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α-BSM Bone Substitute Material is indicated for filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. «-BSM Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.

α-BSM Bone Substitute Material is a synthetic, biocompatible calcium phosphate implantable paste that hardens at body temperature and converts to an apatitic calcium phosphate. It is provided in single use packages containing either 2.5, 5.0 or 10 grams (nominal) of a-BSM powder in a mixing bulb, sterile mixing solution, an appropriately sized syringe, and a 16 gauge needle.

α-BSM Bone Substitute Material is supplied sterile for single patient use. The product is packaged in a clear plastic sterilization pouch (with a second outer sterility barrier) containing: a unit does of sterile a-BSM Bone Substitute Material (dry, white powder) contained with an elastomeric (silicone) mixing bulb (available in 2.5, 5.0 or 10cc dose sizes) with a septum closure, a sterile syringe, a 16 gauge needle, and a vial of sterile saline. The saline is injected aseptically into the mixing bulb and the material is mixed by kneading the bulb with the fingers. Once the liquid and powder are well mixed, the bulb is opened and the material, now in paste form, can be administered to the site via a syringe or by manual application. The material can be shaped into the desired form prior to application or shaped in situ in the defect. The setting process occurs in vivo at neutral pH and is non-exothermic and non-caustic.

α-BSM Bone Substitute Material is synthesized from reagent grade inorganic raw materials composed of salts of calcium and phosphates. There are no substances of biological origin used in the synthesis or processing of the product. No additional preservatives or medicinal substances are present.

This 510(k) submission for the α-BSM Bone Substitute Material is a Special 510(k), which indicates that the device undergoes minor modifications compared to a previously cleared predicate device. Special 510(k)s typically focus on demonstrating that the changes do not significantly alter the device's safety or effectiveness, and therefore, extensive new clinical studies with detailed acceptance criteria might not be required in the same way as for novel devices.

Based on the provided text, the submission relies on demonstrating substantial equivalence to the predicate device (α-BSM Bone Substitute Material cleared in K011048) rather than presenting new performance data against a specific set of acceptance criteria from a new study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

There is no explicit table of acceptance criteria or new reported device performance data presented in the provided document. The submission's core argument is substantial equivalence to a predicate device based on commonalities:

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

No new test set data is presented in this Special 510(k) submission to demonstrate performance against new acceptance criteria. The claim is based on the previously established performance of the predicate device. Therefore, no information on sample size for a new test set or its provenance is available.

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

Since no new test set data is presented for this specific submission, there is no mention of experts used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no new test set data is presented.

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

Not applicable. This device is a bone substitute material, not an imaging or diagnostic device that would typically involve human readers for interpretation. Its effectiveness is assessed through its physiological performance (resorption and replacement with bone), which would be evaluated in studies (likely pre-clinical or clinical studies for the original predicate device) by clinical and histological outcomes, not human reader interpretation of images.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical bone substitute material, not an algorithm.

7. Type of Ground Truth Used

For the original predicate device (K011048) upon which this submission's substantial equivalence is based, the "ground truth" would have been established through clinical and/or pre-clinical studies demonstrating:

• Biocompatibility: Absence of adverse reactions.
• Resorption rates: How quickly the material breaks down.
• Bone ingrowth/replacement: Evidence of new bone formation.
• Mechanical integrity: Ability to fulfill its function.

This would involve histology (pathology) to observe cellular activity and bone formation, and potentially imaging (X-ray, CT) to assess filling of voids and radiographic bone density changes, and clinical outcomes data related to patient recovery and functional improvement.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable.

In summary: This Special 510(k) relies on the prior clearance of a predicate device. The "acceptance criteria" are implicitly met by demonstrating that the modifications made to the device (labeling, IFU, part numbers) do not alter the fundamental characteristics or performance that allowed the predicate device to be cleared. No new studies or performance data are presented in this document for the K072636 submission itself.

