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The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.

We added 6 sizes, 28 S, 28 M, 28 L, 32 S, 32 M, and 32 L of ceramic ball heads to the SC Total Hip System, which was cleared for marketing by FDA on 10/15/03 (K031474). These ball heads allow the surgeon a further option to meet the patient's needs.

This document is a 510(k) summary for a medical device modification, specifically the addition of new sizes of SC Ceramic Ball Heads to an existing hip replacement system. It is a regulatory submission, not a study report, and therefore does not contain the detailed information typically found in clinical or performance studies.

Therefore, many of the requested sections (2-9) cannot be answered from the provided text as the information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Available in the Provided Text:

The following information is not present in the 510(k) summary, as it is a regulatory document focused on demonstrating substantial equivalence rather than a detailed report of a specific study's methodology:

• 2. Sample sizes for the test set and data provenance: No information on the actual number of ceramic ball heads tested, or where the data came from (e.g., country of origin, retrospective/prospective).
• 3. Number of experts used to establish ground truth and their qualifications: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
• 4. Adjudication method for the test set: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
• 7. The type of ground truth used: For biomechanical tests, the "ground truth" would be the measured physical properties. The document states "Biomechanical tests have been performed," but does not detail the specific measurements or reference standards used.
• 8. The sample size for the training set: Not applicable, as this was a biomechanical test, not an AI or machine learning study.
• 9. How the ground truth for the training set was established: Not applicable, as this was a biomechanical test, not an AI or machine learning study.

Summary of the Study (as described in the document):

The document refers to "Biomechanical tests" that were performed to demonstrate the equivalence of the new SC Ceramic Ball Heads to existing, similar implants. The study's conclusion, as stated, is that "The test results were equivalent to other similar implants and are sufficient for in vivo loading." This indicates the device met the implicit acceptance criteria of performing comparably to already cleared devices. However, the specifics of these tests (e.g., fatigue testing, static strength, wear resistance, the standards followed, the number of devices tested) are not detailed in this 510(k) summary. This type of information would typically be found in the full 510(k) submission, not in the publicly available summary.

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The Orthopedic Alliance Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion ( pseudarthrosis ).

The Orthopedic Alliance Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

The Orthopedic Alliance Spine System is a top-loading multiple component posterior spinal fixation system which consists of fixed and swivel-head pedicle screws, rods, locking cap screws, and a transverse linking mechanism. The screws are available in various lengths and diameters. The swivel-head pedicle screws are assembled at the factory to provide variable axis screw assemblies. The rods are 4mm in diameter and available in various lengths. The locking cap nuts are applied to the screws after the rods are placed to lock them into position. Cross linkage braces are also available to connect from one rod to another in bilateral constructs.

Materials: The devices are manufactured from CP Titanium and Ti6Al-4V ELI Titanium alloy per ASTM and ISO standards.

Function: The Orthopedic Alliance Spine System functions to provide immobilization and stabilization of the spine as an adjunct to fusion in the treatment of chronic instabilities or deformities of the spine.

The provided text describes a spinal fixation system, not a device that would typically have acceptance criteria in the context of AI/ML performance metrics. The document is a 510(k) premarket notification for the "Orthopedic Alliance Spine System," which is a medical implant (pedicle screw system).

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets), which are typically associated with performance evaluations of AI/ML-driven diagnostics or imaging analysis devices, is not applicable to this submission.

The document discusses:

• Device Description: Multi-component posterior spinal fixation system (screws, rods, locking caps, transverse linking mechanism).
• Materials: CP Titanium and Ti6Al-4V ELI Titanium alloy.
• Intended Use/Indications: Immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal instabilities and deformities (e.g., degenerative spondylolisthesis, fracture, scoliosis, spinal tumor).
• Substantial Equivalence: Comparison to predicate devices (Xia Spinal System, Global Spinal Fixation System, Synergy Spine System). The basis for clearance is that "There are no significant differences between the Orthopedic Alliance Spine System and other spinal fixation systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use."

No performance study in the sense of accuracy, sensitivity, or specificity (as would be relevant for an AI/ML device) is mentioned. The clearance is based on substantial equivalence to existing predicate devices, implying that the device meets existing safety and effectiveness standards through its design, materials, and intended use being similar to already approved devices, rather than through a novel performance study proving specific diagnostic or analytical metrics.

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The SC Total Hip System is indicated for use in the treatment of severcly disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.

The SC Femoral Hip Stem is indicated for use with or without bonc cement.

The SC Acetabular Cup is for use with bone cement only.

The SC Total Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The femoral stems are straight, non-porous collarless designs in standard and lateralized configurations. Revision lengths are also available. The acctabular components are UHMWPE, in various diameters, with various offset options.

The provided text is a 510(k) summary for the "SC Total Hip System." This document is a premarket notification to the FDA, asserting that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document does not describe or report on a study performed to demonstrate specific acceptance criteria for the device's performance through clinical trials or a specific performance study.

Instead, the summary focuses on demonstrating substantial equivalence to existing, legally marketed hip systems (predicate devices) based on design, function, materials, and intended use. The FDA's letter confirms this substantial equivalence.

Therefore, many of the requested elements for describing an acceptance criteria study and its results cannot be populated from the provided text.

Here's a breakdown of why and what information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific study. The "acceptance criteria" here is implicitly that the device is "substantially equivalent" to predicate devices, meaning it should perform comparably to devices already on the market.
• Reported Device Performance: No specific quantitative performance data (e.g., success rates, complication rates, longevity figures) from a dedicated study are reported in this 510(k) summary. The summary only generally states: "The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma."

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 / Not provided. A specific "test set" for a performance study is not described. The substantial equivalence determination is based on a comparison to predicate devices, not on a new clinical study with a test set of patients.

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 / Not provided. There was no specific "test set" requiring expert ground truth establishment for a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable / Not provided. There was no specific "test set" requiring adjudication.

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 / Not provided. This device is a total hip system (an implant), not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not provided. This device is a mechanical implant, not an algorithm, so a standalone performance study in this context is irrelevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable / Not provided. No specific "ground truth" was established for a new clinical performance study. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate devices already on the market.

8. The sample size for the training set

• Not applicable / Not provided. This device is a mechanical implant. There is no "training set" in the context of an algorithm or AI.

9. How the ground truth for the training set was established

• Not applicable / Not provided. (See point 8).

Summary of what the document does provide:

• Device Name: SC Total Hip System
• Intended Use: Treatment of severely disabled hip joints from painful osteo-, rheumatoid, and post-traumatic arthritis, late stages of avascular necrosis, and revision of previous hip surgeries.
• Materials: Ti6Al-7Nb Titanium alloy, CoCrMo alloy, Ultra High Molecular Weight Polyethylene (UHMWPE).
• Function (general): To provide pain relief and improved function to the disabled hip.
• Predicate Devices: SL-Plus Hip Stem, Zweymuller SL Hip System, Lester Press Fit Hip System, Alloclassic Zweymuller SL Hip Stem.
• Basis for market clearance: Substantial equivalence to these predicate devices based on design, function, materials, and intended use.

This 510(k) summary is a regulatory filing asserting equivalence, not a report on a detailed clinical performance study with specific acceptance criteria and outcome measurements.

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