(181 days)
Archer^R PSI System is indicated as an orthopedic instrument to assist the physician in the intraoperative positioning of total shoulder replacement components and in guiding the drill and the cut of the bone.
Archer^R PSI System must only be used conjointly with Archer™ CSR Total Shoulder (K152825, K173812, K181287, K182500, K191811), Catalyst EA Convertible Stemmed Shoulder (K222317) and Archer™ R1 Reverse (K202611, K211991, K213349, K223655, K232583) components in the context of primary total shoulder replacement and following a delto-pectoral approach only. Archer^R PSI System is manufactured from a pre-operative planning validated by the surgeon in the 'Archer™ 3D Targeting' platform (K213779). Archer^R PSI System is indicated for patient population fulfilling the Archer™ CSR Total Shoulder, Catalyst EA Convertible Stemmed Shoulder and Archer™ R1 Reverse indications and for which CT images are available with identifiable placement anatomical landmarks and compliant with imaging protocol provided by Archer 3D Targeting.
The device is intended for single use only.
The device is intended for adult patients.
The device has to be used by a physician trained in the performance of surgery.
The "Archer PSI System" device is a patient-matched additively manufactured single use surgical instrument (PSI). Archer PSI System is an instrument set containing a glenoid guide and its bone model and/or a humeral guide and its bone model. This patient-specific medical device is designed to fit the patient's anatomy to transfer a patient-specific pre-operative plan to the operating room. It is intended for surgical interventions in orthopaedic procedures for total shoulder arthroplasty.
The Archer PSI system instruments are designed from a draft treatment plan available via the Archer™ 3D Targeting' platform. Based on computed tomography (CT) of the shoulder anatomy, 3D CAD models of the bones and positioning and sizing of the glenoid and humeral components are submitted for evaluation to the surgeon. Upon the surgeon's approval, the guides and bone models are designed based on the validated planning and are manufactured using additive manufacturing.
The provided FDA 510(k) summary for the "Archer PSI System" does not contain the detailed acceptance criteria or the specific study that directly proves the device meets those criteria in a quantitative manner as typically expected for medical device performance studies involving sensitivity, specificity, accuracy, etc. However, it does outline the types of non-clinical and cadaveric testing performed to demonstrate substantial equivalence to a predicate device.
Here's an attempt to structure the information based on the request, extracting what is available and noting what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not overtly state quantitative "acceptance criteria" (e.g., "accuracy must be > 95%") nor does it provide "reported device performance" in terms of explicit metrics like sensitivity, specificity, or error rates. Instead, the "performance" is described in terms of demonstrating "substantial equivalence" through various engineering and cadaveric tests.
A more accurate representation, based on the provided text, would be:
| Acceptance Criteria Category | Description (from document) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Integrity | Demonstrate mechanical integrity post-processing. | Testing was conducted. |
| Debris Generation | Assess debris generation. | Testing was conducted. |
| Intra-Designer Variability | Assess variability within a single designer's output. | Testing was conducted. |
| Inter-Designer Variability | Assess variability between different designers' outputs. | Testing was conducted. |
| Biocompatibility | Ensure material biocompatibility. | Assessment conducted. |
| Cleaning & Sterilization | Validate cleaning and sterilization processes. | Validations conducted. |
| Manufacturing Cleaning | Validate manufacturing cleaning processes. | Validation conducted. |
| Packaging & Shelf-life | Validate packaging integrity and shelf-life. | Validation conducted. |
| Functional Equivalence | Demonstrate functional equivalence to manual techniques for positioning and guiding drill/cut. | Cadaveric testing executed to demonstrate substantial equivalence between two techniques (manual and PSI, for both anatomic and for reverse techniques). |
| Pre-operative Planning | Manufactured from a pre-operative planning validated by the surgeon in the 'Archer™ 3D Targeting' platform (K213779). | The device design is based on surgeon-validated plans within the Archer™ 3D Targeting platform. This implies an acceptance of the planning accuracy by the surgeon. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Cadaveric Testing: The document states that "Cadaveric testing was executed" but does not specify the sample size (number of cadavers or procedures) used for this testing.
- Data Provenance: The cadaveric testing is implied to be prospective in nature, as it was "executed to demonstrate the substantial equivalence." There is no information provided regarding the country of origin of the cadaveric data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: The document states that "a pre-operative planning validated by the surgeon" is part of the process. For the cadaveric testing, it does not explicitly state the number of experts (e.g., surgeons) involved in establishing the "ground truth" or assessing the "substantial equivalence."
- Qualifications of Experts: The document mentions that the device is to be used by a "physician trained in the performance of surgery." For the validation of the pre-operative plan, the expert is identified as "the surgeon." While this indicates a medical professional, specific qualifications (e.g., years of experience, subspecialty) are not provided.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the cadaveric testing or any other performance evaluation. The "validation by the surgeon" for the pre-operative plan suggests a form of single-expert consensus at the planning stage, but not for the overall performance assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size: As no MRMC study was performed, no effect size of human readers improving with AI vs. without AI assistance is reported. The Archer PSI System is a patient-specific instrument, not an AI diagnostic or assistive tool in the MRMC sense. The comparison was between manual surgical techniques and PSI-assisted techniques in cadavers.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Not explicitly in terms of an "algorithm only" performance study. The device itself is a physical, patient-specific instrument derived from a digital plan. The document describes "Cadaveric testing" which evaluates the combined PSI system (planning software output + physical guide) in a simulated surgical environment, not just the planning algorithm in isolation from its physical manifestation or use.
- The "Intra- and Inter-Designer Variability testing" and "Mechanical Integrity" tests are standalone evaluations of aspects of the device's design and manufacturing, but not of the surgical guidance algorithm's performance on its own.
7. Type of Ground Truth Used
- For Pre-operative Planning: The ground truth for the design of the PSI System is based on a "pre-operative planning validated by the surgeon" using CT images and anatomical landmarks. This can be considered a form of expert consensus/validation on the desired surgical outcome/instrument design.
- For Cadaveric Testing: The "ground truth" for the cadaveric study would be the actual anatomical targets and the achieved drill/cut placements, compared to the planned placements and traditional manual techniques. While experts (surgeons) would perform and assess these, the ultimate "truth" is the physical reality within the cadaver. The document implies comparison to "manual techniques" as a reference.
8. Sample Size for the Training Set
The document does not provide any information regarding a "training set sample size." The Archer PSI System is described as being "designed from a draft treatment plan" and "manufactured from a pre-operative planning validated by the surgeon." This suggests a patient-specific design process rather than a machine learning model trained on a large dataset. The underlying "Archer™ 3D Targeting' platform (K213779)" (a separate cleared device) would be the system performing the planning, and its own 510(k) might contain training data details if it uses AI/ML. However, for the Archer PSI System itself, no training set information is present.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned for the Archer PSI System in this document, no information is provided on how its ground truth would have been established.
§ 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.”