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The Maxx Libertas Bipolar Head is intended for use in combination with a Maxx Libertas Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other devices or treatments for these indications have failed.

The Maxx Libertas Bipolar Head consists of three factory-assembled parts: a cobalt chromium outer shell, a UHMWPE liner, and a UHMWPE retention ring. The outer shell has a highly polished spherical outer surface for articulating with the acetabular joint socket. The liner has an hemispherical inner surface for articulating with the spherical head component of the Libertas femoral stem (28 mm). The retention ring provides a locking function to resist dislocation of the femoral head from the bipolar head.

The provided FDA 510(k) clearance letter and summary for the Maxx Libertas Bipolar Hip Head (K243634) describe the device and its intended use, but it does not contain information regarding statistically significant acceptance criteria derived from a clinical or standalone study comparing the device's performance against specific metrics.

Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761) primarily through non-clinical mechanical testing and engineering analysis. This type of submission relies on showing that the new device is as safe and effective as a legally marketed device, often by demonstrating similar design, materials, and performance in simulated conditions.

Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, ground truth type) are typically not included in a 510(k) summary that relies solely on bench testing and
engineering analysis for substantial equivalence.

Here's an analysis of the information that is available and what is not based on the provided document:

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

• Range of Motion tests were performed.
• Static push-out tests were performed.
• Static Lever-out tests were performed.
  Engineering Analysis:
• Impingement scenarios analysis was performed.

Overall Conclusion: The device performed "identical to the predicate device," supporting substantial equivalence. |

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 applicable/Not provided. The "test set" in this context refers to physical test articles used for mechanical testing, not a patient cohort or imaging dataset. The number of physical samples tested is not specified in the summary.
• Data Provenance: Not applicable/Not provided in the summary. Mechanical testing data does not have country of origin in the same way clinical data would.

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. For mechanical and engineering testing, "ground truth" is established by standard engineering principles, test methods (e.g., ASTM or ISO standards, though not explicitly cited here), and simulation results, not by human experts interpreting clinical data.

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

• Not applicable. This concept applies to human interpretation of clinical data in studies, not to device mechanical testing.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/software devices where human-in-the-loop performance is evaluated. The Maxx Libertas Bipolar Hip Head is a physical orthopedic implant.

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

• No, a standalone performance evaluation in the context of an "algorithm only" or AI device was not done. The "standalone" performance here refers to the mechanical and engineering performance of the physical device.

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

• The "ground truth" for demonstrating substantial equivalence for this device was established based on mechanical test results and engineering analysis comparing the subject device's performance to that of the predicate device under simulated conditions. There is no expert consensus, pathology, or outcomes data mentioned in this submission summary.

8. The sample size for the training set

• Not applicable. This term refers to data used to train AI models. This device is a physical orthopedic implant, not an AI/software device that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

Summary of what the study did demonstrate:

The provided document indicates that the Maxx Libertas Bipolar Hip Head gained 510(k) clearance primarily by demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761). This was achieved through:

• Mechanical Testing: Including Range of Motion, Static push-out, and Static Lever-out tests.
• Engineering Analysis: Specifically for impingement scenarios.
• Technological Comparison: The subject device was deemed "identical to the Predicate Device in design, material, chemical composition, principle of operation."

The conclusion was that the device "performed identical to the predicate device" based on these non-clinical tests, thus supporting its substantial equivalence for the stated Indications for Use.

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The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Avascular necrosis of the femoral head.
3. Non-union of femoral neck fractures.
4. Certain high subcapital and femoral neck fractures in the elderly.
5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
6. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

The DePuy CORAIL Cemented Femoral Stems are indicated only for use with bone cement.

The CORAIL Cemented Femoral Stem is manufactured from wrought high nitrogen stainless steel, and is designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty. The CORAIL Cemented Femoral Stem implants are uncoated with a polished finish, intended for use with bone cement. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for a wide range of patients. The CORAIL Cemented Femoral Stem is designed to provide a cemented version of the primary predicate DePuy CORAIL AMT Hip Prosthesis stem (cleared under 510(k) K123991).

