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The "BioGend" Interbody Fusion System 001 Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment with an intervertebral cage. "BioGend" Interbody Fusion System 001 Cage is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine

"BioGend" Interbody Fusion System 001 Cage is designed to be inserted into the intervertebral body space of the spine as an adjunct to fusion. "BioGend"Interbody Fusion System 001 Cage consists of lumbar cages which are available in various heights and lengths to fit the patient's anatomical and physiological requirements. The superior and inferior surfaces of the "BioGend" cages have teeth to help prevent implant dislodgement or expulsion once placed in the desired location. The cages are made of polyetheretherketone (PEEK) which complies with ASTM F2026, and the radiographic markers incorporated into the cages are made of titanium alloy (Ti-6Al-4V ELI) conforming to ISO 5832-3 and ASTM F136. The cages are supplied sterile and intended for single use only. All implants should not be reused under any circumstances.

This document is a 510(k) summary for a medical device called the "BioGend" Interbody Fusion System 001 Cage. It is used for spinal fusion procedures. This summary focuses on non-clinical performance testing rather than AI/software performance. Therefore, most of the requested information regarding AI/software acceptance criteria and studies is not applicable or cannot be extracted from this document.

However, I can provide information relevant to the non-clinical acceptance criteria and the study that proves the device meets them, as described in the document.

Acceptance Criteria and Device Performance (Non-Clinical)

The document primarily discusses non-clinical testing for equivalence to a predicate device.

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

   Test Performed	Acceptance Criteria (Stated)	Reported Device Performance
   Sterilization verification	Not explicitly detailed beyond "Sterilization verification" and "The cages are supplied sterile". Implies compliance with relevant standards to ensure sterility.	"All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Specific data not provided in this summary.)
   Shelf life	Not explicitly detailed beyond "Shelf life". Implies compliance with relevant standards to ensure the device remains safe and effective for its designated shelf life.	"All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Specific data not provided in this summary.)
   Biocompatibility	Not explicitly detailed beyond "Biocompatibility". Implies compliance with ISO 10993 series and other relevant standards to ensure the materials are safe for use in the human body.	"All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Specific data not provided in this summary.)
   Performance Testing	Compliance with:

• ASTM F2077-22 (Standard Test Methods for Intervertebral Body Fusion Devices)
• ASTM F2267-22 (Standard F2267, Standard Test Method for Measuring the Load Bearing Response of a Spinal Implant When Subjected to a Static Compressive Force. Note: The document states 2267-22, which is for compressive load, but the test listed is "static compression-shear test" which typically aligns with F2077-22, and F2267 is specifically for static compression.
• FDA guidance "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device".

Specific tests mentioned include:

• Static and dynamic axial compression test
• Static compression-shear test
• Compressive Subsidence test
• Static and dynamic torsional test
• Expulsion test

Overall Acceptance: The subject device must meet the requirements of its pre-defined acceptance criteria and intended use, and be substantially equivalent to the predicate device. For dimensions, while similar, the device "meets the requirements," implying it is within acceptable ranges for function. | "All test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." (Specific numerical data from the tests are not included in this summary, only the statement of compliance.) For dimensions, it is stated that even with slight differences, "The performance of the subject device is not affected and meets the requirements. Thus, it would not affect the equivalence." |

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

   • Sample Size: Not specified in this 510(k) summary. The summary refers to a "series of tests," but does not quantify the number of devices or observations per test.
   • Data Provenance: The tests are non-clinical, likely conducted in a controlled laboratory environment. The submitting company is BioGend Therapeutics Co., Ltd., located in Taipei, Taiwan. The document does not specify the country of origin of the raw data beyond the submitter's location. The data is retrospective in the sense that it was collected prior to submission for FDA review.

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 question is not applicable to this document. The "ground truth" here is established through mechanical and material testing standards (ASTM, ISO), rather than clinical expert interpretation or labeling of images. The device is a physical interbody fusion cage, not an AI or software device that interprets medical images.

