Search Results
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510(k) Data Aggregation
(266 days)
EBI, LLC
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
This submission is a line extension to Nextgen Altius OCT System to add an alternate style of multiaxial screws to the system.
The provided documents describe findings for a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) cannot be answered from the provided text.
However, I can extract information related to the device's mechanical performance and the study conducted.
Here is the information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was tested) | Reported Device Performance (How the device performed) |
|---|---|
| Static interconnection testing | Met all mechanical test requirements based on worst-case construct testing. |
| Compression bending fatigue | Met all mechanical test requirements based on worst-case construct testing. |
| Dissociation testing | Met all mechanical test requirements based on worst-case construct testing. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for individual tests. The text refers to "worst-case construct testing."
- Data Provenance: Not applicable. This refers to mechanical testing, not clinical data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus.
4. Adjudication method for the test set
Not applicable. Mechanical tests have pass/fail criteria based on engineering 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 device is not an AI/ML diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical spinal fixation system.
7. The type of ground truth used
For mechanical testing, the "ground truth" or reference criterion is based on established engineering standards (ASTM F1717, ASTM F1798) and relevant FDA guidance (FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(355 days)
BIOMET SPINE (AKA EBI, LLC)
The MaxAn® Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.
The MaxAn® Anterior Cervical Plate System Cervical Plate System consists of titanium alloy plates and screws intended for use in anterior cervical discectomy and fusion (ACDF) procedures. Cervical plates are intended for use at 1-5 levels, and are available in lengths from 8mm-130mm. Screws are available in both fixed and variable versions in sizes 4.0mm and 4.5mm in various lengths. All components are available in both sterile and non-sterile configurations.
The purpose of this submission is to add MR Conditional labeling for the components of the MaxAn system.
Here's a breakdown of the acceptance criteria and the study details for the MaxAn® Anterior Cervical Plate System, based on the provided text:
Important Note: The provided document is a 510(k) summary for adding MR Conditional labeling to an already cleared device (MaxAn® Anterior Cervical Plate System). Therefore, the "study" described herein specifically pertains to MR compatibility, not the primary clinical effectiveness or safety of the spinal fixation itself, which would have been established in the original K080646 submission. The information below reflects what's available in this specific document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM Standard) | Reported Device Performance (MaxAn® Anterior Cervical Plate System) |
|---|---|
| ASTM F2052-06 (Magnetically Induced Displacement Force on Medical Devices) | Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of magnetically induced displacement. |
| ASTM F2119-07 (Evaluation and Labeling of MR Image Artifacts) | Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of MRI artifacts. |
| ASTM F2182-11a (Heating of Medical Devices During MRI) | Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of device heating. |
| ASTM F1717-04 (Static & Dynamic Testing of Spinal Constructs) | Qualitative torque testing was presented. (The document states these tests were conducted, implying performance met standards, but specific quantified acceptance criteria and performance values are not detailed in this summary for these mechanical tests). |
| Static compression bending | (Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.) |
| Static torsion | (Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.) |
| Dynamic compression | (Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in this 510(k) summary. The document refers to "testing conducted" according to ASTM standards, which would imply a number of device samples were used for each test. Specific quantities are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing described is bench testing (mechanical and MR compatibility), not human or animal studies, so "retrospective or prospective" is not applicable in the typical clinical sense. The tests were performed to evaluate the physical properties of the device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the "ground truth" for these tests is the direct measurement of physical properties against established ASTM standards, not expert interpretation of clinical data or images. The "experts" involved would be engineers and technicians executing the tests and interpreting the raw data, but their number and specific qualifications are not detailed in this regulatory summary.
4. Adjudication Method for the Test Set
- This is not applicable. As these are bench tests measuring physical properties, there is no "adjudication method" in the sense of reconciling differing expert opinions. The outcome is determined by whether the measured physical property (e.g., heating, displacement) falls within the acceptable limits defined by the ASTM standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. This submission pertains to MR Conditional labeling for a device, which involves bench testing, not clinical performance comparison with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This is not applicable. The device is a physical spinal implant, not an algorithm or AI system. The testing performed is to assess the physical device's compatibility with an MRI environment.
7. Type of Ground Truth Used
- The "ground truth" used for these tests is the objective measurements of physical forces, temperatures, and image artifacts as defined and evaluated against the specified ASTM (American Society for Testing and Materials) standards. These standards provide the accepted methodology and limits for determining MR compatibility and mechanical performance.
8. Sample Size for the Training Set
- This is not applicable. The device is a physical implant, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reason as point 8.
