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510(k) Data Aggregation
(58 days)
Medacta International S.A.
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(90 days)
Medacta International S.A.
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(162 days)
Medacta International S.A.
The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:
- Pedicle Screw Placement (Thoracic and Lumbosacral spine)
- Sacro-Iliac Screw Placement
NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.
The NextAR Spine platform is intended to be used in combination with NextAR™ Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning, surgical planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.
NextAR Spine sterile drill and pins
The sterile drills, pins and iliac pins are part of the NextAR Spine platform which is intended as an aid for precisely locating anatomical structures in either open / mini open or percutaneous spine procedures. The NextAR Spine sterile drills pins and iliac pins are intended for use with the NextAR Spine platform according to its approved indications for use. All the drills are motorized. Pins may be used either motorized or manually. Iliac pins are manual.
The NextAR™ Spine platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:
- Navigation software which displays information to the surgeon
- Augmented Reality glasses
- Optical tracking system
- PC based hardware platform
- Fiducial Block
- Surgical instruments for spine surgery procedures
The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile.
NextAR™ Spine aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. The platform uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D scan in order to register the spine to navigation elements. The registration can be performed with one of the following approaches: 1) Direct 3D: based on the use of an intra-operative 3D scan, or 2) 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D scan.
Where the Direct 3D approach is utilized, NextAR™ Spine allows for planning of screw positioning on the patient's intraoperative DICOM images just before system setup. The application allows for navigating the spine with a screw planning superimposed on the acquired scan.
The NextAR™ Spine platform also includes the rod planning tool, which gives the surgeon information about the length and the rod type to best fit the spine anatomy and to perform the desired curvature correction.
The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.
The FDA 510(k) clearance letter for NextAR™ Spine (K250477) provides limited details on a comprehensive study proving acceptance criteria. However, based on the provided text, we can infer some aspects of the performance data and the methods used to demonstrate the device's substantial equivalence.
Here's an attempt to structure the information based on your request, highlighting what is explicitly stated and what can be inferred or is missing from this document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list acceptance criteria in a quantitative table format nor does it provide numerical performance metrics. Instead, it relies on comparative evaluations and qualitative assessments to demonstrate substantial equivalence to predicate devices. The "Performance Data" section primarily focuses on non-clinical studies.
| Acceptance Criteria Category | Acceptance Criteria (Inferred/Implicit) | Reported Device Performance |
|---|---|---|
| Software Functionality | Software operates as intended and displays information accurately. | "Software testing" was performed, indicating the software functions were verified. |
| Instrument Equivalence | New instruments perform equivalently to previously cleared instruments. | "Comparative evaluations to demonstrate that the subject instruments are substantially equivalent to the predicate instruments used with NextAR Spine and cleared within K210859." |
| Surgical Suitability (Cadaver) | Instruments and system are adequate for intended surgical use. | "Cadaver workshops to demonstrate that the subject instruments are adequate for their intended use." |
| Tracking System Accuracy | The optical tracking system and fiducial registration maintain accuracy. | Stated as a shared characteristic with the predicate: "tracking system accuracy" and "fiducial registration accuracy" are maintained. No specific numerical thresholds or achieved performance reported in this document. |
| Biocompatibility | New instruments are biocompatible. | "The biocompatibility evaluation of the subject instruments leveraged identical materials and manufacturing to previously cleared instruments (K210859 and K200391)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of cases or subjects. "Cadaver workshops" imply surgical procedures performed on anatomical models (cadavers), but the number is not provided.
- Data Provenance: The document does not specify the country of origin for the cadaver studies or the software testing. The studies were non-clinical. The studies were likely prospective in nature, as they were "performed in support of a substantial equivalence determination."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the mention of "Cadaver workshops" suggests that surgeons or other qualified medical professionals would have been involved to assess the adequacy of the instruments and system for surgical use.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. Given that these were "cadaver workshops" to demonstrate adequacy, it's likely qualitative assessments by the participating surgeons, rather than a formal, multi-reader quantitative adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document explicitly states: "No clinical studies were conducted." This indicates that no MRMC study comparing human readers with and without AI assistance was performed. The device, NextAR™ Spine, is a surgical navigation platform, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies for reader performance improvement (e.g., radiologists interpreting images).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Not explicitly detailed with performance metrics. The "Software testing" and "Comparative evaluations" could be considered forms of standalone assessment of the algorithmic components and instrument performance, but no specific quantitative standalone performance (e.g., accuracy, precision) of the navigation algorithms themselves is provided in this summary. The device's primary function is as a navigation aid where a human surgeon is always in the loop.
