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510(k) Data Aggregation
(29 days)
The 4.5mm Facet Compression Device, which is included in the Disposable Posterior Lumbar Stabilization Procedure Kit, is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.
The intended use of the 4.5mm Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm Facet Compression Device.
The 4.5mm Facet Compression Device(s) contained in the Disposable Posterior Lumbar Stabilization Procedure Kit is a double-helix screw with a compression-locking collar and self-retaining washer. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. Disposable surgical instruments for use in implanting the device are also included in the kit. The kit is provided "STERILE"; sterilization is by gamma radiation. The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclaye) and is performed on-site.
Here's an analysis of the provided 510(k) summary regarding the Disposable Posterior Lumbar Stabilization Procedure Kit, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Triage Medical Disposable Posterior Lumbar Stabilization Procedure Kit (K062391) is a premarket notification for a Class II medical device. For such devices, the acceptance criteria are generally based on substantial equivalence to a previously cleared predicate device. This typically means demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The document does not explicitly state numerical "acceptance criteria" in terms of performance metrics (e.g., a specific strength value that must be met). Instead, the performance is evaluated in comparison to the predicate device to establish substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicit from 510(k) process) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Meets established material standards for implants. | Made of titanium alloy meeting ASTM F-136. Materials are identical to those in legally marketed orthopedic spinal fixation devices. |
| Functional Performance | Device performs its intended stabilization function safely and effectively. | "Performance test results indicate that the device is safe and satisfies functional and performance requirements when used as indicated." |
| Instrument Performance | Associated surgical instruments perform their intended function safely and effectively. | "The associated instruments have also met functional and performance requirements." |
| Substantial Equivalence | Demonstrates equivalence in intended use, technological characteristics, and safety/effectiveness to predicate device. | "Test results demonstrate that the devices contained in the Disposable Posterior Lumbar Stabilization Procedure Kit is substantially equivalent to the predicate devices and are capable of safely and effectively performing the stated intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on specific sample sizes for any mechanical or performance testing. It generally states "performance test results indicate..." without quantifying the number of units tested.
Regarding data provenance, the document does not specify the country of origin for the testing or whether the data was retrospective or prospective. Given the nature of a 510(k) for an orthopedic implant, the testing would typically involve in vitro mechanical testing and material characterization, rather than clinical data in the same way an AI/software device would generate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this 510(k) document. The device is a physical medical implant (a facet screw and associated instruments). "Ground truth" established by experts, especially for a "test set" in the context of diagnostic or AI performance, is not a relevant concept for this type of device submission. The primary evaluation is based on engineering principles, material science, and mechanical testing, often performed by engineers and material scientists, not clinical experts establishing ground truth from patient data.
4. Adjudication Method for the Test Set
This is not applicable to this 510(k) document for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human expert disagreement needs resolution. This is not how the performance of a facet screw is assessed for a 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images, often assisted by AI. This device is a surgical implant; therefore, MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical surgical implant and instruments; it does not involve an algorithm or AI.
7. The Type of Ground Truth Used
As mentioned, "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly relevant for the performance evaluation of this specific device for its 510(k) submission. The "ground truth" for the device's characteristics and performance would be derived from:
- Material specifications: Conformance to ASTM F-136.
- Mechanical testing standards: (Implicitly) demonstrating strength, fatigue resistance, and other biomechanical properties relevant to spinal stabilization.
- Predicate device's known performance: The BONE-LOK® 4.5mm Facet Screw, which serves as the benchmark for "substantial equivalence."
8. The Sample Size for the Training Set
This is not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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(81 days)
The 3.8mm CS Facet Compression Device is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion. The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.
The 3.8mm CS Facet Compression Device is a double-helix screw with a compressionlocking collar, and is provided with or without a self-retaining washer. It is available in various length ranges fabricated from either Titanium 6Al-4V, which meets the requirements of ASTM F-136 or stainless steel, which meets the requirements of ASTM F-138.
This document describes the 510(k) summary for the Triage Medical, Inc. 3.8mm CS Facet Compression Device. This device is a facet screw intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints.
The provided text describes a medical device submission for regulatory clearance (510(k) application) and details related to its non-clinical performance and a comparison to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria related to AI/software performance or diagnostic accuracy. The performance data mentioned is focused on mechanical and biocompatibility aspects, not AI-driven predictive or diagnostic capabilities.
Therefore, many of the requested sections about acceptance criteria, study details for AI performance, sample sizes for AI training/testing, ground truth establishment, and MRMC studies cannot be generated from the given text.
Here's the information that can be extracted and a clear statement about what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Satisfy functional performance requirements | "Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements." |
| Biocompatibility | Made from biocompatible materials; meet ASTM standards for Titanium 6Al-4V ELI (F-136) or surgical grade Stainless Steel (F-138). | "The 3.8mm CS Facet Compression Device is made from either Titanium 6Al-4V ELI, which meets the requirements of ASTM F-136 or surgical grade Stainless Steel, which meets the requirements of ASTM F-138." |
| Substantial Equivalence | Similar in basic design, materials, and intended use to predicate device (NuVasive™ 3.5mm Triad™ Facet Screw System K020411). | "The 3.8mm CS Facet Compression Device is similar in basic design, materials and intended use to the NuVasive™ 3.5mm Triad™ Facet Screw System cleared under 510(k) K020411.""The 3.8mm CS Facet Compression Device is similar in materials, design, construction and mechanical performance to the predicate devices." |
| Safety and Effectiveness | Safe when used as indicated; accurately perform stated intended use. | "Documentation provided, and test results demonstrate that the 3.8mm CS Facet Compression Device is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use." |
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 available in the provided text. The document refers to non-clinical mechanical and biocompatibility testing, not clinical studies or AI algorithm testing with a "test set" in the common sense for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. The device is a physical implant, and its evaluation relies on engineering tests and material standards, not expert-derived ground truth for AI performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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
This information is not available in the provided text. This device is not an AI-driven diagnostic or assistive tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not available in the provided text. This device is a physical facet screw, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical and biocompatibility performance, the "ground truth" would be established by engineering standards and test methodologies (e.g., ASTM standards for materials, recognized biomechanical testing protocols). This is not the typical "ground truth" concept as applied to AI/diagnostic devices.
