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The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

The BiPolar-i is intended for use in the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement,
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• Revision of failed partial hip replacements in which the acetabulum does not require replacement

The BiPolar-i is indicated for cementless use only.

The BiPolar-i is a preassembled bipolar head comprised of an ultra-high molecular weight polyethylene (UHMWPE) liner and a highly polished cobalt-chromium alloy (CoCr) outer shell. The BiPolar-i is used in combination with a 22mm or 28mm CoCr modular head (dependent on the BiPolar i size) and compatible hip stem, both supplied separately. When assembled, the modular head is maintained captive and articulates within the UHMWPE liner. The BiPolar-i is intended for use in partial hip replacement (hemiarthroplasty) to provide increased patient mobility and reduce pain by replacing the natural femoral head and to restore hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. The BiPolar-i is intended for use with a Corin femoral head and hip stem prosthesis with a compatible 12/14 taper connection and is designed to articulate in the patient's natural acetabulum.

The provided document is a 510(k) summary for the Corin BiPolar-i, a hip joint femoral (hemi-hip) metal/polymer prosthesis. This document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, intended use, and non-clinical testing. It explicitly states that clinical testing was not necessary for this particular submission.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not available within this document because a clinical study of the device's performance against pre-defined acceptance criteria was not conducted or reported for this 510(k) submission.

This type of submission relies heavily on non-clinical testing to demonstrate that the new device performs as safely and effectively as legally marketed predicate devices, rather than establishing numerical performance metrics against acceptance criteria from a clinical trial.

However, I can provide the non-clinical testing information that was conducted:

1. Acceptance Criteria and Device Performance (from non-clinical testing):

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical human test set was used. This refers to non-clinical laboratory testing. The document does not specify the sample sizes used for each non-clinical test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical human test set requiring expert ground truth was used.

4. Adjudication method for the test set: Not applicable, as no clinical human test set was used.

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 a physical hip prosthesis, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip prosthesis, not an algorithm.

7. The type of ground truth used: For the non-clinical testing, the "ground truth" is defined by the requirements and test methodologies outlined in the referenced ASTM and ISO standards, and the performance of the predicate device. For BET, it's the absence of bacterial endotoxins.

8. The sample size for the training set: Not applicable, as no training set for an algorithm was used.

9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm was used.

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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)."

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The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
  The Corin Metafix Hip Stem is intended for cementless use only.

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL,V ) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-03(2009). The stem is indicated for use with Corin CoCr modular femoral heads and ceramic modular femoral heads with a 12/14 taper. (NOTE : the ceramic modular heads are not subject of this 510(k) submission.) The stem is available in nine sizes, each available in three offsets including standard (135°), lateralized 135°, and standard (125°).

The Corin Bipolar Head (K925897) is comprised of an outer CoCr shell, an inner liner of ultra high molecular weight polyethylene (UHMWPE), and an inner CoCr head. The Bipolar head is available in a range of outer diameter sizes and a variety of head offsets and is compatible with all Corin 12/14 taper femoral stems. The Corin Optimom Modular Head (K111911) is a polished, truncated CoCr alloy sphere with a high tolerance internal female taper and is available in a range of diameters with a variety of offsets. It is compatible with Corin 12/14 taper titanium and stainless steel femoral stems. The Bipolar and the Optimom Modular Heads are indicated for hip hemi-arthroplasty.

The purpose of this submission is to modify the labeling for the Metafix Femoral Hip Stem to include hip hemi-arthroplasty to the indications for use when the stem is mated with a Corin CoCr hemi-arthroplasty femoral head.

The provided text describes a 510(k) premarket notification for a medical device, the Corin Metafix Femoral Stem for Hemi-arthroplasty. This document is a regulatory submission for pre-market clearance, not a study evaluating device performance against acceptance criteria in the way a clinical trial would.

Here's an analysis based on the information provided, specifically addressing why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

This information is typically found in a clinical study report or a design verification/validation report, neither of which is present in the provided 510(k) summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study.

The document states:

• "A comparison of design, materials, size range, and indications for use demonstrate substantial equivalence with the predicate components."
• "Testing was submitted in the predicate 510(k) submissions and as demonstrated in the substantial equivalence table, the Metafix Femoral Stem, when coupled with the Corin hip hemi-arthroplasty heads is substantially equivalent to the predicate devices and expected to be safe and effective for the proposed indications."

Therefore, there are no specific performance acceptance criteria or reported device performance metrics in this document. The "performance" is implicitly tied to the established performance of the predicate 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. No "test set" in the context of a clinical study or performance evaluation is discussed. The submission relies on equivalence to predicate devices, which would have had their own historical data, but that data is not detailed here.

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. No "ground truth" establishment by experts for a test set is described.

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

Not applicable. No adjudication method is described as there is no test set in the context of this submission.

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 a physical hip prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This device is a physical hip prosthesis, not an algorithm.

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

Not applicable. No specific ground truth determination process is described for the device itself. The established safety and effectiveness of the predicate devices serve as the "ground truth" for the equivalence claim.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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

The document describes a Substantial Equivalence Study documented in a 510(k) premarket notification (K120362).

• Study Goal: To demonstrate that the Corin Metafix Femoral Stem for Hemi-arthroplasty is substantially equivalent to legally marketed predicate devices, particularly for an expanded indication for hip hemi-arthroplasty.
• Methodology:
  • Comparison to Predicate Devices: The Metafix Femoral Stem (K082525), Corin Optimom Modular Heads (K111911), and Corin Bipolar Heads (K925897) were identified as predicate devices.
  • Basis of Equivalence: The submission argues that the Corin Metafix Hip Stem, when used for hemi-arthroplasty with compatible Corin CoCr hemi-arthroplasty femoral heads, is substantially equivalent based on:
    • Identical Intended Use/Indications for Use (for the heads): The Optimom and Bipolar heads are identical to predicate femoral heads in these aspects.
    • Identical Design, Materials, and Sizes: For the Metafix Femoral Stem, it is identical to the previously cleared Metafix Femoral Stem (K082525) in materials and sizes. The subject of the submission is a modification of Indications for Use.
    • Similar Components: The inner 26mm Eurocone CoCr femoral head of the Corin Bipolar Head is manufactured of the same material, is similar in design, and is within the range of previously indicated compatible components for the Metafix Femoral Stem.
  • Non-Clinical Testing: The document states, "Testing was submitted in the predicate 510(k) submissions." This implies that the current submission relies on the non-clinical testing performed for the predicate devices to support the equivalence claim, rather than presenting new non-clinical tests for the modified indication. This non-clinical data would have included mechanical testing, material characterization, etc.
  • Clinical Testing: The document explicitly states, "Clinical testing was not necessary to determine substantial equivalence between the Metafix Femoral Stem for total hip arthroplasty and the Metafix Femoral Stem for Hemi-arthroplasty." This indicates that no new clinical study was conducted for this specific submission to demonstrate performance.

In essence, the "study" is a regulatory comparison against existing, cleared devices, rather than a de novo performance study against defined acceptance criteria.

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