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StageOne™ Select Hip Cement Spacer Molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin Bone Cement R, assembled and inserted into the femoral medullary cavity following removal of the existing femoral and acetabular replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-hip prosthesis made from the StageOne™ Select Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (Refobacin Bone Cement R), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

The StageOne™ Select Hip Cement Spacer Molds are sterile, single use medical devices made of silicone with a stainless steel reinforcement stem, head insert and neck length adapter. The device is used to create a temporary hip implant component made from antibiotic bone cement, Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After removal of the initial femoral and acetabular implants, the prepared cement spacers are assembled using the neck length adapter and placed into the femoral joint space using Refobacin® Bone Cement R as the first stage of a two-stage revision surgical procedure. The temporary hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage revision procedure is performed to implant a conventional hip joint prosthesis.

The provided text is related to an FDA 510(k) premarket notification for a medical device called "StageOne™ Select Hip Cement Spacer Molds." It details the device's purpose, indications for use, and a comparison to predicate and reference devices to establish substantial equivalence.

However, the document DOES NOT contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML medical device submission. This document pertains to a physical medical device (cement molds) and the testing described is non-clinical (biocompatibility, packaging, shelf-life, sterilization, MRI analysis, fatigue performance, antibiotic elution, BET, and pyrogenicity testing) and does not involve AI/ML performance evaluation.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of AI/ML, as the provided text does not contain such information.

If you have a different document related to an AI/ML medical device, please provide it, and I will be happy to assist.

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STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD).

When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis.

STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR).

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client's existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user's current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs.

The provided document is a 510(k) premarket notification for SpinTech, Inc.'s "STAGE" device. It outlines the device description, indications for use, comparison to a predicate device, and a summary of non-clinical testing. However, it explicitly states that clinical testing was not necessary to demonstrate substantial equivalence, and therefore, does not contain information about a study proving the device meets specific acceptance criteria based on human reader performance, expert-established ground truth, or MRMC studies.

Here's a breakdown of the information available based on your request, highlighting the missing elements:

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

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested (e.g., sensitivity, specificity, AUC values).

It states: "All predefined acceptance criteria for the performance testing were met. The results from the performance testing executed on STAGE produced results consistently according to its intended use." This is a general statement that the device passed internal testing, but no specific metrics are quantified or presented.

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 as there was no clinical testing. The non-clinical testing focused on software verification and validation.

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

This information is not provided as there was no clinical testing involving expert-established ground truth for a test set.

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

This information is not provided as there was no clinical testing (and thus no test set adjudicated by experts).

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 as explicitly stated, "Clinical testing was not necessary to demonstrate substantial equivalence of STAGE to the predicate device." Therefore, no effect size of human reader improvement with or without AI assistance is reported.

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

The document states: "STAGE was tested in accordance with SpinTech's verification and validation procedures," and "All predefined acceptance criteria for the performance testing were met." This implies standalone testing of the algorithm's performance against internal acceptance criteria (e.g., accuracy of calculations, image generation quality). However, specific metrics (like quantitative measures of accuracy, precision for the generated images or maps) for this standalone performance are not detailed. The focus is on the device generating outputs according to its intended methodology and not on diagnostic accuracy in a clinical context without human interpretation. The device is a "post-processing software medical device intended for use in the visualization of the brain" and "When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis." This indicates it's designed to be used with human interpretation, not as a standalone diagnostic tool.

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

For the non-clinical performance testing, the "ground truth" would likely be based on established computational models, mathematical correctness of transformations, or comparison to reference data generated by known methods, rather than clinical ground truth like pathology or expert consensus. Specific details on the type of ground truth used for the verification and validation are not provided.

8. The sample size for the training set

This information is not provided. The document describes the device as a software that analyzes input data to generate various images and maps. While some methodologies might involve "fitting" (e.g., lease squares fitting), it's not explicitly stated if a machine learning model requiring a distinct "training set" was utilized in a conventional sense for the image generation process, beyond the CROWN filtering algorithm being "intended to improve specific STAGE outputs." The document details the methodologies as unchanged from the predicate, and focuses on the generation of images/maps based on specific signal processing and mathematical transformations, rather than a machine learning model that would require a large training dataset for learning.

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

This information is not provided, as details about a distinct training set for a machine learning model are absent.

In summary, this 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical software verification and validation, without the need for clinical studies involving human observers or detailed performance metrics against clinical ground truth.

