testing and the demonstration of substantial equivalence serve this purpose for a 510(k) submission.
- Device Performance Reported: The device's ability to perform under expected conditions was demonstrated, with results indicating substantial equivalence to predicate devices based on the mechanical tests.
- Sample sizes/Data provenance: Not specified for mechanical tests in this summary.
- Clinical Testing: "Clinical testing was not required," indicating that the FDA did not deem a human clinical trial necessary to establish safety and effectiveness for this substantial equivalence submission.
§ 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.”