(78 days)
Smith & Nephew Global Femoral Head Trials are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems in their cleared Indications for Use as provided below.
Smith & Nephew Uncemented Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Uncemented Hip Systems and their cleared Indications for Use.
Uncemented Femoral Stems 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; old, remote osteomyelitis with an extended drainage-free period; 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.
Smith & Nephew Cemented Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cemented Hip Systems and their cleared Indications for Use.
Cemented Femoral Stems are indicated for cemented 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 ioint 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; old, remote osteomyelitis with an extended drainage-free period; 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.
Smith & Nephew PLUS Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use.
Smith & Nephew Inc PLUS Femoral Stems are indicated for:
- The SL-PLUS Stem Primary is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
- The SLR-PLUS STEM, a revision component, is also available to replace previously failed femoral him arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
- The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute). These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
- The SL-PLUS MIA Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
- The POLARSTEM Standard and Lateral Femoral Stems are indicated for: advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, all forms of osteoarthritis, patients with hips at risk of dislocation, and femoral neck fracture or proximal fracture to hip joint.
Per U.S Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Instruments that are designed to assist in the implantation of Class II Smith & Nephew Hip Systems are classified as Class II devices and are subject to premarket notifications and regulations.
The subjects of this 510|k) are the Smith & Nephew Global Femoral Head Trials. The femoral head trials are instruments used to assist in the implantation of cleared Smith & Nephew hip systems.
The subject devices are similar to existing femoral head trials currently being used by surgeons when implanting femoral hip systems. The trials are manufactured from polyphenylsulfone (PPSU) with up to 10% of the radiopacifier barium sulfate. In addition, colorants are blended into the PPSU resin to allow for differentiation between the various sizes. The same materials are used in the manufacturing of existing hip system trials.
This document is a 510(k) premarket notification for the Smith & Nephew Global Femoral Head Trials. It's a regulatory submission, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would for a diagnostic or therapeutic device.
The document describes Technological Characteristics and Substantial Equivalence Information to argue that the new device is as safe and effective as previously cleared predicate devices. It states: "The subject devices are similar to existing femoral head trials currently being used by surgeons when implanting femoral hip systems. The trials are manufactured from polyphenylsulfone (PPSU) with up to 10% of the radiopacifier barium sulfate. In addition, colorants are blended into the PPSU resin to allow for differentiation between the various sizes. The same materials are used in the manufacturing of existing hip system trials." And further: "When compared to the previously cleared device-specific instruments listed in Table 2, the proposed instruments utilize the same raw materials, manufacturing processes, and sterilization methods (where applicable). It should also be noted that the nature of body contact is the same as found with the predicate devices that have been identified in this premarket notification."
Here's an attempt to answer your questions based on the provided text, but it's crucial to understand that this document does not contain a study report with performance metrics or acceptance criteria as typically requested for AI/diagnostic devices.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in terms of quantifiable metrics (e.g., sensitivity, specificity, accuracy, precision, etc.). The submission relies on demonstrating substantial equivalence to existing devices, implying that if the new device is technologically similar and has the same intended use, its performance is assumed to be acceptable by virtue of its similarity to already cleared devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for an orthopedic surgical instrument (femoral head trials), not a study evaluating performance against a test set of data.
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)
Not applicable. There is no test set or ground truth established for performance evaluation in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 not an AI or diagnostic device that involves human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The submission focuses on substantial equivalence based on material composition, manufacturing processes, and intended use, rather than performance against a "ground truth."
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied as this is not an AI or data-driven device.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Acceptance Rationale from the Document:
The acceptance criteria for the Smith & Nephew Global Femoral Head Trials are implicitly met by demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" (or rather, the justification) provided by the manufacturer can be summarized as:
"When compared to the previously cleared device-specific instruments listed in Table 2 [Radiopaque Trial Necks, K113039, cleared 10/5/2012 by Smith & Nephew], the proposed instruments utilize the same raw materials, manufacturing processes, and sterilization methods (where applicable). It should also be noted that the nature of body contact is the same as found with the predicate devices that have been identified in this premarket notification."
The materials used are "polyphenylsulfone (PPSU) with up to 10% of the radiopacifier barium sulfate," and "colorants are blended into the PPSU resin to allow for differentiation between the various sizes." The document explicitly states: "The same materials are used in the manufacturing of existing hip system trials."
Therefore, the "acceptance criteria" is that the new Global Femoral Head Trials are technologically similar and intended for the same use as existing cleared devices (specifically, the Radiopaque Trial Necks, K113039). The "proof" is the detailed comparison of materials, manufacturing, sterilization, and intended use, which are deemed identical or sufficiently similar to the predicate device to warrant a finding of substantial equivalence by the FDA.
§ 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.