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ACTIFUSE ABX, ACTIFUSE SHAPE and ACTIFUSE MIS:

Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware and intervertebral disc space. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

When used in the intervertebral disc space, Actifuse must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE:

ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). ALTAPORE can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE SHAPE:

ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE SHAPE can be used by itself or with autograft as a bone graft extender in posterolateral spinal fusion procedures. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space. ALTAPORE SHAPE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE MIS: ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE MIS can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE MIS resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE MIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS

Actifuse is a phase-pure, porous, silicate-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse is similar to human cancellous bone. After it is implanted, ACTIFUSE undergoes physiologically-mediated resorption and is replaced by natural bone

ACTIFUSE is osteostimulatory based upon in vitro studies that show cellular responses, such as metabolic activity and proliferation, are accelerated when compared to an identical that did not contain 0.8% silicon by weight..

ACTIFUSE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ACTIFUSE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses.

The Actifuse bone void filler is presented in multiple product variants:

ACTIFUSE ABX

ACTIFUSE ABX presents the ACTIFUSE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable aqueous gel carrier packaged in a wide-bore applicator. ACTIFUSE ABX is a sterile, single-use device available in volumes of 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml.

ACTIFUSE ABX is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood, autologous bone marrow aspirate, or autologous bone at the discretion of the surgeon.

ACTIFUSE MIS

ACTIFUSE MIS System is an ACTIFUSE ABX packaging configuration in which the ACTIFUSE ABX implant material is supplied in a sterile 7.5ml cartridge packed with ACTIFUSE ABX implant material is presented with a delivery applicator and as a separate 7.5ml refill cartridge.

ACTIFUSE SHAPE

ACTIFUSE SHAPE supplies the ACTIFUSE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable Alkylene Oxide co-polymer carrier as a shaped wax-like putty in a sterile pouch. ACTIFUSE SHAPE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ACTIFUSE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

ALTAPORE

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca. P. O. H. Si).

ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available in 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml configurations.

ALTAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE undergoes cell-mediated remodeling and is replaced by natural bone.

ALTAPORE MIS

ALTAPORE MIS System is an ALTAPORE packaging configuration in which the ALTAPORE implant material is supplied in a sterile 7.5ml cartridge is presented with a delivery applicator and as a separate 7.5ml refill cartridge.

ALATAPORE MIS System (hereafter referred to as "Altapore MIS) is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE MIS is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE SHAPE

ALTAPORE SHAPE supplies the ALTAPORE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable Alkylene Oxide co-polymer carrier as a shaped wax-like putty in a sterile pouch. ALTAPORE SHAPE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

ALTAPORE SHAPE is bioactive based on in vitro studies that show it forms a surface apatitelayer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE SHAPE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE SHAPE undergoes cell-mediated remodeling and is replaced by natural bone.

The provided document describes a 510(k) premarket notification for several bone void filler devices (Actifuse ABX, Actifuse MIS, Actifuse Shape; ALTAPORE, ALTAPORE SHAPE; ALTAPORE MIS) by Baxter Healthcare Corporation. The submission aims to expand the indications for use to include intervertebral disc space applications.

Crucially, the document explicitly states that "no additional non-clinical data was needed to support the expanded indications proposed in the current submission" because "the subject device is identical to the previously cleared primary predicate device (K232315)." This means that the current submission relies entirely on the performance data of the predicate device (Catalyst Bone Void Filler, OssDsign AB, K232315) and existing reference devices (Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575; Altapore, Baxter, K192363; Altapore Shape, Baxter, K200640; Altapore MIS, Baxter, K201464).

Therefore, I cannot provide detailed acceptance criteria or study results for the currently submitted devices directly from this document, as no new performance testing specific to this submission's expanded indication for these devices is reported. The information requested below would typically come from the original 510(k) submission for the predicate device (K232315) or the reference devices.

However, I can extract the available information as specifically related to this submission's approach to demonstrating substantial equivalence.

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

As stated above, no new performance data or acceptance criteria are provided in this specific submission for the expanded indications. The submission argues for substantial equivalence based on the device being identical to a predicate (K232315) and similar to reference devices (K082575, K192363, K200640, K201464).

Acceptance Criteria (Implicit via Substantial Equivalence to Predicate): The device is considered to meet acceptance criteria if its technological characteristics, intended use, and performance are substantially equivalent to the cleared predicate and reference devices, implying it is as safe and effective.