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

   • This question is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for AI/software, to resolve discrepancies in expert interpretation of clinical data. This document describes non-clinical engineering/materials testing where results are quantitative and compared against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This question is not applicable to this document. This device is a physical implant, not an AI-assisted diagnostic or treatment planning software. No clinical studies, MRMC or otherwise, were conducted or referenced for this 510(k) submission.

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

   • This question is not applicable to this document. This is not an algorithm or software device. Bench testing was done on the physical device itself.

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

   • The "ground truth" for the non-clinical testing is compliance with established international and FDA-recognized mechanical testing standards (e.g., ASTM F2077-22, ASTM F2267-22) and biomaterial standards (e.g., ASTM F2026 for PEEK, ISO 5832-3 and ASTM F136 for Ti-6Al-4V ELI). These standards define the performance requirements and test methods for such devices.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

   • Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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Agilon Strip is indicated for use in voids or gaps of the skeletal system. i.e., the extremities, pelvis, and posteroateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. Agilon Strip may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Strip resorbs and is replaced with bone during the healing process.

Agilon Strip is a flexible, resorbable, wicking, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules bound by type I collagen fibers to facilitate shaping and containment of the implant. The osteoSPAN granules in Agilon Strip are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate, with a thin laver of calcium phosphate throughout its entire porosity.

The provided text describes a 510(k) premarket notification for a medical device called "Agilon Strip," a resorbable calcium salt bone void filler. The submission aims to demonstrate substantial equivalence to a predicate device, Morpheus (K142828).

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity. Instead, the document focuses on demonstrating substantial equivalence through:

• Comparison of technological characteristics: Comparing the composition and properties of Agilon Strip to the predicate.
• Bench testing: Verifying that the addition of collagen does not affect granule chemistry, crystallinity, porosity, pore diameter, and pore interconnectivity, along with sterilization and shelf-life studies.
• Biocompatibility testing: Following ISO 10993-1 for biological effects such as cytotoxicity, sensitization, systemic toxicity, genotoxicity, and implantation.
• In vivo testing: Using critically sized defect models and a clinically relevant spinal fusion model to assess bone formation, resorption, remodeling, and fusion rates compared to the predicate and controls.

The "Performance Data" section discusses various tests and their outcomes but does not specify quantitative acceptance criteria for these tests (e.g., "fusion rate must be X% or higher"). The conclusion is based on the device being "substantially equivalent" to the predicate, implying that its performance in these tests was comparable and acceptable, but no explicit thresholds are provided.

Therefore, I cannot populate the requested table and details as the necessary information (explicit acceptance criteria, detailed quantitative performance metrics against those criteria, data provenance, expert qualifications for ground truth, sample sizes for test/training sets with detailed ground truth establishment methods, MRMC studies, or standalone algorithm performance) is not present in the provided text.

The document is a regulatory submission for a bone void filler, not an AI/ML device that would typically have performance metrics like sensitivity, specificity, or accuracy, which necessitate the kind of detailed study design outlined in the prompt (e.g., multi-reader multi-case studies, expert adjudication for ground truth).

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Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.

Agilon Moldable collagen enhanced bone graft substitute is a moldable, resorbable osteoconductive bone void filler composed of 1-2mm osteoSPAN granules suspended in a biocompatible orqanic binder to facilitate implant mixing, shaping, and containment. The osteoSPAN granules in the product are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate, with a thin layer of calcium phosphate throuqhout its entire porosity. The orqanic binder is a combination of a biocompatible polymer and type I collagen fibers to provide enhanced intraoperative handling. The polymer is rapidly absorbed in-situ, leaving behind osteoSPAN granules and collagen fibers as an osteoconductive scaffold.

The provided text describes a 510(k) submission for the Agilon Moldable device. This document is a premarket notification to the FDA, asserting substantial equivalence to a predicate device. It primarily focuses on the device's characteristics, indications for use, and a summary of performance data rather than a detailed study protocol for acceptance criteria.

