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Foundation DRS+ Solo is indicated for the management of wounds including:

• · Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• · Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• · First dearee burns
• · Partial thickness burns (superficial second-degree burns)
• · Donor sites and other bleeding surface wounds
• · Abrasions
• · Trauma wounds (abrasions, lacerations, skin tears)
• · Dehisced wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)

Foundation DRS+ Solo may be cut to size.

Foundation DRS+ Solo is a conformable, advanced wound care device that consists of a porous matrix of chitosan derived from shellfish, sodium chondroitin sulfate, a glycosaminoglycan, and hyaluronic acid. The chitosan- glycosaminoglycan- hyaluronic acid biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.

The provided document is a 510(k) summary for the Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo. It details that this device is substantially equivalent to a previously cleared predicate device, Foundation DRS+ Duo (K240298), with the primary difference being the absence of a backing layer. It also leverages information from a secondary predicate, Foundation Dermal Regeneration Scaffold (DRS) Solo (K231937), which also lacks a backing layer but has a different matrix formulation.

The document states that clinical testing was not necessary to demonstrate substantial equivalence. This means there was no multi-reader multi-case (MRMC) comparative effectiveness study, nor a standalone performance study in the traditional sense of evaluating an algorithm's performance against a clinical ground truth.

Therefore, the acceptance criteria and study that proves the device meets them are focused on non-clinical performance characteristics rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-clinical submission, the "acceptance criteria" are related to physical and biological properties. The document mentions that the tests performed "indicate that the Foundation DRS+ Solo is substantially equivalent to the predicate devices." This implies that the results of the performed tests met pre-defined internal acceptance criteria for substantial equivalence to the predicates.

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

• The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for hydration or dimensional stability). Regulatory submissions often state compliance with standards, which implicitly defines aspects of sample sizes.
• Data Provenance: The data is generated from laboratory testing of the device itself and leveraged from previous FDA clearances (K240298 and K231937). The country of origin for the data is not explicitly stated, but it's likely linked to the manufacturer's R&D/testing facilities. The testing is prospective in the sense that it was performed specifically for this 510(k) submission, or leveraged from previous submissions.

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

• This question is not applicable in the context of this 510(k) submission. "Ground truth" in this context refers to the defined acceptable ranges and standards for material properties and biological responses, which are established by industry standards (e.g., ISO, ASTM, USP) and regulatory guidance, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set:

• This is not applicable as there is no human interpretation of data requiring adjudication for clinical endpoints. The "adjudication" is essentially confirming that the test results meet the specified acceptance criteria of the relevant standards.

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

• No. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence." Therefore, no MRMC study was performed.

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

• No. This device is a medical product (dermal scaffold), not a software or AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The closest equivalent is the standalone performance of the physical device in meeting its non-clinical specifications.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests is established by validated test methods, industry standards (e.g., ISO, ASTM), and predetermined specifications for material properties, sterility, packaging integrity, and biocompatibility. It's not based on expert consensus, pathology, or outcomes data related to human clinical performance.

8. The Sample Size for the Training Set:

• This question is not applicable as this is not an AI/ML device requiring a training set.

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

• This question is not applicable as this is not an AI/ML device requiring a training set.

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Foundation DRS+ Duo is indicated for the management of wounds including:

• · Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Diabetic ulcers
• · First degree burns
• · Partial thickness burns (superficial second-degree burns)
• · Donor sites and other bleeding surface wounds
• · Abrasions
• · Trauma wounds (abrasions, lacerations, skin tears)
• · Dehisced wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)

Foundation DRS+ Duo may be cut to size.

Foundation DRS+ Duo is a conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish, sodium chondroitin sulfate, a glycosaminoglycan, and hyaluronic acid. The chitosan- glycosaminoglycan- hyaluronic acid biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades. The Foundation DRS+ Duo has a semipermeable polyurethane backing layer (offered with or without perforations) providing a flexible covering for the wound surface.

