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510(k) Data Aggregation
(84 days)
OSTEOMED LP
The OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula. The ExtremiLOCK Ankle Plating System implants are intended for single use only.
The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and pediatric patients.
The OSTEOMED ExtremiLOCK Ankle Plating System is a comprehensive ankle fracture system intended to provide solutions for various bony fractures, including simple to complex fractures of the distal tibia and fibula. The plates are provided in a variety of shapes and sizes, offering surgeons compression, non-locking and locking hole designs. The ExtremiLOCK Ankle Plating System includes angulated locking screws and standard non-locking screws as well as K-wires. Surgical instrumentation is provided to facilitate insertion, modification and/or removal of implants.
The implants of the OsteoMed ExtremiLOCK Ankle Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
The provided text describes a medical device, the OsteoMed ExtremiLOCK Ankle Plating System, and its performance evaluation for substantial equivalence, not a study involving AI or human readers. Therefore, many of the requested points related to AI/human reader studies, ground truth establishment for training sets, and expert consensus for test sets are not applicable.
Here's an analysis of the acceptance criteria and the study as described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: Meet required mechanical strength for intended use. | Verification Evaluations: Underwent pull-out, torque, and bending tests. |
| Biocompatibility: Materials are biocompatible. | Material Composition: Implants made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), same as predicate devices; these materials are biocompatible. |
| Functional Equivalence: Similar intended use, function, design, technology, and operational principles to predicate devices. | Performance Equivalence: Shown through verification and comparison to predicate devices. Substantial equivalence based on similarities in intended use, function, performance, design, technology, and operational principles to listed predicate devices. |
| Safety and Effectiveness: No new safety or effectiveness issues. | No New Issues: Similar extended use, design, technology, and operational principles to predicate devices imply no new safety or effectiveness issues. |
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 or patient samples. The performance evaluation involved verification evaluations (pull-out, torque, bending tests) on the device components themselves. The provenance of the data for these engineering tests (e.g., country of origin, retrospective/prospective) is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The study described is a mechanical performance evaluation of hardware, not an assessment requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described above, this was a mechanical performance evaluation, not a study requiring adjudication of expert opinions.
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. This document describes a 510(k) submission for a medical device (bone plating system) focusing on its mechanical properties and substantial equivalence to predicate devices, not an AI-assisted diagnostic or prognostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not a study of an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" in this context would be the established mechanical standards and performance of the predicate devices. The new device's mechanical performance (pull-out, torque, bending) was compared against these established benchmarks to demonstrate equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI or machine learning study.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
Summary of the Study:
The study conducted was a mechanical performance evaluation of the OsteoMed ExtremiLOCK Ankle Plating System. This involved:
- Verification evaluations including pull-out, torque, and bending tests on the device's implants.
- Comparison of these results to the performance of legally marketed predicate devices (Synthes Dynamic Compression Locking Plating System, OsteoMed Foot Plating System, OsteoMed Super Screw 3.5mm, and Merete Locking Bone Plate System III).
- The primary goal was to demonstrate substantial equivalence in terms of intended use, function, performance, design, technology, operational principles, and material composition to existing devices, without raising new safety or effectiveness issues.
- The document explicitly states that clinical testing was not required to support substantial equivalence for this device.
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(29 days)
OSTEOMED LP
The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.
The OsteoMed ExtremiLOCK Foot Plating System consists of plates of various shapes and sizes featuring compression, locking, elongated or compression elongated holes, angulated locking, non-locking and cannulated screws, implantable K-Wires, washers, and appropriate instrumentation. Modifications to plates of the subject system include increasing the thickness of the plates, material changes, and addition of features.
The implants of the OsteoMed ExtremiLOCK Foot Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
The provided text describes a medical device submission (K131445) for the OsteoMed ExtremiLOCK Foot Plating System. It's a 510(k) submission, which focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical efficacy studies.
Here's an analysis of the acceptance criteria and study information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantified acceptance criteria in terms of performance metrics (e.g., specific thresholds for strength, accuracy, or clinical outcomes). Instead, the acceptance criteria are implicitly met by demonstrating performance equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength | "ExtremiLOCK implants underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." Performance equivalence was shown through "verification comparison to the predicate devices." |
| Material Biocompatibility | "ExtremiLOCK implants are manufactured from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), the same materials used in the manufacture of the predicate devices. These materials are biocompatible." |
| Design & Functionality | "A design, dimensional, and performance comparison was performed to establish substantial equivalence to the legally marketed predicate devices... The basis of substantial equivalence for this device is based on similarities in intended use, material, function, performance, design, technology and operational principles..." |
| Intended Use | "The intended use of the OsteoMed ExtremiLOCK implants is the same as the OsteoMed Foot Plating System and the OsteoMed Calcaneal Foot and Screw Fixation System." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for specific mechanical tests or their provenance. The device's clearance is based on non-clinical tests (mechanical verification and comparisons) rather than human clinical trials.
