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510(k) Data Aggregation
(163 days)
Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments.
Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.
The provided text is a 510(k) clearance letter for the Incompass Total Ankle System. It outlines the device's indications for use, its classification, and declares its substantial equivalence to predicate devices based on non-clinical evidence.
However, the clearance letter explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
This means that the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies proving a device meets acceptance criteria, especially for AI/ML-based devices or those requiring clinical trials) is not included in this document. The clearance was based on non-clinical performance bench testing to demonstrate substantial equivalence in wear, articular stability, lock detail, manufacturing processes, static strength, fatigue strength, fretting, corrosion, and MRI safety, rather than clinical efficacy studies.
Therefore, I cannot provide the requested information from this document. If this were a submission for a device that required clinical performance data to demonstrate safety and effectiveness (e.g., an AI/ML device), this section would typically contain summaries of those studies.
Based on the provided document, here's what can be inferred or explicitly stated regarding the acceptance criteria and study proving adherence to them:
The device in question is a Total Ankle System, a type of orthopedic implant, not an AI/ML-based device or one that underwent a clinical efficacy study for its 510(k) clearance.
The "study" that proves the device meets acceptance criteria, in this context, refers to non-clinical performance bench testing.
1. A table of acceptance criteria and the reported device performance:
Since no clinical efficacy study was conducted for this 510(k) clearance, there's no data to populate such a table detailing clinical performance metrics (like sensitivity, specificity, or human reader improvement).
The acceptance criteria for this device were related to substantial equivalence through bench testing. The document states:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (from Non-Clinical Bench Testing) |
|---|---|
| Demonstrate wear performance comparable to predicate. | Testing performed to demonstrate substantial equivalence in wear. |
| Demonstrate articular stability comparable to predicate. | Testing performed to demonstrate substantial equivalence in articular stability. |
| Demonstrate lock detail comparable to predicate. | Testing performed to demonstrate substantial equivalence in lock detail. |
| Adherence to manufacturing processes. | Testing performed to demonstrate substantial equivalence in manufacturing processes. |
| Demonstrate static strength comparable to predicate. | Testing performed to demonstrate substantial equivalence in static strength. |
| Demonstrate fatigue strength comparable to predicate. | Testing performed to demonstrate substantial equivalence in fatigue strength. |
| Demonstrate fretting performance comparable to predicate. | Testing performed to demonstrate substantial equivalence in fretting. |
| Demonstrate corrosion resistance comparable to predicate. | Testing performed to demonstrate substantial equivalence in corrosion. |
| Demonstrate MRI safety. | Testing performed to demonstrate substantial equivalence in MRI safety. |
| Overall, no new questions of safety or effectiveness raised compared to predicates. | "The differences in design specifications do not raise any new questions of safety and effectiveness over the predicate, which is demonstrated in the performance testing and process validation." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the document, as it refers to engineering and materials testing (bench testing) rather than a dataset of patient cases. For bench testing, "samples" would refer to the number of devices or components tested.
- Data Provenance: Not applicable in the context of clinical patient data (e.g., country of origin, retrospective/prospective), as the evidence was non-clinical bench testing. The testing would have been conducted in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined for AI/ML or clinical studies (e.g., expert consensus on medical images) was not established. The "ground truth" for bench testing is determined by engineering standards, material science principles, and established testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for studies involving human reviewers or AI output, not for materials and mechanical bench 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. This type of study is specifically for AI/ML-assisted diagnostic devices. The Incompass Total Ankle System is a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is relevant for AI/ML algorithms.
7. The type of ground truth used:
- The "ground truth" for this clearance was established through engineering standards, material specifications, and validated bench testing protocols comparing the device's physical and mechanical properties against those of legally marketed predicate devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm.
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(90 days)
The INBONE Total Ankle System and INFINITY Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE Total Ankle System and INFINITY Total Ankle System are additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INBONE™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.