This document is an FDA 510(k) clearance letter for a medical device called "Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo." It does not contain information about an AI/ML-driven medical device, hence it does not provide details on acceptance criteria or studies related to AI/ML performance.

The document discusses the substantial equivalence of the DRS+ Duo device to a predicate device based on:

1. Biocompatibility Testing: Conducted according to ISO 10093-1:2018, evaluating cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, bacterial reverse mutation, genotoxicity (Mouse Lymphoma Assay), systemic toxicity study, implantation studies (ISO 10993-6), and bacterial endotoxins.
2. Performance Testing: Assessed through additional endpoints within the Implantation (ISO 10993-6) model, functionality testing on aged devices (hydration, dimensional stability, handling characteristics) with saline and autologous body fluids.
3. Animal Testing: 14, 28, 42, and 91-day implantation studies in a porcine wound healing model on full thickness dermal wounds. These evaluated wound healing characteristics, dynamics, biological response, and residence time.
4. Sterilization and Packaging Validation: Leveraged from previous clearances (K210949 and K231937), performed per ISO 14937, ISO 10993-7, ANSI/AAMI/ISO 11607-1, ASTM D4169, ASTM F2096, and ASTM F88. Viral inactivation was also leveraged.

Conclusion stated: "Clinical testing was not necessary to demonstrate substantial equivalence." This means that the device's clearance was based on non-clinical data as described above, not on a study proving human reader improvement with AI assistance (MRMC) or standalone algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device per the prompt's outlined points (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and training set ground truth establishment), as this document does not pertain to an AI/ML medical device.

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Foundation DRS Solo is indicated for the management of wounds including:

• · Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Diabetic ulcers
• · Partial thickness burns (superficial second-degree burns)
• Donor sites and other bleeding surface wounds
• · Abrasions
• · Trauma wounds (abrasions, lacerations, skin tears)
• Dehisced wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)

Foundation DRS Solo may be cut to size.

Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.

The provided text is a 510(k) summary for the Foundation Dermal Regeneration Scaffold (DRS) Solo. This document describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document states, "Clinical testing was not required for the labeling update to include moistening of the device by autologous bodily fluids, in addition to saline." This immediately indicates that no clinical study was conducted to prove the device meets acceptance criteria related to its clinical performance for the specific change being submitted (the labeling update).

Therefore, I cannot provide information for all the requested points, as no clinical study was performed for this 510(k) submission. The provided information focuses on non-clinical testing performed to support the substantial equivalence claim.

Here's what can be extracted from the document regarding acceptance criteria and non-clinical testing, as well as the points that cannot be answered due to the absence of a clinical study:

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The submission is for a labeling update to an existing device (Foundation DRS Solo, cleared under K210949). The primary focus of the provided document is to demonstrate that this labeling change (allowing moistening with autologous body fluids in addition to saline) does not raise new questions of safety or effectiveness. As such, no new clinical study was required or performed for this specific submission to prove clinical acceptance criteria are met. The document leverages existing data from the predicate device and conducts focused non-clinical tests to address the change.

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

Since no clinical study was performed for this submission, there are no clinical acceptance criteria or performance metrics reported in the typical sense for a clinical trial. The acceptance criteria and performance reported are for non-clinical tests and are aimed at demonstrating that the label change does not negatively impact the device's fundamental characteristics or safety.

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

• Non-Clinical Tests (Hydration, Dimensional Stability, Handling Characteristics): The document states these tests were performed but does not explicitly mention the sample size or exact provenance. These would be laboratory tests, typically conducted prospectively.
• Leveraged Tests (Biocompatibility, Sterilization, Packaging, Performance): These were leveraged from the primary predicate device (K210949). Specific sample sizes and provenance for these original tests are not detailed in this 510(k) summary. These would also be laboratory or animal studies, conducted prospectively.

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, as no clinical study with human readers/experts establishing ground truth was performed for this submission. The ground truth for non-clinical tests is based on established scientific methods and standards.