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 applicable as the clearance is based on non-clinical, mechanical testing and comparisons to predicate devices, not on expert clinical evaluation of cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the clearance is based on non-clinical, mechanical testing and comparisons to predicate devices, not on expert clinical evaluation of cases.
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 applicable. The device is a surgical fixation system, not an AI or diagnostic imaging tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering specifications and established mechanical testing standards for bone fixation devices, aiming to demonstrate equivalence to predicate devices that have prior regulatory clearance.
8. The sample size for the training set
This information is not applicable as there is no mention of a training set; the evaluations are based on mechanical verification and comparative analysis.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved in this regulatory submission for a physical medical device.
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(167 days)
OSTEOMED LP
The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.
The OsteoMed smartflex Cranial Spring Distraction System is a distraction osteogenesis system consisting of distractors in various sizes. The distractor is anchored to the cranium by the distractor foot plate. The distractor gradually distracts the bone segments by applying a continuous force to the bones of the skull facilitating remodeling to expand the prematurely closed suture. The distractors are removed after consolidation. The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors. The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.
This document describes the OsteoMed smartflex Cranial Spring Distraction System and its comparison to predicate devices for 510(k) clearance. The study presented is not a diagnostic device study, but rather a mechanical performance verification and clinical data comparison for a surgical implant. Therefore, several of the requested categories are not directly applicable or are interpreted differently in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on demonstrating "substantial equivalence" to predicate devices in terms of safety and effectiveness. This is achieved through engineering tests and comparison to clinical outcomes of similar devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Stress on Infant Cranial Bone (below yield strength) | Finite Element Analysis showed stress on cranial bone was 80% below the stress of the predicate Cranial Distractor. |
| Maximum Distraction Distance (safe and effective range) | Maximum possible distraction distance of 55mm was identified as safe. 91 clinical cases with similar devices showed 31 cases reaching 55mm and 60 cases going beyond 55mm with only one skin infection and 3 spring repositioning complications. |
| Distraction Rate (comparable to clinical practice for similar devices) | Average distraction rate of 1.39mm per day (over a six-week duration) was obtained from clinical data and compared to the predicate's 1mm per day (0.5mm twice a day). |
| Spring Geometry and Force Targets (as described in literature/design specification) | Spring geometry was verified using an optical comparator. Force was measured during compression between footplates to simulate initial implantation force, verifying targets were met. |
| Biocompatibility (Medical Grade Stainless Steel per ASTM F-138) | Stated as "Biocompatible" and comparable to the predicate device OsteoMed External Mandibular Distraction System (K063792) which uses similar material. |
| Sterility (Provided Sterile) | Stated as "Provided Sterile (Gamma)" and comparable to predicate device K922211 for sterility method. |
| Overall Safety and Effectiveness (comparable to predicate devices) | "In conclusion, the device is safe and effective and performs as well as the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices." Substantiated by similarities in intended use, indications for use, function, performance, operational principle, and materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Finite Element Analysis: The sample size is not explicitly stated beyond "Cranial Vault Distractor Predicate and the OsteoMed SmartFlex Cranial Spring Distractor were created," implying a comparison of two models. Data provenance is implied to be simulated data based on infant skull properties.
- Distraction Distance and Rate Clinical Data:
- Sample Size: 91 clinical cases.
- Data Provenance: Clinical data obtained by surgeons, with cranial spring devices similar to the device, manufactured by a physician. No country of origin is specified, but it's referred to as "clinical data," suggesting retrospective human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Finite Element Analysis: Not applicable in the context of expert ground truth. The "ground truth" here would be established by engineering principles and validated models.
- Distraction Distance and Rate Clinical Data: The data was obtained by "surgeons." The number of surgeons is not specified. Their qualifications are implicitly that they are "a physician in cranial distraction," suggesting expert practitioners in the field.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense of multiple experts reviewing and reaching consensus on an output, as this is not a diagnostic study. For the clinical data, the "ground truth" appears to be the observed clinical outcomes as recorded by the treating surgeons. There is no mention of independent expert review or adjudication of these historical clinical outcomes for the purpose of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study compares the performance of the new device to predicate devices and existing clinical data, but not in a multi-reader, human-AI assisted vs. human-only paradigm.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical surgical implant, not an algorithm or AI system. Therefore, the concept of "standalone" algorithm performance is not applicable. The performance described relates to mechanical characteristics and clinical outcomes of the physical device.