Reported Device Performance:
The document describes the characteristics and prior in vitro/in vivo findings of the devices, which would have supported their initial clearances, but does not present new performance test results against new acceptance criteria for the expanded indication.

• ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS:
  • Osteostimulatory: Based on in vitro studies showing accelerated cellular responses (metabolic activity and proliferation) compared to an identical product without 0.8% silicon by weight.
  • Bioactive: Based on in vitro studies showing formation of a surface apatite layer in simulated body fluid.
  • Osteoconductive: Based on in vivo animal studies demonstrating bone healing in a critical defect model, confirmed by radiographic, histopathological, histomorphometric, and mechanical analyses.
• ALTAPORE, ALTAPORE SHAPE, ALTAPORE MIS:
  • Bioactive: Based on in vitro studies showing formation of a surface apatite layer in simulated body fluid.
  • Osteoconductive: Based on in vivo animal studies demonstrating bone healing in a critical defect model, confirmed by radiographic, histopathological, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone.

The remaining points cannot be fully addressed from the provided text for this specific K-submission, as it explicitly states that no additional non-clinical data was needed. This implies that the current submission relies on previous data and FDA's prior determinations of substantial equivalence for the predicate and reference devices.

To answer points 2-9, one would need to access the original 510(k) submissions for:

• Primary Predicate: Catalyst Bone Void Filler, OssDsign AB, K232315
• Reference Devices:
  • Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575
  • Altapore, Baxter, K192363
  • Altapore Shape, Baxter, K200640
  • Altapore MIS, Baxter, K201464

Without those specific predicate/reference 510(k) summaries, I cannot provide the requested details regarding sample sizes, data provenance, ground truth establishment, or specific study methodologies.

Summary based on information provided for the current K241564 submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A: No new test set data was reported as needed for this submission. Reliance on previously cleared predicate (K232315) and reference devices (K082575, K192363, K200640, K201464).

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)
* N/A: No new ground truth establishment reported as needed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* N/A: No new test set reported as needed 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
* N/A: This device is a bone void filler, not an AI/imaging device, so MRMC studies are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* N/A: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A: No new ground truth reported as needed for this submission. However, for the original clearances of the predicate/reference devices, the descriptions mention "radiographic, histopathological, histomorphometric, and mechanical analyses" in animal studies, which serve as forms of ground truth for osteoconductivity.

8. The sample size for the training set
* N/A: This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established
* N/A: Not applicable for a physical medical device.

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ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).

ALTAPORE MIS can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE MIS resorbs and is replaced with bone during the healing process.

Altapore MIS System is a is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicatesubstituted calcium phosphate phase of Altapore is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. Altapore is composed solely of elements that exist naturally in normal bone (Ca. P. O, H. Si).

Altapore MIS System is supplied in a sterile 7.5ml cartridge and contains Altapore microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. Altapore does not set in-situ following implantation.

Altapore MIS System (hereafter referred to as "Altapore MIS) is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

Altapore MIS is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

Altapore MIS is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic. histolopathological, histomorphometric, and mechanical analyses. Altapore MIS undergoes cell-mediated remodeling and is replaced by natural bone.

The provided text is a 510(k) summary for the Altapore MIS system, a medical device intended to fill bony voids. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or human improvement with AI assistance.

Therefore, many of the requested details about acceptance criteria for device performance, clinical study design, and ground truth establishment are not present in this regulatory document.

However, based on the information provided, here's what can be extracted:

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

The document doesn't present a table with specific quantitative acceptance criteria for clinical performance (e.g., bone healing efficacy percentage). Instead, it relies on demonstrating that the modifications to the device (new configurations, materials for applicator and cartridge) do not negatively impact the chemical, structural, and biological properties, and thus maintain the performance of the already cleared predicate devices.

The acceptance criteria are implicitly related to maintaining the performance demonstrated by the predicate devices.

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 refers to "representative samples" for shelf-life testing and performance testing related to chemical changes. It also mentions "in vitro studies" and "in vivo animal studies" for the predicate device, but no specific sample sizes for these are provided within this 510(k) summary for the current device. The document explicitly states "The basis for this premarket notification is the addition of the Altapore MIS System configurations to the Altapore product line." and that the modifications "do not impact the intended use or the fundamental technology." This indicates reliance on existing data from predicate devices rather than new large-scale clinical studies for the new configuration.

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

Not applicable. This is not a study involving expert interpretation of medical images or other diagnostic tests to establish ground truth for a test set. The validation is primarily technical (chemical, physical, sterility, shelf-life) and based on existing data for predicate devices.