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

Not applicable, as no clinical study requiring human interpretation and adjudication was performed for this submission.

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

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This device is a medical product (dermal scaffold), not an algorithm.

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

• For the non-clinical tests (hydration, dimensional stability, handling), the ground truth is based on physical and chemical measurements against defined specifications and industry standards.
• For the leveraged biocompatibility, sterilization, and packaging tests, the ground truth is established through adherence to the specified ISO/ASTM standards and methods.
• For the leveraged performance tests (e.g., wound healing in porcine model), the ground truth would be based on physiological observations and measurements in the animal model.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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Foundation DRS Solo is indicated for the management of wounds including:

• · Full thickness and partial thickness wounds
• Pressure ulcers
• Venous ulcers
• · Ulcers caused by mixed vascular etiologies
• · Diabetic ulcers
• · First degree burns
• · Partial thickness burns (superficial second-degree burns)
• · Donor sites and other bleeding surface wounds
• · Abrasions
• · Trauma wounds (abrations, lacerations, skin tears)
• · Dehisced wounds
• · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)

Foundation DRS Solo may be cut to size.

Foundation DRS Solo is a highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. The chitosan- glycosaminoglycan biodegradable, porous matrix provides a scaffold for cellular invasion and capillary growth. The device is applied on the surface of the wound, and provides a moist wound environment. The dressing may be replaced or may remain in place, acting as a scaffold to promote cellular infiltration and capillary growth as the dressing degrades.

This document, a 510(k) Premarket Notification summary for the Foundation Dermal Regeneration Scaffold (DRS) Solo, does not describe an AI/ML powered medical device or a study involving human readers and AI assistance for diagnostic purposes.

Instead, this document pertains to a medical device that is a dermal regeneration scaffold for wound management. The "acceptance criteria" discussed are related to the safety and performance of this physical wound dressing, not the accuracy or performance of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the device described in the provided text.

The "Summary of Nonclinical Testing" section (page 4-5) lists the studies conducted to demonstrate the safety and performance of the Foundation DRS Solo. These include biocompatibility tests, bacterial endotoxins testing, chemical characterization, sterilization validation, packaging validation, and a Wound Healing Study in a Porcine Model. The document states that "All tests found the device to meet study endpoints and meet acceptance criteria," but it does not specify what those exact acceptance criteria were for each test.

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The Foundation™ 3D Interbody Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation™ 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Foundation™ 3D Interbody Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Foundation™ 3D Interbody Cervical Series Interbody System is an additively manufactured implant comprising of cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The cervical line has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to help optimize implant fit.

The Foundation™ 3D Interbody Lumbar Series Interbody System is an additively manufactured implant comprising of lumbar interbody spacers. They are designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lumbar lines feature a wide variety of lordosis and footprint options with fully porous architectures and varying pore sizes to offer increased room for bone growth with mechanical stability.

The Foundation™ 3D series of intervertebral body fusion devices are made from the titanium alloy Ti-6AL-4V ELI conforming to the ASTM F-136 specifications.

This document is a marketing clearance (510(k)) for a medical device, specifically an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to previously cleared devices based on mechanical and material testing, rather than clinical performance or AI algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for AI algorithms, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI training/testing cannot be extracted from this document. This document describes engineering performance tests, not clinical or AI performance studies.

Here's what can be extracted related to the device and its testing:

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

The document lists performance tests conducted, but does not provide specific numerical acceptance criteria or the quantitative results of these tests. It only states that the results "show that the strength of the Foundation™ 3D Interbody is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Regarding the other points, the document does not contain the required information:

• 2. Sample sized used for the test set and the data provenance: Not applicable for mechanical/material testing.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not an AI/software device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this refers to physical/mechanical properties, not diagnostic accuracy.
• 8. The sample size for the training set: Not applicable (no AI training involved).
• 9. How the ground truth for the training set was established: Not applicable (no AI training involved).