This FDA 510(k) summary describes a new device, the CORAIL Cemented Femoral Stem, and its comparison to predicate devices, but it does not include any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• "No clinical tests were conducted to demonstrate substantial equivalence." (Page 10)
• The non-clinical tests were conducted "to demonstrate its substantial equivalence of safety and effectivenes to the identified predicate devices." (Page 10)

The "acceptance criteria" presented in the document are primarily the technological characteristics of the device being compared to predicate devices to establish substantial equivalence, rather than performance metrics with specific targets. The "study" mentioned consists of a series of non-clinical tests (mechanical, material, sterilization, biocompatibility, etc.) designed to show that the new device is as safe and effective as the predicate devices, not that it meets specific, predefined performance thresholds against a gold standard in a clinical context.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This detailed information is not included. The document compares features of the new device to predicates as shown in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES" (pages 6-9), but these are comparisons of design and material, not performance against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study with a test set is described. Non-clinical tests typically use material samples or prototypes, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set requiring expert ground truth.
4. Adjudication method for the test set: Not applicable as there is no clinical test set.
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 stem, not an AI 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 stem.
7. The type of ground truth used: Not applicable as there is no clinical test set requiring ground truth.
8. The sample size for the training set: Not applicable as there is no machine learning component or training set discussed.
9. How the ground truth for the training set was established: Not applicable as there is no machine learning component or training set discussed.

Summary of Non-Clinical Tests Conducted (relevant to the "study" aspect as provided):

The document lists the following non-clinical tests to demonstrate substantial equivalence:

• Distal fatigue and neck fatigue: performed per ISO 7206-4:2010, ISO 7206:2013 and ASTM F2068-3.
• Range of motion: performed per EN ISO 21535:2009+A1:2016.
• MRI Safety: performed per ASTM F2503-23, ASTM F2182-19e2, ASTM F2052-21, ASTM F2213-17 and ASTM F2119-07.
• Biocompatibility testing: performed per EN ISO 10993-1-2018, ISO 10993-3:2014, ISO 1099-5:2009, ISO 1099-6:2016, ISO 1099-10:2010, ISO 10993-11:2017, ISO 10993-12:2012, ISO 10993-18:2020, BS EN ISO 22442-1:2015 and ISO 10993-17:2002.
• Bacterial endotoxins: performed per ANSI/AAMI ST 72:2019.

The conclusion from these non-clinical tests was that "The CORALL Cemented Femoral Stem is substantialy equivalent to the identified predicates with respect to minded use, indications, materials, geometry, range of sizes, and method of fixation. Results of performance that the CORAL Cemented Femoral Stem performs as well as the predicate devices DePuy CORAIL AMT Hip Prosthesis and C-STEM AMT LE Prosthesis (K123991 and K220216)." (Page 10)

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The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup replacement for skeletally mature patients undergoing a two-stage procedure due to a septic process.

The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement) and positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement.

The molded acetabular cup is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The molded temporary Acetabular cup prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (Bone Cement), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers) throughout the implant period.

The SpaceFlex Acetabular Cup consists of disposable cement spacer molds. The molds are comprised of a lower mold, an upper mold, an injector, and tightening clips. The lower mold has a fixed diameter and couples with one of three upper molds. The upper mold has five channels for air flow and four holes for clips. The injector connects to the upper mold for bone cement injection. Tightening clips secure the upper and lower molds. The system is filled with low viscosity antibiotic polymethylmethacrylate bone cement. After curing, the temporary spacer is removed and placed into the joint space for up to 180 days.

The SpaceFlex Acetabular Cup is a device that consists of disposable cement spacer molds used to create a temporary acetabular cup replacement for patients undergoing a two-stage procedure due to a septic process. The temporary prosthesis is molded using low viscosity antibiotic polymethylmethacrylate bone cement (G3A 40 bone cement).

