Search Results

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.

Ask a specific question about this device

MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. 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. MagnetOs Granules resorbs and is replaced with bone during the healing process.

MagnetOs Granules is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Granules consists of 65-75% tri-calcium phosphate (TCP -Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)c(OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. MagnetOs Granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Granules is a ready-to-use product. MagnetOs Granules is provided in vials in a range of product volumes. MagnetOs Granules is gamma-sterilized and sterile packaged for single use only.

The provided text details the 510(k) summary for MagnetOs Granules, but it does not contain the specific information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.

The document describes a bone void filler and its clinical evaluation (a randomized non-inferiority trial for posterolateral fusion), along with bench testing for material properties. This is a traditional medical device submission, not an AI/ML device.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text. The document does not discuss:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes used for a test set in an AI/ML context.
• Data provenance (e.g., country of origin, retrospective/prospective) for AI/ML data.
• Number of experts, their qualifications, or adjudication methods for ground truth in an AI/ML study.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI/ML.
• Standalone performance of an algorithm.
• Training set details for an AI/ML model.

The text focuses on the substantial equivalence of a physical bone void filler device to predicate devices based on material properties, manufacturing, and clinical performance in a human trial without AI assistance.

Ask a specific question about this device

MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. In the posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone graft extender. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the bony structure.

MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects.

MagnetOs Easypack Putty consists of 65–75% tri-calcium phosphate (TCP – Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.

New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling.

MagnetOs Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects.

MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.

This document does not describe a study involving an AI/ML device, therefore, a description of acceptance criteria and the study that proves the device meets the acceptance criteria is not applicable. The provided text is a 510(k) summary for a medical device called "MagnetOs Easypack Putty," which is a resorbable calcium salt bone void filler. It details the device's characteristics, intended use, and demonstrates substantial equivalence to predicate devices through non-clinical testing and animal studies, not AI/ML performance.

Ask a specific question about this device

si-Mochi is an implant intended to fill bony voids or gaps of the skeletal system (i.e.extremities, pelvis). 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. si-Mochi resorbs and is replaced with bone during the healing process.

si-Mochi contains a multi porous bi-phase Calaium Phosphate ceramic granules, 12mm, suspended in an aqueous polymer carrier gel. The chemical composition of the multi-porous ceramic granules is trace silicate induced bi-phase calcium phosphate ceramic which has 80% hydroxylapatite Ca5(PO4)3(OH) and 20% beta -tricalcium phosphate Ca3(PO4)2 , similar levels to those identified in naturally-growing bone. Its porous structure comprising three types of porosities which are interconnected: macropores (100µm1mm), midipores (10100 µm) and microspaces (110 µm). Calcium phosphate bone graft substitutes have been the topic of extensive clinical studies for several decades. Biocompatibility is addressed in the non-clinical testing section below. The interconnected macro-, midi- and micro- porous structure encourages the rapid formation of host bone and the growth of capillary blood vessels throughout the network of interconnecting pores. After implantation, si-Mochi undergoes physiologically- mediated resorption and is replaced by natural bone. The resorption of the Ca/P porous ceramic granules were controlled by the host nature bone remodelling process due to the proliferated osteocytes formation within the microporous structure of the ceramic granules. The resorption is not controlled by its chemical composition. si-Mochi is supplied in three different types of sterile applicator. si-Mochi does not set in-situ following implantation. si-Mochi does not contain antibiotics.

The provided text is a 510(k) Premarket Notification from Biostone Limited for their device si-Mochi. This document details the device's description, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the content of the provided document, the device in question, si-Mochi, is a resorbable calcium salt bone void filler, not an AI-powered image analysis device. Therefore, the information required to answer the questions about acceptance criteria for an AI/ML device, such as performance metrics (accuracy, sensitivity, specificity, AUC), sample size for test and training sets, expert ground truth establishment, MRMC studies, or standalone performance, are not present in this document.

The document focuses on non-clinical and animal studies to demonstrate substantial equivalence to legally marketed predicate devices (TriPore® K070132, Actifuse ABX™ K082575).

Here's an analysis based on the information available in the document, highlighting what is missing in relation to the prompt:

Missing Information (as per the prompt's requirements for AI/ML device study):

• Acceptance Criteria for an AI device's performance: Not applicable; this is a medical implant, not an AI device.
• Reported Device Performance against AI acceptance criteria: Not applicable.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for AI test sets. The document mentions an animal study (rabbit critical size defect in the distal femora model), but details on sample size within that study are not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for AI. For the animal study, the "ground truth" would be the observed new bone formation in the animal model.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information Available (related to the device's clearance):

The only "study" mentioned in the document is an "animal study, rabbit critical size defect in the distal femora model, making direct comparison against the predicate device, Actifuse ABX."

• Acceptance Criteria (for demonstrating substantial equivalence in this context): The implicit acceptance criterion for this type of device is "substantial equivalence" to predicate devices, meaning it performs as well as the predicate device regarding safety and effectiveness.

  • The document states: "Biostone has determined that si-Mochi is substantially equivalent to the predicate devices on the basis of chemical composition tests on all three devices as prescribed in the 'Class II Special Controls Guidance Document' referenced above."
  • And: "Secondly, si-Mochi itself complies with the requirements of the Special Controls Document referred to above."
  • And: "Animal study, rabbit critical size defect in the distal femora model, making direct comparison against the predicate device, Actifuse ABX. However, the percentage of new bone formations were not statistically significant difference in animal model at all time points post-implantation between si-Mochi and the predicate device."
  • Therefore, the "acceptance criteria" here are demonstrated comparability of chemical composition, compliance with special controls, and non-inferiority/statistical non-significance in new bone formation compared to the predicate in an animal model.

• Reported Device Performance (against the above criteria):

  • Chemical Composition: Stated to be comparable and comply with guidance.
  • Animal Study: "the percentage of new bone formations were not statistically significant difference in animal model at all time points post-implantation between si-Mochi and the predicate device." This indicates the device performed comparably to the predicate.

• Sample Size (for the animal study): Not explicitly stated in the provided text.

• Data Provenance (Animal Study): Rabbit model. Country of origin not specified, but the submitter is in the UK.

• Ground Truth (for Animal Study): The direct measurement of "percentage of new bone formations" in the animal model.

In summary, this document is for a medical implant, not an AI/ML diagnostic tool, and as such, the specific metrics and study designs outlined in your prompt for AI applications are not relevant or present.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device