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510(k) Data Aggregation
(103 days)
Integra External Fixation System
The Integra® External Fixation System is an external fixation device in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
- · Correction of deformity
- · Revision procedures where other treatments or devices have been unsuccessful
- · Bone reconstruction procedures
- · Fusions and replantations of the foot
- · Charcot reconstruction and Lisfranc dislocations
- · Ankle distraction (arthrodiastasis)
The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. The modifications to the device include material and minor design updates to the Universal Wire Fixation Bolt and Slotted Posts which do not affect the safety and effectiveness of the device. An update was also made to the position of the olive on the 530mm olive wire. Lastly, the sharpness of the olive wire and k-wire were modified.
The provided text describes a 510(k) submission for the Integra® External Fixation System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that establishes acceptance criteria for a novel device's performance.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this specific document. This document details modifications to an existing device and confirms that these modifications do not negatively impact its safety and effectiveness compared to the predicate.
However, I can extract information related to the performance comparison and the "acceptance criteria" as defined by substantial equivalence to the predicate device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" for the modified device (Integra® External Fixation System K160830) is that its performance should be statistically equivalent to the predicate device (Integra® External Fixation System K140463) for the specific elements that were modified.
| Acceptance Criteria (for modified components) | Reported Device Performance (K160830) |
|---|---|
| Stiffness statistically equivalent to predicate | Stiffness was statistically equivalent to predicate. |
| Acceptable Torsional Strength | A torsional strength test was performed. (Result implicitly positive, otherwise substantial equivalence would be denied). |
| Acceptable Static Wire Retention | A static wire retention test was performed. (Result implicitly positive). |
| Acceptable Dynamic Wire Retention | A dynamic wire retention test was performed. (Result implicitly positive). |
| Olive wire position validation | Validation performed, no further verification needed. |
| Wire sharpness validation | Validation performed, no further verification needed (no effect on part strength). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes used for the dynamic, static, and torsional tests. It mentions "constructs were tested" implying multiple samples of the modified components.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer as part of their design control and validation processes. It is prospective testing aimed at proving specific performance characteristics of the modified components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "ground truth" here is the physical and mechanical performance of the device components, measured through engineering tests, not an interpretation by medical experts. The evaluation is based on objective measurements and comparison to predefined engineering standards or the performance of the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessment. For mechanical testing, the results are quantitative and typically assessed against pre-defined engineering thresholds or comparative data from the predicate device.
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 an external fixation system (a physical medical device), not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance assessment of the modified components is their measured mechanical properties and physical characteristics (e.g., stiffness, tensile strength, wire retention forces, olive position, sharpness). These are objective engineering measurements compared against the predicate device's corresponding properties.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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(228 days)
INTEGRA EXTERNAL FIXATION SYSTEM
The Integra External Fixation System is an external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include:
- Correction of deformity
- Revision procedures where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- Fusions and replantations of the foot
- Charcot reconstruction and Lisfranc dislocations
- Ankle distraction (arthrodiastasis)
The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. Special instruments (e.g. wrenches) are required for proper assembly of the apparatus. Adjustment of the fixator is possible during the course of treatment. When properly used by an experienced clinician, the Integra External Fixation System may preserve limb function by minimizing operative trauma to anatomical structures and preserving blood supply.
The Integra External Fixation System is a medical device and the provided text describes its regulatory clearance, not a study of its clinical performance with acceptance criteria typical for AI/software devices. The information available pertains to the mechanical performance of the device compared to a predicate, not clinical outcomes. Therefore, many of the requested categories for AI/software studies are not applicable.
Here's an attempt to answer the questions based on the provided text, highlighting where information is not available or not applicable:
Acceptance Criteria and Study for Integra External Fixation System (K140463)
The provided document describes the FDA 510(k) clearance for the Integra External Fixation System. This is a mechanical device, and the study described focuses on demonstrating its substantial equivalence to a predicate device through mechanical testing. It is not an AI/software device, and therefore, many of the requested metrics related to clinical studies, expert-based ground truth, and human-in-the-loop performance are not applicable or not provided in this regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria described relate to the mechanical stiffness of the Integra External Fixation System compared to a predicate device.
| Acceptance Criteria Objective | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Stiffness | "The stiffness of the 2 systems was compared and was statistically equivalent." | "The performance of the Integra External Fixation System was verified to be statistically equivalent to that of the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of number of devices tested, but it refers to "the construct" of both the predicate and the Integra system. This typically implies a statistically sufficient number of physical devices or components to perform mechanical testing.
- Data Provenance: The study was a prospective mechanical testing conducted by the manufacturer
(Ascension Orthopedics/Integra LifeSciences). The country of origin for the data is not specified but would likely be the location where the manufacturer's testing facilities are located (e.g., USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For mechanical device testing, "ground truth" is established by standard engineering principles and validated testing methodologies, not by clinical experts. The testing would be performed by engineers or technicians skilled in biomechanical testing.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving human interpretation or consensus, typically for diagnostic or prognostic devices. This was a mechanical engineering study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was a mechanical engineering comparison of two external fixation systems, not a clinical study involving human readers or AI assistance in interpretation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This is a mechanical device, not an algorithm. There is no "standalone" algorithmic performance to report.
7. Type of Ground Truth Used
- The "ground truth" for this engineering study was the mechanical stiffness measured under dynamic and static loading conditions, as per established biomechanical testing standards. This would be quantified by physical measurements obtained from calibrated testing equipment.
8. Sample Size for the Training Set
- Not Applicable. This is a mechanical 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, this question is not relevant.
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