Here's an analysis of its acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes bench testing for performance evaluation. Specific sample sizes for each test are not explicitly detailed in the provided text. However, for the Gentamicin Elution Test, it mentions "different sizes (52 and 60 mm)" were tested. The data provenance is from bench testing conducted by G21, S.r.l. and is prospective in nature, as it involves testing the manufactured device components. This is not clinical data, but rather engineering and material property testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the described studies are bench tests (mechanical and material property assessments) rather than studies requiring expert interpretation of clinical data or images. The "ground truth" for these tests is established by industry standards (e.g., ASTM, ISO) and the device's design specifications.

4. Adjudication Method for the Test Set:

This information is not applicable for the bench tests described. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided text describes only bench testing of the device's mechanical properties and material interactions, not a study involving human readers or clinical effectiveness compared to an alternative.

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

This information is not applicable. The SpaceFlex Acetabular Cup is a physical medical device (molds for a temporary prosthesis), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The ground truth for the performance tests is based on engineering and material science standards (e.g., ASTM 3090-20:2020, ISO 14242-1-2014) and the device's defined specifications (e.g., 400 N compression strength, 500,000 cycles for fatigue and wear, 120°C temperature limit, comparable elution profiles, no chemical modification).

8. The Sample Size for the Training Set:

This information is not applicable. As this is a physical medical device undergoing bench testing, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

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Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Femoral neck fractures.

Correction of functional deformities.

The Vario-Cup System consists of an UHMWPE component encased in an ultra-smooth polished EndoDur (CoCrMo) outer metal casing, for articulation in the bony acetabulum. It is to be used in conjunction with femoral components of the LINK Total Hip Systems. The 22 mm inner diameter Vario-Cup Prostheses are available in outer diameters ranging from 39-43 mm in 1 mm increments. Vario-Cups are self-centering which provides for a functional view of their position in post-op X-rays. An anti-luxation feature resists dislocation: an UHMWPE Safety Ring is placed in a groove at the entrance of the polyethylene insert after assembly of Vario-Cup and femoral components.

This FDA submission focuses on a medical device, the Vario-Cup System, and does not involve AI/ML performance evaluation. Therefore, the requested information about acceptance criteria for AI models, study design for AI models, and related AI-specific details cannot be extracted from the provided text.

The document primarily addresses the substantial equivalence of the Vario-Cup System to predicate devices based on non-clinical performance data, material characterization, and design similarities. It explicitly states that no clinical performance testing was required for this device.

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COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, canes) throughout the implantation period.

COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.

COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liguid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).

COPAL® exchange G hip spacer will be used with COPAL® exchange G hip trials (510(k) exempt devices).

This response analyzes FDA K220492 for "COPAL® exchange G hip spacer." It is important to note that this device is a physical medical implant, not an AI/ML powered software device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (hip spacer) and not an AI/ML powered device, the "acceptance criteria" are not based on metrics like accuracy, sensitivity, or specificity. Instead, they relate to mechanical performance, material properties, and biocompatibility. The provided document indicates that the acceptance criteria for the modified device were the same as those for the original predicate device (K191016).

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

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical device testing, the sample size would refer to the number of devices or components tested. The document does not specify the exact number of spacers tested for fatigue or endotoxin, but states that "COPAL® exchange G hip spacer meets endotoxin limits" and "The fatigue performance testing as per ISO 7206-6 was performed... The acceptance criteria were not altered...". This implies that standard testing was conducted on an appropriate number of samples to demonstrate compliance.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The performance data is generated from laboratory mechanical and material testing. The document states the manufacturer is Heraeus Medical GmbH, located in Germany, implying the testing was conducted under their control.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. For a physical device, "ground truth" is established by engineering specifications, material standards, and validated testing methodologies, not by expert consensus on clinical images or patient data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data for AI/ML models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical implant, not a diagnostic AI tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical device, so there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, international standards (e.g., ISO 7206-6, DIN EN ISO 14971), and validated laboratory testing results for mechanical properties (fatigue), material composition, and biological safety (endotoxin).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no AI/ML model, there's no training set or ground truth establishment for it.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques

Qualifier:

The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:

-The KYOCERA Medical Corporation ("KYOCERA") Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head.

-The KYOCERA Initia Total Hip System femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.

