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510(k) Data Aggregation
(22 days)
CFR 888.3670)
- HSD- Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690
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 and contraindications: 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 and contraindications: 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 non-sterile and sterilized at the hospital. They are used intra-operatively 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 the submission is that the CT Reconstruction internal software application was updated with an improved AI/ML locked model for automatic segmentation and also retraining the model with new production grade scapula and humerus CT segmentations. The AI/ML model is used in the Segmentation step only within the CT Reconstruction internal software application prior to manual segmentation performed by the Zimmer Biomet operator. The use of AI has not changed since predicate K232425. In addition, the Landmarking step within the internal software application was updated with option to select additional configurable landmarks in the Planning application (used to determine the reference coordinate systems to provide native bone information).
The provided FDA 510(k) clearance letter for the Signature™ ONE System does not contain a detailed study with specific acceptance criteria, reported performance, or comprehensive information about the data used for testing and training. This document focuses on demonstrating substantial equivalence to a predicate device, K232425 Signature™ ONE System.
The information regarding acceptance criteria and the study that proves the device meets them is very limited in this document. The submission states that "Performance tests documented to ensure the performance of the implemented features and verify related design inputs" were conducted, but does not provide details of these tests or their results.
Here's an attempt to extract and infer the requested information based on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance Study for Signature™ ONE System (AI/ML Segmentation Update)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric/Description (Inferred) | Reported Device Performance |
|---|---|---|
| AI/ML Segmentation | Accuracy, precision, recall for automatic segmentation of scapula and humerus CT images. | Not explicitly stated. The document indicates the model was "retrained with new production grade scapula and humerus CT segmentations" and is "used in the Segmentation step only within the CT Reconstruction internal software application prior to manual segmentation performed by the Zimmer Biomet operator." This implies sufficient performance to assist operators, but no quantitative metrics are provided. |
| Landmarking | Correct placement and configuration of additional landmarks in the Planning application. | Not explicitly stated. The document notes "additional configurable landmarks" were added, and it "uses existing landmarks to determine the reference coordinate systems." This suggests functionality was verified, but no specific performance targets or results are given. |
| Overall System Performance | Performance of implemented features and verification of related design inputs, in line with prior predicate device performance. | "Performance tests documented to ensure the performance of the implemented features and verify related design inputs." No specific results or metrics are given. |
| Usability Engineering | Performance regarding human factors engineering. | "This remains unchanged and applicable from the predicate K232425." No specific results are provided. |
| Validation | Related user needs, intended use, safety, and effectiveness. | "Validation performed to validate related user needs, intended use and safety and effectiveness. This remains unchanged and applicable from the predicate K232425." No specific results are provided. |
| Software Verification and Validation | Adherence to IEC 62304 and FDA guidance for software functions, demonstrating no new safety/effectiveness questions. | "The testing demonstrates that the Signature™ ONE System does not raise any different questions of safety and effectiveness as compared to the predicate devices." No specific tests or results detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions the AI/ML model was "retrained with new production grade scapula and humerus CT segmentations" and previous "humerus scans were exploratory quality." This implies a test set was used to establish the "new production grade" status, but the exact size is not provided.
- Data Provenance: Not specified. It only mentions "production grade scapula and humerus CT segmentations." The country of origin and whether the data is retrospective or prospective are not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The AI/ML model is described as assisting "prior to manual segmentation performed by the Zimmer Biomet operator," implying an assistive role, but no comparative study is detailed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not explicitly stated as a standalone "study." The language "used in the Segmentation step only (...) prior to manual segmentation" suggests the AI performs segmentation independently before human review/modification, but its standalone performance metrics are not provided. The overall system is described as having manual segmentation by an operator after the AI step.
7. Type of Ground Truth Used
- Type of Ground Truth: The document refers to "new production grade scapula and humerus CT segmentations." This implies that the ground truth for segmentation was established by expert review and/or manual segmentation deemed as high quality (i.e., "production grade"). It does not specify if this was expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document states the model was "retrained with new production grade scapula and humerus CT segmentations." The size of this new training set is not provided.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: The ground truth for the training set was established through "production grade scapula and humerus CT segmentations." This suggests that human experts (likely trained Zimmer Biomet operators or clinicians) performed manual segmentations that were then refined and verified to a high standard, serving as the ground truth for training the AI/ML model.
