Search Results

The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) is indicated for preoperative analysis of primary total hip arthroplasty. Corin OPS™ FHA is intended to be used as a pre-operative tool which provides the Surgeon with functional acetabular cup orientations based on the patient pelvic kinematics and presents a visualisation of the patient's hemipelvis.

The Corin OPS™ FHA is intended for use with the Corin Trinity Acetabular System (K093472, K11481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) consists of a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.

The Corin OPS™ FHA assists the surgeon in determining a patient specific target orientation for the acetabular cup using anatomical landmarks of the pelvis obtained from pre-operative CT scan and X-ray data and a subsequent functional pelvic kinematic analysis (FHA report), and visualisation of the patient's 3-dimensional anatomy (PSV report).

The provided text describes the Corin Optimized Positioning System Functional Hip Analysis (OPS™ FHA) and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving performance.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document mentions a "Reproducibility and Repeatability study" was performed and that it demonstrated the process used to generate the FHA report is "reliable and repeatable." However, it does not provide specific numerical acceptance criteria or the reported performance metrics (e.g., specific values for reproducibility, repeatability, accuracy, precision).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions a "Reproducibility and Repeatability study" was performed but does not specify the sample size used, the country of origin of the data, or whether the data was retrospective or prospective.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

The document states, "Clinical testing was not necessary for this Traditional 510(k)." This implies that a MRMC comparative effectiveness study was not performed as part of this submission. The device is a pre-operative analysis tool to assist surgeons, not a diagnostic tool requiring human reader improvement comparison.

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

The "Reproducibility and Repeatability study" described likely assessed the standalone performance of the FHA report generation process. However, specific metrics of this standalone performance are not provided.

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

The document describes the device as providing "functional acetabular cup orientations based on the patient pelvic kinematics." The ground truth for the reproducibility and repeatability study would presumably relate to the consistency of these calculated orientations, but the specific method of establishing "ground truth" (e.g., comparing to a gold standard measurement, or internal consistency checks) is not detailed.

8. The sample size for the training set

The document describes the device as being substantially equivalent to a predicate and mentions "non-clinical testing" including a reproducibility and repeatability study. It does not provide information about a training set size, which is typically relevant for machine learning or AI-based devices. The OPS™ FHA seems to be based on anatomical landmark analysis and kinematic modeling rather than a deep learning model trained on a large dataset.

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

Since information regarding a training set is not provided, how its ground truth was established is also not available in the document.

Summary of available information regarding acceptance criteria and study:

• Study Type: Reproducibility and Repeatability study.
• Purpose: To demonstrate that the process used to generate the FHA report is reliable and repeatable.
• Outcome (general): The study demonstrated reliability and repeatability.
• Clinical Testing: Not deemed necessary for this 510(k).

Missing Information:

• Specific numerical acceptance criteria.
• Detailed reported device performance metrics/values.
• Sample size for the reproducibility and repeatability study.
• Data provenance for the study (country, retrospective/prospective).
• Number and qualifications of experts involved in any ground truth establishment.
• Adjudication method.
• Specific details on how "ground truth" was established for the non-clinical study.
• Information on training set size or ground truth establishment for a training set.

Ask a specific question about this device

The Trinity™ Dual Mobility System is intended for use in the following indications:

• 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
• 2. Rheumatoid Arthritis
• 3. Correction of functional deformity
• 4. Revision of previously failed total hip arthroplasty,
• 5. Patients at increased risk of dislocation
• 6. Developmental dysplasia of the hip (DDH)

The TrinityTM Dual Mobility System is indicated for cementless use only.

The Trinity™ Dual Mobility System is a modular system consisting of two articulating surfaces in the same joint space. The system includes a highly polished Cobalt Chromium Alloy (CoCr) liner that articulates with an ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) mobile insert. A Trinity™ femoral head, 22mm or 28mm CoCr or 28mm BIOLOX® delta heads, articulates within the ECiMa™ mobile insert to allow for a second articulation. The Trinity™ Dual Mobility System is intended to be used only with compatible Trinity™ acetabular Shells. The Trinity™ Dual Mobility System is designed for use with any Corin femoral stem with a 12/14 taper connection. The Trinity™ Dual Mobility System is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Trinity™ Dual Mobility System is intended to be used with the following approved devices:

• Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
• 28mm CoCr heads (K110087, K131647) .
• . 28mm BIOLOX® delta Ceramic Heads (K103120)

This document is a 510(k) premarket notification for a medical device called the "Trinity Dual Mobility System," which is a hip prosthesis. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy in a de novo manner. Therefore, the information provided does not detail an acceptance criteria table or a study proving the device meets an algorithm's acceptance criteria in the way one might expect for a digital health or AI-driven device.

Based on the provided text, here's an analysis of the "acceptance criteria" and "study" that relate to this medical device:

1. A table of acceptance criteria and the reported device performance:

The document does not present a formal table of acceptance criteria with specific numerical targets for performance in the context of an algorithm or diagnostic accuracy. Instead, the "acceptance criteria" for this device's FDA clearance revolved around demonstrating substantial equivalence to existing predicate devices through non-clinical testing.

The acceptance criteria are implied by the types of non-clinical tests performed and their successful outcomes, which showed the device is "expected to be safe and effective."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

For this type of device (hip prosthesis), the "test set" refers to the physical prototypes and materials subjected to non-clinical mechanical and biological testing.

• Sample Size: The document does not specify the exact sample size for each non-clinical test (e.g., how many liners were subjected to wear testing or how many components to push-out tests). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The tests were conducted to evaluate the device itself. There's no "country of origin for data" in the sense of patient data. The tests would have been performed in a laboratory setting, likely in the country of manufacture or a certified testing facility.