In summary, this document is a 510(k) clearance for a physical medical implant, not an AI-powered diagnostic device, and therefore does not contain information about AI acceptance criteria, clinical study designs for AI, or ground truth establishment for patient data. The "performance data" section refers to mechanical engineering tests demonstrating the device's physical strength and equivalence to predicate devices, not its diagnostic or clinical efficacy in a patient population aided by an algorithm.

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Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical some with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by pairent history and radies. Foundation™ Cervical implants are used to facilitate interverebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment. prior to treatment with an intervertebral cage

The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Foundation™ Interbody Devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the graft donation site. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).
The changes to the Foundation™ Interbody Devices cleared in K0733440 and included in this Special 510(k) are:
• Removal of specific surgical approaches for the lumbar devices
• Addition of additional sizes and configurations

The provided text is a 510(k) premarket notification for the "Foundation™ Interbody Devices." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information (like specific performance acceptance criteria, test set details, expert ground truth adjudication, MRMC studies, and standalone algorithm performance) is not applicable or available in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy, as it is a 510(k) submission for a physical medical device (an intervertebral body fusion device). The "performance" being evaluated here is primarily related to mechanical safety, materials, and functional equivalence to existing devices.

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

• Test Set Sample Size: Not applicable. No clinical test set involving patients or data for measuring diagnostic/clinical performance was used in this 510(k) summary. The "test set" for this device's evaluation primarily consisted of engineering analyses (Finite Element Analysis) and material characterization.
• Data Provenance: Not applicable. The evaluations were non-clinical, involving engineering simulations and material specifications.

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

• Not applicable. As no clinical data or diagnostic performance was being evaluated, there was no need for expert ground truth establishment in this context. The "ground truth" for material properties and mechanical performance would be based on established engineering standards and material science data.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication method was employed as there was no clinical test set requiring interpretation or consensus on outcomes.

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

• No, an MRMC study was not done. This evaluation is for a physical orthopedic implant, not an AI or diagnostic imaging device that would typically undergo MRMC studies.

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

• Not applicable. This device is a physical implant and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is implicitly based on engineering standards, material specifications (ASTM F2026, ASTM F560), and the established performance and safety profiles of the predicate devices. The device's substantial equivalence is a regulatory judgment based on these data points, not on clinical outcomes or pathology.

8. The Sample Size for the Training Set

• Not applicable. No machine learning algorithm or AI was involved, so there was no "training set."

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

• Not applicable. As there was no training set, no ground truth needed to be established for it.

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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis; .
• avascular necrosis of the femoral condyle; .
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities; .
• treatment of fractures that are unmanageable using other techniques. .
  This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for cemented applications.

The change that is the subject of this 510(k) is to add a coating of Titanium Nitride (TiNbN) to the entire surface of the above listed femoral components. Additionally, the porous coating has been removed from the Foundation Knee Femoral Component. There is no change to the fundamental scientific technology of the referenced knee systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.

The provided document is a 510(k) summary for a medical device modification, specifically adding a Titanium Nitride (TiNbN) coating to existing femoral components of the Foundation® Knee System. This type of submission focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical testing, rather than establishing efficacy or accuracy through clinical studies.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC effectiveness studies is not applicable to this document.

Here's why and a summary of what the document does provide:

• Device Type: This is a knee joint prosthesis, a mechanical implant. The evaluation for such devices often relies heavily on biomechanical testing, material characterization, and manufacturing process validation rather than AI performance metrics.
• 510(k) Purpose: The 510(k) submission seeks to clear a modification (adding a coating) to already cleared devices. The primary goal is to show that the modified device is "substantially equivalent" to predicate devices, meaning it is as safe and effective. This is typically achieved through non-clinical bench testing rather than clinical trials involving human subjects, especially for material changes.
• "Clinical Testing: None provided": The document explicitly states "Clinical Testing: None provided," confirming that no human clinical trials were conducted to evaluate this specific modification.