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

Not applicable, as no human reader adjudication for clinical interpretation is described.

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 not an AI-assisted diagnostic device, nor does the document describe an MRMC study.

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

Not applicable. This is a medical implant, not an algorithm.

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

For the predicate device (from which the current device draws its equivalence), the document mentions:

• Bioactivity: "based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid..."
• Osteoconductivity: "based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histopathological, histomorphometric, and mechanical analyses."

For the current device modifications, the "ground truth" (or verification) is established through:

• Chemical analysis to confirm no change in chemistry or structure.
• Conformity to ISO standards (e.g., ISO-10993-1, ISO 10993-11, ANSI/AAMI/ISO 11137-2) for biocompatibility and sterility.
• USP for bacterial endotoxin testing.
• Package integrity tests (Visual Inspection, Seal Strength, Bubble Leak).
• Shelf-life testing on "representative samples."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).

ALTAPORE SHAPE can be used by itself or with autograft as a bone graft extender in posterolateral spinal fusion procedures. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE SHAPE resorbs and is replaced with bone during the healing process.

ALTAPORE SHAPE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicatesubstituted calcium phosphate phase of ALTAPORE SHAPE is similar to human cancellous bone and is intended to support bone growth with macro and micro-porosity. The microgranule phase ALTAPORE SHAPE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si).

ALTAPORE SHAPE is supplied as a shaped wax-like putty in a sterile pouch containing ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable Alkylene Oxide co-polymer carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

The provided text describes the 510(k) premarket notification for the Altapore Shape device, which is a resorbable calcium salt bone void filler. The submission focuses on aligning the indications for use of Altapore Shape for posterolateral spinal fusion procedures with a previously cleared predicate device, Altapore (K192363).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results for this submission (K200640). Instead, it relies on the substantial equivalence to previously cleared predicate devices. The key "performance criterion" for this submission is demonstrating that the change in indications (specifically referring to its use in posterolateral spinal fusion as a stand-alone graft) does not alter the safety and effectiveness, leveraging prior studies.

However, the document mentions that for the initial clearance of Altapore Shape (K191513) and Altapore (K192363), various tests were conducted and met acceptance criteria. Based on the provided text, the relevant performance characteristics and implicitly met acceptance criteria are:

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

The document does not specify a distinct "test set" in the context of this 510(k) submission (K200640) for human clinical trials. The submission focuses on leveraging previous substantial equivalence.

• Animal Studies: A preclinical animal study was conducted to evaluate the effectiveness of Altapore (or similar material) for posterolateral spinal fusion. The sample size for this animal study is not specified in the provided text. The data provenance would be prospective (animal study) from wherever the animal studies were conducted (country of origin not specified).

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

This information is not provided in the text. For animal studies, the "ground truth" (e.g., bone healing confirmation) would typically be established by veterinary pathologists or histomorphometrists.

4. Adjudication Method

This information is not provided in the text. For animal studies, typically, the assessment of outcomes (e.g., histopathology, radiological findings) is performed by qualified individuals, but a formal "adjudication method" like 2+1 or 3+1 among experts is usually not described in such summaries unless there's a specific need for it in complex interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied in the provided text. This type of study is more common for diagnostic AI devices, not directly for a bone void filler material itself, especially in a 510(k) submission focused on material equivalence and a slight indication expansion based on prior animal data.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done through the preclinical animal study and the in vitro studies.

• In vitro studies: Demonstrated bioactive properties (apatite layer formation).
• Animal study: Evaluated effectiveness for use in posterolateral fusion. This study directly assessed the material's ability to achieve bone healing. While the exact details of how "performance" was measured (e.g., fusion rates, bone density) are not given, the study was conducted on the device material itself.

7. Type of Ground Truth Used

For the animal studies mentioned:

• Histopathology: Assessing tissue changes at a microscopic level.
• Histomorphometry: Quantitative analysis of tissue structure (e.g., amount of new bone formation).
• Radiographic analysis: Imaging techniques to visualize bone healing.
• Mechanical analyses: Testing the strength of the healed bone segment.

These methods collectively served as the "ground truth" to determine bone healing and fusion in the animal model.

8. Sample Size for the Training Set

The document does not mention a training set. This is because Altapore Shape is a medical device (a material), not an AI algorithm that requires a training set for model development. The performance is based on its material properties and biological interactions demonstrated in non-clinical studies.