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):

This question is not applicable to a physical medical device like a hip prosthesis in the context of its 510(k) submission for substantial equivalence. "Ground truth" and "experts" in this sense typically refer to the validation of diagnostic accuracy for software or imaging devices. For this device, standard engineering and materials science testing methods are used, and the "ground truth" is established by adherence to recognized ASTM or ISO testing standards. The experts involved would be qualified engineers and scientists in fields such as mechanical engineering, materials science, and biocompatibility testing. Their qualifications are not specified in this summary.

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

Not applicable. Adjudication methods like "2+1" are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. The non-clinical tests for this device involve objective measurements against predetermined acceptance limits based on engineering standards.

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. MRMC studies are associated with the evaluation of diagnostic performance for imaging systems or AI algorithms where human interpretation plays a role. This document concerns a physical implant.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical testing of this device is established by:

• Engineering Standards: Compliance with industry-recognized ASTM, ISO, or other relevant standards for mechanical strength, wear, corrosion, and material properties.
• Predicate Device Performance: The performance characteristics of the legally marketed predicate devices serve as an established baseline that the new device must meet or exceed to demonstrate substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical hip prosthesis device or its 510(k) clearance process. This terminology applies to machine learning algorithms.

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

Not applicable. As there is no training set, there is no ground truth for it.

Ask a specific question about this device

The TaperFit Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar revision. Prosthesis hemi-arthroplasty femoral heads.

The TaperFit Hip Stem is indicated for cemented, single use only.

The TaperFit Hip Stem is a highly polished, double tapered, collarless, stainless steel femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from stainless steel in accordance with ISO 5832-9 -Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel and is provided with a polymethylmethacrylate (PMMA) Stem Centralizer. The stem is designed to be used in conjunction with Corin Eurocone (E100.XXX cleared in K003666) and Trinity CoCrMo modular femoral heads (E321.XXX cleared in K093472, K110087, K122305, K123705, K130128, K130343 and K131647). The stem is available in sizes, 0 through 4 with 3 offsets 50mm, 45mm, and 38mm, as well as a CDH option with a 36mm offset.

The TaperFit Hip Stem was originally cleared in K142761. This submission is being made to modify the indications for use to include hemi-arthroplasty when used with previously cleared Corin hemi-arthroplasty femoral heads as compatible components. The Corin CoCr Modular 26mm heads (E100.X26) have been cleared as compatible components of the Taper-Fit Hip stem (K003666). The Corin CoCr Modular 26mm heads (E100.X26) are part of the construct of the bipolar heads. Included in this submission is the Corin Bipolar Femoral Head (K925897) as a compatible component, which is indicated for hemi-arthroplasty.

This document is a 510(k) premarket notification for a medical device called the "TaperFit Hip Stem". It's a regulatory submission to the FDA, not a study evaluating device performance against acceptance criteria in the way described in the prompt. Therefore, much of the requested information (acceptance criteria, sample sizes for test/training sets, expert qualifications, etc.) is not present in this document because it pertains to a different type of evaluation.

Here's a breakdown of the information that is available or can be inferred, and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Absent. This document does not present a table of acceptance criteria or report specific performance metrics for the device. It refers to non-clinical testing data from previous submissions for establishing substantial equivalence.

2. Sample size used for the test set and the data provenance

• Absent. This document does not describe a "test set" in the context of an AI/algorithm performance evaluation. The "non-clinical testing" mentioned involved mechanical and fatigue testing, not a data-driven test set with human-equivalent performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Absent. Not applicable to this type of regulatory submission. The ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images or data.

4. Adjudication method for the test set

• Absent. 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

• Absent. This is a hardware device (hip stem), not an AI algorithm. Therefore, MRMC studies and AI-assisted reading are not relevant.

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

• Absent. This is a hardware device, not an algorithm.

7. The type of ground truth used

• For the non-clinical testing mentioned, the "ground truth" would be engineering standards, material specifications (e.g., ISO 5832-9 for stainless steel), and the results of mechanical fatigue, static, rotational torque, and fretting/corrosion tests.

8. The sample size for the training set

• Absent. Not applicable. This is not an AI/ML device.

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

• Absent. Not applicable.

Summary of available information related to the device and its evaluation (from the document):

• Device Name: TaperFit Hip Stem
• Type of Device: Hip joint metal/polymer semi-constrained cemented prosthesis
• Indications for Use: Relief of pain and restoration of hip function following femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis, and total hip revision. Also indicated for hemi-arthroplasty when used with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads. Indicated for cemented, single use only.
• Predicate Devices:
  • Corin TaperFit Hip Stem (K142761)
  • Corin Taper-Fit Hip Stem (K992234, K003666)
• Substantial Equivalence Claim: The TaperFit Hip Stem (subject of this submission) is claimed to be identical in design, materials, coating, and sizes to K142761, and similar in intended use/indications. It's also claimed to be identical in materials and coating, and similar in design, sizes, and intended use/indications to K992234 and K003666. The main modification in this submission is an expanded indication for use to include hemi-arthroplasty with compatible Corin hemi-arthroplasty femoral heads.
• Non-Clinical Testing Mentioned: FEA (Finite Element Analysis), mechanical fatigue testing, static testing, rotational torque testing, fretting and corrosion testing, and range of motion testing. These tests were performed and submitted in previous TaperFit and Taper-Fit Hip Stem submissions (K142761, K992234, and K003666).
• Clinical Testing: "Clinical testing was not necessary in this Traditional 510(k)."

Ask a specific question about this device