7. Type of Ground Truth Used
- Type of Ground Truth:
- For instrument performance, the ground truth would likely be established through engineering specifications and comparative measurements against predicate instruments.
- For the cadaver workshops, the ground truth was likely surgical outcomes/adequacy as determined by the participating surgeons in a realistic (cadaveric) surgical environment. This is a form of expert assessment of functional performance. It is not pathology, or clinical outcomes data, as no clinical studies were performed.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document describes a traditional medical device (navigation system) with software components, not an AI/Machine Learning device that undergoes a train-test split methodology with large datasets for model training. The software functionality and instrument performance are verified through testing and comparative evaluation, not
ML model training on patient data.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as this is not an AI/ML system requiring a dedicated training set with established ground truth in the typical sense for image interpretation or diagnosis. The "ground truth" for the device's functionality would stem from its design specifications, engineering principles, and the known anatomical relationships it aims to navigate.
In summary, the FDA 510(k) summary for NextAR™ Spine focuses on demonstrating substantial equivalence through non-clinical performance data, primarily through comparative evaluations with predicate devices and cadaveric workshops, rather than extensive clinical studies or AI model performance metrics.
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(434 days)
Medacta International S.A.
Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells.
Total Hip Arthroplasty is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components.
The Mpact Constrained Liner is an acetabular preassembled liner consisting of an UHMWPE liner incorporating a bipolar head.
The subject device is available in six sizes and two configurations, flat or 10° face-changing.
The Mpact Constrained Liner implants are provided sterile and individually packaged.
The provided document, an FDA 510(k) clearance letter for the "Mpact Constrained Liner," focuses on establishing substantial equivalence for a medical implant. It DOES NOT describe the acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/algorithm-based medical device performance study.
The document details the physical characteristics, intended use, and comparison to predicate devices for a hip joint prosthesis liner. The "Performance Data" section lists various non-clinical tests and validations (e.g., mechanical tests, biocompatibility, shelf-life) which are standard for implantable devices to ensure their physical integrity, safety, and compatibility with the human body. These are not related to "acceptance criteria" and "study proving device meets acceptance criteria" as requested in the prompt, which specifically implies evaluation of an algorithm's performance (e.g., diagnostic accuracy, sensitivity, specificity).
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training, expert and adjudication details, MRMC study, standalone performance, ground truth types, training set details) from this document, as it pertains to a physical medical device and not an AI/algorithm-based device.
To provide the information requested in your prompt, I would need a document describing the regulatory submission and performance evaluation of an AI/algorithm-based medical device.
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(58 days)
Medacta International S.A.
MOTO Medial, MOTO Lateral and MOTO Sphere Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The MOTO Partial Knee System Extension is a Medacta partial knee prosthesis portfolio extension including implantable devices, provided individually packed, sterile and single-use. Specifically, the purpose of this submission is to gain the clearance for: MOTO Sphere femoral components, made of Co-Cr-Mo according to ISO 5832-4 and available in 5 sizes with or without TiNbN coating. They are intended to replace the medial or lateral femoral compartment of the natural knee joint and must be implanted in combination with the tibial component of MOTO Medial or MOTO Lateral (K162084, K183029 and K213071); 7mm thick MOTO Medial and MOTO Lateral inserts fixed made of E-cross, available in 8 sizes and intended to be coupled with the subject MOTO Sphere femoral components as well as MOTO Medial or MOTO Lateral tibial components (K162084, K183029 and K213071).
The provided document is a 510(k) Clearance Letter from the FDA for the MOTO Partial Knee System Extension. This document grants clearance for a medical device (knee implant components) and describes its intended use and comparison to predicate devices, but it does not contain the detailed acceptance criteria and study results you are asking for regarding a software or AI-based device.
