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Genex® Bone Graft Substitute injectable paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
• Genex® Bone Graft Substitute is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure
• Genex® Bone Graft Substitute is indicated to be gently packed into voids or defects of the skeletal system (i.e long bones, extremities, posterolateral spine and pelvis)
• Genex® Bone Graft Substitute resultant paste can be injected, digitally packed into the bone in situ or moulded into solid implants that are to be gently packed into the defect
• The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® Bone Graft Substitute provides a bone graft substitute that resorbs and is replaced with bone during the healing process

Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste. When injected the mixture sets to form Genex® Bone Graft substitute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.
Genex® Bone Graft Substitute, accessories and packaging are not made from natural rubber latex.

The provided text is a 510(k) summary for the Genex® Bone Graft Substitute. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness or outcomes.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Genex® K082381) based on:

• Intended Use / Indications for Use: These are stated to be the same as the predicate device.
• Technological Differences: The subject device is presented as a closed mixing system with differences in the number of syringes and mixing method, but these are claimed not to raise safety and effectiveness concerns.
• Non-Clinical Testing: This includes "Biocompatibility testing, Shelf-Life validation studies and Porosity testing." The summary states that these tests demonstrate substantial equivalence and do not raise new safety or effectiveness concerns.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets them because this information is not present in the provided text. The document is concerned with regulatory clearance via substantial equivalence, not with presenting a efficacy study.

Here's a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions "non-clinical testing" like biocompatibility, shelf-life, and porosity, but it doesn't list specific acceptance criteria (e.g., a certain percentage of bone growth, time to resorption) or performance outcomes from these tests.
2. Sample size used for the test set and the data provenance: Not provided. No efficacy or outcome study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human interpretation of results for an efficacy study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a bone graft substitute, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. No efficacy or outcome study is described.
8. The sample size for the training set: Not applicable. This device is a medical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.

Genex® is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extemities, spine and pelvis).

Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect

The bony defects or cavaties may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Genex® is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process.

Genex® is completely resorbed and replaced with bone during the healing process.

Genex® is provided sterile for single use only

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device. The document is a 510(k) summary for a bone void filler called Genex®, dating from 2008.

The document discusses:

• Device Description: Genex® as a calcium salt bone graft substitute.
• Intended Use/Indications: For bony voids or defects not intrinsic to stability, to be packed/injected into the skeletal system.
• Summary of Technology & Non-Clinical Testing: States that Genex® has the same technological characteristics as the predicate device and is substantially equivalent. It notes that "Data supplied demonstrates that Genex® is substantially equivalent to the predicate device and any differences do not any concerns regarding safety and effectiveness." This implies non-clinical testing was done, but the details of the specific tests, their methodologies, and acceptance criteria are not provided.
• Substantial Equivalence: Asserts that indications, contraindications, risks, and potential adverse events are the same as the predicate device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is focused on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that does not typically involve the kind of performance studies with specific acceptance criteria and ground truth validation that you've described for AI/ML devices.

To answer your questions accurately, I would need a document that describes the development and validation of an AI/ML medical device, including performance metrics, test sets, ground truth establishment, and study designs.

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Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis. Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.

Genex® Putty is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® Putty is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process. Genex® Putty is completely resorbed and replaced with bone during the healing process.

This 510(k) summary for the Genex® Putty does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria in the way one might expect for a diagnostic or AI-driven device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is the typical path for 510(k) clearances for relatively straightforward medical devices like bone void fillers. This means the key "acceptance criteria" revolve around showing similarity in intended use, technological characteristics, safety, and effectiveness to an already legally marketed device.

Here's an attempt to structure the information based on your request, highlighting what is (and isn't) present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• None stated. The document does not describe a clinical "test set" in the context of human subjects or a clinical trial with specific sample sizes. The evaluation is based on non-clinical testing and comparison to a predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This type of information is relevant for studies involving human interpretation (e.g., radiology reads) where ground truth needs to be established by panels of experts. For a bone void filler comparison, this concept doesn't directly apply. The "ground truth" here is regulatory acceptance of the predicate device and the non-clinical data demonstrating equivalency.