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(336 days)
PHX |
| Secondary Product Code | KWS, HSD |
| Regulation Number: | 21 CFR 888.3660, 21 CFR 888.3690
• Reverse Shoulder Prosthesis
The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stems are intended for cemented or cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The Reverse Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
• Anatomic Shoulder Prosthesis
The Medacta Anatomic Shoulder Prosthesis is intended for use as a hemi or total shoulder replacement for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The humeral stems are intended for cemented or cementless use.
The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The humeral short stem is intended for cementless use.
• Reverse Shoulder Prosthesis – monobloc stem
The reverse shoulder prosthesis using the standard monobloc stem is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
The reverse shoulder prosthesis using the short monobloc stem is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The short monobloc stem is intended for cementless use only.
The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.
• Anatomic Shoulder Prosthesis – monobloc stem
The anatomic shoulder prosthesis using the standard monobloc stem is intended for use as a hemi or total shoulder replacement. It is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The standard monobloc stem is intended for cementless use only. Two optional cortical bone screws should be used.
The anatomic shoulder prosthesis using the short monobloc stem is indicated for hemi or total primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint and severe arthropathy.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.
The glenoid component is intended for cemented application. The short monobloc stem is intended for cementless use only.
The MSS – Monobloc stem is a Medacta Shoulder System line extension including the following implantable, individually packed, sterile and single-use devices:
- Monobloc stem, 11 sizes available in both standard and short versions. Short version has been designed, as the standard version, made of Ti6Al7Nb with Ti+HA coating, but also made from Ti6Al4V powder through an additive manufacturing process;
- Monobloc stem spacer small and large;
- Monobloc stem double eccenter small and large;
- Monobloc stem spacer/double eccenter screw;
- Distal screws with lengths from 18 to 36 in 2mm steps;
- Humeral reverse liners small and large available both in UHMWPE highcross and UHMWPE + vitamin E;
- Humeral reverse metaphysis small concentric and eccentric.
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(25 days)
|
| Regulation Number: | 21 CFR 888.3660 (Shoulder Prosthesis, Reverse Configuration)21 CFR 888.3690
The prostheses from FH Industrie are designed for specific indications such as:
Simple humeral prosthesis
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
Total anatomical prosthesis (cemented glenoid implant with pegs)
- Centred glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Post-traumatic sequela, functional rotator cuff with glenoid injury.
TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)
- Centred glenohumeral osteoarthritis
- Rheumatoid polyarthritis
- Post-traumatic sequela with glenoid injury
- Revision for glenoid loosening
- Glenoid bone loss, where bone graft is needed
A functional rotator cuff is necessary to use this device
REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.
At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation. Metaphyseal stems and diaphyseal stems are intended for use without cement. The glenoid bases (metal-back or porous) are intended for cementless use with the addition of cortical and cancellous bone screws.
The JARVIS Metaphyseal Stem is modification to the metaphysis component of the Arrow Short Stem prosthesis (K202024). The Metaphyseal Stem is intended to be used with the diaphyseal component of the modular ARROW Short Stem device (K202024), including the JARVIS Diaphyseal Stem Standard (K253345). The subject modifications include optimized leading edges as well as the inclusion of suture holes for soft tissue reattachment. The JARVIS Metaphyseal Stem is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3 with a pure titanium plasma spray coating per ASTM F1580.
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(89 days)
Shoulder Joint humeral (hemi-shoulder) metallic uncemented (21 CFR 888.3690)3.
The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.
When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:
- Non-inflammatory degenerative joint disease
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.
In Reverse:
The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Revision of devices if sufficient bone stock remains
The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.
The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.
Note: All implant components are single use.
The AETOS Shoulder System Meta Humeral Prosthesis Size 0 subject to this submission is intended for press-fit fixation as of an implant construct in anatomic and/or reverse total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.
N/A
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(29 days)
Semi-Constrained, Metal/Polymer Cemented
Classification: Class II
Regulation Number: 21 CFR 888.3690
The prostheses from FH Industrie are designed for specific indications such as:
SIMPLE HUMERAL PROSTHESIS
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH PEGS)
- Centred glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Post-traumatic sequela, functional rotator cuff with glenoid injury.
TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)
- Centred glenohumeral osteoarthritis
- Rheumatoid polyarthritis
- Post-traumatic sequela with glenoid injury
- Revision for glenoid loosening
- Glenoid bone loss, where bone graft is needed
A functional rotator cuff is necessary to use this device
REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.
For all types of prosthesis, the glenoid baseplate (porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem and diaphyseal stem) is intended for cementless use.
At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.
The JARVIS Diaphyseal Stem Standard is an extension of humeral stem range of the Arrow prosthesis. The JARVIS Diaphyseal Stem Standard is intended to be used with the Metaphyseal component of the modular ARROW Short Stem device (K202024). The JARVIS Diaphyseal Stem Standard is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3.
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(88 days)
Shoulder Joint humeral (hemi-shoulder) metallic uncemented (21 CFR 888.3690)3.
The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.
When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:
- Non-inflammatory degenerative joint disease
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.
In Reverse:
The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Revision of devices if sufficient bone stock remains
The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.
The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.
The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.
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(123 days)
, Semi-Constrained, Metal/Polymer, Uncemented |
| Regulation Number | 888.3670, 888.3650, 888.3660, 888.3690
Hemiarthroplasty/Conventional Total Application:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Reverse Application:
Identity Revision Humeral Stem products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Identity Revision Humeral Stem is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
The Identity Revision Humeral Stems are comprised of titanium alloy. The diameters of the stems range in 1mm increments from 4mm to 18mm in a revision length of 133-134mm. The stem is designed with a distal portion that is cylindrical in shape with a tapered and a proximal portion that is flared, eight-sided shape. The devices have a machine finish distally and a plasma-spray titanium porous coating proximally. To support placement and bone reconstruction in fracture cases, the Identity Revision Humeral Stems feature proximal suture holes as well as etch lines for stem length respect to the native humeral head. The humeral stems employ an oval reverse taper which allows the attachment of either an Identity Humeral Stem Adapter for hemi- and anatomic total shoulder applications or an Identity Humeral Tray for reverse shoulder applications.
I apologize, but the provided FDA 510(k) clearance letter for the "Identity Revision Humeral Stems" does not contain any information about acceptance criteria or a study that proves the device meets those criteria for software-related performance.
This document is for a medical device (humeral stems, which are a type of orthopedic implant) and focuses on the mechanical, material, and design aspects of the device, comparing it to predicate devices to establish substantial equivalence.
Specifically, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section lists:
- Fatigue Testing
- Range of Motion Analysis
- Magnetic Resonance Imaging (MRI)
It explicitly states: "No animal or clinical testing provided." This reinforces that the clearance is based on bench testing and comparison to existing devices, not on a human-in-the-loop study involving AI or a comprehensive performance study as you've described in your request.
Therefore, I cannot fulfill your request for information regarding:
- A table of acceptance criteria and reported device performance (for AI-related metrics).
- Sample sizes for test sets or data provenance.
- Number of experts, qualifications, or adjudication methods for ground truth establishment.
- MRMC studies, effect sizes, or standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
This document pertains to a physical orthopedic implant, not a software or AI-driven diagnostic/therapeutic device that would typically involve the types of studies and acceptance criteria you've asked about.
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(104 days)
CFR 888.3660)
- HSD - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690
Hemiarthoplasty/Conventional Total Application:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Reverse Application:
Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants, and a functional deltoid muscle is necessary.
The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Comprehensive Nano Stemless Shoulder System
- Primary total shoulder arthroplasty.
- Non-inflammatory degenerative joint disease including
Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for uncemented biological fixation applications.
The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may be inserted without bone cement.
The Identity Shoulder System is previously cleared (K213856/K240876) as a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty. The Identity Shoulder System is cleared for hemi-arthroplasty and conventional total shoulder replacement in both the anatomic and reverse configurations. The current submission is for the anatomic configuration.
The subject Comprehensive Humeral Head Adapter (CHHA) is a line extension to the Identity Shoulder System (K213856) cleared for the hemi-arthroplasty configuration and anatomic Total Shoulder Configuration.
The new CHHA (PN SAHHA002) allows additional compatibility with the previously cleared Identity Humeral Heads (K213856) and the Comprehensive humeral components, excluding fracture stems, as noted below:
Based on the provided FDA 510(k) clearance letter for the "Identity Shoulder System" (K250848), here's an analysis of the acceptance criteria and the study that proves the device meets them:
Crucial Observation: The provided document is a 510(k) clearance letter for a medical device that does not appear to be software or an AI/ML enabled device. It is for an orthopedic implant (shoulder system). Therefore, several of the requested points related to AI/ML (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of traditional medical device submission.