The prompt specifically asks for details about a study that proves the device meets acceptance criteria, including information on "human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)", "ground truth," "training set," etc. These are all concepts related to the validation of Artificial Intelligence (AI) / Machine Learning (ML) enabled software as a medical device (SaMD), often used in diagnostics or image analysis.
The MOTO Partial Knee System Extension is an implantable medical device (hardware). The document explicitly states:
- "No clinical studies were conducted." This is a key indicator that a comparative effectiveness study involving human readers or standalone algorithm performance was not performed or required for this type of device clearance.
- The "Performance Data" section lists "Non-Clinical Studies" focusing on mechanical properties and biocompatibility (e.g., fatigue endurance, contact pressures, wear behavior, pyrogenicity, shelf-life). These are standard tests for orthopedic implants, not AI/ML software.
Therefore, because the provided text is for a hardware implant and not an AI/ML software device, I cannot extract the detailed acceptance criteria and study information related to AI/ML performance from this document.
To answer your request, I would need a 510(k) clearance letter or summary for an AI/ML-enabled medical device.
If you were to provide a document for an AI/ML device, the table and information would be structured as follows (but cannot be populated from the current input):
Acceptance Criteria and Study Proof for an AI/ML Device (Hypothetical, based on expected content)
Since the provided document is for a hardware implant (MOTO Partial Knee System Extension) and not an AI/ML-enabled software device, it does not contain the specific performance evaluation metrics, study designs (e.g., MRMC, standalone), or ground truth establishment methods typically associated with AI/ML device validation.
If this were an AI/ML device, the information requested would be typically found in a "Performance Data" or "Clinical Performance" section of the 510(k) Summary, detailing studies conducted to demonstrate the algorithm's accuracy, sensitivity, specificity, or impact on human reader performance.
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example)
| Acceptance Criteria (e.g., for AI-assisted image analysis) | Reported Device Performance |
|---|---|
| Standalone Performance: | |
| Sensitivity for Condition A: ≥ 90% | 92.5% |
| Specificity for Condition A: ≥ 85% | 88.0% |
| AUC for detecting Condition B: ≥ 0.90 | 0.93 |
| Human-in-the-Loop Performance (MRMC): | |
| Improvement in Reader ROC AUC with AI vs. without AI: statistically significant (p |
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(106 days)
Medacta International S.A.
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
The MectaLIF 3D Metal are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671, K181970 and K212831) and MectaLIF Oblique and Posterior TiPEEK implants (K133192, K181970 and K212831). Specifically, the purpose of this submission is to obtain the clearance of MectaLIF 3D Metal Posterior, Oblique and Oblique Dome additively manufactured from Ti6Al4V according to ASTM F2924-14. MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft. The subject implants are provided individually packed, sterile and single-use.
This document is an FDA 510(k) clearance letter for a medical device called "MectaLIF 3D Metal." This type of document is a regulatory submission demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not generally contain acceptance criteria or detailed study results for AI/software-as-a-medical-device (SaMD), as it pertains to a physical implant.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text because it is not relevant to this type of device or submission.
The document details the following for a physical medical device (intervertebral body fusion device):
- Device Name: MectaLIF 3D Metal
- Regulation Number: 21 CFR 888.3080
- Regulation Name: Intervertebral Body Fusion Device
- Regulatory Class: Class II
- Product Code: MAX
- Indications for Use: The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion.
- Predicate Devices: MectaLIF Extension (K212831), MectaLIF Posterior Extension (K181970), MectaLIF TiPEEK (K133192), MectaLIF Extension (K131671), MectaLIF (K110927).
- References Devices: Mpact 3D Metal Implants – DMLS Technology (K202568), GMK 3D Metal Tibial Tray (K221850).
- Performance Data (Non-Clinical Studies): Mechanical standard tests (static and dynamic axial/shear compression, axial compressive subsidence), expulsion test, wear analysis, stereological evaluation, abrasion test, static tensile test, static shear test, pyrogenicity testing, biocompatibility assessment, and shelf-life evaluation. These tests are conducted according to various ASTM and ISO standards for intervertebral body fusion devices and implant materials.
