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Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Interspace Shoulder 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.).

The Interspace Shoulder devices is a temporary device composed of fully formed PMMA bone cement with gentamicin and an inner stainless steel metal core. The design mimics a hemi-shoulder prosthesis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tecres Interspace Shoulder Temporary Shoulder Prosthesis:

Based on the provided 510(k) summary (K112983), this submission is for a modified medical device, not a new AI/software-as-a-medical-device (SaMD) or diagnostic device. As such, the typical "acceptance criteria" and "study" questions you'd ask for an AI model's performance metrics (like sensitivity, specificity, AUC) are not directly applicable in this context.

Instead, the "acceptance criteria" here refer to production specifications and performance adequate for in vivo application under temporary conditions of use, and the "study" is a performance testing conducted to demonstrate substantial equivalence to a previously cleared device.

Here's the breakdown of the information as requested, translated into the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the performance testing was to verify that the implant performance "continues to meet the production specifications and be adequate for in vivo application under the temporary conditions of use." The primary "acceptance criteria" seem to be demonstrating that the modified device is substantially equivalent to its predicate (K060535) despite the addition of a metal reinforcing structure and a new material supplier.

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

• Test Set Sample Size: Not explicitly stated. The "performance testing" described is likely mechanical and chemical testing of the device itself and its components, rather than a clinical trial with patient data. Therefore, the "test set" would refer to the number of devices or material samples subjected to laboratory tests (e.g., fatigue testing, tensile strength, gentamicin elution studies). Without further documentation, the exact number cannot be determined from this summary.
• Data Provenance: Not applicable in the sense of patient data. The testing would have been conducted in a laboratory setting by the manufacturer (Tecres S.p.A.).

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

• Number of Experts: Not applicable. For material and mechanical performance testing, "ground truth" is established through standardized engineering and chemical testing methods, not expert consensus on clinical cases.
• Qualifications of Experts: Not applicable. The testing would be performed by qualified engineers, chemists, and technicians following established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This type of testing involves objective measurements against predefined specifications, not human interpretation requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance, which is not the nature of this device.

• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is an implanted prosthesis, not an algorithm or a software device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the performance testing, the "ground truth" would be established by:
  • Engineering specifications and standards: For mechanical properties (e.g., ISO standards for implant materials, internal design specifications for strength and durability).
  • Chemical analysis standards: For gentamicin release and stability (e.g., pharmacopeial methods, validated analytical chemistry techniques).
  • Comparison to predicate device's established performance: To demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The device itself is the product. The term "training set" is not relevant here.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set."

Summary of the 510(k) Submission's Core Argument:

The K112983 submission for the Interspace Shoulder Temporary Shoulder Prosthesis argues for substantial equivalence to its own previously cleared version (K060535). The key modifications are the introduction of a metal reinforcing structure and a new material supplier. The manufacturer conducted performance testing (mechanical properties, gentamicin release, and stability data) to demonstrate that these changes did not negatively impact the device's ability to meet its production specifications and remain adequate for its temporary in vivo application. The FDA's clearance indicates that they found this demonstration of substantial equivalence sufficient without requiring complex clinical trials or new performance metrics beyond what was presented for the predicate device.

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Spacer-K 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.

Spacer-K 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).

Spacer-K is not intended for use for more than 180 days, at which time it must be explanted and permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Spacer-G 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 intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-G 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.).

Spacers are temporary joint prostheses. Spacer-G is a single piece device that mimics a hemi-hip prosthesis, and is available in six sizes. Spacer-K includes a femoral and tibial component, and is available in three sizes. Spacer-G and Spacer-K are made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin). Spacer-G contains 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 methylmethacrylate, N,N-dimethyl-p-toluidine, hydroquinone; the powder component consists of polymethymethacrylate, barium sulphate, benzovl peroxide, and gentamicin sulphate.

The Spacer devices 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 a 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.

