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510(k) Data Aggregation
(214 days)
Arthrex Univers Apex OptiFit Humeral Stem
The Arthrex Univers Apex OptiFit Humeral Stem is indicated in replacement when conditions include severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; of the humeral head; or other difficult clinical management problems where arthrodesis or re-sectional arthroplasty is not acceptable.
The glenoid components are designed fixation in the joint and must only be used with an appropriate bone cement.
The proposed Univers Apex OptiFit Humeral Stem is the humeral stem component of a shoulder prosthesis system. It consists of a stem, a trunion, an inclination block, pins, and screws. All the components are comprised of titanium with a titanium plasma spray (TPS) coating.
The provided text describes the regulatory clearance for a medical device called "Arthrex Univers Apex OptiFit Humeral Stem." It focuses on demonstrating substantial equivalence to a predicate device rather than outlining detailed acceptance criteria and performance data for a novel artificial intelligence (AI) or machine learning (ML) device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI/ML. The performance data mentioned refers to:
- Yield strength testing on samples with and without titanium plasma spray coating, with the acceptance criteria being "met for all samples." This is a material property test, not a performance study for an AI/ML diagnostic or assistive device.
- Computational electromagnetic simulation testing to assess RF heating in bone tissue, demonstrating the device is "MR Conditional." This relates to MRI compatibility, not a diagnostic or therapeutic performance study.
In summary, this document is a 510(k) premarket notification for a traditional medical device (humeral stem), not an AI/ML device. As such, it does not provide the information requested about AI/ML device acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment.
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(26 days)
Arthrex Univers Apex, Size 5 Stem
The Arthrex Univers Apex, Size 5 Stem is indicated for:
The Arthrex Univers Apex is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
The Arthrex Univers Apex, Size 5 Stem, subject to this submission, is a smaller version of the previously cleared Arthrex Univers Apex (K131633). It is a modular stem with fixed inclination angle design and is the identical size as the previously cleared Size 5 Univers II stems (K103466). The stem is machined of titanium alloy. The distal section of the stem has a conical design. The proximal section of the stem is rectangular in design and has a morse-taper for the mating of humeral heads. The stem's surface finish is textured for cemented or press-fit (non-cemented) implantation. The Arthrex Univers Apex, Size 5 Stem falls within the length range of the previously cleared Univers Apex stems (K131633).
The document is a 510(k) premarket notification for the Arthrex Univers Apex, Size 5 Stem, a shoulder prosthesis. This submission is a line extension to a previously cleared device. Therefore, the acceptance criteria and study described are not for a medical imaging AI/ML device but for a physical medical device (shoulder prosthesis).
The relevant sections for acceptance criteria and performance are found in the "Special 510(k): Arthrex Univers Apex, Size 5 Stem" section, specifically under "Substantial Equivalence Summary."
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Safety and Effectiveness Equivalence: The device should be substantially equivalent to predicate devices in intended use, design, size range, and material, with any differences not raising new questions of safety and effectiveness. | The device is a "smaller version of the previously cleared Arthrex Univers Apex (K131633)" and the "identical size as the previously cleared Size 5 Univers II stems (K103466)." The submission asserts: "An differences between the Arthrex Univers Apex, Size 5 Stem and the predicates are considered minor and do not raise questions concerning safety and effectiveness." |
| Mechanical Performance: The device's mechanical performance should be adequate for its intended use and equivalent to predicate devices. This implies meeting certain strength, durability, and functional requirements under simulated use conditions. | "The submitted in vitro testing (cyclic compression loading) The submitted mechanical testing data demonstrated that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Univers Apex, Size 5 Stem is adequate for their intended use." |
| Biocompatibility (implied): As a metal alloy implant, biocompatibility is a critical implicit criterion. While not explicitly detailed as "acceptance criteria," the use of "titanium alloy" (a commonly used and well-understood biomedical material) in a device found substantially equivalent implies that biocompatibility has been addressed through material selection and prior clearance of similar devices. | "The stem is machined of titanium alloy." The substantial equivalence claim based on material with predicate devices (which would have undergone biocompatibility assessment) serves as the performance evidence. |
| Design and Features: The design features should be consistent with the intended use and not introduce new safety or effectiveness concerns compared to predicate devices. This includes aspects like modularity, inclination angle, distal and proximal sections, and surface finish. | "It is a modular stem with fixed inclination angle design... The distal section of the stem has a conical design. The proximal section of the stem is rectangular in design and has a morse-taper for the mating of humeral heads. The stem's surface finish is textured for cemented or press-fit (non-cemented) implantation." These design features are compared to those of the predicate devices. |
| Length Range Compliance: The device length should fall within the range of previously cleared predicate devices or be justified. | "The Arthrex Univers Apex, Size 5 Stem falls within the length range of the previously cleared Univers Apex stems (K131633)." |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a mechanical performance study involving "in vitro testing (cyclic compression loading)." The document does not provide details of this study beyond its type.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the in vitro mechanical testing. For physical devices, "sample size" typically refers to the number of devices tested.