- Clinical Studies: No clinical studies were conducted for this submission, as is often the case for 510(k) clearances when substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.
In summary, the provided text does not contain information about acceptance criteria or performance studies related to AI/software, as it describes the 510(k) clearance for a physical orthopedic implant.
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(7 days)
Medacta International S.A.
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(59 days)
Medacta International S.A.
Mfinity femoral stems are indicated in patients requiring hip arthroplasty.
Total or partial hip arthroplasty is indicated in the following cases:
- Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute fracture of the femoral head.
- Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty.
- Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty.
- Primary pathology involving the femoral head but with a non-deformed acetabulum.
- Failure of previous hip surgery:
- Conservative hip surgery.
- Internal fixation.
- Arthrodesis.
- Partial or total hip arthroplasty.
- Hip resurfacing replacement.
The Mfinity Femoral System includes implantable devices provided individually packed, sterile and single-use intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The product range is composed of three different versions (Mfinity collarless, Mfinity collared and Mfinity L) available in standard and lateral offset.
The Mfinity femoral stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).
The subject devices are made of titanium alloy according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite according with ASTM F1185.
The provided text is an FDA 510(k) clearance letter for the Mfinity Femoral System, which is a hip prosthesis, not a diagnostic AI device. Therefore, the information requested regarding acceptance criteria and studies that prove a device meets those criteria, specifically concerning AI performance metrics, expert adjudication, training set, and test set details, is not applicable to this document.
The document discusses the substantial equivalence of the Mfinity Femoral System to predicate devices based on non-clinical performance data (fatigue tests, ROM evaluation, surface analyses, biocompatibility, shelf-life, pyrogenicity) and states that no clinical studies were conducted.
The acceptance criteria for this type of medical device (hip prosthesis) would typically involve demonstrating mechanical strength, durability, biocompatibility, and sterilization effectiveness based on recognized standards (e.g., ISO, ASTM, European Pharmacopoeia, USP). The "reported device performance" would consist of the results of these non-clinical tests meeting the specified limits of those standards.
Below is a general interpretation of what "acceptance criteria" and "reported device performance" would entail for a hip prosthesis based on the provided document, acknowledging that specific numerical details of these criteria and results are not explicitly stated in this letter but would be in the full 510(k) submission.
Based on the provided FDA 510(k) Clearance Letter for the Mfinity Femoral System:
This document describes the clearance of a hip prosthesis, not an AI-powered diagnostic device. Therefore, the typical elements of acceptance criteria and study designs relevant to AI (such as sensitivity, specificity, AUC, expert consensus, training/test set sizes, etc.) are not applicable to this submission.
The "acceptance criteria" for this device would generally refer to meeting established mechanical, material, and biological performance standards for medical implants. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.
Here's an attempt to populate the requested table and answer the questions based on the information available, while highlighting the irrelevance of AI-specific questions:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (General based on device type) | Reported Device Performance (Summary from letter) |
|---|---|---|
| Mechanical Performance | - Fatigue strength (ISO 7206-4, ISO 7206-6) |
- Pull-off strength of femoral head
- Range of Motion (ISO 21535) | - Mfinity Fatigue tests performed according to ISO 7206-4 and ISO 7206-6 (Results are assumed to have met specified limits)
- Pull-Off Test On CoCr Femoral Head performed (Results are assumed to have met specified limits)
- Evaluation of ROM according to ISO 21535 performed (Results are assumed to have met specified limits) |
| Material Performance | - Coating characteristics (cross-section, SEM, XRD) | - Cross sectioned area evaluation of double coated implant surfaces performed - Scanning Electron Microscopy pictures of double coated implant surfaces taken
- XRD analyses comparing HA coating on Mfinity stem and planar samples performed (Results are assumed to demonstrate acceptable coating properties) |
| Biocompatibility | - Material safety - Cytotoxicity, sensitization, irritation, genotoxicity, chronic toxicity, etc. | - Biocompatibility assessment performed (Results are assumed to demonstrate compliance with standards) |
| Sterilization & Endotoxin| - Bacterial endotoxin levels (European Pharmacopoeia §2.6.14 / USP ) - Pyrogenicity (USP ) | - Bacterial endotoxin test (LAL test) performed
- Pyrogen test performed (Results are assumed to meet requirements, though note indicates not labeled as non-pyrogenic or pyrogen free) |
| Shelf-Life | - Maintain integrity and performance over specified shelf-life | - Shelf-life evaluation performed (Results are assumed to demonstrate acceptable shelf-life) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the FDA letter. For non-clinical tests (like fatigue or material analysis), sample sizes would be determined by the specific ISO/ASTM standards referenced, but these are not diagnostic "test sets" in the AI context.
