(194 days)
The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
- 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.
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component).
Shoulder Hemiarthroplasty is also indicated for: - Ununited humeral head fractures.
- Avascular necrosis of the humeral head.
- Rotator cuff arthropathy.
- Deformity and/or limited motion.
The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.
The Modular Total Shoulder System consists of a line of proximal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural numeral nead may befficient bearing surface, or in conjunction with the glenoid, as a gronold proximal bodies and humeral stems are manufactured from total replacemont: "The and connect together via a Morse type taper. The humeral theads are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and are offered in both concentric and eccentric configurations. The humeral head may onered in both contral glenoid bone if it is of sufficient quality, or against the all antionate against the naturanid. The glenoid is manufactured from ultra high polycthylone oomonton gronone (UHMVPE) and is offered in a keeled and pegged molecular weight porychylons (Ornaare designed to function with both the concentric and eccentric heads.
The provided document is a 510(k) summary for a medical device (Ascension® Modular Total Shoulder System) and primarily focuses on establishing substantial equivalence to predicate devices through design, function, and laboratory testing. It does not describe a study involving a comparison of device performance against pre-defined acceptance criteria related to a specific diagnostic or clinical efficacy outcome that would typically apply to AI/ML or imaging devices.
Instead, the "acceptance criteria" and "study" in this context refer to the engineering and biocompatibility tests conducted to demonstrate that the new device is as safe and effective as the predicate devices. The "performance" being reported is the outcome of these engineering tests, not a clinical diagnostic performance.
Therefore, many of the requested categories in your prompt related to diagnostic studies (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set size, how training ground truth was established) are not applicable to this type of device submission.
Here's an adaptation of your requested table and information based on the content available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test / Performance Metric | Predicate Device Reference(s) (Acceptance Level Implied) | Reported Device Performance (Ascension Modular Total Shoulder System) |
|---|---|---|---|
| Mechanical Durability & Connection Integrity | Axial Disassembly Force of Taper Connections | K032126/K063578 (Smith & Nephew/PLUS PROMOS Modular Shoulder System) | Tested to substantiate equivalence. (Specific numerical result not provided in summary, but assumed to meet or exceed predicate.) |
| Mechanical Durability & Fatigue | Bending Taper Fatigue Endurance | K032126/K063578 (Smith & Nephew/PLUS PROMOS Modular Shoulder System) | Tested to substantiate equivalence. (Specific numerical result not provided in summary, but assumed to meet or exceed predicate.) |
| Mechanical Stability & Loosening Resistance | Dynamic Evaluation of Glenoid Loosening | K962082 (Osteonics' All Polyethylene Glenoid Shoulder Keeled Components) | Tested to substantiate equivalence. (Specific numerical result not provided in summary, but assumed to meet or exceed predicate.) |
| Geometrical Comparison | Overall Design, Function, and Intended Use | K032126/K063578, K962082 | No significant differences in design, function, and intended use that would adversely affect product use when compared to predicate devices. |
Study Description:
The study conducted to demonstrate the device meets the acceptance criteria was primarily a series of benchtop engineering tests and a geometrical comparison to establish substantial equivalence with legally marketed predicate devices.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of human subjects or imaging data. The "sample size" refers to the number of device components or assemblies tested for each engineering test. Specific numbers were not provided in the summary, but standard engineering practices would dictate sufficient samples for valid statistical analysis for each test type.
- Data Provenance: The data originates from laboratory testing performed by or for Ascension Orthopedics, Inc. The location of the testing facility is not specified, but it's internal to the device development and regulatory submission process. It is prospective in the sense that these tests were specifically designed and executed for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context is determined by engineering specifications, material properties, and established test standards (e.g., ASTM or ISO standards for orthopedic implants), not by clinical experts interpreting data.
4. Adjudication method for the test set: Not applicable. The "adjudication" is based on objective measurements and comparison against predefined engineering performance limits or performance of predicate devices, not on expert consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, which is not the case for an orthopedic implant's substantial equivalence submission based on mechanical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone performance study was not done. This concept is specific to AI/ML algorithms, not to mechanical orthopedic implants.
7. The type of ground truth used:
- Engineering Specifications: Performance standards derived from industry norms (e.g., ISO, ASTM for orthopedic implants) and the known performance characteristics of the predicate devices.
- Predicate Device Performance: The primary "ground truth" for showing substantial equivalence is the established safety and effectiveness profile of the predicate devices (Smith & Nephew/PLUS PROMOS Modular Shoulder System and Osteonics' All Polyethylene Glenoid Shoulder Keeled Components). The new device's performance in mechanical tests is compared against that of these predicates.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device submission. The design and manufacturing process are analogous to "training" in the sense of refinement and optimization, but not in the data-driven AI sense.
9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission is for an orthopedic implant, where substantial equivalence is demonstrated through engineering characterization and comparison to predicate devices, rather than through clinical diagnostic performance studies typically associated with AI/ML or imaging devices. Therefore, many of your specific questions are not relevant to the type of data presented in this document.
§ 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.”