The information necessary to fully answer all parts of your request (especially concerning specific acceptance criteria and detailed study designs for proving those criteria) is not comprehensively present in this type of FDA letter. However, I can extract the available information and indicate where details are missing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA letter and associated documents for a 510(k) submission typically don't explicitly list "acceptance criteria" in a table format with numerical targets. Instead, the demonstration of substantial equivalence is based on comparing the subject device's characteristics and performance to a legally marketed predicate device. The performance data presented focuses on equivalence to a predicate device and positive control rather than predefined numerical thresholds for the new device.

From the text, the key performance indicator mentioned is "Fusion rates."

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

• Test set sample size: Not explicitly stated. The study involved multiple time points and comparisons between Agilon Moldable, a predicate device (Morpheus), and a positive control (autograft) in an in vivo animal model. However, the exact number of subjects or samples per group is not provided in this summary.
• Data provenance: Prospective in vivo animal testing in a validated, clinically relevant, single-level posterolateral spinal fusion model. The country of origin of the data is not specified, but the submission is to the U.S. FDA.

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

Not explicitly stated. The ground truth would likely be established by trained veterinary histopathologists and radiologists/imaging specialists for the animal study. The exact number and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not explicitly stated. For animal studies, evaluation usually involves standardized scoring by expert histopathologists for histology and morphometry, and radiologists for x-ray and micro-CT. Whether these involve independent assessment or consensus is not mentioned.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a bone void filler, a physical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI is irrelevant to this device.

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

Not applicable. As noted above, this is a physical implant, not an algorithm.

7. The type of ground truth used

The ground truth for the in vivo study included:

• Mechanical analysis: Objective quantitative assessments of bone strength/fusion.
• Histology and Histomorphometry: Microscopic examination and quantitative measurements of tissue samples, evaluating new bone formation, tissue integration, and implant resorption.
• X-ray and Micro-CT analyses: Imaging techniques to assess fusion status, bone volume, and structural characteristics.
• Observation of adverse reactions: Clinical and pathological assessment for any negative responses to the implant.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a distinct "training set." The in vivo study involved a test set.

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

Not applicable, as there is no training set for this type of device. The ground truth for the in vivo performance study was established through the various analyses mentioned in point 7.

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BIOGENNIX Morpheus-C is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

Morpheus-C is a moldable, resorbable osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a biocompatible organic binder to facilitate shaping and containment of the implant. The osteoSPAN granules in Morpheus-C are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate with a thin laver of calcium phosphate throughout its entire porosity. The organic binder in Morpheus-C is a combination of a biocompatible polymer and type I collagen fibers. The polymer is rapidly absorbed in-situ, leaving behind osteoSPAN granules and collagen fibers as an osteoconductive scaffold. The collagen in Morpheus-C provides improved intraoperative handling.

The provided document is a 510(k) premarket notification for a medical device called Morpheus-C, a resorbable calcium salt bone void filler. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way one might for an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance measures, and ground truth establishment cannot be found or inferred from this document.

This document describes a traditional medical device (a bone void filler) where performance is typically assessed through:

• Biocompatibility testing: As detailed in Section VII, "Biocompatibility evaluation of Morpheus-C was conducted in accordance with 'Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.'" This included tests for cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, and implantation.
• In vivo testing: "In vivo testing of Morpheus-C was conducted using a critically sized defect model. Device performance was evaluated at multiple time points against the primary predicate and negative controls using histology, histomorphometry, x-ray, and micro-CT analyses."
• Bench testing: "Bench testing results for various physical and chemical characteristics of the primary predicate apply to the subject device since the addition of the type I collagen does not affect the granule chemistry, crystallinity, porosity, pore interconnectivity, or density."
• Sterilization validation and shelf-life aging studies.

These tests are designed to show the device is safe and effective for its intended use and performs similarly to legally marketed predicate devices, not to meet "acceptance criteria" in the sense of a machine learning model's performance on a dataset.

In summary, none of the specific information requested in points 1-9 is available in this 510(k) document because it pertains to a different type of device (a physical implant) and a different type of evidentiary standard (substantial equivalence) than what is typically asked for AI/ML devices.

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The Sypher Spacer System is a standalone intervertebral body fusion system for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) at one or two contiguous levels of the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Supplemental fixation is required whenever fewer than 3 bone screws are utilized.