- Data Provenance: The data comes from the "Non-Clinical Studies" and "Performance Testing" conducted by Medacta International S.A. No country of origin is explicitly stated for the testing labs or data generation, but the company is based in Switzerland. The studies are by nature prospective in that they are conducted specifically to test the device's performance against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a hip prosthesis, not an AI diagnostic device. There is no concept of "ground truth" established by experts in the context of interpreting images or medical conditions for this device. The "ground truth" for the performance tests would be the established scientific and engineering principles and the limits defined by the relevant ISO/ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this is not an AI diagnostic device, no adjudication method was used. Performance is assessed directly against objective engineering and material standards.
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
- Not Applicable. This is a hip prosthesis, not an AI-assisted diagnostic tool. No MRMC study was performed, and there is no AI assistance involved. The letter explicitly states: "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device. The device (a physical implant) is evaluated standalone based on its inherent properties and performance against physical and material standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical performance tests is based on established engineering and material science standards and specifications (e.g., ISO 7206, ISO 21535, ASTM F1580, ASTM F1185, European Pharmacopoeia, USP). The device's performance is compared against the requirements and acceptance limits set forth in these standards.
8. The sample size for the training set
- Not Applicable. This device did not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not Applicable. This device did not involve machine learning or a "training set."
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(267 days)
Medacta International S.A.
Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.
Mpact 3D Metal Augments are indicated in cases of:
- Acetabular dysplasia;
- Acetabular fractures;
- Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.
The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user.
The devices subject of this submission are:
- Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924;
- Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3.
The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.
This FDA 510(k) clearance letter pertains to a medical device, specifically the Mpact 3D Metal Augments II, which are implants for hip replacement surgeries. The document focuses on establishing substantial equivalence to existing predicate devices based on design and performance testing. However, it does not describe a clinical study in the traditional sense, especially not one that involves human subjects or assesses AI performance.
The provided text details non-clinical performance data and validations to support the device's substantial equivalence to its predicate. It does not contain information about acceptance criteria for AI performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
Therefore, many of the requested sections (including specific tables for acceptance criteria and device performance based on AI metrics, details about test sets, ground truth establishment for AI, MRMC studies, and standalone performance) cannot be filled from the provided document.
Here's a breakdown of the information that is available:
1. A table of acceptance criteria and the reported device performance
The document describes performance testing as "Fatigue testing in single and double augment configurations" and "Rationale of comparison – EBM Additive Manufacturing Technology." It also mentions "Design Validation on Mpact 3D metal Augments II." However, it does not disclose specific acceptance criteria or quantitative performance results for these tests. It only states that "testing activities were conducted to written protocols" and these validations are "provided in support of the substantial equivalence determination." This is typical for a 510(k) summary, which generally summarizes the data rather than providing all raw or detailed results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | - Fatigue testing results in single and double augment configurations (details not provided) |
| Not specified in document | - Design Validation on Mpact 3D metal Augments II (details not provided) |
| Pyrogenicity control (using LAL test per ISO11737-3 and EP §2.6.14, and in-vivo evaluation in rabbit per USP ) | Pyrogenicity is controlled and validated, meeting standards (specific quantitative results not provided) |
| Biocompatibility | Biocompatibility assessed (details not provided) |
| Shelf-life | Shelf-life evaluated (details not provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "tests" here refer to non-clinical laboratory and material tests, not clinical studies involving 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 is not applicable to the type of device and study described. There's no "ground truth" to be established by experts in the context of material fatigue or design validation for an orthopedic implant as presented here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the type of device and study described. Adjudication methods are typically used in clinical trials or studies involving expert review of medical images or outcomes.
