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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.

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TriPore HA, TriPore BP90, TriPore BP15, is a synthetic bone graft intended to be packed into bone defects of the sketal system (extremities, posterolateral spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Synthetic bone graft granules of one of the following three materials packed in a multi-purpose applicator (MPA):
(A) 100% pure hydroxylapatite (TriPore HA)
(B) biphasic mixture of 90% hydroxyapatite and 10% tri-calcium phosphate (TriPore BP90)
(C) biphasic mixture of 15% hydroxyapatite and 85% tri-calcium phosphate (TriPore BP15)

I'm sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for a medical device (synthetic bone graft) and primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general information about the device. It does not describe any specific study that proves the device meets acceptance criteria, define acceptance criteria, or provide details about a performance study with sample sizes, expert involvement, adjudication, or ground truth establishment.

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TriPore TDDHA, TDDBPS, and TDDgP15 is intended to be packed into bone defects of the skeletal system (extremities, posterolateral spine or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

TriPore TDD is an open bore syringe prefilled with TriPore synthetic bone graft granules in three different compositions: (1) 100% pure hydroxylapatite; (2) biphasic mixture of 90% hydroxlyapatite and 10% tri-calcium phosphate; (3) biphasic mixture of 15% hydroxlyapatite and 85% tri-calcium phosphate TriPore TDD comes in two sizes - containing 5cc and 10cc of TriPore granules.

The provided documents describe a 510(k) premarket notification for the TriPore TDD device, which is a synthetic, porous calcium phosphate bone graft. This submission is for demonstrating substantial equivalence to predicate devices, not for a de novo marketing authorization or a PMA. Therefore, the information typically found in a study demonstrating specific performance against acceptance criteria for a novel device, especially in the context of AI/ML or diagnostic performance, is not present.

The submission focuses on proving that the TriPore TDD is essentially the same as already approved devices, rather than testing new performance metrics.

Based on the provided text, here's what can be extracted and what cannot be answered:

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

This information is not applicable/not provided in this type of 510(k) submission. The acceptance criteria here are related to demonstrating substantial equivalence in terms of material composition and delivery mechanism to predicate devices, not specific performance metrics against a defined threshold.

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

This information is not applicable/not provided. There was no "test set" in the context of a new performance study. The data provenance refers to prior animal studies on the predicate device (TriPore, K070132), which were deemed applicable to the current device. The document explicitly states: "Extensive animal studies on TriPore, and recorded in K070132 apply to TriPore TDD and have not been repeated."

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 applicable/not provided. There was no study with a "test set" requiring expert-established ground truth.

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

This information is not applicable/not provided.

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

This information is not applicable/not provided. This device is a bone graft, not a diagnostic AI system or an imaging modality, so MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This information is not applicable/not provided. As explained above, this is a physical medical device, not an algorithm.

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

For the prior animal studies referenced (K070132), the "ground truth" would likely be histological analysis and other biological assessments of bone ingrowth and material resorption, which are standard for evaluating bone grafts in animal models. However, the specifics for K070132 are not detailed in this document. For K110787, the "ground truth" for substantial equivalence relies on material identity.

8. The sample size for the training set

This information is not applicable/not provided. There was no training set in the context of the type of study typically associated with this question.

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

This information is not applicable/not provided.

Summary of the study and acceptance criteria from the provided document:

Acceptance Criteria for Substantial Equivalence (as implied by the submission):

The primary acceptance criterion for this 510(k) submission is that the TriPore TDD device is "substantially equivalent" to its predicate devices in terms of:

• Material Composition: The synthetic bone graft granules (TriPore HA, BP90, BP15) are identical to those in the predicate device TriPore K070132.
• Delivery Mechanism: The open bore syringe used is identical to the one in the predicate device FibriJet Graft Delivery Device K100754.
• Intended Use: The intended use is consistent with the predicate devices (packing into bone defects of the skeletal system for resorption and replacement with bone).
• Safety and Effectiveness: Demonstration that the device is safe, effective, and functions as well as the predicate devices based on the substantial equivalence argument.

Reported Device Performance / Determination of Substantial Equivalence:

The Orthogem Ltd concludes that the TriPore TDD is substantially equivalent based on the following:

• Non-Clinical Data: "Orthogem has determined that TriPore TDD is substantially equivalent to the predicate devices on the basis that the synthetic bone graft granules in TDD are exactly those in the predicate device."
• Animal Data: "Extensive animal studies on TriPore, and recorded in K070132 apply to TriPore TDD and have not been repeated. Animal data is not applicable to the TDD syringe." This means previous animal study data for the identical bone graft material (from K070132) was leveraged.
• Technological Characteristics Comparison: The submission explicitly states the TriPore TDD contains the exact same TriPore granules as K070132 and the exact same open bore syringe as K100754.

Conclusion by Orthogem:

"Orthogem concludes that the non-clinical tests carried out on TriPore TDD demonstrate that it is safe. Effective and function as well as the predicate devices."

The FDA's letter (K110787) confirms their agreement with this conclusion, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

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