The "acceptance criteria" for this device are generally based on non-clinical performance testing to demonstrate the device's physical and mechanical properties meet established standards and are substantially equivalent to predicate devices. There are no "reported device performance" metrics in the sense of clinical performance (like sensitivity/specificity for AI, diagnostic accuracy, etc.) because it's a physical implant, not a diagnostic or AI-driven system.
Acceptance Criteria and Study Details (Based on the provided document)
Since the document provided is for a physical orthopedic implant, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a traditional medical device, primarily through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|---|---|
| Mechanical Performance | Fatigue Verification | Device withstands specified cyclic loading without failure, demonstrating durability comparable to predicates. | Non-clinical verification successfully performed. |
| Fretting Corrosion Verification | Device components resist fretting corrosion under specified conditions, comparable to predicates. | Non-clinical verification successfully performed. | |
| Fixation Stability Verification | Device maintains stable fixation under simulated physiological loads, comparable to predicates. | Non-clinical verification successfully performed. | |
| Static Modular Junction Strength Verification | Modular junctions maintain integrity and strength under static loads, comparable to predicates. | Non-clinical verification successfully performed. | |
| Compatibility | ROM Verification | Device allows for intended range of motion when implanted, comparable to predicates. | Non-clinical verification successfully performed. |
| Imaging Compatibility | MRI Verification | Device is compatible with MRI (e.g., minimal artifact, no excessive heating), comparable to predicates. | Non-clinical verification successfully performed. |
| Material Equivalence | Materials composition | Identical to legally marketed predicate devices. | "Identical to predicates" |
| Design Equivalence | Design Features | Similar to legally marketed predicate devices, with any differences not raising new safety/effectiveness concerns. | "Similar to predicates" |
| Packaging Equivalence | Packaging | Identical to legally marketed predicate devices, ensuring sterility and protection. | "Identical to predicates" |
| Sterilization Equivalence | Sterilization Method | Identical to legally marketed predicate devices, ensuring sterility. | "Identical to predicates" |
| Intended Use Equivalence | Intended Use | Identical to legally marketed predicate devices. | "Identical to predicates" |
| Indications for Use Equivalence | Indications for Use | Identical to legally marketed predicate devices. | "Identical to predicates" |
Note: For traditional orthopedic implants, specific numerical values for acceptance criteria and device performance (e.g., "Fatigue life > X cycles at Y load") are typically contained within the full 510(k) submission and are not usually detailed in the public clearance letter. The letter only states that these verifications were "successfully performed" and support the conclusion of substantial equivalence.
AI/ML Specific Questions (Answered as "Not Applicable" for this device)
Given that this is a 510(k) for a physical orthopedic implant and not an AI/ML device, the following points are not applicable (N/A):
- Sample sizes used for the test set and the data provenance: N/A. This device does not have a "test set" of patient data in the typical sense for AI/ML validation involving images or clinical parameters. Its evaluation involves mechanical testing of physical samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts for clinical data is not relevant for this device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. This applies to review of clinical data, not mechanical testing.
- 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: N/A. MRMC studies are for evaluating human reader performance, typically with diagnostic images, in conjunction with AI. This is not a diagnostic or AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device's performance is derived from standardized mechanical testing methods and compliance with material specifications.
- The sample size for the training set: N/A. This device does not use a "training set" as it's not an AI/ML model.
- How the ground truth for the training set was established: N/A.
Summary of the Study:
The "study" that proves the device meets the acceptance criteria is described as a series of non-clinical verifications. These tests are designed to objectively assess the physical and mechanical properties of the Comprehensive Humeral Head Adapter (CHHA) and its compatibility within the Identity Shoulder System, thereby demonstrating its substantial equivalence to previously cleared predicate devices.
The specific non-clinical tests performed include:
- Fatigue Verification: Assesses the device's ability to withstand repeated stress without failure, simulating long-term use.
- Fretting Corrosion Verification: Evaluates the device's resistance to material degradation caused by small-amplitude oscillatory motion between contacting surfaces.