The Sypher Spacer System is a standalone intervertebral body fusion system intended for the lumbar spine. The Sypher Spacer System implants include cylinder shaped blocks manufactured from PEEK-OPTIMA™ LT1 conforming to ASTM F2026, tantalum markers conforming to ASTM F560, titanium alloy self-tapping, self-drilling bone screws conforming to ASTM F136, and titanium alloy cage lock assemblies conforming to ASTM F136.

The implants are available in a variety of footprints. heights, and lordotic angles. The device features a hollow center to accommodate autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone). The implants have integrated anterior screw holes to allow for medial placement of screws, and a titanium alloy cage lock assembly for securing the screws in place. The superior and inferior surfaces of the implant have a pattern of teeth to prevent movement.

This document is a 510(k) summary for the Sypher Spacer System, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and mechanical testing. As such, the document does not contain the detailed information typically found in an AI/ML device submission regarding acceptance criteria, performance studies involving human readers, or detailed ground truth establishment.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Study Details for the Sypher Spacer System

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "Substantial Equivalence is supported by the results of mechanical testing and Finite Element Analysis (FEA)." However, it does not provide the specific acceptance criteria thresholds or the quantitative results from these tests. It only lists the types of tests performed.

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

This information is not provided in the document. The document describes mechanical testing of a medical device (intervertebral spacer), not an AI/ML diagnostic or predictive tool that would utilize a "test set" in the context of data. The mechanical tests would typically involve a certain number of manufactured units, but this sample size is not disclosed.

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

This information is not applicable/provided. The device is a physical implant, and its performance is assessed through mechanical testing against standards, not by an expert review of a "test set" of patient data for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of data, which is not relevant to the mechanical testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable/provided. An MRMC study is relevant for AI-powered diagnostic tools to assess the impact on human reader performance. This document describes a physical medical implant, not an AI system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/provided. The device is a physical intervertebral spacer. It does not have an "algorithm-only" performance as it is not an AI/ML software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering standards and specifications for mechanical properties and biocompatibility, as evidenced by the mention of ASTM standards (e.g., ASTM F2077, ASTM F560, ASTM F136). The device's design also ensures it can accommodate autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) for fusion.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a physical implant and does not involve a "training set" in the context of AI/ML models.

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

This information is not applicable/provided. As above, there is no "training set" for this type of device. The design and manufacturing process would adhere to established quality systems and design controls rather than data-driven ground truth establishment.

Summary of what the document does provide:

• Device Type: Intervertebral body fusion system (Sypher Spacer System).
• Regulatory Status: 510(k) clearance (K181337) based on substantial equivalence.
• Predicate Devices: Biogennix Sypher Spacer System (K141798) as primary, Zimmer Biomet Solitaire (K081395, K081501) and Zimmer Biomet ROI-A® ALIF Cage System (K153495) as reference predicates.
• Performance Study: Mechanical testing including static compression, static shear compression (both per ASTM F2077), expulsion testing (per ASTM Draft Standard F-04.25.02.02), and Finite Element Analysis (FEA).
• Conclusion: The device demonstrated substantial equivalence based on indications for use, technological characteristics, and comparison with predicate devices supported by mechanical testing and FEA.

The provided document is a 510(k) summary for a traditional medical device (implant), not an AI/ML-powered device. Therefore, many of the requested criteria related to AI/ML device validation are not present or applicable.

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The Biogenesis Implant System –Kisses is in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Biogenesis Implant System - Kisses is for single and two stage surgical procedures. It is for delayed loading.

The Biogenesis 110 Implant System - Kisses is a dental implant system made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches. This product is a substructure of a dental implant system to replace a single tooth, partial tooth and the lost root of edentulous patients. It consists of the hex part to be coupled to the superstructure, the single thread part to be fixed to the bone, and the cutting edge part with the self-tapping function.

The Biogenesis™ Implant System offers bone level implants in the size range of 3.8 – 5.5 mm diameter with 7 – 14.5mm length.

The Biogenesis TM Implant System also offers the following components.

