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The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

The Corin Unipolar Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is designed to be used with a number of femoral hip stem designs which incorporate a compatible male taper. The Corin Unipolar Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm and a variety of offsets.

Please find below the requested information regarding the acceptance criteria and study details for the Corin Unipolar Modular Head, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Non-Clinical Testing: Non-clinical testing and analysis included Finite Element Analysis, mechanical fatigue testing, mechanical axial pull-off and dimensional comparison." No specific sample size for a "test set" in the context of clinical data is mentioned, as the evaluation was based on non-clinical engineering and material testing. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable to this type of testing.

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

Not applicable. The evaluation relied on engineering and material testing standards, not clinical expert consensus for ground truth.

4. Adjudication method for the test set

Not applicable. There was no clinical 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. This device is a mechanical implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.

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

Not applicable. This device is a mechanical implant, not an algorithm.

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

For the non-clinical testing, the "ground truth" was based on established engineering principles, material standards (e.g., ASTM F75), and the performance characteristics of legally marketed predicate devices. The objective was to demonstrate substantial equivalence, meaning the new device performs similarly to or better than existing, cleared devices.

8. The sample size for the training set

Not applicable. This device's evaluation did not involve a "training set" in the context of machine learning or AI.

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

Not applicable. No training set was used.

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The Unitrax® Modular Unipolar System is intended to be used with a Howmedica Osteonics hip stem. When assembled to a hip stem, the resultant component functions in Ostcomes imp stem. "When assemmooprosthesis. The endoprosthesis is used as a hemia shillial for the following indications: femoral neck fractures, idiopathic avascular necrosis and non-unions.

The Unitrax® component is a unipolar head that accepts a neck adjustment adaptor or sleeve. The neck adjustment sleeve is then assembled to the trunnion of the desired Howmedica Osteonics femoral stem. The design modification to the unipolar head involves a reduction in the wall thickness and removal of the inner "ribs". The manufacturing process modification involves changing the size 45mm components from machined to cast parts which results in a material change from ASTM F1537 to ASTM F75. The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365. The Unitrax® Modular Unipolar Heads are manufactured from Vitallium® (CoCr) Alloy which conforms to ASTM standards F75 (cast) and F1537 (wrought). The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads.

This submission describes design, manufacturing process, and material modifications to the Unitrax® Modular Unipolar System, a unipolar hip implant component. The information provided does not contain details about acceptance criteria, device performance, or a study that uses statistical measures to evaluate performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and material verification, rather than clinical performance or AI/software validation.

Therefore, many of the requested fields cannot be answered directly from the provided text.

Here's the breakdown of what can be extracted and what is not available, based purely on the provided text:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for device performance (e.g., accuracy, sensitivity, specificity). The acceptance criteria implicitly revolve around demonstrating substantial equivalence to the predicate device through design, material, and manufacturing process changes, and possibly mechanical testing (though specific results are not detailed).
• Reported Device Performance: No quantitative performance metrics are reported. The document states:
  • "The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365."
  • "The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads."

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

• Sample Size for Test Set: Not specified. This document is a 510(k) summary for modifications to an existing device, and such submissions often rely on bench testing (mechanical, material, etc.) rather than clinical test sets with human subjects, unless a major change in safety/effectiveness is suspected.
• Data Provenance: Not specified. Likely involves in-house laboratory testing of the device components.
• Retrospective or Prospective: Not applicable as no clinical study or human data is mentioned.

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. This device is a mechanical implant; ground truth would relate to material properties and mechanical performance, established through engineering standards and testing, rather than expert interpretation of data.

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

• Not applicable. No expert adjudication process is described as there is no clinical data or expert interpretation involved in the substantial equivalence argument presented.

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 is a hip implant, not an AI or imaging device. No human readers or AI assistance are part of this device or its evaluation in the provided text.

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

• Not applicable. This is a hip implant, not an algorithm or software device.

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

• The ground truth in this context would likely be engineering standards and specifications (e.g., ASTM standards for materials, recognized test methods for mechanical strength, fatigue, etc.) that the modified device components must meet to demonstrate substantial equivalence and safety/effectiveness. No clinical ground truth (pathology, outcomes) is mentioned.

8. The sample size for the training set

• Not applicable. No training set is involved as this is not a machine learning or AI device.