This is a 510(k) premarket notification for a medical device (INFINITY and INBONE Total Ankle Systems) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates substantial equivalence to predicate devices, focusing on design, materials, and non-clinical performance.
Therefore, many of the requested points cannot be answered from the provided text. I will address the points that can be inferred or directly stated.
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported device performance in the form of a table with numerical values for metrics like sensitivity, specificity, or image quality, as would be expected for a diagnostic or AI-driven device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Chemical Analysis | Demonstrated equivalence to predicate devices |
| Compressive Strength | Demonstrated equivalence to predicate devices |
| Shear and Tensile Strength | Demonstrated equivalence to predicate devices |
| MRI Safety Analysis | Minimal risk to patients in an MR environment (MR Conditional) |
| Direct Metal Laser Sintering (DMLS) Process Validation | Demonstrated equivalence to predicate devices (Performance Qualification, Mechanical validation, Microstructure, Powder Bed Position Validation) |
| Endotoxin ( |
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(162 days)
The PROSTEP TBC Implant System is indicated for bone reconstruction. Examples include:
- · Bi-Cortical osteotomies in the foot
- Distal metatarsal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.)
The PROSTEP TBC Implant System is intended for use in bone reconstruction and osteotomy of the first metatarsal. The implants are provided sterile and consist of one PROSTEP TBC implant, one MICA screw, and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.
This document describes the PROSTEP TBC Implant System, a medical device for bone reconstruction and osteotomy of the first metatarsal. It is a 510(k) summary, which means no specific acceptance criteria or study details regarding device performance against such criteria are provided in the given text.
The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical evidence, rather than presenting a study proving performance against defined acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document, as they pertain to clinical or performance studies that are not included here.
Here's what can be inferred from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria nor does it report specific device performance metrics against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The substantial equivalence is based on non-clinical testing (static and fatigue construct testing, bacterial endotoxin assessments), not a clinical test set.
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 provided. No clinical test set with ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No clinical test set with adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an implantable system, not an AI or algorithm-based device. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As no clinical study with a test set is described, no specific ground truth type is mentioned. For the non-clinical testing, the "ground truth" would be the engineering specifications and performance standards for static, fatigue, and bacterial endotoxin assessments.
8. The sample size for the training set
This is not applicable as the document describes a physical implant system, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable as the document describes a physical implant system, not a machine learning model.
Summary based on available information:
| Detail | Information from Document |
|---|---|
| Acceptance Criteria and Reported Device Performance | Not explicitly stated in terms of specific performance metrics against defined acceptance criteria for a study. The document focuses on establishing substantial equivalence based on technological characteristics and non-clinical testing. It states: "The subject was evaluated through static and fatigue construct testing and bacterial endotoxin assessments to support the safety and effectiveness of the subject device system." and "The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate and are substantially equivalent." |
| Sample size for test set & data provenance | Not applicable for a clinical test set; non-clinical testing (static, fatigue, bacterial endotoxin) was performed, but sample sizes for these tests are not provided. Data provenance is not mentioned. |
| Number of experts & qualifications for ground truth (test set) | Not applicable; no clinical test set requiring expert ground truth is described. |
| Adjudication method (test set) | Not applicable; no clinical test set requiring adjudication is described. |
| MRMC comparative effectiveness study & effect size with/without AI assistance | Not applicable; no MRMC study or AI component is mentioned. |
| Standalone (algorithm only) performance | Not applicable; this is a physical implant system, not an algorithm. |
| Type of ground truth used | For non-clinical testing, the "ground truth" would be engineering specifications and performance standards for static and fatigue testing, and accepted methodologies for bacterial endotoxin assessments. No clinical ground truth (e.g., pathology, outcomes data) is used because no clinical study is presented. |
| Sample size for training set | Not applicable; this is a physical implant system, not a machine learning model. |
| How ground truth for training set was established | Not applicable; this is a physical implant system, not a machine learning model. |
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