The Bipolar Head is for uncemented use only.

Bipolar outer heads are not for use with acetabular shells and liners.

The Renovis Surgical Hip Replacement System (K112897) includes multiple subsystem offerings, including:

• K131354: Renovis Bipolar Hip System ●
  Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification is additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation. Japan Initia Total Hip System (now Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K131354 Kyocera Bipolar Hip System.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance results, or any study details that would allow me to answer your request.

The document is a 510(k) premarket notification from the FDA, which primarily focuses on establishing substantial equivalence to a predicate device. It discusses:

• Device name and classification.
• Intended use and indications for use.
• Comparison to a predicate device.
• Compliance with design controls and FDA guidance.

It does not contain any data from performance studies, clinical trials, or validation tests that would outline acceptance criteria and how a device achieved them. Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Therefore, I cannot fulfill your request for this specific document.

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This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
• Noninflammatory degenerative joint disease (NIDJD), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.
• Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.
• Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.
This stem is for uncemented use only.

The Fitmore® Hip Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The component is an uncemented stem which is coated proximally with Titanium Vacuum Plasma Spray and rough-blasted distally for primary stability. The stem design is curved and features a trapezoidal cross-section.
The 12/14 femoral stem is available in multiple sizes, consisting of three stem families. The different family designs were developed in order to meet various patients' anatomic needs. As the anatomic offset varies considerably between individuals, the Fitmore® Hip Stem offers a wide range of offset options. Each family is designed with a CCD angle of 140°, 137°, 129° and 127°.

This document is a 510(k) premarket notification for a medical device called the "Fitmore Hip Stem." It concerns the substantial equivalence of the device to legally marketed predicate devices.

Based on the provided text, the device is a hip implant, and the performance data described is focused on non-clinical aspects like packaging and sterilization, not on the clinical performance or diagnostic accuracy of an AI or software-as-a-medical-device (SaMD) product.

Therefore, most of the requested information regarding acceptance criteria, study methodologies (sample size, expert ground truth, adjudication, MRMC, standalone performance), and training set details for AI/SaMD devices is not applicable to this document. This document is for a physical orthopedic implant.

Here's what can be extracted and what cannot:

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

The document describes non-clinical performance testing for packaging and labeling integrity. It does not provide specific quantitative acceptance criteria or performance metrics in a table format that would be typical for an AI/SaMD product.

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

• Sample Size: The document mentions "representative worst-case products" were used for packaging configuration testing, but no specific sample size (N) is provided.
• Data Provenance: Not applicable in the context of clinical data for a physical implant. The testing was conducted by the manufacturer (Zimmer GmbH). The document implies the tests are laboratory-based, not patient-derived data.

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

This information is not applicable. The "ground truth" for a physical implant's packaging integrity is based on testing against ISO standards, not expert medical opinion on imaging or diagnostic accuracy.

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

This information is not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., radiologist reads) in clinical studies, not for objective engineering tests of packaging.

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:

This information is not applicable. This device is a physical hip stem, not an AI or software product. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable. This is not an algorithm or software device.

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

The "ground truth" for the non-clinical performance (packaging) was based on compliance with international standards (ISO 11607-1:2009 and ISO 11607-2:2006) and physical integrity. No expert consensus, pathology, or outcomes data were used for this type of testing.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This information is not applicable for the same reason as above.

In summary: The provided document is an FDA 510(k) clearance letter for a conventional medical device (a hip stem), not a software or AI-driven diagnostic/therapeutic device. Therefore, the questions related to AI/SaMD performance metrics and study methodologies are generally not relevant to the content of this document.

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COPAL® exchange G knee (polymethylmethacrylate/gentamicin) is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. COPAL® exchange G knee is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

COPAL® exchange G knee is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). COPAL® exchange G knee is only indicated for patientswho will consistently use traditional mobility assist devices e.g. crutches, walkers, canes) throughout the implantation period.

COPAL® exchange G hip (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion, perm etc.). COPAL®exchange G hip is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

The COPAL® exchange G Hip and Knee Spacers are combination products that provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to 1) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization.