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a-BSM™ Bone Substitute Material is a synthetic calcium phosphate hydroxyapatitic material intended to be implanted for use in the filling, repair, reconstruction and augmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas with a surface area no larger than 25cm².

ETEX x-BSM™ Bone Substitute Material for Cranioplasty is a self-setting, synthetic calcium phosphate hydroxyapatitic powder that hardens in an aqueous environment at body temperature. The a-BSMM powder is mixed with saline at the time of use and the resulting paste is applied directly to the defect site. Prior to implantation, it remains moldable for several hours. After implantation, the material hardens in approximately one hour. The material is dimensionally stable during setting, and has been demonstrated to be highly biocompatible with mammalian tissues. After implantation, the material resorbs and is replaced by natural bone.

As supplied, each transparent plastic pouch of a-BSMTM Bone Substitute Material contains a unit dose of sterile a-BSM™ Bone Substitute Material (dry white powder) contained within an elastomeric mixing bulb (available in 0.5, 1.0, 2.5, 5.0, 10 and 25 gram dose sizes); a sterile syringe, a 16 gauge needle, and a vial containing sterile saline; and Instructions for Use. The saline is injected aseptically into the mixing bulb and the material is mixed by kneading the bulb with the fingers. The material can be shaped into the desired form prior to application or shaped in situ in the defect. &-BSM™ Bone Substitute Material is synthesized from reagent grade inorganic raw materials composed of salts of calcium and phosphates. There are no substances of biological origin used in the synthesis or processing of the product. No additional preservatives or medicinal substances are present.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the a-BSM™ Bone Substitute Material for Cranioplasty:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K983009) for a-BSM™ Bone Substitute Material for Cranioplasty does not explicitly list numerical "acceptance criteria" in the format typically seen with performance metrics for AI/software devices (e.g., sensitivity > X%, specificity > Y%). Instead, it establishes "substantial equivalence" to a predicate device (BoneSource™) by demonstrating similar physico-chemical properties and superior or equivalent biocompatibility and functional outcomes through a series of tests.

The "acceptance criteria" can be inferred as demonstrating that a-BSM™ is either equivalent or superior to BoneSource™ in relevant aspects, and that it meets general safety and biocompatibility standards. The reported device performance is presented as a comparison table and a summary of test results.

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

This document describes pre-clinical (in vitro and animal) testing, not human clinical trials with "test sets" in the context of diagnostic device assessment. Therefore, the concept of sample size for a "test set" and provenance (country of origin, retrospective/prospective) as typically applied to clinical data for AI/software evaluations is not directly applicable.

Instead, we can identify the following from the document:

• Animal Studies:
  • Dog Femur Model: Used for "Chronic Safety/Efficacy Study," "Histology and Histomorphometry Evaluation," and "Biomechanical Strength Testing." The precise number of dogs/femurs is not specified but the studies ran for "one year."
  • Rabbit Model: Used for "Muscle Implantation" (implantation in rabbit muscle sites) and "Pyrogen Test." The number of rabbits is not specified.
• In Vitro/In Vitro Equivalent Studies:
  • Mutation Assay (Ames Test), Micronucleus Test, Hemolysis Assay, MEM Elution Test, USP Systemic Toxicity Test, Delayed Contact Sensitization Test, Intracutaneous Toxicity Test, Bacterial Endotoxin (LAL) Evaluation, Physico-Chemical Testing (FTIR, X-ray Diffraction, Ca:P ratio, Solubility, Mechanical properties). These typically involve lab samples, cell cultures, or specialized testing apparatus, not "test sets" of patient data.

Data Provenance: The document does not specify the country of origin for the animal studies or laboratory tests. Given it's an FDA 510(k) submission from "ETEX Corporation" in "Cambridge, Massachusetts, U.S.A.", it's highly probable the studies were conducted in the U.S. or by labs compliant with U.S. regulatory standards. All tests described are preclinical.