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

• Not applicable. No training set or associated ground truth.

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The ULTIMA* Unipolar Head is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to:

1. femoral neck fracture,
2. avascular necrosis of the femoral head,
3. osteoarthritis,
4. abnormalities where:

• the major pathology affects the femoral head,
• the acetabular cavity is normal and not deformed or weakened,
• acetabular replacement is not required or desirable.

The ULTIMA* Unipolar Head is provided in a size range of 38mm to 63mm (outer diameter), in 1mm increments. Sizes from 44mm through 63mm are manufactured as a twopiece assembly. The two pieces are made of cast cobalt-chromium-molybdenum alloy conforming to ASTM F75. Both pieces are treated with hot isostatic pressing and solution annealing. The two cast pieces are machined and then joined permanently by electron beam welding to form a hollow unipolar head. Sizes from 38mm through 43mm are cast from cobalt-chromium-molybdenum alloy as a solid head, and are isostatic pressed and solution annealed before machining. Both of these size ranges are finish machined to the outer diameter size. The outer diameter is highly polished for articulation with the implant recipient's natural acetabulum.

The ULTIMA* Unipolar Head has a tapered bore which can receive a variety of Adapter Sleeves. The adapter sleeves can be tapered on the outside to the mate with the unipolar head, and tapered on the inside to mate with the appropriate femoral stem trunnion. The adapter sleeves are available in a 10/12 taper, in size increments for -3mm, +0mm, +5mm. and +10mm neck lengths; in a 11/13 taper, in size increments for +0mm, +6mm, and +12mm neck lengths: and in a 12/14 taper, in size increments for +0mm, +3.5mm, and +7mm neck lengths. The adapter sleeves are machined from cobalt-chromium-molybdenum alloy in wrought bar form conforming ASTM F799.

The provided text describes the ULTIMA* Unipolar Head and Adapter Sleeves, a medical device for hip replacement procedures. The document focuses on establishing substantial equivalence to previously approved devices rather than presenting a study with specific acceptance criteria and performance metrics in the way one would for a diagnostic AI device.

Therefore, an analysis cannot be provided based on the requested format as it is not applicable to the given text.

Here's why and what information can be extracted:

• No Acceptance Criteria and Reported Device Performance Table: The document does not define specific performance metrics (e.g., accuracy, sensitivity, specificity) or acceptance thresholds for these metrics. Its purpose is to demonstrate substantial equivalence, not to prove standalone performance against defined criteria.
• No Sample Size for Test Set or Data Provenance: This is not a study involving patient data for performance evaluation. It's a regulatory submission for a medical device's physical and functional equivalence to existing devices.
• No Experts Used for Ground Truth: The concept of "ground truth" as it applies to diagnostic or AI performance evaluation is not relevant here. The ground truth for this device would be its mechanical and material properties, which are evaluated through engineering tests and adherence to standards, not expert consensus on patient data.
• No Adjudication Method: Not applicable for a device equivalence submission.
• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is for evaluating observer performance (e.g., radiologists) with and without AI assistance. The ULTIMA* Unipolar Head is a physical implant, not a diagnostic tool or AI algorithm.
• No Standalone Performance Study: The document focuses on equivalence to existing devices, not a standalone performance evaluation against clinical outcomes or diagnostic accuracy.
• No Type of Ground Truth (Expert Consensus, Pathology, Outcomes Data): As stated, the "ground truth" for this device relates to its engineering specifications and material properties, not typical clinical or AI ground truth.
• No Sample Size for Training Set: There is no "training set" in the context of this device. This is a manufactured product, not a machine learning model.
• No Ground Truth Establishment for Training Set: Again, not applicable.

Information that can be extracted from the document related to "acceptance" (in the sense of regulatory approval) and "study" (in the sense of engineering analysis):

1. Acceptance Criteria and Reported Device Performance (as inferred from "substantial equivalence"):

The document states: "Furthermore, analysis results demonstrate that the ULTIMA* Unipolar Head and Adapter Sleeves meets the set criteria for the establishment of 'substantial equivalence'."