- Data Provenance: The testing was "in vitro," meaning it was conducted in a lab setting, not using human or animal subjects. No specific country of origin for the data is mentioned, but the manufacturer is based in Naples, FL, USA. The testing is assumed to be prospective in nature, as it's conducted to support a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a physical medical device (shoulder prosthesis) and not an AI/ML device requiring expert interpretation for ground truth. Mechanical testing relies on engineering standards and measurements, not expert consensus on diagnostic images.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as above. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in diagnostic studies, not for mechanical device 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:
This information is not applicable. This is not an AI-assisted diagnostic device. The study involved mechanical testing of a shoulder implant, not human readers or AI assistance. The document explicitly states: "Clinical data and conclusions are not needed for this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the mechanical performance of the implant itself, which was assessed through in vitro testing.
7. The type of ground truth used:
For this device, the "ground truth" for proving its performance is mechanical testing data against established engineering standards and performance of predicate devices. This is based on quantifiable physical measurements of strength, durability, and other mechanical properties under simulated conditions.
8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of a physical device's mechanical testing in the way it is used for AI/ML models.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
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(115 days)
ARTHREX UNIVERS APEX
The Arthrex Univers Apex is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
The Univers Apex is the humeral stem component of a shoulder prosthesis system. It consists of a stem, a trunion, an inclination block and pins and screws. All of the components are comprised of titanium. The Short Stem is identical to the existing Univers II Stem, except for the overall length.
The provided text describes the Arthrex Univers Apex, a shoulder prosthesis. However, it does not contain information about acceptance criteria and a study proving that a device meets those criteria for software or AI.
The document is a 510(k) summary for a medical device (shoulder prosthesis) seeking clearance based on substantial equivalence to predicate devices, not on performance against specific acceptance criteria in a clinical study of AI/software. It details the device's components, intended use, and materials. The "study" mentioned is mechanical testing to demonstrate the fatigue strength of the proposed device as comparable to predicates, which is a common requirement for orthopedic implants.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in the context of AI/software performance. The provided document is about a physical medical device (shoulder prosthesis) and its clearance process, which relies on demonstrating substantial equivalence, including material and mechanical property comparisons to existing legally marketed devices, rather than a clinical performance study with specific acceptance criteria as you would find for an AI/software product.
Here’s a breakdown of why I cannot answer your specific questions based on the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence to predicate devices through material and mechanical testing comparisons, not on fulfilling specific performance acceptance criteria for a software/AI system.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software test set. The "testing" mentioned is mechanical testing of the implant.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software test set is not relevant here.
- Adjudication method for the test set: Not applicable.
- 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 document is not about AI assistance or reader studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: Not applicable for AI/software. For the mechanical testing, the "ground truth" would be the measured mechanical properties of the device and comparator devices.
- The sample size for the training set: Not applicable. This is not an AI/software product.
- How the ground truth for the training set was established: Not applicable.
The "study" mentioned is:
- "The submitted mechanical testing data demonstrates that the fatigue strength of the proposed devices are comparable to that of the predicate device for the desired indications."
This is a mechanical performance study on a physical device, not a clinical or AI/software performance study.
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