(29 days)
The hip stem components of the GT Spectron are made of metal alloys. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The devices are for single use. Cement fixation is available with these devices. The Spectron Hip Stems have the same function as other hip stems designed for cemented and cementless fixation.
The Global Taper (GT) Spectron Hip Stems have a new taper.
The hip stem components of the GT Spectron are made of metal alloys.
Here's a breakdown of the requested information based on the provided text:
Analysis of the provided text:
The provided text ("Exhibit 5 - Summary of Safety and Effectiveness") is a 1997 submission document for a medical device (Global Taper Spectron Hip Stem). It primarily focuses on the device's indications for use, material composition, and a general statement about its performance relative to other hip stems.
*Crucially, this document does not contain any information about acceptance criteria, specific performance metrics, or details of any study performed to demonstrate its safety and effectiveness in the way a modern AI/diagnostic device submission would.
Therefore, I cannot populate most of the requested fields. This document is a historical regulatory submission for a physical orthopedic implant, not a software-based medical device that would involve AI, reader studies, or detailed performance metrics like accuracy, sensitivity, or specificity.
Unable to Extract Information from the Provided Text:
Based on the provided "Exhibit 5 - Summary of Safety and Effectiveness," I cannot extract the requested information regarding acceptance criteria and a study that proves the device meets those criteria.
Here's why and what's missing:
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Nature of the Document: This document is a regulatory summary for a physical orthopedic implant (hip stem) from 1997. It describes the device, its materials, and its indications for use. It is not a document detailing a study with statistical performance metrics, acceptance criteria, or ground truth establishment in the way such information would be presented for a diagnostic device or an AI algorithm.
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Absence of Key Information: The document does not describe:
- Specific acceptance criteria (e.g., a required sensitivity, specificity, accuracy).
- Any quantitative performance metrics (e.g., sensitivity, specificity, AUC).
- Details of a study (e.g., sample size, study design, reader involvement, ground truth methodology).
- Any mention of AI or software performance.
The statement "Analysis results were acceptable and the components of the GT Spectron Hip should perform as well as other hip stems" is a very general conclusion, not a detailed reporting of study results against specific criteria.
I cannot create the table or answer the specific questions below because the necessary information is not present in the provided Exhibit 5. The information required pertains to a type of study and data reporting not included in the provided text.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.