- Fixation Stability Verification: Confirms the secure attachment and stability of components under load.
- Static Modular Junction Strength Verification: Measures the strength of the connections between modular parts under static loading conditions.
- ROM Verification: Ensures the device allows for the intended range of motion within the joint.
- MRI Verification: Confirms the device's safety and compatibility when exposed to magnetic resonance imaging environments.
The results of these tests, along with the asserted identicality of intended use, indications for use, materials, packaging, and sterilization, and similarity in design features, were deemed sufficient by the FDA to conclude that:
- any differences do not raise different questions of safety and effectiveness; and
- the proposed device is as safe and effective as the legally marketed predicate device.
This conclusion of substantial equivalence is the basis for the 510(k) clearance for the Identity Shoulder System's new line extension, the Comprehensive Humeral Head Adapter.
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(265 days)
hemihumeral metallic uncemented or cemented
REGULATION NUMBER: 21 CFR §888.3360, §888.3560, §888.3690
Regulation Number: 21 CFR §888.3360, §888.3560, §888.3690
Product Codes: KWL, KWY, JWH, HSD
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| Regulation and Procode | 21 CFR 888.3360 (Hip; KWL, KWY) 21 CFR 888.3560 (Knee; JWH) 21 CFR 888.3690
(Shoulder; HSD) | 21 CFR 888.3360 (Hip; KWL, KWY) | 21 CFR 888.3560 (Knee; JWH) | 21 CFR 888.3690 (Shoulder
The Hip Spacer with gentamicin preserves the joint space and the length of the affected limb, which results in the maintenance of the entire abductor and stabilizer apparatus of the hip. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Hip Spacer is implanted after the removal of the infected implant, as a regular Hemiarthroplasty. The spacer is inserted into the femoral canal, and a handmade ring of PMMA bone cement with antibiotic may be added to the base of the spacer's neck in order to increase stability. The spacer is kept "in place" until it is replaced by the final prosthesis according to medical criteria. The Hip Spacer must not remain implanted for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.
The Knee Spacer with gentamicin maintains the articular space, the length of the affected limb, and the ligament apparatus of the knee. Its use is indicated for a limited period, in patients who require a Two stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Knee Spacer is placed like a regular arthroplasty, after the removal of the original implant. This knee spacer consists of two independent parts: a tibial plate and a femoral component. The first has a flat base where the femoral component articulates. It is recommended that both components be adapted to the bone by means of a small amount of bone cement with antibiotic. The Knee Spacer must not remain implanted more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.
The Shoulder Spacer with gentamicin preserves joint space and length of the affected limb, resulting in maintenance of the entire shoulder muscle and stabilizer complex. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Shoulder Spacer is placed as a hemiarthroplasty after the original implant has been removed. The spacer is inserted into the humeral canal and a ring of bone cement with antibiotic can be added to the base of the neck of the spacer for added stability. The Shoulder Spacer should not remain in place for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.
The Synicem Hip, Knee, and Shoulder Spacers are combination products made from fully formed polymethylmethacrylate (bone cement) with gentamicin. The bone cement is prepared from a powder component and a liquid component. The hip and shoulder spacers contain a stainless steel core of 316L in accordance with ASTM F138. The spacers are temporary implants utilized to maintain the joint space during two-stage revision arthroplasties. The spacer implant is placed as part of the first stage of the two-stage revision when the original prostheses are removed due to joint infection. Once the infection is cleared, the spacers are removed and replaced with a permanent prosthesis as part of the second stage of the revision process. The joint spacers are not intended to be implanted for longer than 6 months. They are a single use device and supplied sterile.
This document is a 510(k) clearance letter for the Synicem Hip, Knee, and Shoulder Spacers. These are medical devices, specifically temporary implants used in two-stage revision arthroplasties following joint infections.
The information provided outlines the substantial equivalence of the Synicem Spacers to previously cleared predicate devices. It describes the device, its intended use, technological characteristics, material composition, sizes, and various performance tests conducted.
However, a critical point to understand is that this document DOES NOT describe an AI/ML-based device. It is a clearance for a traditional medical device (joint spacers). Therefore, many of the requested criteria related to AI/ML systems (such as test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.
The document focuses on demonstrating that the new Synicem Spacers are "substantially equivalent" to existing, legally marketed predicate devices in terms of safety and effectiveness, based on non-clinical performance testing (mechanical, antibiotic elution), biocompatibility, and MRI safety.