The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release

COPAL® exchange G Hip Spacer is a single use device that mimics a hemi-hip prosthesis and is available in 8 sizes and usable for both left and right hips.

The COPAL® exchange G Hip Spacers are combination products made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin). The COPAL® exchange G Hip Spacers contain an inner stainless steel (AISI 316L stainless steel) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. The liquid component consists of methyl methacrylate, N, N-dimethyl-p-toluidine, hydroquinone. The powder component consists of polymethymethacrylate, calcium carbonite, benzoyl peroxide, and gentamicin sulphate. The raw materials and a summary of the manufacturing process are found below.

COPAL® exchange G Knee Spacer is a single use device that is comprised of a tibia and femur component and is available in 3 sizes to form one knee spacer that is usable for left and right knee.

The provided text describes a 510(k) premarket notification for Heraeus Medical GmbH's COPAL® exchange G Hip and Knee Spacers. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo clinical performance with specific acceptance criteria that an AI/ML device would typically face.

Due to the nature of this submission (510(k) for a physical medical device, not an AI/ML algorithm), the information required for filling out the requested table regarding acceptance criteria and performance of an "AI/ML device" is largely not applicable or not present in the document. The performance testing section refers to physical and biological tests, not AI model metrics.

However, I will extract what is available and clearly state what information is missing based on your request.

Here's an attempt to address your request based solely on the provided text, while making the critical distinction that this document does not pertain to an AI/ML device:

Acceptance Criteria and Study for COPAL® exchange G Hip and Knee Spacers (as described in K191016)

Note: The provided document describes the 510(k) clearance for physical medical devices (hip and knee spacers) and not an Artificial Intelligence/Machine Learning (AI/ML) device. Therefore, the typical acceptance criteria and study design elements requested for an AI/ML device (e.g., sensitivity, specificity, expert ground truth, MRMC studies, training/test sets) are not relevant or present in this submission. The "acceptance criteria" for this device are demonstrated through equivalence to predicate devices via various physical, chemical, and biological performance testing, not through AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

• Irritation: No signs of irritation; classified as not irritant.
• Delayed-type hypersensitivity: No reactions identified as sensitization.
• Acute systemic toxicity: No acute systemic toxic characteristics.
• Reverse mutation assay: Non-mutagenic.
• In vitro mammalian cell gene mutation assay: Non-mutagenic.
• Femoral bone implantation/subchronic systemic toxicity: No inflammatory or degenerative findings at implantation sites.
• Summary: COPAL® exchange G spacers are biocompatible according to ISO10993-2016. |
  | Sterilization Validation | Sterility Assurance Level (SAL) of 10-6 according to ISO 11135 and AAMI TIR 28. | Chosen sterilization process (ethylene oxide gassing) is valid; sterile units achieved with defined bioburden and SAL of 10-6. |
  | Shelf Life | Maintain sterility (DIN EN ISO 11737. Part 2), compressive strength (ISO 7206-6 and ISO 14879-1), gentamicin content, and gentamicin impurities over 36 months at 25 ± 2 °C. | All hip/knee spacers sterile throughout 36-month storage. Compressive strength within specified range. Gentamicin content and impurities remained within specified range.
  Summary: Stable at 25 ± 2 °C and 50% humidity for 36 months. |
  | Sterile Barrier Integrity | Adherence to ISO 11607-1 and ISO 11607-2, including maintenance over 5 years of transport and shelf life. | Integrity of the system shown; maintenance of sterile barrier system demonstrated over 5 years. |
  | Mechanical Performance | Compressive strength (ISO 14879-1, ISO 7206-4, ISO 7206-6), cyclic fatigue (ISO 14879-1, ISO 14242-1:2012), abrasion (ISO 14243-1:2009, ISO 14242-1:2012) demonstrating equivalence to predicate devices. | - Compressive strength: Equivalent to predicate devices.
• Cyclic fatigue: Equivalent to predicate devices.
• Abrasion: Equivalent to predicate devices. |

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

Due to the nature of the device (physical implant, not software/AI):