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StageOne™ Shoulder Cement Spacer Molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from StageOne™ Shoulder Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The subject device is a sterile, single use device made of silicone and is used to create a temporary hemi-shoulder implant component made from antibiotic bone cement, Refobacin® Bone Cement R. After removal of the initial implant the prepared cement spacer is placed into the glenohumeral

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "StageOne™ Shoulder Cement Spacer Molds." It describes the device's intended use, indications for use, and a summary of performance data (nonclinical).

However, the document does not contain information about:

• Acceptance criteria for an AI/ML device.
• A study that proves the device meets AI/ML acceptance criteria.
• Details about the test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, or training ground truth establishment.

The document explicitly states that Clinical Testing was deemed not necessary to establish substantial equivalence for the proposed device modifications, and the focus was on non-clinical performance testing for a physical medical device (molds for bone cement).

Therefore, based on the provided text, I cannot describe the acceptance criteria or a study proving an AI/ML device meets those criteria because this document does not pertain to an AI/ML device.

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StageOne™ Knee Cement Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The knee prosthesis made from the StageOne™ Knee Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the knee prosthesis material (Refobacin® Bone Cement R), the temporary knee prosthesis is only indicated for patients who will consistently use traditional mobility devices (e.g. crutches, walkers) throughout the implant period.

The subject device is a sterile, single use device made of silicone and is used to create temporary tibial and femoral implant components made from antibiotic bone cement, Refobacin® Bone Cement R. After removal of the initial implant the prepared cement spacers are placed into the tibiofemoral joint space using Refobacin® Bone Cement R as the first stage of a two-stage revision surgical procedure. The temporary spacers remain in place (180 days or less) until the second stage of the two-stage revision procedure is performed to implant a conventional knee joint prosthesis.

This document describes the StageOne™ Knee Cement Spacer Molds, a device used to mold temporary total knee replacements in a two-stage revision procedure due to a septic process.

Here's an analysis based on your request:

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

The provided text does not contain a specific table of acceptance criteria with corresponding performance results. Instead, it lists various non-clinical performance tests conducted to support the modifications and establish substantial equivalence to a predicate device. The underlying assumption is that the device met the acceptance criteria for these tests, as the FDA concluded substantial equivalence.

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

The document focuses on non-clinical performance testing. Therefore, there is no patient-specific test set sample size or provenance information (country of origin, retrospective/prospective) for clinical data provided. The testing relates to the physical and chemical properties of the device and its molded cement.

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)

Since this is a non-clinical device, there were no clinical experts used to establish ground truth for a test set in the traditional sense (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would have been based on established standards, protocols, and scientific principles followed by engineers, material scientists, and microbiologists involved in the testing. The document does not specify the number or specific qualifications of these individuals, but it's understood that qualified personnel would conduct such tests.

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

No adjudication method was used for a test set because this was entirely non-clinical testing. Adjudication methods are typically relevant for clinical studies involving human interpretation or decision-making.

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 MRMC comparative effectiveness study was done. This device is a cement spacer mold, not an AI or imaging-related 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

No standalone algorithm performance study was done. This device is a physical medical device, not a software algorithm.

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

For the non-clinical tests, the "ground truth" was established by recognized industry standards, scientific principles, and internal specifications for biocompatibility, packaging, sterilization, wear, and antibiotic elution. For example, biocompatibility testing would adhere to ISO 10993 standards, and sterilization validation would follow established guidelines to ensure a certain sterility assurance level (SAL).

8. The sample size for the training set

There is no "training set" as this is a physical medical device and not a machine learning model.

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

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

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STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM ) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD).

When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis.

STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition (e.g., T2 FLAIR).

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated medical grade computer (STAGE Module) connected to the user's local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user's current DICOM viewing software.

Here's a breakdown of the acceptance criteria and study information for the STAGE device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific quantitative acceptance criteria in a table format, nor does it provide a numerical "reported device performance" against those criteria. Instead, it makes general statements about meeting predefined acceptance criteria for image quality and clinical user needs.

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

The document states: "A reader study was conducted to demonstrate acceptable diagnostic image quality and equivalent radiologic finding classes compared to the predicate device."

• Test Set Sample Size: The exact number of cases or images in the test set for the reader study is not specified in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. It mentions that "When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis." but this does not directly address the ground truth establishment for the reader study.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set in the reader study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document states: "A reader study was conducted to demonstrate acceptable diagnostic image quality and equivalent radiologic finding classes compared to the predicate device." This suggests a comparative study was performed, but it does not explicitly mention whether it was an MRMC study in the standard sense (comparing human readers with and without AI assistance).