7. The Type of Ground Truth Used
- Finite Element Analysis: Engineering models and "infant skull properties" as established physical parameters.
- Distraction Distance and Rate: Clinical outcomes data (observed distraction distances and rates, and complications) from actual patient cases.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. The clinical data on 91 cases mentioned for distraction distance and rate appears to be the primary observational data used for performance comparison and justification, not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no explicitly defined "training set" for an algorithm in this submission. The 91 clinical cases' outcomes were established by the treating surgeons and their medical records.
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(48 days)
OSTEOMED LP
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (PrimaLIFTM LLIF) is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) and these patients may have up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation systems such as PrimaLOK™ SP and PrimaLOK™ FF which have been cleared for use in the lumbar spine.
The PrimaLIFTM LLIF implants are intended for single use only.
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System is a comprehensive interbody cage system that provides structural stability of the anterior column. It is comprised of unitary PEEK interbody cages of various sizes. The instruments provided with the system include osteoteomes, implant trials, and an inserter to facilitate placement of the interbody device.
The provided document is a 510(k) Summary for the OsteoMed PrimaLIF™ LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
Based on the content, this device is a physical intervertebral body fusion system, not an AI/ML-driven solution. Therefore, many of the requested categories (like sample size for test/training set, ground truth, experts, MRMC studies, standalone performance) are not applicable to the information provided.
The "Performance/Clinical Data" section states: "The PrimaLIF™ LLIF device has been tested in static and dynamic axial compression per ASTM F2077 and static subsidence per ASTM F2267. The intended use of the device is the same as the predicate devices. Clinical testing is not required to support substantial equivalence." This indicates that the regulatory pathway for this device relied on demonstrating mechanical equivalence and material biocompatibility to predicate devices, rather than clinical performance studies using human data or AI-specific evaluations.
Therefore, an AI system is not applicable to the provided information as the device is a physical medical device.
If this were an AI medical device, the following would be how I would format the response if the information was available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| (Not Applicable to this device) | (Not Applicable) | (Not Applicable) |
2. Sample size used for the test set and the data provenance
(Not Applicable - no test set for an AI/ML device was used as this is a physical medical implant)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
(Not Applicable - no ground truth development for an AI/ML device was required)
4. Adjudication method for the test set
(Not Applicable - no test set for an AI/ML device was used)
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 - no MRMC study conducted as this is a physical medical implant)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
(Not Applicable - no standalone algorithm performance evaluated as this is a physical medical implant)
7. The type of ground truth used
(Not Applicable - no ground truth developed as this is a physical medical implant)
8. The sample size for the training set
(Not Applicable - no training set for an AI/ML device was used as this is a physical medical implant)
9. How the ground truth for the training set was established
(Not Applicable - no ground truth for an AI/ML device was established as this is a physical medical implant)
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(112 days)
OSTEOMED LP
OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed Wrist Plating System implants are intended for single use only.
The OsteoMed Wrist Plating System is a rigid fixation and fusion system , consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification, implantation, or removal of the implants. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking or non-locking head in various lengths. These screws are either solid core or cannulated and can be used with or without plates.
Plates and screws are supplied in a variety of configurations. The plates and screws are made of titanium alloy (ASTM F136). K-wires are made of titanium alloy (ASTM F136) or stainless steel (ASTM F138). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
The provided text describes a 510(k) summary for the OsteoMed Wrist Plating System. This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting a de novo clinical study with specific acceptance criteria, sample sizes, and ground truth establishment for novel device performance.
Therefore, the requested information regarding acceptance criteria, a study proving device meeting these criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set is not applicable or available within this 510(k) submission.
The document states:
- "Analyses of plate and screw strength were conducted to compare the OsteoMed Wrist Plating system components to predicate devices." This implies mechanical bench testing for equivalence, not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
- "Equivalence for OsteoMed Wrist Plating system is based on similarities in intended use, design and operational principle to the referenced predicates. Based on the similarities, we believe that the OsteoMed Wrist Plating System does not raise any new safety or effectiveness issues." This is the core argument for a 510(k) submission.
Without a clinical study explicitly designed to measure performance against predefined acceptance criteria, it's impossible to populate the requested table and answer many of the questions.
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