• Sample Size for Test Set: This concept doesn't directly apply in the "AI/ML" sense of a data test set. The document refers to "tests performed" and "results obtained" for various physical and biological properties. Specific quantitative sample sizes for each test (e.g., number of hip spacers tested for compressive strength) are not provided in this summary.
• Data Provenance: Not applicable in the context of an AI/ML algorithm (e.g., country of origin of patient data). The testing data is generated in a lab setting through physical and chemical tests on the manufactured devices. The document implies these tests were conducted by the manufacturer (Heraeus Medical GmbH, Germany).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This is not applicable for this type of device submission. Ground truth, in the AI/ML context, refers to expert labeling of data (e.g., images). For this physical device, "ground truth" is established by adherence to recognized international standards and laboratory testing protocols performed by qualified professionals in those fields (e.g., materials science, microbiology, mechanical engineering). The specific number or qualifications of these testing personnel are not detailed in the summary.

4. Adjudication Method for the Test Set

• This is not applicable for this type of device submission. Adjudication, in the AI/ML context, is typically used for resolving disagreements among multiple human annotators during ground truth establishment. For a physical device, passing/failing criteria are set by the established standards and internal quality control.

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

• This is not applicable as the device is not an AI/ML algorithm intended to assist human readers.

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

• This is not applicable as the device is not an AI/ML algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for these physical devices is established by compliance with recognized international standards (e.g., ISO, ASTM) for material properties (e.g., mechanical strength, chemical composition), biological interactions (biocompatibility), and manufacturing processes (sterilization, shelf life). The "outcome data" is whether the device meets these pre-defined physical and biological performance specifications and demonstrates equivalence to the predicate device.

8. The Sample Size for the Training Set

• This is not applicable as the device is not an AI/ML algorithm. There is no concept of a "training set" in this context. The product is manufactured based on design specifications and then tested for performance.

9. How the Ground Truth for the Training Set was Established

• This is not applicable as the device is not an AI/ML algorithm.

In conclusion, the provided FDA 510(k) submission is for a physical medical device (hip and knee spacers) and not for an AI/ML-based device. Therefore, the requested information regarding AI/ML-specific acceptance criteria, study methodologies (e.g., human-in-the-loop, standalone, MRMC), and data sets (training, test, ground truth establishment) is largely irrelevant to this document. The document primarily focuses on demonstrating substantial equivalence through various physical, chemical, and biological performances tests against established standards and predicate devices.

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The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stems for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• Femoral neck and trochanteric fractures of the proximal femur;
• . Osteonecrosis of the femoral head;
• . Revisions procedures where other devices or treatments for these indications have failed

The iNSitu Bipolar Hip System consists of a factory assembled UHMWPE (ASTM F648) liner in a cobalt chrome (ASTM F75) outer shell, and UHMWPE (ASTM F648) retention ring with a Ti-6Al-4V ELI (ASTM F136) spring. These Bipolar Heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller Bipolar Heads (38 to 43 mm) have an inner diameter that mates with the subject 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with the previously cleared 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with an iNSitu Total Hip System Femoral Stem (K161184/K172501) for hemiarthroplasty.

This document describes the regulatory clearance of a medical device, specifically the iNSitu Bipolar Hip System. It refers to performance testing done for a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The provided text is a 510(k) summary for a traditional medical device (a hip prosthesis), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (the BioPro Bipolar Head) based on identical design, materials, indications for use, and manufacturing methods.

Here's a breakdown of the relevant information provided, adapted to the context of a traditional device:

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

The document does not explicitly state "acceptance criteria" in the way one would for an AI/ML algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it relies on the mechanical and functional equivalence to a predicate device.

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

• Test set sample size: Not specified. The "testing" refers to mechanical and functional tests of the physical device components, not a "test set" of data as in AI/ML.
• Data provenance: Not applicable in the context of mechanical device testing.

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. Ground truth as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant for the mechanical testing of a hip prosthesis. The "ground truth" here is adherence to mechanical and material standards and performance comparable to a predicate device.