Summary of Information from the Document (Addressing the spirit of the request where applicable):

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

• Not Applicable. This document does not present acceptance criteria or reported device performance in the context of diagnostic accuracy, sensitivity, or specificity, as it's not a diagnostic AI device. Instead, it lists non-clinical tests performed to demonstrate safety and performance of the material modification.
• Non-Clinical Tests Performed:
  • Accute System Toxicity Study
  • Bone Implantation Study
  • Cytotoxicity Study
  • GC/MS Fingerprint Study
  • Irritation Study
  • 28 Day Muscle Implantation Study
  • 90 Day Muscle Implantation Study
  • Sensitisation Study
  • Coating Chemical Composition
  • Coating Thickness
  • Coating Hardness
  • Adhesion Strength
  • Roughness
  • Wear Resistance
• The document implies that these non-clinical tests were successful in demonstrating substantial equivalence, but specific pass/fail criteria or quantitative results are not detailed in this summary.

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. No human test sets or patient data were used for this 510(k) submission, as "Clinical Testing: None provided." The sample sizes for the non-clinical tests (e.g., number of test specimens for wear, number of animals for toxicity/implantation) are not specified in this summary.

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

• Not Applicable. No clinical test set or ground truth in the context of diagnostic performance was established for this submission.

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

• Not Applicable. No clinical test set or adjudication was performed.

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

• Not Applicable. This is a mechanical implant, not an AI software device. No MRMC study was conducted.

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

• Not Applicable. This is a mechanical implant, not an AI algorithm.

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

• Not Applicable. The "ground truth" for this device's safety and performance comes from the established scientific understanding of biomaterials and biomechanics, as validated by the non-clinical tests listed.

8. The sample size for the training set

• Not Applicable. No training set was used, as this is not an AI/machine learning device.

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

• Not Applicable. No training set or associated ground truth was established.

In summary: The provided document is a regulatory submission for a material modification to existing knee prostheses. Its focus is on non-clinical substantiation of equivalent safety and performance, not on clinical performance metrics typically associated with AI or diagnostic devices.

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The Foundation Spinal System is intended for thoracolumbar (T4-L4) anterolateral screw fixation and posterior, non-cervical (T1-S1) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

The Foundation Spinal System consists of rods, hooks, staple plates, monoaxial and multiaxial screws with set screws and crosslinks with fastening set screws. Rods are available either straight or pre-contoured in a variety of lengths. Hooks and staple plates are offered in a variety of sizes. Solid and cannulated screws are available in standard and reduction versions in a variety of diameter-length combinations to accommodate differing patient anatomy.

The provided text describes the "Foundation Spinal System," a spinal fixation system, and its FDA 510(k) summary. For devices seeking 510(k) clearance, the primary acceptance criterion is substantial equivalence to a predicate device, rather than explicit performance metrics against predefined thresholds. The "study" that proves this acceptance is a comparison of technological characteristics and mechanical performance testing.

Here's a breakdown of the requested information based on the provided text:

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

2. Sample size used for the test set and the data provenance
The document describes mechanical testing of device constructs, not a clinical study with patients. Therefore, the concept of a "patient sample size" or "data provenance" (country of origin, retrospective/prospective) in the traditional clinical sense does not apply here. The "test set" would refer to the number of device constructs tested. The specific number of constructs tested for static and dynamic compression bending and torsion is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. "Ground truth" established by experts typically pertains to clinical diagnostic devices where expert interpretation is compared to an algorithm's output. For a spinal fixation system undergoing mechanical testing, the "truth" is determined by established engineering standards (ASTM F1717) and physical measurements of strength and durability.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when multiple readers interpret data to establish a consensus "ground truth." For mechanical tests, the results are quantitative and objective, based on physical measurements against engineering 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. An MRMC study is relevant for diagnostic imaging devices involving human readers and AI assistance. This document describes a spinal implant, which does not involve human readers or AI in its primary performance assessment for 510(k) clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical spinal implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical performance data, the "ground truth" is based on established engineering standards (ASTM F1717) and the measured physical properties of the tested constructs. The comparison is made against the performance of predicate devices as determined by similar mechanical testing.