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(167 days)
BIOMET SPINE (AKA EBI, LLC)
The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.
The Biomet Graft Delivery Syringes provide the surgeon with a method to manually deliver bone grafting material such as allograft, autograft and synthetic bone grafting materials to all orthopedic surgical sites. The sterile syringes are available in three different sizes to hold different volumes of grafting materials. The graft delivery syringe consist of a syringe barrel with a plunger, a removable female luer cap and removable end cap and will be provided empty or pre-filled with commercially available bone grafting materials. The syringes will be available with and without an internal stainless steel strainer.
This is a 510(k) premarket notification for the Biomet Graft Delivery Syringes. The document indicates that the device is substantially equivalent to legally marketed predicate devices, and therefore does not provide the detailed acceptance criteria and study data typically found in a clinical trial report or a performance study summary for novel devices.
However, based on the provided text, here's what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance | "device functions as intended to deliver bone graft materials to an orthopedic surgical site." |
| Substantial Equivalence | "The Biomet Graft Delivery System is substantially equivalent to the predicate syringes as a graft delivery syringe in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles." |
| Safety & Effectiveness | "does not raise any new issues regarding safety and effectiveness." |
Missing Information: Specific quantitative acceptance criteria (e.g., maximum force to deliver graft, leakage rates, specific flow rates) and the precise quantitative performance results are not detailed in this summary. The performance is stated in qualitative terms (e.g., "functions as intended," "substantially equivalent").
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the "simulated use testing."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing is described as "simulated use testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the study described is a "simulated use testing" focused on device function, not on clinical interpretation or an evaluation requiring expert ground truth for diagnostic accuracy.
4. Adjudication method for the test set:
- This information is not provided and is not applicable given the nature of the described "simulated use testing."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (syringe) and not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical instrument, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the simulated use testing would likely be based on engineering specifications and functional requirements for the device (e.g., successful delivery of graft material without clogging, leakage, or structural failure). It is not based on expert consensus, pathology, or outcomes data in the clinical sense for this type of device.
8. The sample size for the training set:
- Not applicable. This device is hardware; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of Study:
The document describes "Simulated use testing" which was conducted to demonstrate that the Biomet Graft Delivery Syringes function as intended to deliver bone graft materials. The purpose of this testing was to support the claim of substantial equivalence to predicate devices, ensuring that the new device does not raise new safety or effectiveness concerns. The details of this simulated use testing (e.g., protocols, specific pass/fail criteria, actual quantitative results, sample size) are not provided in this 510(k) summary, only the conclusion that it successfully demonstrated the device functions as intended.
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(98 days)
EBI, LLC
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to clear modifications to Polaris Translation Screw and to update the labeling.
Here's a summary of the acceptance criteria and study information for the Polaris Spinal System - Translation Screw, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Static Compression Bending (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. |
| Static Torsion (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. | |
| Dynamic Compression Bending Fatigue (ASTM F1717) | Met all mechanical test requirements based on worst-case construct testing. | Device met all mechanical test requirements based on the worst-case construct testing. | |
| Resistance to cantilever loading or non-axial torque | Ability to resist cantilever loading or non-axial torque comparable to the predicate device. | Testing verified the ability of the subject device to resist cantilever loading or non-axial torque compared to the predicate device. | |
| Substantial Equivalence | Intended Use | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices (K131615, K123549, K090203, K061441). |
| Indications for Use | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Design | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Materials | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Manufacturing Methods | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Sterility | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Fundamental Technology | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. | |
| Operational Principles | Substantially equivalent to predicate devices. | Substantially equivalent to Polaris Spinal System predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes mechanical testing as the primary method to demonstrate performance. For this, the sample size is not explicitly stated as a number of devices or constructs, but it mentions testing was performed on "worst-case construct testing." There is no information about country of origin or whether the data was retrospective or prospective, as this pertains to physical device testing rather than clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance data is based on mechanical laboratory testing against established ASTM standards and direct comparison to predicate devices, not on expert assessment of a test set.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation is based on objective mechanical testing in a laboratory setting, not on human adjudication of cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (spinal fixation system modification). This document focuses on the mechanical substantial equivalence of a medical device, not the interpretive accuracy of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical spinal implant, not an algorithm or AI system. Its performance is inherent in its mechanical properties and design.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- ASTM F1717 Standard: This standard dictates specific methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model. Compliance with this standard represents a recognized and accepted "ground truth" for mechanical performance in this domain.
- Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate devices (K131615, K123549, K090203, and K061441). The subject device's performance is compared directly to these.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
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(240 days)
BIOMET SPINE (AKA EBI, LLC)
The Biomet probes/guidewires and dilators are intended for tissue dilation and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
The Biomet insulated probes/guidewires and dilators are intended to dilate tissue and be used as intraoperative neuromonitoring (IONM) stimulation accessories by connectially available IONM equipment for locating and identifying peripheral nerves including spinal nerve roots during spinal surgery. The Biomet insulated probes/guidewires have a length of 305mm, an exposed stimulation area of .167 cm², and an outer diameter of 2.6mm. The Biomet insulated dilators have a length ranging from 229mm to 254mm, an exposed stimulation are of .167 cm², an inner diameter ranging from 3.2mm to 9.8mm, and an outer diameter ranging from 5.8mm to 13.8mm.
This Biomet submission (K132373) is for nerve stimulation accessories (probes/guidewires and dilators), not for a device that relies on AI/ML. Therefore, the requested information elements related to AI/ML device performance (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable and are not present in this 510(k) summary.
The acceptance criteria and supporting studies for this device are focused on electrical and mechanical performance, as well as biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Non-cytotoxic (ISO 10993-5) | No evidence of cytotoxicity |
| Sensitization | Non-sensitizing (ISO 10993-10) | No evidence of sensitization | |
| Irritation | Non-irritant (ISO 10993-10) | No evidence of irritation | |
| Systemic Toxicity | No systemically toxic (ISO 10993-11) | No signs of toxicity | |
| Pyrogen Test | Non-pyrogenic | No signs of pyrogens | |
| Electrical Performance | Total Resistance | Equivalent to predicate devices | Results demonstrate equivalence |
| System Impedance | Equivalent to predicate devices | Results demonstrate equivalence | |
| Current Density | Equivalent to predicate devices | Results demonstrate equivalence | |
| Mechanical Performance | Mechanical Testing | Equivalent to predicate devices | Results demonstrate equivalence |
| Material Conformance | Wrought Stainless Steels | ASTM F899:2012 compliance | Device conforms to ASTM F899:2012 |
| Sterilization | Radiation Sterilization | AAMI/ANSVISO 11137-2:2006 compliance | Device conforms to AAMI/ANSVISO 11137-2:2006 |
| Ethylene Oxide Sterilization | ANSI/AAMI/ISO 11135-1:2007 compliance | Device conforms to ANSI/AAMI/ISO 11135-1:2007 | |
| Packaging | Performance Testing | ASTM D4169:2009 compliance | Device conforms to ASTM D4169:2009 |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench test conducted (Total Resistance, System Impedance, Current Density, Mechanical/Electrical Testing) or for the biocompatibility tests. It states that "Biocompatibility testing was conducted" and "Bench testing was conducted," implying a sufficient number of samples were tested to gain confidence in the results, but the specific N is not provided. The data provenance is internal testing by Biomet Spine.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of device (electrical stimulus and dilator) is based on objective measurements from bench testing and adherence to recognized standards, not subjective expert assessment of data like images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. There was no expert adjudication process involved for the objective bench and biocompatibility testing. The outcomes are concrete measurements against defined standards or comparisons to predicate device performance.
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 device is not an AI/ML-driven diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument (probes/guidewires and dilators) used with commercially available neuromonitoring equipment during surgery. It does not have an "algorithm-only" or "standalone" performance in the AI/ML sense.
7. The type of ground truth used
The "ground truth" for this device's performance is established through:
- Objective Bench Test Measurements: Electrical properties (resistance, impedance, current density) and mechanical integrity were measured and compared to predicate devices' known performances and acceptable ranges.
- Biocompatibility Standards: Adherence to international standards like ISO 10993 (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity) where "ground truth" is defined by the absence of adverse biological reactions as per the standard's methodologies.
- Material and Sterilization Standards: Compliance with recognized ASTM and AAMI/ISO standards for materials and sterilization processes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(93 days)
BIOMET SPINE (AKA EBI, LLC)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista and Cypher MIS instruments are intended to be used with Ballistal Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by turnor and/or trauma. Pedicle screw fixation is limited to a posterior approach.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This line extension is to add downsized components and additional rod and connector styles to the Polaris Spinal System.