• · Duplex Abutment
• Duplex Milling Abutment
• Simplex Abutment
• Temporary Abutment
• · Solid Screw Abutment
• · Ball Abutment
• Ball Cap

The implants are intended for use with straight implant only straight implants are included in the submission.

The provided text is a 510(k) summary for the Biogenesis™ Implant System - Kisses, a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through the kind of studies you describe.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be fully extracted from this document. This kind of detailed study information is typically found in the full submission, not in the public 510(k) summary.

However, I can provide the limited information available regarding non-clinical testing and general acceptance of performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "the test results met the pre-set criteria" for various performance tests. However, it does not explicitly list quantified acceptance criteria or specific numerical reported device performance values. It only confirms conformance.

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

The document does not provide details on:

• Specific sample sizes used for the non-clinical tests (e.g., sterilization, shelf life, biocompatibility).
• Data provenance (e.g., country of origin, retrospective or prospective) for any test sets. Non-clinical studies like these are typically lab-based and not derived from clinical patient data in the same way clinical trials are.

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

This information is not applicable to the non-clinical bench testing described. These tests involve laboratory measurements and standards conformance, not expert assessment of clinical data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to the non-clinical bench testing described.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through comparison of technical characteristics and non-clinical bench testing to predicate devices, not on evaluating human reader performance with or without AI assistance.

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

No, a standalone (algorithm-only) performance study was not mentioned. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference points were established by recognized international and national standards:

• ISO 17665-1/2 and ANSI/AANI ST79 for sterilization validation.
• ASTM F1980 for shelf life testing.
• ISO 10993-1 for biocompatibility testing.
• FDA Guidance Document for Endosseous Dental Implants and Abutments for overall conformance.

These standards define methods and acceptable limits for the performance characteristics being evaluated.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a physical medical device (dental implant), not an AI/ML algorithm that would typically require a training set.

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

This information is not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation to facilitate fusion.

The Sypher Spacer System implants are cylinder shaped blocks made of PEEK Optima® LT1 (Polyether ether ketone per ASTM F2026), with tantalum alloy radiological position markers (per ASTM F560), titanium alloy self-drilling and self-tapping bone screws (per ASTM F136), and titanium alloy cage lock assemblies (per ASTM F136).

The implants are available in a variety of footprints, heights and lordotic angles. The shape of the Sypher product allows for a larger implant (height and width) to be used allowing for more surface area contact. The Sypher Spacer System is offered in a closed graft space design. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium alloy cage lock assembly for securing the screws once in place. Additional or other supplemental fixation may be used, as patient needs dictate. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The Sypher Spacer System is intended to be used with autologous bone graft.

The provided text describes the 510(k) premarket notification for the Sypher Spacer System, an intervertebral body fusion device. While it mentions performance testing, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in the way you've outlined.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Static axial compression bending per ASTM F2077-11
• Static compressive shear per ASTM F2077-11
• Static subsidence per ASTM F2267-04 and ASTM F2077-11
• Dynamic axial compression per ASTM F2077-11
• Dynamic compressive shear per ASTM F2077-11
• Expulsion per ASTM Draft Standard F-04.25.02.02 |
  | Comparative Strength | The device's strength is considered "substantially equivalent to legally marketed predicate devices." |

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

• Sample Size for Test Set: Not specified. The document only mentions that the device "has been tested" in various modes. It refers to "non-clinical testing," which typically means bench testing or cadaver studies, not human clinical trials.
• Data Provenance: The testing is "non-clinical," implying it was conducted in a laboratory setting, likely in the US where the company and consultants are located. It is not clinical data (retrospective or prospective from patients).

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

• Not applicable. This document describes non-clinical, mechanical performance testing of an implantable medical device, not a diagnostic device or a study requiring expert interpretation of results to establish ground truth. The "ground truth" for mechanical testing is typically the adherence of the device's physical properties to engineering standards and comparison to predicate devices, measured by instruments.

4. Adjudication Method for the Test Set

• Not applicable. As this is mechanical testing, there is no "adjudication method" in the sense of expert consensus on clinical or imaging readings. The results are quantitative measurements against established engineering standards.