8. The sample size for the training set
This question is not applicable as this is not an AI/machine learning device.

9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/machine learning device.

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The FOUNDATION device is a collagen-based bone filling augmentation material for use in filling of extraction sockets.

The FOUNDATION bone filler device is a sponge-like absorbable natural collagen plug designed to be used as indicated. FOUNDATION consists of approximately 85-95% Type I collagen and approximately 5-15% Type III collagen from bovine dermis.

The provided text is a 510(k) summary for the FOUNDATION device, a collagen-based bone filling augmentation material. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing performance data against specific acceptance criteria for a new device.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information about standalone algorithm performance (as this is a medical device, not an AI/algorithm-based one).
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The core of this submission is to show that the new FOUNDATION device is substantially equivalent to an existing FOUNDATION predicate device, with the primary difference being the country source for the bovine raw material. The submission asserts that "Appropriate controls and validations assure there is no effect on the safety, performance, and thus substantial equivalence of the new FOUNDATION compared to the predicate." This implies that the performance expectations are met by demonstrating the raw material change does not alter the established safety and performance of the predicate device, rather than through new performance metrics against specific criteria.

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Foundation Dental Resin is used to fabricate teeth and gums that are intended for use as removable full and partial dentures as well as occlusal splints and night guards. This dental resin material is used by dental professionals including dentists and dental technicians. They can be used to make various sizes, shapes, and color shades for anterior and posterior preformed plastic teeth. We are applying an approval as dental resin material as well as preformed product using this material.

Foundation Dental Resin is intended for use by a qualified/trained dentists or dental laboratory technicians on dental plates for dentures (false teeth), temporary crowns, artificial teeth and orthodontic devices.

Foundation Dental Resin material is a thermoplastic resin that is used to fabricate dental prosthesis. The resin is used in an injection molding or pressing device to fabricate the prostheses. Foundation Dental Resin, which is characterized by the fact that the principal component is a copolymer polypropylene.

This is a 510(k) summary for a dental resin material, Foundation Dental Resin, seeking approval from the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (Cosmetic Dental Materials, Inc.'s DuraFlex (K063626)) rather than presenting a study for meeting specific acceptance criteria for a novel device. Therefore, much of the requested information about device performance against acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving novel device efficacy, is not present in this type of submission.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of specific quantitative acceptance criteria with corresponding performance data. Instead, it states that "Extensive testing has been performed on the Foundation Dental Resin to demonstrate compliance with the following EN ISO standards" and mentions biocompatibility tests. The general statement is that the product is "as safe and effective as the predicate device."

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

• Sample Size for Test Set: Not specified. The document mentions "Extensive testing" and "animal testing results" but does not provide numbers for subjects or samples tested.
• Data Provenance: Not explicitly stated but implies laboratory testing for biocompatibility and physical properties. It does not mention clinical trials with human subjects. The anecdotal study regarding allergic reactions does not specify its provenance.

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

Not applicable/Not mentioned. This information is typically relevant for studies involving diagnostic or prognostic devices where expert consensus defines ground truth. For a material science device like dental resin, ground truth is established through adherence to material standards and laboratory tests.

4. Adjudication method for the test set:

Not applicable/Not mentioned. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among experts when establishing ground truth, typically in image-based diagnostic studies. This is not relevant for the type of testing described for a dental resin material.

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

Not applicable. This device is a dental resin material, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the impact of AI on human reader performance.

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

Not applicable. As stated above, this is a material science device, not an algorithm.

7. The type of ground truth used:

For the performance and safety testing, the "ground truth" is adherence to established EN ISO standards for biocompatibility and material properties. For the claim of "no allergic reactions," it relies on an "anecdotal study," which is weaker than controlled clinical data.

8. The sample size for the training set:

Not applicable/Not mentioned. Training sets are relevant for machine learning algorithms. This document describes a physical material, not an algorithm that requires training.

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

Not applicable. See point 8.

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