Here's an analysis of the provided 510(k) summary regarding the Polaris Spinal System:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Guidance) | Reported Device Performance |
|---|---|
| Static compression bending | Met all mechanical test requirements |
| Static torsion | Met all mechanical test requirements |
| Dynamic compression bending fatigue (ASTM F1717) | Met all mechanical test requirements |
| Interconnection testing (ASTM F1798) | Met all mechanical test requirements |
Note: The document explicitly states that the device "met all mechanical test requirements based on the worst-case construct testing." The specific numerical thresholds for these acceptance criteria are not provided in this summary but would be detailed in the full test reports referenced by the FDA's "Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "worst-case construct testing," implying that specific configurations were tested, but the number of samples per test type is not detailed.
- Data Provenance: This is a retrospective study in the sense that the testing was conducted on samples of the device components. The data is generated from laboratory mechanical testing, not from patient data or clinical trials. The country of origin of the data is implicitly the USA, where the testing was conducted to FDA guidance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes a mechanical performance study, not a study requiring expert interpretation of medical images or patient data to establish ground truth. Therefore, this section is not applicable. The "ground truth" here is the physical performance of the device against established engineering standards.
4. Adjudication Method for the Test Set
Not applicable. As this is a mechanical performance study, there is no "adjudication method" in the clinical sense. The results are objective measurements against defined engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, typically in diagnostic imaging. This document describes mechanical testing of a spinal implant system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study (in the context of an algorithm or AI) was not done. This document describes the mechanical performance of a physical medical device (spinal implant system).
7. Type of Ground Truth Used
The ground truth used for this study is based on established engineering standards and regulatory guidance for spinal implant testing, specifically:
- ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model
- ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004
8. Sample Size for the Training Set
Not applicable. This is a study of a physical device's mechanical properties, not an AI or algorithm-based product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant.
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(93 days)
BIOMET SPINE (AKA EBI, LLC)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.
For pediatric patients, the Polaris System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Nextgen Altius OCT Spine System. The Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F 136, unalloyed titanium per ASTM F 67, stainless steel per ASTM F 138 or ASTM F 1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM 1537. The system includes screws, various types and sizes of rods, locking nuts, hooks. lateral connectors, plugs. fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This line extension is to expand the indications for use for Polaris Spinal System using previous cleared system components.
This document describes a 510(k) submission for the Polaris Spinal System, a medical device. The information provided heavily focuses on the comparison to predicate devices to establish substantial equivalence rather than detailing specific device performance or clinical studies with acceptance criteria for a novel AI or diagnostic device.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or are not explicitly stated in the provided text. The document is primarily a regulatory submission demonstrating equivalence, not a detailed performance study report.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (Static Compression Bending, Static Torsion, Dynamic Compression Bending per ASTM F1717) | Implicit historical data: "The implants included in the submission were previously tested for static compression bending, static torsion and dynamic compression bending per ASTM F1717." |
| Safety and Effectiveness for Pediatric Pedicle Screw Fixation (especially Adolescent Idiopathic Scoliosis) | "The assessment concluded that pedicle screw fixation is safe and effective for use in pediatric patients for the treatment of adolescent idiopathic scoliosis." (Based on clinical literature assessment) |
| Substantial Equivalence (Intended Use, Indications, Design, Materials, Manufacturing Methods, Sterility, Fundamental Technology, Operational Principles) | The Polaris Spinal System is deemed "substantially equivalent" to multiple predicate devices (Revere" 4.5 Stabilization System, CD Horizon" Spinal System, TSRH* Spinal System, and previous Polaris Spinal System versions) based on these characteristics. |
Missing Information/Not Applicable: The document does not specify quantitative acceptance criteria (e.g., "must achieve X N-m of torque" or "failure rate must be below Y%"). The "reported device performance" for mechanical strength is a statement that it was "previously tested" and "already demonstrated," indicating compliance with prior standards or predicate device performance, but no specific values or criteria are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study with a specific sample size.
- Mechanical Testing: While mechanical tests per ASTM F1717 were performed, the sample size for these tests is not mentioned.
- Clinical Literature Assessment: This involved reviewing "published clinical data." The number of patients or studies included in this assessment is not specified, nor is the country of origin, or whether it was retrospective or prospective. It's a review of existing data, not a new data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The document does not describe a study involving expert-established ground truth for a test set. The clinical literature assessment likely involved review by the regulatory affairs team, but not in the context of establishing "ground truth" for a device performance study.
4. Adjudication Method for the Test Set
This information is not applicable as no "test set" requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done or mentioned. This device is a surgical implant, not a diagnostic imaging AI, so such a study would not typically apply in this direct comparison context.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
This information is not applicable. The Polaris Spinal System is a physical implant, not an algorithm. Standalone performance for mechanical devices relates to their physical integrity and function under simulated use, which is addressed by the ASTM F1717 testing.