Here's a breakdown of the acceptance criteria and study information for the Tecres Spacer-G and Spacer-K, based on the provided documents:

Acceptance Criteria and Device Performance

The provided 510(k) summary (K101356) does not explicitly state specific quantitative acceptance criteria or detailed performance data in a table format. Instead, it relies on substantiating that the modified devices (Spacer-G and Spacer-K) are substantially equivalent to their previously cleared versions (K062274 for Spacer-K and K062273 for Spacer-G).

The core acceptance criterion implicitly stated is:

• The modified Spacer devices must perform equivalently to their previously cleared versions, ensuring continued safety and effectiveness for their intended temporary use.

The reported device performance is described as:

• "Performance testing was conducted to verify that implant performance continues to meet the production specifications and be adequate for in vivo applications under the temporary conditions of use."
• "Mechanical properties, gentamicin release and stability data were evaluated and found to support the substantial equivalence of the devices."

Without quantitative metrics provided in these documents, a table cannot be fully populated. However, we can infer the categories of assessment:

Study Information

The 510(k) summary for K101356 describes an evaluation for "substantial equivalence" rather than a de novo clinical study with patients. The study primarily involves performance testing to compare a modified device (minor material change) to an established, previously cleared device.

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

   • The document does not specify the sample size for any test set in terms of clinical data or patient cohorts. The performance testing appears to be conducted on the devices themselves (e.g., in vitro mechanical testing, elution studies).
   • Data provenance: Not explicitly stated as retrospective or prospective clinical data. Given the nature of a 510(k) for a minor material change to a previously cleared device, the testing would likely be bench testing and possibly some in vitro or ex vivo studies. No specific country of origin for clinical data is mentioned as such data doesn't appear to be the primary basis for this particular submission.

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

   • Not applicable in the context of this 510(k) submission. The evaluation is based on engineering and material science performance testing, not on interpretation of patient data by medical experts. "Ground truth" here refers to established material properties and performance benchmarks.

3. Adjudication method for the test set:

   • Not applicable as there is no mention of a human expert review or adjudication process for a test set of clinical cases. The evaluation is against engineering specifications and pre-established performance of the predicate device.

4. 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 temporary orthopedic implant, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This device is a physical medical device.

6. The type of ground truth used:

   • Engineering specifications and performance characteristics of the previously cleared predicate devices (K062274 and K062273). The "ground truth" for the modified device's performance is that it matches or exceeds the established performance of its predecessors, as demonstrated through mechanical, gentamicin release, and stability testing.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set."

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

   • Not applicable.

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Spacer-G is indicated for temporary use (maximum 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 femoral and acetabular implants and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Spacer-G 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.).

Spacer-G is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-hip prosthesis.

This 510(k) summary for the Spacer-G device primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics are not explicitly detailed in this document. The core of this submission is to show that the modified Spacer-G is just as safe and effective as already approved devices by having similar design, materials, performance characteristics, and gentamicin release profile.

Here is an attempt to address your requests based on the provided text, highlighting where information is absent:

Acceptance Criteria and Study to Prove Device Meets Criteria: Spacer-G Modification

The provided 510(k) summary for the Spacer-G device demonstrates substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria directly linked to a novel performance claim for the modified device. The "acceptance criteria" can be inferred as the standard for substantial equivalence, meaning the device must perform comparably to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission relying on comparison to existing devices, it is unlikely a large "test set" in the sense of a clinical trial was used for this specific modification. The "performance" assessment appears to be based on engineering principles and potentially laboratory testing rather than human clinical outcomes data.

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

This information is not applicable/provided. The submission focuses on substantial equivalence based on technical and material characteristics, not on a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

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 temporary hip prosthesis, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable. This device is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance characteristics of the legally marketed predicate devices. The modified Spacer-G is evaluated against these established benchmarks. No pathology, outcomes data, or expert consensus specific to the modified device's novel performance is referenced as a "ground truth" to meet new performance criteria.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI algorithm requiring a training set.

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

This information is not applicable. This device is not an AI algorithm.

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Spacer-K is indicated for temporary use (maximum 180 days) as an adjunct in total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethilmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes ) throughout the implantation period.