While not explicitly tabular acceptance criteria like for an AI device, the document implies that the device "meets the set criteria" by demonstrating similarity and comparable intended use, design, and materials to predicate devices. The "performance" is implicitly its ability to meet the same functional requirements as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set: Not applicable. This document refers to the physical and material properties of the device, not a test set of patient data.
• Data Provenance: The "data" pertains to engineering specifications, material standards (ASTM), and comparative analysis with previously approved devices (K940190 and K902365).

The document is a regulatory submission for a physical medical device, not a clinical study or an AI performance evaluation. The "study" referenced is the analysis performed to demonstrate substantial equivalence based on engineering, material, and design comparisons.

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The OPTEON Unipolar Endoprosthesis is for use with a modular femoral stem when hemiarthroplasty is indicated. The change to a total hip replacement can then be accomplished in the future without removing the femoral stem.

The OPTEON Unipolar is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture .

The OPTEON Unipolar Endoprosthesis is a polished, truncated sphere made of cast cobalt chrome, ASTM F75. The high tolerance taper connection machined at the base of each unipolar component will mate with all Exactech femoral hip stems.

The external geometry approximates the shape of the normal femoral head and is intended for use in hemiatthroplasty. The modular system allows for future total hip arthroplasty without removal of the femoral stem.

This document is a 510(k) premarket notification for a medical device (Opteon® Unipolar Endoprosthesis), which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about a formal clinical study with acceptance criteria and device performance as typically seen for novel devices.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, ground truth, training set sample size) cannot be directly extracted as they are not part of this type of submission.

However, I can extract information related to the device's characteristics and its comparison to predicate devices, which serves as the "proof" for its acceptance based on substantial equivalence.

Here's a summary tailored to the provided input, explaining why some sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not explicit performance metrics derived from a new clinical study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of material, design, and intended use. The "reported device performance" is essentially that the device shares the characteristics and has the expected performance profile (based on a long history of similar devices) of the predicate devices.

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

• Not applicable. This 510(k) submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a "test set" of patients or data in the way a clinical trial would. The "data provenance" primarily consists of public domain literature (advertisements, brochures, catalogs) from predicate device manufacturers, along with Exactech's own design drawings and material specifications.

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

• Not applicable. No external "ground truth" establishment by experts for a specific test set was conducted or reported in this 510(k) document. The equivalence relies on comparison by the manufacturer and review by the FDA.

4. Adjudication method for the test set:

• Not applicable. No test set or formal adjudication method among experts was described for this 510(k) 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 passive implant (hip endoprosthesis), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI comparison is irrelevant.

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

• Not applicable. As above, this is a passive implant, not an algorithm.

7. The type of ground truth used:

• Not applicable in the typical sense of a clinical study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices (Corin® Unipolar Endoprosthesis #K881288, Howmedica Unitrax® Unipolar System #K902365, and generally devices on the market prior to May 28, 1976). The "ground truth" for the device's material properties comes from ASTM standards (e.g., F75-87) and mechanical testing results.

8. The sample size for the training set:

• Not applicable. This 510(k) involves a physical device, not a machine learning model, so there is no training set.

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

• Not applicable. As there is no training set, this question is not relevant.

Summary of "Study" Proving Acceptance Criteria:

The "study" or justification for acceptance in this 510(k) is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer provided:

• Detailed descriptions and specifications of the Opteon® Unipolar Endoprosthesis (design drawings, material specifications, photos).
• Material certificates/testing results demonstrating compliance with ASTM F75-87 for cast cobalt chrome, including mechanical properties (tensile strength, yield strength, elongation, reduction of area).
• References to predicate devices (Corin® Unipolar, Howmedica Unitrax® Unipolar) and general categories of pre-amendment devices, asserting similarities in materials, design (e.g., spherical geometry, taper connection), and intended use (hemiarthroplasty indications).
• Commercial literature from predicate manufacturers to demonstrate their characteristics.
• Assertions regarding biocompatibility based on ASTM F75-87 and historical clinical use of the material.
• Description of a standard and acceptable sterilization protocol (gamma irradiation per AAMI guidelines).

The conclusion drawn is that because the Opteon® Unipolar Endoprosthesis is of similar design, materials, and intended use as devices already on the market (and those cleared through 510(k)s), it is equally safe and effective. This type of submission does not require a new, prospective clinical trial to establish novel safety or effectiveness data.

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