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

As there is no mention of a training set (relevant for AI), this question is not applicable.

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ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). ALTAPORE can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si).

ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available in 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml configurations.

ALTAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatitelayer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE undergoes cell-mediated remodeling and is replaced by natural bone.

The provided text describes the Baxter Healthcare Corporation's ALTAPORE device, a resorbable calcium salt bone void filler, and its 510(k) premarket notification (K192363). The information focuses on the substantial equivalence to a predicate device and clinical performance.

However, the provided text does not contain the detailed information required to fill out a table of acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. This is because the document is a 510(k) clearance letter and summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with specific acceptance criteria and outcome metrics for a novel AI/device.

Specifically, the document does not include:

• A table of acceptance criteria (e.g., specific thresholds for sensitivity, specificity, or other performance metrics).
• Any information regarding the use of AI in the device. The device described, ALTAPORE, is a physical medical device (bone void filler), not a software or AI-driven diagnostic tool.
• Sample sizes for a test set as would be used for an AI/software performance study.
• Data provenance (country, retrospective/prospective) related to AI study data.
• Number/qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone algorithm performance details.
• Ground truth type beyond "successful fusion based on CT scans".
• Training set sample size or how ground truth for training was established, as this is not an AI/ML device.

Therefore, it is not possible to answer the request using only the provided text. The text pertains to a physical medical device (bone void filler) and its regulatory clearance process, not a device that involves AI/ML and associated performance studies as outlined in the prompt's request for acceptance criteria and study proof.

The document does mention a clinical study for ALTAPORE:

Clinical Performance Testing:

• Study Design: A single-arm, prospective clinical study.
• Population: Patients with degenerative disc disease, spondylolisthesis, or spinal stenosis undergoing Posterolateral Fusion (PLF) surgery with ALTAPORE.
• Primary Endpoint: Solid fusion at postoperative month 12, assessed using computed tomography (CT) scans, with motion assessed using flexion-extension radiographs.
• Clinical Outcomes: Oswestry Disability Index, 36-item short-form health survey for quality-of-life, visual analog scale for pain scores, and neurological assessments.
• Adverse Events: Recorded.
• Per Protocol Population (N): 102 for the primary endpoint evaluation.
• Results:
  • Successful fusion: 59/89 (66.3%) at month 6, 88/102 (86.3%) at month 12 (primary endpoint), and 87/96 (90.6%) at month 24.
  • Improved disability and pain, maintained neurological function.
  • Adverse events: 43 (33.3%) of 129 patients experienced AEs; back pain most frequent (n=10); 9 and 14 patients experienced SAEs related to device and procedure, respectively.

While these are performance metrics for a medical device, they are not framed as "acceptance criteria" for an AI/ML model's output in the way the prompt implies (e.g., sensitivity, specificity thresholds). The study described is a clinical trial to demonstrate safety and effectiveness, as required for a physical medical implant.

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ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine).

ALTAPORE SHAPE must be used in combination with autograft as a bone graft extender in posterolateral spinal fusion procedures. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

ALTAPORE SHAPE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicatesubstituted calcium phosphate phase of ALTAPORE SHAPE is similar to human cancellous bone and is intended to support bone growth with macro and micro-porosity. The microgranule phase ALTAPORE SHAPE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si).

ALTAPORE SHAPE is supplied as a shaped wax-like putty in a sterile pouch containing ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable Alkylene Oxide co-polymer carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

The provided text describes the 510(k) premarket notification for the Altapore Shape device, a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to predicate and reference devices, outlining the device's composition, intended use, and nonclinical testing.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

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

The document doesn't explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the traditional sense of a clinical study with primary endpoints. Instead, the "acceptance criteria" are implied by the various nonclinical tests performed to demonstrate substantial equivalence to legally marketed predicate devices. The "reported device performance" is the conclusion that the device met these implied criteria, making it substantially equivalent.

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 refers to preclinical animal studies for performance testing. However, it does not provide details on the sample size for these animal studies.
The provenance of the data (e.g., country of origin) is also not specified. The studies appear to be prospective in nature, as they were conducted to evaluate the device's performance.

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 in the document. The animal studies involved radiographic, histopathological, histomorphometric, and mechanical analyses, which would typically involve expert interpretation. However, the number and qualifications of these experts are not detailed.

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

The document does not describe any adjudication methods for the test set. Animal study results would typically be analyzed by the study researchers.

