(120 days)
The CAS PSI Shoulder is intended to be used as a surgical instrument to construct and transfer a pre-surgical plan to orthopaedic surgical procedures. The CAS PSI Shoulder 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 otherwise precluded from being radiologically scanned.
The CAS PSI Shoulder is to be used with the Zimmer® Trabecular Metal™ Reverse Shoulder Baseplate in accordance with the implant system's indications and contraindications.
The CAS PSI Shoulder hardware components (jigs and bone model) are intended for single use only.
The CAS PSI Shoulder consists of both software and hardware components and requires the patient to be radiologically scanned. The CAS PSI Shoulder has been developed with the fundamental goals to assist in pre-operative planning (using the CAS PSI Shoulder Software) and to accurately construct and transfer a pre-operative plan to orthopedic surgical procedures (using the CAS PSI Shoulder Hardware). The hardware (jigs and bone model) have features designed to mate with legally marketed instruments to aid in the implantation of legally marketed Class II implant devices. The hardware components are designed to mate with legally marketed instruments and thus indirectly aid in the placement of legally marketed implants. The software is developed in C++ programming language for a windows operating system. The hardware (jigs and bone guide) are made from biocompatible polyamide (Duraform) with press-fit 304 and 17-4 Stainless Steel components.
The provided text describes the "CAS PSI Shoulder" device, a surgical planning and instrument guidance system for shoulder replacement procedures. However, the document does not contain the level of detail requested in the prompt regarding acceptance criteria and a specific study proving the device meets those criteria.
Instead, it provides a general overview of non-clinical performance studies and a high-level conclusion.
Here's a breakdown of what can and cannot be extracted from the given text based on your request:
What can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document states: "Non-clinical testing demonstrated that the CAS PSI Shoulder meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy."
However, it does not provide a specific table of acceptance criteria nor quantified device performance metrics from these tests. It only lists the types of non-clinical studies conducted.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail. The document generally indicates meeting "performance requirements as defined by Design Control activities" and achieving "substantial equivalence." | "Meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified for any of the listed non-clinical studies.
- Data Provenance: Not specified for any of the listed non-clinical studies (e.g., country of origin, retrospective/prospective). The studies are listed as "Simulated Use Testing," "Cadaveric Testing," etc., implying laboratory or cadaver-based testing rather than clinical patient data.
3. 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):
- This information is not provided in the document. The non-clinical studies (Simulated Use, Cadaveric) would likely involve internal experts or engineers evaluating performance, but their number and qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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:
- No, an MRMC comparative effectiveness study was not done or reported. The document focuses on non-clinical testing and states that "clinical data and conclusions were not needed to demonstrate substantial equivalence." The device assists in planning but the studies listed are not designed to measure human reader improvement with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes "Software Verification and Validation" as one of the non-clinical studies. This would likely involve evaluating the algorithm's performance in a standalone capacity internally. However, specific metrics of its standalone performance (e.g., accuracy, precision) are not reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical studies:
- Simulated Use Testing & Cadaveric Testing: The ground truth would likely be based on established anatomical landmarks, surgical protocols, engineering specifications, and possibly measurements of implant or instrument placement accuracy against a predefined ideal.
- Software Verification and Validation: Ground truth would be based on expected software output given specific inputs, adherence to design specifications, and computational accuracy.
- Specific methodologies for establishing ground truth are not detailed.
8. The sample size for the training set:
- Not applicable/Not provided. The document describes a "Software Verification and Validation" study and does not mention machine learning or AI in a way that suggests a distinct training set for an AI model. The software component aids in pre-operative planning, which is a rules-based or computational task rather than a traditional machine learning model requiring a training set in the context of this document.
9. How the ground truth for the training set was established:
- Not applicable/Not provided for the same reasons as point 8.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance studies (simulated use, cadaveric, biocompatibility, sterilization, dimensional stability, drop testing, and software verification/validation). It explicitly states that clinical data and conclusions were not needed. As such, it lacks the detailed performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods typically found in studies evaluating AI diagnostic or prognostic devices against specific acceptance criteria.
§ 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.”