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

Not applicable. This concept is for resolving disagreements in expert labeling of data, which is not part of this device's evaluation.

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 not an AI/ML device, so no MRMC study would be conducted for human reader improvement with AI assistance.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this medical device's performance is adherence to established material specifications (e.g., ASTM F75 for cobalt chromium, ASTM F648 for UHMWPE, ASTM F136 for Ti-6Al-4V) and demonstrated mechanical performance comparable to a legally marketed predicate device as determined through physical testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for this type of device.

In summary: The provided document is for a traditional hip implant, not an AI/ML powered device. The "acceptance criteria" are implied to be the successful demonstration of mechanical and material properties that are substantially equivalent to a cleared predicate device, as confirmed by physical performance testing. The questions regarding AI/ML specific aspects (sample sizes, experts, adjudication, MRMC, standalone performance, training sets, etc.) do not apply to this submission.

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The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications:

• Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.

• Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of this prosthesis is generally only indicated in skeletally mature patients.

The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis

• Correction of functional deformity

• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The ic-Bipolar Head System consists of a bipolar liner, retaining ring, and femoral head. The system is used for hip replacements in which the femur requires replacement but the acetabulum does not (i.e. hemi-arthroplasty) The ic-Bipolar Head System articulates directly with the natural (non-replaced) acetabulum on the outer side and with a femoral head on the inner side. The ic-Bipolar Head System is manufactured of CoCrMo and UHMWPE. The ic-Bipolar Head System is used in conjunction with the EcoFit® Hip System (K163577) and MUTARS® Proximal Femur Replacement System (K181778).

The provided FDA 510(k) summary (K191569 for the implantcast ic-Bipolar Head System) outlines performance testing but does not specify numerical acceptance criteria or provide detailed study results for those criteria. Instead, it generally states that testing was performed to assure substantial equivalence and demonstrate performance as intended.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that "All necessary testing has been performed... to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended." However, it does not explicitly list quantitative acceptance criteria for each test (e.g., "Taper Disassembly Force > X N" or "Range of Motion > Y degrees") nor does it provide the specific results obtained during these tests.

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

• Sample Size for Test Set: Not specified. The document mentions "test units representative of finished devices" were used for performance testing, but the number of units tested per performance test is not provided.
• Data Provenance: Not specified. Performance testing is generally conducted in a laboratory setting by the manufacturer (Implantcast GmbH) or a contracted testing facility. The document doesn't specify if any data used for testing was derived from clinical sources (e.g., country of origin, retrospective/prospective). Given the nature of mechanical and material tests, it's highly likely to be prospective laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable / Not specified. This type of information (expert review for ground truth) is typically relevant for AI/ML device submissions where clinical images or data require expert interpretation. For a physical medical device like a hip implant, ground truth is established through standardized engineering and material testing methods, often against international standards (e.g., ISO, ASTM, which are not explicitly cited here but are implied by "Performance Testing").

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Mechanical and material tests do not involve expert adjudication in the way clinical diagnostic studies do. The "adjudication" is determined by whether the test results meet pre-defined performance specifications derived from standards or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, not done. An MRMC study is not relevant for this type of device (bipolar head system). This is a physical implant, not a diagnostic AI device requiring human reader interaction.

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

• No, not applicable. This device is a physical implant, not an algorithm or AI product. "Standalone performance" in this context would refer to the device's mechanical and material performance, which is what the "Performance Testing" section generally describes.

7. The Type of Ground Truth Used

• Engineering and Material Specifications / Predicate Device Performance: The "ground truth" for the performance measures described would be established by:
  • Industry standards: Conformance to relevant ISO or ASTM standards for implant materials and mechanical properties (e.g., fatigue strength, wear resistance, dimensional accuracy).
  • Predicate device characteristics: Demonstrating that the device performs "substantially equivalently" to the predicate device (Aesculap Bipolar Acetabular Cup K060707) in terms of mechanical and material properties. This usually involves showing that test results fall within an acceptable range or meet specific thresholds generally accepted for such devices.

8. The Sample Size for the Training Set

• Not applicable. This device does 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. See point 8.

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