• Effect Size of Human Readers with vs. without AI: This information is not provided in the document. The study aimed to show "equivalent radiologic finding classes compared to the predicate device," which implies a comparison between STAGE outputs and outputs from a predicate device, rather than a direct comparison of human reader performance with and without STAGE assistance on the same case.

6. Standalone (Algorithm Only) Performance Study

The document describes STAGE as "post-processing software medical device intended for use in the visualization of the brain" and states that "When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis." It clarifies that "STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition."

This suggests that STAGE is intended as a tool for a physician and not for standalone diagnostic use by the algorithm itself. Therefore, a standalone (algorithm-only) performance study, in the sense of the algorithm making a diagnosis without human input, was likely not performed or reported as part of this submission, given its described role as a "post-processing software."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the test set (e.g., expert consensus, pathology, outcome data). It only mentions demonstrating "acceptable diagnostic image quality and equivalent radiologic finding classes compared to the predicate device," implying comparison against established clinical understanding or predicate device outputs.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only mentions the "Methodology" of STAGE and its use of input data.

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

The document does not specify how ground truth for the training set was established. It only describes the technical process of STAGE, stating it "analyzes input data from MR imaging systems" and uses "magnitude and phase data acquired with specific parameters to generate" various images and maps. This implies that the algorithms learn from MR imaging parameters and derived data, but the explicit method for establishing ground truth for training data is not detailed.

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Disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G Bone Cement and Refobacin® Bone Cement R), 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 disposable cement spacer molds (femoral and tibial) are sterile disposables made of medical grade silicone. They are intended to be filled with PALACOS® R+G Bone Cement or Refobacin® Bone Cement R*, either by injecting with a dispenser/gun, or by pouring the prepared cement into the mold. After the cement cures, the temporary spacers are to be removed from the molds and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional knee joint prosthesis.

The provided document is a 510(k) premarket notification for a medical device (StageOne™ Disposable Cement Spacer Molds for Temporary Knee Prosthesis). It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or algorithm validation study would.

This FDA letter and the associated 510(k) summary primarily focus on demonstrating substantial equivalence to a previously legally marketed predicate device. This regulatory pathway generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a predicate device, rather than requiring extensive clinical trials to prove efficacy against "acceptance criteria" in the sense of an AI/ML or diagnostic study.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The device is a "Disposable Cement Spacer Mold" used to create temporary knee prostheses from bone cement. It's a manufacturing aid, not a diagnostic tool or an AI/ML algorithm.
• Regulatory Pathway: The document clearly states it's a 510(k) submission, specifically demonstrating "substantial equivalence." This means the manufacturer is arguing their device is similar enough to an existing one that it doesn't need a full Premarket Approval (PMA), which would typically involve extensive clinical trials and pre-defined acceptance criteria for performance.
• Performance Data: The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states:
  • Non-Clinical Tests: "Mechanical performance testing and Gentamicin Elution testing... was conducted. The results demonstrated that StageOne® Knee Spacers fabricated with PALACOS® R+G Bone Cement and Refobacin® Bone Cement R possess mechanical and elution characteristics equivalent to those of the predicate device." This is about equivalence to a predicate, not meeting a new set of performance thresholds.
  • Clinical Tests: "Clinical data was not required to establish substantial equivalence between the subject StageOne™ Knee Spacer Molds and the predicate device." This is the most crucial point – no clinical study (and therefore no acceptance criteria or human reader studies) was required or conducted for this 510(k) clearance.

Therefore, I cannot provide the requested table and study details because the provided document does not contain them. The 510(k) process for this type of device (a Class II device based on the regulation number) typically emphasizes bench testing, material compatibility, and comparison to a predicate, rather than human performance studies with specific accuracy/sensitivity/specificity targets or MRMC studies.

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Disposable cement spacer molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using PALACOS® R+G Bone Cement or Refobacin® Bone Cement R. assembled and 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).

The hemi-hip prosthesis made from the StageOne™ Select disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (PALACOS® R+G Bone and Refobacin® Bone Cement R), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are intended to be filled with PALACOS® R+G Bone Cement or Refobacin® Bone Cement R* by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-hip prosthesis is to be removed from the molds with the reinforcement remaining as the core of the hemi-hip prosthesis, assembled using the neck length adapter and placed into the joint space. The hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.

