(35 days)
The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following:
- Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- Omarthrosis.
- Rheumatoid arthritis.
- Revision of shoulder prosthesis.
- Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
The Anatomica Humeral Stem Component is intended for replacement of the proximal portion of the humerus. The Anatomica Humeral Stem is a metallic humeral component manufactured from forged stainless steel alloy (ISO 5832-9). It is available in four sizes which are determined by the diameter of the stem. The proximal aspect of the stem is "trumpet shaped" to match the metaphysis of the humeral shaft. Rotational stability is ensured by a proximal fin on the lateral aspect. Two holes in the fin and one in the medial stem body allow for attachment of the tuberosities via sutures/wires. The stem features a slit-ball head fixed at an angle of 135°. An impact screw and expansion cone are inserted through a shaft in the lateral aspect of the stern and into the slit-ball head at the time of surgery. This forces the slit-ball feature to spread open allowing fixation of one of the humeral heads used with the system. The use of the slit ball has the advantage of allowing fixation of the head in a variety of angles. A traumatology cone identical to the expansion cone, except with positioning pegs for head placement, is also available. The heads are manufactured from cast CoCrMo alloy (ISO 5832-4). They are available in 10 sizes with diameters ranging from 40-52mm (in 2mm increments). Sizes 48, 50 and 52mm are offered in two head heights. The spherical female recess for attachment to the slit-ball head of the stem is situated eccentrically to the radius of the humeral head. This recess also features two internal holes for defining position in fracture cases (used in conjunction with the traumatology cone).
The provided text is a 510(k) summary for the "Sulzer Orthopedics Anatomica Humeral Stem/Heads." This document describes a medical device and its intended use, but it does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The document primarily focuses on:
- Product Description: Detailing the materials, design, and sizes of the humeral stem and heads.
- Specific Diagnostic Indications: Listing the conditions for which the device is intended (e.g., arthritis, omarthrosis, revision of shoulder prosthesis, traumatology).
- Substantial Equivalence: Comparing the device to other legally marketed predicate devices. It states that "Static and Dynamic Testing indicated that the device would survive physiologic loading," but does not provide details of this testing, specific acceptance criteria, or the results.
- FDA Review Letter: The letter indicates that the FDA has determined the device to be substantially equivalent to devices marketed prior to May 28, 1976.
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.
Here is what can be inferred or explicitly stated from the document, though it falls short of the detailed request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: "Static and Dynamic Testing indicated that the device would survive physiologic loading." No specific performance metrics (e.g., fatigue life, strength thresholds) or quantitative results are provided.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified, but implied to be laboratory testing (static and dynamic).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical study or expert-based ground truth is described. The "testing" referred to is mechanical.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this document describes a mechanical orthopedic implant, not an AI or imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable as this is not an algorithm or AI device.
7. The type of ground truth used:
- For the engineering tests, the "ground truth" would be established mechanical engineering principles and benchmarks for orthopedic implants (e.g., ISO standards for an implant or similar specific standards). The document only states the device "would survive physiologic loading," implying it met some pre-defined mechanical performance criteria.
8. The sample size for the training set:
- Not applicable as this is not a machine learning/AI device.
9. How the ground truth for the training set was established:
- Not applicable as this is not a machine learning/AI 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.”