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510(k) Data Aggregation
(126 days)
The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.
The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The Remedy® Shoulder Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).
The Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.
The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.
The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.
The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.
This document appears to be a 510(k) Summary for a medical device called the "Remedy® Shoulder Spacer." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study designed to meet specific acceptance criteria in the way one would for an AI/ML powered device.
Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it describes a physical orthopedic implant, not a software algorithm.
Below is an attempt to map the available information to the closest relevant categories, with explanations for why certain sections are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
As this is not an AI/ML device, the concept of "acceptance criteria" for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not present. Instead, the document discusses performance testing designed to demonstrate safe and effective mechanical function and material properties, and equivalence to a predicate device. The "acceptance criteria" would be compliance with relevant standards and demonstration of properties comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization: Compliance with international standards. | Sterilization cycles validated following international standards. |
| Shelf Life: Established through stability testing. | Established through stability studies. Shelf life is 5 years, same as predicate. |
| Biocompatibility: Safe, biocompatible materials for intended use, compliant with ISO 10993 and FDA Draft Guidance. | Biocompatibility evaluation performed, showing device materials are safe, biocompatible, and suitable for intended use, taking into account ISO 10993 and FDA Draft Guidance. |
| Mechanical Performance: Static and fatigue performance acceptable and comparable to predicate. | Performance testing included evaluation of static and fatigue performances. (The document states "The performance data demonstrate that the new devices are substantially equivalent to the predicate device Tecres' Interspace Shoulder" implies these tests met the necessary benchmarks for equivalence). |
| Surface Roughness: Acceptable and comparable to predicate. | Performance testing included evaluation of surface roughness. (Implied acceptability and equivalence to predicate). Reference devices for surface roughness: Tecres InterSpace Knee (K062273 and K062274) and OsteoRemedies Knee Modular Spacer (K112470). |
| Disassembling: Acceptable performance. | Performance testing included evaluation of disassembling. (Implied acceptability and equivalence to predicate). |
| Antibiotic Elution: Gentamicin elution effective and comparable to predicate. | Performance testing included antibiotic (gentamicin) elution testing. (Implied acceptability and equivalence to predicate). The device is made of PMMA containing gentamicin, and the predicate also contains gentamicin. The indications for use specify "where gentamicin is the most appropriate antibiotic." |
| Material Composition: Same as predicate. | Main Components: Polymethylmethacrylate (PMMA), Methylmethacrylate (MMA), Barium Sulphate (Same as predicate). |
| Other Components: Benzoyl peroxide, N,N-Dimethyl-p-toluidine, Hydroquinone (Same as predicate). | |
| Antibiotics: Gentamicin Sulphate (Same as predicate). | |
| Inner core: Stainless Steel (AISI 316 ESR) (Same as predicate). | |
| Design (Shape): Different but functionally equivalent. | Design is Head + Stem (separated) for Remedy® vs. Head + Stem (monoblock) for predicate. This is a "Different" characteristic, but the overall performance data is presented to show substantial equivalence. |
| Modularity: Different from predicate. | Remedy® has 3 heads, 3 stems, offset adjustment vs. None for predicate. This is a "Different" characteristic, but the overall performance data is presented to show substantial equivalence, suggesting the modularity does not negatively impact safety or efficacy. |
| Sizes: Different but comparable range. | Head Size: Ø: 40 – 45 – 50 mm (Remedy®) vs. Ø: 41 – 46 mm (Predicate). |
| Stem Size: L: 101 mm Ø: 7 mm, L: 116 mm Ø: 10.5 mm, L: 131 mm Ø: 14 mm (Remedy®) vs. L: 99 mm Ø: 7 mm, L: 125 mm Ø: 11 mm (Predicate). While "Different," the sizes are intended to cover most shoulder prosthesis configurations currently available, indicating a functional expansion rather than a deviation in core performance. | |
| Stem-neck angle: Same as predicate. | 130° (Same as predicate). |
| X-ray visibility: Yes (Same as predicate). | Yes (Same as predicate). |
| Single-use device: Yes (Same as predicate). | Yes (Same as predicate). |
| Provided Sterile: Yes (Same as predicate). | Yes (Same as predicate). |
| Sterilization Method: Ethylene Oxide (Same as predicate). | Ethylene Oxide (Same as predicate). |
| Sterility Assurance Level (SAL): 10-6 (Same as predicate). | 10-6 (Same as predicate). |
2. Sample size used for the test set and the data provenance
This is not applicable for a physical device 510(k) submission in the context of diagnostic "test sets." The performance data is based on laboratory testing of the device itself and its components, according to established engineering and material science protocols. There is no biological "data" in the sense of patient images or clinical outcomes that would have "provenance."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. "Ground truth" in this context refers to a standard of truth for diagnostic or clinical outcome data, which is not evaluated here. The "truth" for device performance is established through physical and chemical testing against engineering standards and comparison to a predicate device.
4. Adjudication method for the test set
This is not applicable. There is no clinical "test set" requiring adjudication by experts.
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 is not applicable as this is not an AI/ML device or a diagnostic device involving "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI/ML device.
7. The type of ground truth used
This is not applicable in the AI/ML sense. The "ground truth" for the device's acceptable performance is defined by:
- Compliance with recognized standards: e.g., ISO for biocompatibility, sterilization standards.
- Engineering and material science principles: for mechanical strength, fatigue, material composition.
- Comparative data to a legally marketed predicate device: demonstrating that the new device is "substantially equivalent" in terms of safety and effectiveness.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical orthopedic implant.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device.
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(26 days)
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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