7. Type of Ground Truth Used
- Mechanical Testing: The "ground truth" for mechanical testing would be the physical properties and performance metrics defined by the ASTM F1717 standard.
- Clinical Efficacy (for pediatric pedicle screw fixation): The "ground truth" was derived from a "clinical literature assessment," meaning conclusions drawn from existing published clinical data and expert consensus in the medical community about the safety and effectiveness of pedicle screw fixation for the stated conditions.
8. Sample Size for the Training Set
This information is not applicable, as there is no "training set" in the context of a medical device like this. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this device.
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(98 days)
BIOMET SPINE (AKA EBI, LLC)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista/Ballista II instruments are intended to be used with Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
The Polaris Spinal System is a non-cervical spinal fixation device. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This submission is a line extension to Polaris Spinal System to add other styles of multiaxial screw, including a screw with translating feature, and to provide the Polaris Spinal System sterile packed.
The provided document describes a 510(k) summary for the Biomet Spine Polaris Spinal System - Translation Screw, which is a non-cervical spinal fixation device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Static compression bending per ASTM 1717-11a | Met all mechanical test requirements based on worst-case construct testing. |
| Static torsion per ASTM 1717-11a | Met all mechanical test requirements based on worst-case construct testing. |
| Dynamic compression bending fatigue per ASTM 1717-11a | Met all mechanical test requirements based on worst-case construct testing. |
| Substantial Equivalence: | Reported as substantially equivalent to predicate devices regarding material, design, operational principles, intended use, indications, and fundamental technology. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance. The testing performed was mechanical testing of the device hardware.
- Test Set Sample Size: Not applicable in the context of clinical data or algorithm performance.
- Data Provenance: Not applicable. The "data" comes from physical mechanical tests conducted on the device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of algorithm performance, typically refers to expert-validated clinical diagnoses or outcomes. This submission focuses on mechanical performance data of a physical medical device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert opinions for clinical ground truth. Mechanical testing has well-defined pass/fail criteria per ASTM 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
No, an MRMC comparative effectiveness study was not done. This device is a physical spinal fixation system, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is for a physical medical device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the mechanical testing was the established pass/fail criteria defined by ASTM 1717-11a standard test methods for static and fatigue testing of spinal implant constructs in a vertebrectomy model.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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(24 days)
BIOMET SPINE (AKA EBI, LLC)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista/Ballista II instruments are intended to be used with Ballista/Ballista II/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista II instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a noncervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
The Polaris Spinal System is a non-cervical spinal fixation device. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos and various cross connectors. Various instruments are also available for use by the surgeon to facilitate implantation of the device. This submission is a line extension to Polaris Spinal System to add another style of Ballista rods to the system.
The provided text describes a 510(k) premarket notification for the "Polaris Spinal System - Ballista II Rods," a non-cervical spinal fixation device. This submission is a line extension to add another style of Ballista rods to the existing system. The core assertion is that the new components are "substantially equivalent" to predicate devices, meaning they have the same or similar technological characteristics and do not raise new issues of safety or effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Substantial Equivalence) | The new Ballista II rods are substantially equivalent to predicate rods (K121130 & K061441) with respect to intended use and indications, technological characteristics, and principles of operation. No new issues of safety or effectiveness are presented. |
| Mechanical Performance | An engineering analysis concluded that mechanical testing was not required for this specific style of rod because the combination of components did not create a new worst-case construct. |
| Compatibility with System Instruments | Validation testing was conducted to verify that the modified rods can be used with the system's instrumentation. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of this submission. The "study" here is primarily an engineering analysis and validation testing, not a clinical study on human subjects or a dataset in the typical sense for AI/machine learning.
- Data Provenance: Not applicable. The validation testing would have been performed in a laboratory setting by the manufacturer, Biomet Spine. The data is internal to the company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not applicable. This submission focuses on engineering analysis and mechanical/compatibility testing, not on establishing ground truth from expert interpretations of medical data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There is no human interpretation of data requiring adjudication mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence from a mechanical and functional perspective, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
- No, a standalone study (in the context of an algorithm's performance) was not done. This is a hardware device submission, not an AI or software device submission.
7. The Type of Ground Truth Used:
- Ground Truth: The "ground truth" in this context is defined by established engineering principles, mechanical testing standards for spinal implants, and the functional compatibility requirements with existing instrumentation. This is engineering/performance data and manufacturing specifications.
