(359 days)
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Subject of this Traditional 510(k) are the Smith & Nephew Radiopaque Trial Necks. The Radiopaque Trial Necks are intended to be used to determine the correct modular neck implant option for the femoral stems developed as part of the Smith & Nephew SMF Hip Stem System and MDF Revision Hip System cleared via premarket notifications K080625 and K081124, respectively.
The subject devices are manufactured from polyphenylsulfone (PPSU) with 6% of the radiopacifier barium sulfate, which makes them visible on an x-ray in the instance that they become dislodged during the trialing process. Colorants are blended with the PPSU resin to differentiate the various radiopaque trial necks.
The provided text describes a 510(k) premarket notification for "Radiopaque Trial Necks" and demonstrates substantial equivalence to predicate devices rather than providing a study that proves the device meets specific acceptance criteria in the traditional sense of a performance study with quantitative metrics.
Therefore, many of the requested sections about explicit acceptance criteria, performance data, sample sizes, and expert ground truth are not applicable or cannot be extracted from this type of regulatory document. The document focuses on demonstrating biocompatibility and substantial equivalence in materials, sterilization, and design features, rather than a performance study measuring accuracy, sensitivity, or specificity of an algorithm.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission like this is demonstrating substantial equivalence to existing, legally marketed predicate devices. This involves showing similar indications for use, material equivalence (or demonstrating safety if different), sterilization equivalence (or demonstrating safety of the chosen method), and comparable design features and intended use.
- Reported Device Performance:
- Biocompatibility: "Biocompatibility testing has been conducted on the subject devices according to ISO 10993:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."
- Conclusion of Biocompatibility: "A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the Radiopaque Trial Necks."
- Clinical Data: "Clinical data was not needed to support the safety and effectiveness of the devices."
- Substantial Equivalence: The device is considered substantially equivalent to the predicate devices based on similarities and acceptable biocompatibility testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | No new issues related to safety. Biocompatibility per ISO 10993:2009. | Biocompatibility testing conducted according to ISO 10993:2009. "A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the Radiopaque Trial Necks." The material (PPSU with Barium Sulfate) is compared to the predicate's material (PPSU for shoulder trials), and the radiopacifier is an added feature for visibility on X-ray if dislodged, implying an enhancement in safety/utility during a specific use case. |
| Effectiveness | Effectiveness for its intended use (determining correct modular neck implant option), comparable to predicate devices. | The device's intended use is to "determine the correct modular neck implant option" for specific hip stem systems. The document states, "Clinical data was not needed to support the safety and effectiveness of the devices," implying that the recognized equivalence to predicate trial instruments (Promos Reverse Shoulder System Trial Inserts - K081016) regarding material and sterilization and the known function of trial instruments are sufficient to establish effectiveness. |
| Substantial Equivalence | Similar indications for use, comparable design features, material equivalence (or demonstrated safety of different materials), and equivalent sterilization methods compared to predicate devices. | - Indications for Use: Same as SMF Hip Stem System (K080625) and MDF Revision Hip System (K081124). |
- Material: Polyphenylsulfone (PPSU) with 6% Barium Sulfate (Color Added). Compared to Promos Reverse Shoulder System Trial Inserts (K081016) which also use Polyphenylsulfone. The addition of Barium Sulfate provides radiopacity.
- Sterilization: Non-sterile (as are the Promos Shoulder Trial Inserts).
- Design Features: Functionally similar as trial instrumentation. Comparison table in the document details these aspects and finds them similar or equivalent enough for substantial equivalence. |
2. Sample sized used for the test set and the data provenance
- Not Applicable. This document describes a 510(k) submission for mechanical/instrumentation devices, not an AI/algorithm-based diagnostic device requiring a specific "test set" in the context of performance metrics like sensitivity/specificity. The evaluation relies on biocompatibility testing and comparison to predicate devices, not statistical analysis of a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, no "ground truth" and expert review for a test set were conducted for this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method as described for an AI/algorithm.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/algorithm. This is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" in this context is the established safety and effectiveness of the existing predicate devices and the ISO standards for biocompatibility.
8. The sample size for the training set
- Not Applicable. This is not an AI/algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/algorithm.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.