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

This information is not applicable to the type of device and study described. Since this is a bone substitute material, the "ground truth" is established through direct observation (e.g., absence of mutation, signs of inflammation), histological examination (e.g., new bone formation), and biomechanical measurements, rather than expert consensus on diagnostic images. The evaluations were performed by laboratory and pathology experts, but their specific number or detailed qualifications (e.g., "radiologist with 10 years experience") are not provided in this summary.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a diagnostic device involving a "test set" requiring adjudication of interpretations. The studies are pre-clinical evaluations of material properties and biological response.

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

Not applicable. This device is a bone substitute material, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This device is a bone substitute material, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the various tests can be categorized as follows:

• Physiological/Biological Response:
  • Absence/Presence of Toxic Effects: (e.g., no mutations, no cytotoxicity, no systemic toxicity, no pyrogenic effects, no irritation, no hemolysis).
  • Histopathology: Microscopic evidence of tissue response to the implant (e.g., slight cellular effects in muscle implantation, new bone growth and remodeling in femurs).
  • Macroscopic Observation: Gross observation of tissue irritation (e.g., no macroscopic evidence of tissue irritation in muscle implantation study).
• Engineered Properties:
  • Chemical/Crystalline Composition: Determined via spectroscopy (FTIR) and diffraction (X-ray Diffraction).
  • Quantitative Measurements: Calcium:Phosphorus ratio, Solubility Product, Hardening Time, Biomechanical Strength (torsion loading to fracture).

8. The Sample Size for the Training Set

Not applicable. This device is a bone substitute material, not a machine learning model, so there is no "training set" in this context.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the preclinical studies was established through standard scientific methodologies, laboratory protocols, and animal model evaluations as described in point 7.

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a-BSM™ Bone Substitute Material is a synthetic calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.

«-BSM™ Bone Substitute Material Kit is a synthetic, calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, to reduce alveolar bone pocket depth and increase alveolar bone thickness and height, to aid in gain in clinical attachment and for repair of cysts or other defects in the alveolar ridge or wall. &-BSM™ Bone Substitute Material Kit is provided in dry white powder form, it contains no pvrophosphates or amorphous tricalcium phosphate. The device is mixed with sterile water or saline just prior to its application to the desired periodontal defect.

The provided text describes a 510(k) summary for a medical device (α-BSM™ Bone Substitute Material Kit) and focuses on its substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria and a study demonstrating achievement of those criteria.

Therefore, many of the requested sections regarding detailed study design (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details) are not available in the provided document.

Here's an analysis of what is available:

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

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

• Not provided. The document mentions "Testing of x-BSM™ Bone Substitute Material was designed to characterize the finished material and assure the biocompatibility of the device," but does not detail sample sizes, study design (retrospective/prospective), or data provenance for these tests. This is typical for a 510(k) where the focus is on substantial equivalence based on material properties and basic safety, rather than clinical performance trials with controlled test sets.

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/Not provided. No clinical test set requiring expert ground truth is described. The 'testing' refers to material characterization and biocompatibility assays, not diagnostic or clinical performance.

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

• Not applicable/Not provided. No clinical test set requiring adjudication 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 device is a bone substitute material, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• Not applicable. This device is a bone substitute material, not an algorithm.

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

• For the material and biocompatibility testing, the "ground truth" was based on:
  • Biocompatibility Standards: Established guidelines for biological response to materials.
  • Material Standards: ASTM Standard F 1185 for Composition of Ceramic Hydroxylapatite for Surgical Use.
  • Sterility Standards: USP 23 (United States Pharmacopeia).
• For the substantial equivalence claim, the "ground truth" was the performance and properties of the predicate devices (OsteoGen® and HAPSET®) and the regulatory framework that deems devices with similar characteristics and indications as equivalent.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" in the context of this device and testing. The device is a material, not a machine learning model.

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

• Not applicable/Not provided. As there is no training set, this question is not relevant.

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