This document is a 510(k) premarket notification for a medical device, the StageOne™ Select Disposable Cement Spacer Molds for Making Temporary Hemi-Hip Prosthesis with Reinforcement Stem. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device.

The "acceptance criteria" discussed in this document revolve around the concept of "substantial equivalence" to a legally marketed predicate device (K080979 - StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement). The study described is a non-clinical performance comparison to demonstrate this equivalence.

Here's the information broken down based on your request, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the mechanical performance testing, gentamicin elution testing, or bacterial endotoxin testing. It only states that these tests were performed and demonstrated equivalence.

The data provenance is not explicitly detailed beyond being "Non-Clinical Tests" presented by Biomet Inc. It is retrospective in the sense that it's a comparison to existing, defined characteristics of a predicate device. The country of origin of the data is not specified.

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

Not applicable. This submission relies on non-clinical comparative testing against a predicate device and established specifications (like pyrogen limits). There is no mention of experts being used to establish ground truth for a test set in the context of diagnostic accuracy or similar applications.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no diagnostic test set with human interpretation requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention any MRMC study. The device is a physical medical device (spacer molds), not an AI-assisted diagnostic tool for human readers.

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

Yes, in a sense, the non-clinical tests performed are "standalone" in that they assess the physical characteristics and performance of the device itself (or the prosthesis molded from it) against predefined specifications and a predicate device, without direct human interaction as part of the "performance" measurement. However, this is not an "algorithm-only" standalone performance as typically discussed for AI devices.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

• Predicate Device Performance: The established mechanical and elution characteristics of the legally marketed predicate device (K080979).
• Established Specifications: Pyrogen limit specifications for bacterial endotoxin testing.
• Material Properties: The known properties of PALACOS® R+G Bone Cement and Refobacin® Bone Cement R.

8. The Sample Size for the Training Set

Not applicable. This is a medical device for physical implantation, not an AI model 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 an AI model.

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Disposable cement spacer molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Palacos® R+G Bone Cement or Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from the StageOne™ disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Palacos® R-G Bone Cement and Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The single-use cement spacer molds are sterile disposables made of medical grade silicone. They are intended to be filled with Palacos® R+G Bone Cement or Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-shoulder prosthesis is to be removed from the mold and placed into the joint space. The hemi-shoulder prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional shoulder joint prosthesis.

The document describes the StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis and its substantial equivalence to predicate devices, but it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-enabled medical device.

This document is a 510(k) premarket notification for a medical device (a cement spacer mold), which is a physical product, not an AI/ML diagnostic or therapeutic tool. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, and associated sample sizes for training and testing are not applicable to the information provided.

The performance data mentioned (mechanical performance and gentamicin elution testing) is for the physical characteristics of the cement spacer and the bone cement combination, comparing it to an existing predicate device.

Here's a breakdown of the information that is available, and why the requested information is largely absent based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative targets for performance (e.g., sensitivity, specificity, accuracy) for an AI/ML system. For this physical device, "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices in terms of mechanical and elution characteristics.
• Reported Device Performance:
  • Mechanical performance testing: "StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin® Bone Cement R were compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess mechanical... characteristics comparable to those of the predicate device."
  • Gentamicin Elution testing: "...and Gentamicin Elution testing of StageOne™ ... compared to that of the predicate. The results demonstrated that StageOne™ Shoulder Spacers fabricated with Palacos® R+G Bone Cement and Refobacin Bone Cement R possess... elution characteristics comparable to those of the predicate device."
  • Design validation: "Design validation test results confirm that the StageOne™ Shoulder Spacer Molds utilized with Palacos® R+G Bone Cement and Refobacin® Bone Cement R meet design requirements for use."

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

• Not applicable/Not mentioned. The "test set" here refers to the physical samples of the cement spacers and bone cement used for mechanical and elution testing, not a dataset for an AI/ML model. The document does not specify the number of samples tested or the provenance of these physical samples.

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 question pertains to expert review for AI/ML model ground truth. The "ground truth" for this device is based on laboratory testing of physical properties (mechanical strength, drug elution) and comparison to a predicate device, not expert interpretation of medical images or data.

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

• Not applicable. This is relevant for resolving discrepancies in expert opinions for AI/ML ground truth. Not relevant for physical device 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

• Not applicable. This study type is specific to evaluating AI/ML's impact on human performance in diagnostic tasks. The StageOne™ device is a physical medical device.