8. The Sample Size for the Training Set:
- Not applicable. This submission does not involve an AI system with a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This submission does not involve an AI system with a "training set."
Summary of the Study Proving Device Meets Acceptance Criteria:
The "study" in this context consists of an engineering analysis and validation testing.
- Engineering Analysis: This analysis was conducted to determine if new mechanical testing was required for the different style of rod. The conclusion was that because the new component combination did not create a "new worst-case construct" compared to the predicate devices, additional general mechanical testing of the rod itself was not deemed necessary to demonstrate substantial equivalence for the main mechanical properties.
- Validation Testing: This testing specifically verified the compatibility and functionality of the modified rods with the existing Polaris Spinal System instrumentation. This ensures that surgeons can safely and effectively use the new rods with the established toolset.
The overall approach to proving the device meets acceptance criteria (which is primarily substantial equivalence) relies on demonstrating that the new components maintain the same intended use, indications, technological characteristics, and principles of operation as legally marketed predicate devices, and that the minor modifications do not introduce new safety or effectiveness concerns, supported by engineering analysis and specific compatibility testing.
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(28 days)
BIOMET SPINE (AKA EBI, LLC)
The Biomet Lateral Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Biomet Lateral Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Lateral Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Lateral Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Biomet Lateral Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
As an intervertebral body fusion device, the Biomet Lateral Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Biomet Lateral Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Biomet Lateral Spacer System may be implanted via an open or minimally invasive lateral approach.
The purpose of this submission is the introduction of a new device for intervertebral body fusion and vertebral body replacement. The Biomet Lateral Spacer System is constructed of medical grade Polyetheretherketone (PEEK-Optima LT1 per ASTM F-2026) and tantalum (per ASTM F-560) radiographic markers, and is available in multiple lengths/widths/heights and lordotic angles to meet varying patient anatomies.
The provided text is a 510(k) Summary for the Biomet Lateral Spacer System, a medical device. This document describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence based on technological characteristics and mechanical performance.
However, the 510(k) Summary does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of typical AI/ML device evaluations. This document details mechanical testing of the device's structural integrity, not a clinical study or evaluation of a diagnostic or predictive AI algorithm's performance against specific clinical or analytical acceptance criteria.
The questions asked (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, ground truth for training set) are highly relevant to the evaluation of AI/ML-driven medical devices, especially those performing diagnostic or assistive functions. These types of details are absent from the provided text.
The Biomet Lateral Spacer System is a physical implant (intervertebral body fusion device), and its "performance data" refers to its mechanical strength and durability as assessed by engineering standards, not its diagnostic accuracy or the effectiveness of an AI component.
Therefore, I cannot populate the requested table or answer the specific questions based on the provided text, as the document describes a mechanical device assessment, not an AI/ML device study.
Here's the closest I can get to addressing your request, based on the document's content, while acknowledging the mismatch:
1. Table of "Acceptance Criteria" and Reported Device Performance (as per the document's context):
| Acceptance Criteria (Implied by standard) | Reported Device Performance (as stated) |
|---|---|
| Mechanical strength sufficient for intended use | Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use. |
Explanation of the Mismatch:
- Acceptance Criteria: For a physical implant, "acceptance criteria" generally refer to meeting specified engineering standards (e.g., load-bearing capacity, fatigue life) under various conditions. The document states that "Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use," implying these acceptance criteria were met, but it doesn't quantify them (e.g., "must withstand X Newtons of force"). It only lists the types of tests conducted (Static Axial Compression, Dynamic Axial Compression, etc.) according to specific ASTM standards (F-2077, F-2267, F-560, F-2026, and an ASTM Draft).
- Reported Device Performance: Instead of numerical performance metrics, the document provides a qualitative statement that the device's mechanical strength is "sufficient."
Regarding the other specific questions (2-9):
These questions are designed for AI/ML device studies and are not applicable to the type of device and evaluation described in the provided 510(k) summary.
- Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data analysis.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is typically determined by engineering measurements and adherence to standards, not expert clinical consensus.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study evaluates human reader performance, usually with medical images, often with and without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm described.
- The type of ground truth used: For mechanical testing, the "ground truth" is compliance with engineering specifications and stress tests, not clinical outcomes, pathology, or expert consensus in the diagnostic sense.
- The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the provided text describes the mechanical performance testing of a physical medical implant (Biomet Lateral Spacer System) to demonstrate its safety and effectiveness through substantial equivalence to predicate devices, based on established ASTM engineering standards. It does not contain information relevant to the assessment of an AI/ML medical device, which is what your questions seem to pertain to.
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