The Spacer-K is a temporary device that mimics a "total knee prosthesis". The two-component unconstrained design incorporates a femur and tibial component, it's fully formed by gentamicin/polymethyImethacrylate (PMMA) bone cement.

This 510(k) summary for the Spacer-K knee prosthesis modification does not include the detailed information required to describe acceptance criteria and a study proving device performance in the way you've outlined. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria.

However, I can extract information related to the device's characteristics and the basis for its clearance:

Here's what can be gathered, and what is explicitly missing from the provided text:

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

• Missing from the document. The 510(k) summary states that the modified Spacer-K has "equivalent performance and mechanical characteristics" to the predicate Spacer-K (K032522) and a "similar gentamicin release profile" to another predicate (K050210). However, it does not provide specific acceptance criteria (e.g., minimum tensile strength, specific drug release rates) or reported numerical performance data from a study.

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

• Missing from the document. There is no description of a specific test set or clinical study with patient data. The equivalence is based on design, materials, and mechanical characteristics (likely bench testing or literature review, but details are not provided).

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)

• Missing from the document. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation), which is not the primary focus of this 510(k) application.

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

• Missing from the document. Not applicable given the type of 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

• Missing from the document. Not applicable. The Spacer-K is a physical medical device (a temporary knee prosthesis), not an AI-assisted diagnostic tool.

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

• Missing from the document. Not applicable.

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

• Missing from the document. For a device like this, "ground truth" would typically refer to established engineering standards for materials and mechanical properties, or validated methods for drug release testing. The document refers to "equivalent performance and mechanical characteristics" and "similar gentamicin release profile," implying that these aspects were compared to predicate devices, but the specific methodologies for determining this "truth" are not detailed.

8. The sample size for the training set

• Missing from the document. Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Missing from the document. Not applicable.

Summary of what the document DOES provide regarding clearance:

The device (Spacer-K Modification) received 510(k) clearance (K062274) based on a demonstration of substantial equivalence to legally marketed predicate devices.

• Predicate Devices:
  • Spacer-K device (K032522): The modified Spacer-K has the "same design, incorporates the same materials, has equivalent performance and mechanical characteristics, and has the same shelf and packaging" as this predicate.
  • Biomet Stage One Disposable Cement Spacer Mold for Temporary Knee Prosthesis with Reinforcement Stem (K050210): The modified Spacer-K has a "similar gentamicin release profile" when used with Biomet Cobalt G HV Bone Cement (K051532).

Key Takeaway: This 510(k) summary is typical for a device modification, where the primary goal is to show that the new version is as safe and effective as a previously cleared device. It does not contain the kind of detailed performance study and acceptance criteria you would expect from a de novo submission or a product requiring extensive clinical trials. The "study" here is essentially the comparison against the predicate devices across defined parameters (design, materials, mechanical characteristics, drug release).

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• Temporary restoration of inlay and onlay preparations
• Temporary fillings and sealings

used for the temporary restoration of inlay and onlay preparations and all kind of temporary fillings. Spacer™ is easy to handle because it is not sticky. Spacer™ has high elasticity and without any debris in the cavity.

The provided text is a 510(k) summary for a dental temporary filling material called "Spacer™" by Vericom Co., Ltd. It focuses on regulatory approval based on substantial equivalence to a predicate device, rather than performance studies with acceptance criteria as typically found in AI/ML medical device submissions. Therefore, many of the requested categories cannot be directly extracted from this document.

Here's an analysis of the available information and what cannot be provided:

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

This document does not provide a table of acceptance criteria or specific performance metrics like sensitivity, specificity, accuracy, etc. It mentions properties like "easy to handle because it is not sticky" and "high elasticity and without any debris in the cavity," but these are descriptive statements, not quantified performance criteria with acceptance thresholds. The 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance study results against predefined acceptance criteria in the way an AI/ML device would.

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

No information about a test set, sample size, or data provenance is provided. This type of information is typically found in performance studies, which are not detailed in this 510(k) summary.

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. There is no mention of a test set, ground truth establishment, or experts for this device in the provided document.

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

Not applicable. There is no mention of a test set or adjudication method.

