(123 days)
The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.
The Signature™ ONE System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the Signature™ ONE System.
The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal Reverse Plus® Shoulder. Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance® Glenoid System.
The Signature™ ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, and Identity™ Shoulder System.
The Signature™ ONE System Guides and bone models are intended for single use only.
The Signature™ ONE System is developed to assist in preoperative planning (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides and bone model) if desired in skeletally mature individuals for Total Shoulder Arthroplasty. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.
The Signature ONE Guides and Bone Models are designed and manufactured of polyamide (nylon) using additive manufacturing selective laser sintering (SLS), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provided nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan on the scapula. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty workflow.
The Signature™ ONE System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.
The purpose of this submission is to introduce new hardware kits for the existing compatible Comprehensive Reverse Augment implants and to include the addition of pre-operative planning of humeral components. A Rotational Guide component will be available as part of these two kits. Modifications have been made to the software applications to accommodate the new guide ordering option. The overall manufacturing process, materials, sterilization methods, have not changed from the previous primary predicate and principal of operation remains similar.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific performance metrics typically found in such documents. The "Summary of Performance Data (Nonclinical and/or Clinical)" section is quite generic, listing categories of tests rather than specific results or acceptance criteria.
Therefore, I cannot fulfill all components of your request with the information provided. However, I can extract what is available and highlight what is missing.
Here's a summary of the available information and what is absent:
Missing Information:
- Specific Acceptance Criteria and Reported Device Performance (Table): The document lists categories of tests (Performance Tests, Engineering Analysis, Usability Engineering, Validation, Software V&V) but does not provide quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) or the actual reported performance values for the device against these criteria.
- Sample size for the test set and data provenance: The document mentions "Verification and Validation Testing" but does not specify the number of cases or subjects in the test set, nor the country of origin or whether the data was retrospective or prospective.
- Number of experts used to establish ground truth and their qualifications: No information is provided about the experts involved in establishing ground truth for any test sets.
- Adjudication method for the test set: No information is provided regarding adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not mention an MRMC study or any results regarding human reader improvement with AI assistance.
- Standalone (algorithm-only) performance: While software verification and validation are mentioned, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) for the algorithm are not provided.
- Type of ground truth used: The description of "Validation... to validate related user needs, intended use and safety and effectiveness" is generic and does not specify how ground truth was established (e.g., expert consensus, pathology, outcome data).
- Sample size for the training set: There is no mention of a training set or its size.
- How the ground truth for the training set was established: Since a training set is not mentioned, the method for establishing its ground truth is also not provided.
Available Information (Indirectly related to performance):
The document primarily focuses on establishing substantial equivalence to a predicate device (K212560 and K211359) by demonstrating that the new device, the Signature™ ONE System, does not raise new questions of safety or effectiveness despite new features.
The performance data mentioned in the document is categorized as:
- Device Performance Testing:
- Performance Tests: Documented to ensure performance of implemented features and verify related design inputs.
- Engineering Analysis: Documented to ensure performance of implemented features and verify related design inputs.
- Usability Engineering: Performance of the system in regards to human factors engineering.
- Validation: Performed to validate related user needs, intended use, and safety and effectiveness.
- Software Verification and Validation Testing: Conducted to satisfy requirements of the "Content of Premarket Submissions for Device Software Functions Guidance" and IEC 62304. This testing aims to demonstrate the system "does not raise any new issues of safety and effectiveness as compared to the predicate devices."
Conclusion from the document:
The conclusion drawn by the submitter is that "any differences between the subject and predicate devices do not raise different questions of safety and effectiveness and the proposed device is at least as safe and effective as the legally marketed predicate devices." This implies that the performance data (though not detailed here) was sufficient to demonstrate this equivalence.
§ 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.”