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
There is no MRMC or comparative effectiveness study mentioned, as this is a physical medical device (hip augments), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the sense of medical diagnosis or AI performance. The "truth" for these non-clinical tests would be the physical properties and performance characteristics determined by established engineering and materials testing standards.
8. The sample size for the training set
This is not applicable, as there is no "training set" for an AI algorithm mentioned in this document.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" or "ground truth" for it in the context of AI.
Summary of what the document does provide regarding the study/testing:
The document describes non-clinical testing and validations performed to demonstrate the substantial equivalence of the Mpact 3D Metal Augments II to its predicate devices. These tests include:
- Design Validation: Performed on Mpact 3D Metal Augments II (details not provided).
- Performance Testing:
- Fatigue testing in single and double augment configurations.
- Rationale of comparison – EBM Additive Manufacturing Technology.
- Pyrogenicity: Control validated using bacterial endotoxin test (LAL test) per ISO11737-3 and European Pharmacopoeia §2.6.14, and in-vivo evaluation in rabbits per USP .
- Biocompatibility assessment.
- Shelf-life evaluation.
The document states that Medacta International S.A., based in Switzerland, submitted this 510(k). The tests are non-clinical, so data provenance regarding country of origin or retrospective/prospective does not apply in the same way as for clinical data. The studies are laboratory-based and conducted according to written protocols to ensure materials and design meet safety and performance standards for orthopedic implants.
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(145 days)
Medacta International S.A.
The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals. The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the MySpine WebPlanner, clinical judgment, and experience are required.
The MySpine WebPlanner is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users to perform preoperative surgical planning. The data and the information displayed in WebPlanner web interface are computed and loaded by Medacta International's internal software named MyPlanner. The image format supported is DICOM. The end-user can access the MySpine WebPlanner at https://myspine.medacta.com/.
The purpose of the current submission is to obtain clearance to expand the indications for use of MySpine WebPlanner include surgical planning of fusion devices (i.e., cages).
The provided document is an FDA 510(k) clearance letter for the MySpine WebPlanner device. It does NOT contain information about acceptance criteria or supporting studies. The letter primarily focuses on:
- Substantial Equivalence Determination: The FDA has determined the MySpine WebPlanner is substantially equivalent to a legally marketed predicate device (MySpine WebPlanner & MyBalance, K211386). This means it has met the regulatory requirements for clearance, not necessarily that clinical performance metrics have been explicitly evaluated against numerical acceptance criteria in the provided document.
- Device Description and Indications for Use: It describes the device's function (preoperative surgical planning for spinal fixation and fusion devices) and its intended users.
- Comparison to Predicate Device: It highlights that the key difference between the subject device and the predicate is the expansion of indications to include planning for "fusion devices (i.e., cages)."
- Performance Data (Stated Existence): It merely states that "Software verification and validation studies are provided in support of a substantial equivalence determination." It does not actually provide details or results of these studies, nor does it list specific acceptance criteria or performance metrics.
Therefore, based solely on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria and study specifics. The document confirms a substantial equivalence determination but lacks the granular technical and clinical study data you are requesting.
Here's what I can extract and state based on the provided text, and what is explicitly missing:
Acceptance Criteria and Device Performance
- Acceptance Criteria: Not explicitly stated in the provided document.
- Reported Device Performance: Not explicitly stated in the provided document with numerical metrics. The document only states that "Software verification and validation studies are provided in support of a substantial equivalence determination." This implies the device met internal performance requirements as part of the V&V, but the specific metrics are not published here.
| Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|
| Not explicitly stated | Not explicitly stated with numerical data. The device was found substantially equivalent to its predicate, implying its performance is comparable and acceptable for its intended use, but no specific metrics are published here. |
Missing Information from the Provided Document:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The document focuses on regulatory equivalence, not comparative effectiveness.
- Standalone (algorithm only) performance: Not explicitly detailed with metrics. While the device is software, its performance in planning is stated to require clinical judgment and experience from the user.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence. It does not delve into the specific technical details of the performance studies (like acceptance criteria, sample sizes, ground truth establishment, or expert involvement) that would have been submitted to the FDA as part of the 510(k) application.
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