8. The sample size for the training set
This information is not available in the provided text. There is no mention of an AI algorithm or a training set.
9. How the ground truth for the training set was established
This information is not available in the provided text. There is no mention of an AI algorithm or a training set.
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(21 days)
The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.
The intended use of the 4.5mm LS Facet Compression Device with Polymer Washer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
The 4.5mm LS Facet Compression Device is a double-helix screw with a compressionlocking collar. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for single use only.
Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
The provided text describes a 510(k) premarket notification for a medical device, the "4.5mm LS Facet Compression Device with Polymer Washer." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested elements for an AI/algorithm-focused study are not directly applicable or present in this document. I will extract the information that is available and indicate where the information is not provided.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
This document does not present quantitative acceptance criteria or detailed device performance metrics in the format of a clinical study or algorithm validation. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, as determined by mechanical testing and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (materials meet specified standards) | Titanium meets ASTM F-136, Stainless steel meets ASTM F-138. Polymer washer meets USP Class VI and ISO 10993-1. |
| Functional Performance (mechanical similarity to predicate) | "Performance test results indicate that the device is safe and satisfies functional performance requirements when used as indicated." |
| Substantial Equivalence to Predicate Device (BONE-LOK® 4.5mm Facet Screw, K043351) | "The test results demonstrate that the modified 4.5mm LS Facet Compression Device with Polymer Washer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is for a mechanical medical device, not a data-driven AI/algorithm. The "test set" would refer to the mechanical tests performed on the device. However, specific sample sizes for these tests are not provided in this summary. The data provenance would be from laboratory testing of materials and device mechanics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of ground truth.
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 not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance and biocompatibility, the "ground truth" is defined by established material standards (e.g., ASTM, USP, ISO) and laboratory-based functional performance tests compared against the predicate device.
8. The sample size for the training set
Not applicable. This is a mechanical medical device, not an AI/algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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(28 days)
The BONE-LOK® MVP Cortical-Cancellous Compression Device is indicated for use in the general management of fractures and reconstructive surgery.
The BONE-LOK® MVP Cortical-Cancellous Compression Device is a double-helix screw with a compression-locking collar. It is available as 3.5mm or 4.5mm diameter device with a compression looking ochan 1978 - The BONE-LOK® MVP Cortical-Cancellous Compression Device is intended for single use only. Devices provided "STERILE" are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BONE-LOK® MVP Cortical-Cancellous Compression Device, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet requirements of ASTM F-138 (stainless steel) or ASTM F-136 (titanium). | Materials meet ASTM F-138 (stainless steel) or ASTM F-136 (titanium). |
| Functional Performance | Satisfy functional performance requirements when used as indicated. | Performance test results indicate the device is safe and satisfies functional performance requirements. |
| Substantial Equivalence | Demonstrates substantial equivalence to the predicate device. | Test results demonstrate substantial equivalence to the predicate device. |
Explanation of "Acceptance Criteria" in this Context:
It's important to note that the provided 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a detailed list of specific numerical acceptance criteria for clinical or performance outcomes. The acceptance criteria here are implicitly:
- The materials used are biocompatible and commonly accepted for orthopedic devices.
- The mechanical performance is comparable to the predicate device.
- The device is safe for its intended use.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a test set with human or animal subjects, nor does it mention sample sizes for such a set. The document refers to "Performance test results" which are likely referring to mechanical or bench testing.
- Sample Size for Test Set: Not mentioned, likely not applicable in the context of human/animal outcome data for this type of submission.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As there's no mention of a clinical test set requiring human interpretation or ground truth establishment in the traditional sense (e.g., for diagnostic accuracy), this section is not applicable.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable, as there's no mention of a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study (often seen in diagnostic imaging for AI) is not relevant for a bone fixation device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is a physical bone fixation screw, not a software algorithm or AI tool. Therefore, a "standalone algorithm performance" study is not relevant. The "performance data" mentioned refers to mechanical testing.
7. Type of Ground Truth Used
Based on the document, the "ground truth" for the device's performance is established through:
- Compliance with Material Standards: Meeting ASTM F-138 (stainless steel) or ASTM F-136 (titanium) for biocompatibility. These are established industry standards for medical-grade materials.
- Mechanical Performance Bench Testing: The statement "Performance test results indicate that the device is safe and satisfies functional performance requirements" implies benchtop mechanical testing (e.g., strength, compression, fatigue) against established engineering specifications or comparison to the predicate device's known performance.
- Substantial Equivalence to Predicate Device: The ultimate "truth" for 510(k) clearance is demonstrating that the modified device is as safe and effective as a legally marketed predicate device.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not an AI model or software algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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