Here's an analysis based on the provided document, addressing the applicable criteria and explicitly stating where information is not available due to the nature of the device:
Device: Synicem Hip Spacer, Synicem Knee Spacer, Synicem Shoulder Spacer
Type of Device: Traditional Medical Device (Non-AI/ML)
Acceptance Criteria and Reported Device Performance
Given that this is a traditional medical device (joint spacer) and not an AI/ML algorithm, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices through various non-clinical performance tests and adherence to relevant standards. There isn't a "performance metric" in the sense of accuracy, sensitivity, or specificity as one would expect for a diagnostic AI.
The acceptance criteria are implicitly met by demonstrating that the Synicem Spacers "met performance requirements and is substantially equivalent to the predicate device" across several categories.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Category | Acceptance Criteria (Implicit) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Mechanical Performance | Equivalent or superior to predicate devices in relevant mechanical tests. | - Hip Spacers: Femoral stem and neck fatigue, and wear testing performed. Results showed equivalence to predicate. - Knee Spacers: Fatigue performance and wear testing performed. Results showed equivalence to predicate. - Shoulder Spacers: Static and dynamic fatigue testing performed. Results showed equivalence to predicate. |
| Antibiotic Elution Profile | Elution kinetics of gentamicin are equivalent to predicate devices. | Antibiotic Elution Kinetics testing conducted. Results demonstrated elution kinetics equivalent to predicate spacers. |
| Biocompatibility | Biological safety suitable for intended use, in accordance with ISO 10993 standards and FDA guidance. | - Cytotoxicity (ISO 10993-5) - Sensitization (ISO 10993-10) - Irritation (ISO 10993-23) - Acute systemic toxicity (ISO 10993-11) - Material mediated pyrogenicity (ISO 10993-11) - Genotoxicity (ISO 10993-3) - Intramuscular implantation (ISO 10993-6) - Local Effects after Bone Implantation / Subchronic Systemic Toxicity (ISO 10993-6 and ISO 10993-11) - Chemical characterization (ISO 10993-18) - Toxicological risk assessment (ISO 10993-17) Conclusion: Materials are biologically safe and suitable for intended use. |
| MRI Safety | Meet MR safety classifications as "MR Safe" or "MR Conditional" as determined by testing. | - Synicem Knee Spacer: "MR Safe" - Synicem Hip and Shoulder Spacers: "MR Conditional" (Testing conducted according to FDA guidance) |
| Sterilization & Shelf Life | Sterilization methods validated according to international standards and FDA guidance; packaging maintains functionality and safety. | Sterilized using well-established methods; validations performed following international standards and FDA guidance. Compatibility between packaging and sterilization ensured; packaging preserves functionality and safety throughout declared shelf-life. |
Study Details (Applicability to AI/ML context)
Since this is a non-AI/ML device submission, most of the requested study details pertinent to AI/ML performance validation are not applicable (N/A). The "study" here refers to the non-clinical performance testing done to establish substantial equivalence.
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Sample size used for the test set and the data provenance:
- N/A. This is not an AI/ML device. The "test set" would refer to the physical samples of the spacers used for mechanical, biocompatibility, and elution testing. The provenance would be the manufacturing site (United Kingdom).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is not an AI/ML device requiring expert-labeled ground truth data. Performance for this device is based on objective measurements from mechanical and chemical tests, and biological assays.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable for objective non-clinical performance testing of a physical device.
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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. This is a physical medical device (joint spacer), not an AI system designed to assist human readers. MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. There is no "algorithm" in this device. Its performance is inherent in its physical and chemical properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. The "ground truth" for this device's performance is established by validated engineering and scientific test methods (e.g., ASTM standards for material properties, ISO standards for biocompatibility, gravimetric analysis for elution profiles). It's based on physical measurements and biological reactions, not subjective interpretation requiring "expert consensus" in the diagnostic sense.
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The sample size for the training set:
- N/A. This is not an AI/ML device; there is no "training set."
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How the ground truth for the training set was established:
- N/A. Not an AI/ML device; no "training set" or "ground truth for training."
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(181 days)
K190738 |
| Original Applicant | Medacta International SA |
| Regulation Number | 21 CFR 888.3660, 21 CFR 888.3690
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.
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