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This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models feature wire wound polyvinyl chloride (PVC) bodies with side ports in the distal tip, a ported atrial basket drainage site located along the length of the cannula body, and a 3/8-inch (0.95 cm) to 1/2-inch (1.27 cm) connection site. The overall length of each cannula body is approximately 15¼ inch (38.7 cm). Insertion depth marks are provided to aid in positioning of the cannula. Each cannula is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

This document is a 510(k) clearance letter for a medical device: the MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula. It does not contain any information about an AI/ML-driven medical device, nor does it discuss acceptance criteria, test sets, ground truth establishment, or human reader studies related to AI performance.

The clearance is for a physical device used in cardiopulmonary bypass surgery, and the summary of performance data refers to pre-clinical bench testing related to material formulation changes, not algorithmic performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about AI/ML device performance, which are entirely absent from this 510(k) clearance.

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It is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract.

The 3-Stage Balloon Dilation Catheter can provide 3 different sizes and gradually increasing diameters through controlled radial expansion. The specific balloon size is printed on the label of each package and catheter. The 3-Stage Balloon Dilation Catheter is designed to pass through the working channel of the endoscope, and its guidewire cavity can accommodate a 0.035inches (0.89mm diameter) guidewire. In the package, a 0.035inches (0.89mm diameter) guidewire is pre-installed in the guidewire cavity. There is a guidewire locking device connected to the guide wire hole of the catheter. The locking device will be in the "OFF" (closed) position when it leaves the factory. Only when the switch of the locking device is in the "ON" position can it be pushed or moved forward. The guide wire is removed from the catheter. After turning the switch to the "OFF" position, the guide wire will be fixed in the catheter.

This document details the FDA's 510(k) clearance for the VedDilator™ 3-Stage Balloon Dilation Catheter. It does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, the requested information regarding acceptance criteria and performance of an AI/ML-based device cannot be extracted from this document.

The document focuses on the substantial equivalence of this medical device (a physical catheter) to a predicate device based on non-clinical performance testing and biocompatibility.

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

• No AI/Machine Learning: The device is a physical catheter, not a software or AI-based diagnostic tool.
• No Diagnostic Performance Study: The document lists non-clinical bench testing for physical characteristics (e.g., burst pressure, maneuverability, sterility) and biocompatibility, not diagnostic performance metrics like accuracy, sensitivity, or specificity.
• No Human Reader Study: Since it's a physical device, there's no concept of human readers or MRMC studies.
• No Ground Truth Establishment: The "ground truth" in this context refers to the physical properties of the device, measured through standard engineering tests, not a clinical diagnosis established by experts.

Summary of available information (not directly addressing the prompt's request for AI/ML device performance):

• Device: VedDilator™ 3-Stage Balloon Dilation Catheter
• Purpose: To endoscopically dilate strictures of the alimentary tract.
• Study Type: Non-clinical bench testing and biocompatibility testing for substantial equivalence to a predicate device (K112994).
• No Clinical Study: Section 7 explicitly states, "No clinical study is included in this submission."
• Test Performed (Non-Clinical): Rated burst pressure test, Balloon tightness test, Connection firmness test, Maneuverability test, X-ray development performance test, Sterility test, Residual amount of ethylene oxide Test, Balloon fatigue Test, Burst Test of Guidewire, Bend Test of Guidewire, Connection Strength Test of Guidewire, Corrosion resistance Test of Guidewire.
• Biocompatibility Tests: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Material mediated pyrogenicity.
• Conclusion: The device meets design specifications and demonstrates substantial equivalence to the predicate device based on these non-clinical tests.

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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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The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Both the predicate and proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters consist of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device.

Like the predicate, the EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. The guidewire is manufactured by Lake Region Medical; and, is cleared under K935198, Gastroenterology and Urology Guidewire Modifications. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm.

The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).

The Gyrus ACMI EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.

The provided document K180086 describes the Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter and its substantial equivalence to predicate devices, rather than a clinical study establishing specific performance criteria against predefined metrics.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance with numerical values, as these are not part of the substantial equivalence claim.
• Sample size used for the test set or data provenance, as this was not a clinical effectiveness study.
• Number of experts, their qualifications, or adjudication methods for ground truth, as ground truth establishment for a diagnostic output is not relevant here.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance, as AI is not concerned in this submission.
• Information on a standalone algorithm performance, as AI is not concerned in this submission.
• Type of ground truth used (pathology, outcomes data, etc.), as this is a device clearance based on equivalence, not a diagnostic accuracy study.
• Sample size for the training set or how ground truth was established for it, as this is irrelevant for this type of device submission.

However, based on the provided text, I can infer the "acceptance criteria" and how the device (Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter) was shown to "meet" these criteria in the context of a 510(k) submission:

1. Acceptance Criteria (Implied for 510(k) Substantial Equivalence):

For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device:

• Has the same intended use as the predicate device.
• Has the same technological characteristics as the predicate device, or that differences do not raise new questions of safety or effectiveness.

In this specific case, for the "minor process changes" that resulted in "rounders to the balloon; enhancing balloon visualization," the acceptance criteria for these particular changes would have been that the repeated performance tests demonstrated the device still met or exceeded the established specifications and safety profiles.

Reported Device Performance (against equivalence, not quantitative clinical metrics):

The submission asserts that the proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter is "substantially equivalent" to the predicate devices and "presents no new questions of safety or effectiveness."

This is supported by:

• Identical intended use to a predicate Boston Scientific device (K112994).
• Identical design and scientific technology to its own predicate (K143609).
• No material changes from the predicate (K143609).
• Successful completion of a battery of performance tests following minor process changes.

2. Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is the Traditional 510(k) Notification (K180086) document itself, which compares the new device to predicate devices and provides results from non-clinical performance testing.

Relevant information from the document:

• Sample size used for the test set and the data provenance: Not explicitly stated as this is a technical verification, not a clinical study. The performance tests would have been conducted on a sufficient number of device samples to ensure design verification and validation, according to internal company procedures and relevant standards.
• Number of experts and qualifications, and adjudication method: Not applicable as this is a device clearance based on engineering and design comparison, not subjective expert assessment of diagnostic output.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, etc.: No, this is not an AI/diagnostic imaging device, and such a study was not performed or required for this type of 510(k) submission.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the performance tests, the "ground truth" would be the established engineering specifications and safety limits for the device. For example, for "Balloon Burst Testing," the ground truth is a specific pressure at which the balloon must not burst, or a specific range. For "Dimensional Measurements," the ground truth is the specified dimensions.
• The sample size for the training set: Not applicable as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Specific Performance Tests Conducted (following minor process changes leading to improved balloon visualization):

The manufacturer conducted the following performance tests to demonstrate continued safety and effectiveness after minor process changes:

• Visual Inspection
• Dimensional Measurements
• Tensile Testing
• Fatigue Testing
• Luer Gauging Test
• Balloon Working Length
• Tip Stiffness Testing
• Compliance Testing
• Balloon Burst Testing
• Balloon Insertion Force Testing
• Balloon Retrieval Force Testing
• Balloon Friction Testing
• Balloon Deflation Testing
• Balloon Endoscope Compatibility Testing

The successful completion of these tests, along with the detailed comparison tables showing similarities in design features, intended use, and technological characteristics to the predicate devices, collectively serve as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence to its predicates.

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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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