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 dental material, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without 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 dental material, not an algorithm.

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

Not applicable. No ground truth is established or discussed for this dental material.

8. The sample size for the training set:

Not applicable. There is no training set discussed for this dental material; it's a physical product.

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

Not applicable. There is no training set or ground truth established for it.

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Spacer-S is intended for use as a temporary (maximum 180 days) shoulder replacement in patients undergoing a two-stage procedure due to a septic process.

The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection) as defined by physician and/or surgeon.

Spacer-S is indicated for temporary use (maximum 180 days) as an adjunct to total shoulder replacement and hemi shoulder replacement procedures in skeletally mature patients undergoing a two-stage revision procedure due to a septic process. Spacer-S is only indicated for an implantation period of 180 days or less.

Spacer-S is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-shoulder prosthesis.

The K060535 filing describes the Tecres Spacer-S, a temporary shoulder prosthesis. The information provided primarily focuses on its device description, intended use, and a demonstration of substantial equivalence to a predicate device through performance testing, rather than an AI/ML device and its associated acceptance criteria and study data.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable or cannot be extracted from the provided text, as this is a medical device approval for a physical implant, not a software or AI/ML diagnostic tool.

However, I can extract the relevant performance data that was used to establish substantial equivalence.

Here's the information that can be extracted or inferred from the provided text:

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

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

This information is not provided in the document. The performance testing refers to mechanical and material evaluations, not clinical trials with human subjects in the typical sense of test sets for AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. Ground truth, in the context of this traditional medical device, is established through engineering and laboratory testing (e.g., measuring physical properties like strength and antibiotic release), not through expert consensus on diagnostic images or clinical outcomes.

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

This information is not applicable/provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which is not the focus of the performance testing described for this device.

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 is a physical medical implant, not an AI or imaging diagnostic device.

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

This information is not applicable. This is a physical medical implant, not an algorithm.

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

For the performance data, the "ground truth" would be established through engineering standards and laboratory measurements of the device's mechanical properties (fatigue strength, static strength) and its antibiotic release characteristics. There is no mention of clinical pathology or outcomes data being used to define the "ground truth" for these specific performance tests.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this traditional medical device approval based on performance testing of the device itself.

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

This information is not applicable. As there is no "training set," there is no ground truth to establish for it.

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Spacer-G is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in 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 femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-G 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.).

The Spacer-G is a "hemi-hip" style device. The one-piece design incorporates a load bearing endoskeleton of AISI 316L stainless steel and an outer coating of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The implants are supplied sterile to an assurance level (SAL) of 10-6.

This document is a 510(k) premarket notification for the "Tecres Spacer-G" medical device. It describes the device, its indications for use, contraindications, and a summary of performance data. However, it does not provide a detailed "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format requested.

The document states:
"PERFORMANCE DATA
Performance testing was conducted to verify that the implant performance would be adequate for anticipated in vivo load applications under the temporary conditions of use. The fatigue strength, static strength, wear characteristics and antibiotic release rate were evaluated and found to support the safety and effectiveness of the device."

This is a very high-level summary and does not contain the specific information required to complete the table or answer the detailed questions about the study design, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot extract the requested information from the provided text. The document confirms that performance testing was conducted and found to support safety and effectiveness, but it does not detail:

1. A table of acceptance criteria and the reported device performance: No specific criteria or performance values are listed.
2. Sample sizes used for the test set and the data provenance: Not mentioned for any of the performance tests (fatigue, static strength, wear, antibiotic release).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the performance tests described are mechanical/material characteristic tests, not clinical studies involving expert interpretation of data like images or patient outcomes.
4. Adjudication method: Not applicable.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this is not a study type described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical implant, not an algorithm.
7. The type of ground truth used: For mechanical and material tests, the ground truth would be the measured physical properties against established standards. The document does not specify these standards or the measured values. For the antibiotic release, it would likely be laboratory measurements of gentamicin concentration over time.
8. The sample size for the training set: Not applicable as there is no "training set" for physical performance testing of an implant in this context.
9. How the ground truth for the training set was established: Not applicable.

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