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

• No. This type of study (MRMC) is typically done for diagnostic devices where human readers interpret images or other data, and the goal is to assess the impact of an AI tool on reader performance. The Sypher Spacer System is an implantable surgical device, not a diagnostic one, and the reported tests are mechanical performance tests.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. The Sypher Spacer System is a physical intervertebral fusion device, not a software algorithm. Its "performance" is its mechanical integrity and ability to facilitate fusion when implanted, which is assessed through bench testing and, eventually, clinical outcomes (though clinical trial data is not presented here, as this is a 510(k) submission based on substantial equivalence to predicates).

7. Type of Ground Truth Used

• For the non-clinical mechanical testing, the "ground truth" is defined by established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices, and comparison to the mechanical properties of legally marketed predicate devices. The goal is to demonstrate that the Sypher Spacer System's mechanical characteristics are equivalent or superior to these benchmarks.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of mechanical performance testing of a physical medical device. Training sets are relevant for machine learning algorithms.

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

• Not applicable. As there is no training set.

In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical (bench) testing, adherence to material standards, and similar indications for use. It does not contain information about clinical trials, diagnostic performance, or AI algorithms, which are the contexts in which many of your questions would typically apply.

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BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.

osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hvdroxvapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder used in osteoSPAN Morpheus facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.

The provided document is limited in scope and only describes the OsteoSPAN Morpheus device and its expanded indication for use. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving the device meets those criteria.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided text.

However, I can extract what is available and indicate what information is missing.

Here's a summary based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through supplementary preclinical performance testing. The reported performance is a qualitative assessment of this equivalence.

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

The document states "Supplementary preclinical performance testing confirmed..." but does not provide details on the sample size for this testing. It only mentions the "posterolateral spine model."

The data provenance is within the context of a 510(k) submission to the FDA, suggesting the data was generated specifically for supporting this regulatory submission. It does not specify the country of origin of the data or whether it was retrospective or prospective.

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

Not applicable/Not provided. The document describes preclinical performance testing in a "posterolateral spine model," implying animal or in-vitro models were used, rather than human data requiring expert ground truth establishment for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As the testing appears to be preclinical performance testing, an adjudication method for human interpretation of results is not relevant or described.

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

No. The document does not mention any MRMC study or any study involving human readers with or without AI assistance. This device is a bone void filler, not an imaging or diagnostic AI device.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical device (bone void filler), not an algorithm or AI. The concept of "standalone performance" for an algorithm does not apply here.

7. Type of Ground Truth Used

For the preclinical performance testing, the "ground truth" would likely be based on:

• Histopathology/Microscopic analysis: To assess bone ingrowth and tissue reaction in the experimental models.
• Mechanical testing standards: For measuring mechanical strength.
• Material analysis techniques: For determining residual material.

However, the specific methods for establishing this "ground truth" are not detailed in the document beyond stating "preclinical performance testing confirmed."

8. Sample Size for the Training Set

Not applicable/Not provided. This device is a physical medical device and does not involve AI or machine learning models that require a "training set."

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

Not applicable/Not provided. (See point 8).

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BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hydroxyapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.

The provided text describes a 510(k) summary for a medical device called osteoSPAN Morpheus, a resorbable calcium salt bone void filler. The submission does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on:

1. Technological characteristics comparison: A table comparing osteoSPAN Morpheus to a primary predicate (osteoSPAN granules) and a material-reference predicate (Actifuse ABX E-Z-fil Putty) across several characteristics (Calcium Salt, Granule Size, Porosity, Polymer Binder, Osteoconductive).
2. Safety and performance testing: "Chemical and physical testing confirmed acceptable findings and were consistent with prior osteoSPAN predicate device qualifications. Biogennix osteoSPAN Morpheus was thoroughly evaluated for biocompatibility in accordance with ISO 10993 appropriate parts and for performance, through multiple non-clinical in-vivo and ex-vivo studies."

Since this is a conventional medical device submission rather than an AI/ML device, the specific questions regarding AI/ML device performance (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.

Therefore, I cannot provide the requested information from the given text.

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