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

• Not applicable. This refers to the standalone performance of an AI/ML algorithm.

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

• Ground Truth (for the physical device): The "ground truth" for this device's performance is established by objective, quantitative laboratory measurements of mechanical properties (e.g., strength, stiffness) and drug elution profiles, compared against established standards or performance of a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. There is no AI/ML training set for this device.

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

• Not applicable. There is no AI/ML training set for this device.

In summary, the provided document is a 510(k) submission for a physical medical device. The questions posed are primarily designed for AI/ML-enabled medical devices, and thus, most of them are not relevant to the information presented in this document.

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Disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is assembled and 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).

The StageOne" Select hemi-hip prosthesis is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (polymethylmethacrylate/gentamicin), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Cement Spacer Molds are designed to mold a temporary "spacer" hip implant made of antibiotic impregnated bone cement. The spacers are intended for short-term duration use only, not to exceed 6 months.

The StageOne" Select Cement Spacer Molds are a series of Cement Spacer Molds designed to provide modularity of sizing between the femoral stem and the femoral head connponents. The molds provide various stem sizes and various head sizes that can be mated to provide the best fit for each patient. The cement spacer molds are made of biomedical grade silicone. The metal reinforcements within the cement spacer molds are made of implant grade stainless steel.

The provided document is a 510(k) summary for the StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement. It describes the device, its indications for use, and claims substantial equivalence to legally marketed predicate devices.

However, the document does not contain information regarding clinical studies, acceptance criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies because no clinical testing was performed or provided as a basis for substantial equivalence for this device.

The relevant section states:

• "Non-Clinical Testing: Cyclic fatigue testing was conducted on the StageOne™ Select components and the predicate StageOne™ components to provide a direct comparison of the subject and predicate components."
• "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information in the format of a table or answer the specific questions related to clinical trials, as such details are explicitly stated as not being part of the submission for this particular device. The FDA's determination of substantial equivalence was based on non-clinical testing (cyclic fatigue) and comparison to predicate devices, not on human-in-the-loop performance or standalone algorithm performance.

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The Stage-1® Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alone or as the base for a temporary crown. The healing cap is intended for temporary use only up to 30 days.

The Stage-1 ** Temporary/Healing Cap is a cap which is placed over the COC Abutment for protection during soft tissue healing. The Stage-1® Temporary/Healing Cap also offers a base for placement of a temporary crown. The temporary crown can be bonded directly to the Stage-1® Temporary/Healing Cap.

This submission focuses on "Substantial Equivalence Comparison" for the Stage-1® Temporary/Healing Cap. Instead of providing acceptance criteria and a study demonstrating performance against these criteria, the document asserts substantial equivalence to predicate devices based on shared characteristics. Therefore, the requested information on acceptance criteria and a detailed study proving device performance as typically understood for AI/software-based devices is not applicable to this 510(k) submission.

Specifically, the submission from Lifecore Biomedical, Inc. for the Stage-1® Temporary/Healing Cap (K053643) relies on comparing the new device to existing predicate devices to establish substantial equivalence. It does not present a study with performance metrics against acceptance criteria in the manner one would expect for a diagnostic or AI-driven medical device.

Here's an explanation based on the provided text, addressing why the requested information cannot be fully provided:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. The submission does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for a clinical study comparing the device against a benchmark. Instead, it argues substantial equivalence. The "performance" is implicitly tied to the predicate devices being legally marketed and safe/effective for their intended use.

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

• Not applicable. No test set, as would be used in a performance study, is described. The submission is a regulatory comparison.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. Ground truth establishment is not relevant to this type of substantial equivalence comparison.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. No such study is mentioned or implied. This device is a physical healing cap, not a diagnostic or AI-assisted interpretation tool where reader improvement would be measured.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. There is no algorithm or software component for which standalone performance would be assessed. The device is a physical medical implant accessory.

7. Type of Ground Truth Used:

• Not applicable. Ground truth, in the context of diagnostic performance, is not established for this device.

8. Sample Size for the Training Set:

• Not applicable. There is no machine learning component requiring a training set.

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

• Not applicable. No training set or ground truth for it exists in this submission.

Summary of Substantial Equivalence Comparison (as provided in the document):

The submission argues substantial equivalence based on the following:

The FDA's letter (K053643) confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This determination is based on the comparative information provided by the applicant, rather than a performancetesting study with specific acceptance criteria.

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