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. This document describes the clearance of a medical implant (bone void filler), not an AI-powered diagnostic or assistive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Not applicable. As stated above, this is an implantable medical device, not an algorithm.

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

For the animal performance studies, the "ground truth" (or evidence of performance) was established through:

• Radiographic analyses
• Histolopathological analyses
• Histomorphometric analyses
• Mechanical analyses

These are objective measures of bone healing and integration in animal models.

For biocompatibility, the ground truth was based on the results of the specified in vitro and in vivo tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogen, Genotoxicity, Implantation) as per ISO-10993-1 and FDA guidance.

8. The sample size for the training set

The document does not mention a "training set" as it pertains to AI/ML development. This is a traditional medical device submission based on substantial equivalence to existing devices and nonclinical testing.

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

Not applicable, as there is no mention of an AI/ML training set in the document.

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ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine). ALTAPORE may be used with autograft as a bone graft extender or bone marrow aspirate in extremities, and pelvis. ALTAPORE must be used in combination with autograft as a bone graft extender or autogenous bone marrow aspirate in posterolateral spinal fusion procedures. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca. P. O. H. Si).

ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available in 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml configurations.

ALTAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

This document is a 510(k) premarket notification for the Baxter Healthcare Corporation's ALTAPORE device, a resorbable calcium salt bone void filler. It describes the device, its indications for use, and a comparison to predicate devices, along with non-clinical performance and biocompatibility testing.

Here's an analysis of the acceptance criteria and study information provided, focusing on the absence of information as well:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested. Instead, it describes performance through various animal and in vitro studies. The general acceptance criterion implied is that the device should demonstrate "similar performance in normal bone healing response" or "normal bone healing response... equivalent to the predicate device."

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

• Posterolateral Spinal Fusion (Animal Study):

  • Sample Size: 182 New Zealand White Rabbits.
  • Data Provenance: Prospective animal study (conducted with specific treatment groups and follow-up periods). Country of origin is not specified, but typically these studies are conducted in a controlled lab environment.

• Extremities Use (Animal Study):

  • Sample Size: 39 sheep, creating 156 defects total.
  • Data Provenance: Prospective animal study (conducted with specific treatment groups and assessment methods). Country of origin is not specified. This study was "previously carried out... as part of the secondary predicate submission (K130531)."

• In Vitro Bioactivity: The document does not specify a "sample size" in terms of number of samples tested, but implies that representative ceramic bone graft samples were tested in simulated body fluid.

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

• No human experts were used to establish ground truth for a test set in the context of device performance data. The studies described are preclinical animal studies (spinal fusion, extremities) and in vitro lab tests.
• The ground truth in these animal studies would be established through objective measures like:
  • Radiographic imaging analysis (likely interpreted by veterinary radiologists or researchers).
  • Histopathological and histomorphometric analysis (performed by veterinary pathologists or histologists).
  • Mechanical testing (objective data).
  • Manual palpation and macroscopic assessment (by researchers/veterinarians involved in the study).

4. Adjudication Method for the Test Set

• Since the described "test sets" are preclinical animal studies and in vitro tests, there is no human adjudication method in the sense of expert consensus for diagnostics.
• The assessment in animal studies is based on scientific methodologies and objective measurements. Any interpretation of results (e.g., radiography, histology) would typically involve trained personnel, but not an "adjudication panel" as seen in clinical studies for human diagnostics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• No. This type of study was not done.
• The ALTAPORE device is a bone void filler, a physical implant, not an AI software device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this submission.

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

• Not applicable. As stated above, this is a physical medical device, not an algorithm or AI software. There is no algorithm to perform in a standalone manner.

7. The Type of Ground Truth Used

• Preclinical Animal Studies (Spine and Extremities): The ground truth was established through a combination of:
  • Histopathology: Microscopic examination of tissue (bone healing, integration, remodeling).
  • Histomorphometry: Quantitative histological analysis.
  • Radiography: X-ray imaging to assess bone formation and fusion.
  • Mechanical Testing: Objective strength and biomechanical properties of the healed bone.
  • Macroscopic Assessment and Manual Palpation: Visual and tactile evaluation of the surgical site.
• In Vitro Studies: The ground truth was based on objective chemical and material science measurements, such as the confirmed formation of hydroxycarbonate apatite (HCA).

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device, not an AI/machine learning model. Therefore, there is no "training set" in the context of AI development. The preclinical studies serve as verification and validation data.

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

• Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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