4. Adjudication Method for the Test Set

• Not applicable. As there's no described "test set" requiring expert interpretation, no adjudication method is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, not applicable. An MRMC study is relevant for diagnostic devices (e.g., imaging AI) where human readers' performance with and without AI assistance is compared. This device is a biomaterial, not a diagnostic tool, so such a study would not be performed.

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

• No, not applicable. This device is a physical bone void filler, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is established through:
  • Regulatory acceptance of the predicate device: The predicate device itself serves as the benchmark for safety and effectiveness.
  • Non-clinical testing: This would involve laboratory data (e.g., material properties, biocompatibility, mechanical strength, resorption rates) demonstrating that Genex® Putty performs similarly to the predicate device. Specific details of these tests are not provided in the summary but would be part of the full 510(k) submission.

8. The Sample Size for the Training Set

• Not applicable. This concept is relevant for machine learning algorithms. The Genex® Putty is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As above, this device does not involve a training set.

Summary of Study (Implicit)

The "study" presented in this 510(k) summary is not a traditional clinical trial or performance study with defined acceptance criteria for novel performance metrics. Instead, it is a substantial equivalence review.

The document indicates:

• Non-Clinical Testing: Data supplied demonstrates that Genex® Putty is substantially equivalent to the predicate device. This implies laboratory tests were performed to compare material properties, biological interactions (e.g., biocompatibility), and functional characteristics (e.g., resorption). The specifics of these tests are not provided in this summary.
• Comparison to Predicate: The core of the "study" is the comparison of Genex® Putty's indications, contraindications, risks, potential adverse events, and technological characteristics to an already legally marketed predicate device. The conclusion is that they are the "same" or that differences do "not raise any concerns regarding safety and effectiveness."

In essence, the "acceptance criteria" for Genex® Putty were met by demonstrating its equivalence to a predicate device through non-clinical data, rather than through a novel clinical study with a predefined performance endpoint and sample size.

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Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. Genex® bone graft substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect. The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Genex® Bone Graft Substitute consists of synthetic bioabsorbable calcium salts, premeasured mixing solution and tools necessary to mix the components into a paste. These products are provided sterile for singe patient use. When mixed according to directions, the Gonex® Bone Graft Substitute produces biodegradable, radiopaque paste/moulded blocks that resorb in approximately 6 -- 9 months when used according to labelling. After the granular powder is hydrated using all of the mixing solution supplied in each pack, the resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are gently paced into non-load bearing voids or gaps of the skeletal system (i.c. the extremitics, spinc and pelvis). These bone voids may be surgically created osseous defects or osscous defects created from traumatic injury to the hone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

The provided document is a 510(k) summary for the Genex® Bone Graft Substitute. It does not contain acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and direct performance data either cannot be answered or would be speculative based on this document.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not provided in the document. 510(k) summaries primarily demonstrate substantial equivalence, not the fulfillment of specific performance acceptance criteria from a pre-defined study protocol for a novel device.
• Reported Device Performance:

  Performance Aspect	Reported Statement
  Resorption	"resorbs in approximately 6 – 9 months when used according to labelling."
  Replacement	"resorbs and is replaced with bone during the healing process."
  Bone Void Filler	"provides a bone void filler"

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 available in the provided 510(k) summary. The document states "Test results confirm that Genex® Bone Graft Substitute provides a bone void filler which, when placed in contact with healthy bone, resorbs and is replaced with bone during the healing process," but it does not detail the nature, size, or provenance of these "test results."

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 available in the provided 510(k) summary. Given that it's a bone graft substitute, ground truth would likely be established by histological analysis or imaging read by clinical experts, but no details are given.

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

• This information is not available in the provided 510(k) summary.

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

• This is not applicable. The device is a bone graft substitute, not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

• This is not applicable. The device is a physical bone graft substitute, not an algorithm.

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

• The document implies that "test results" confirmed the device's performance, specifically its resorption and replacement by bone. For a bone graft substitute, ground truth would typically involve histological evaluation (pathology) from tissue samples over time to confirm bone ingrowth and material resorption, potentially combined with imaging (radiological) assessment of defect filling and healing. However, the document does not explicitly state the type of ground truth used for its "test results."

8. The sample size for the training set

• This information is not available in the provided 510(k) summary. The document does not describe a "training set" as it would for a machine learning model; the "test results" mentioned are likely from a traditional preclinical or clinical study, but details are not given.

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

• Not applicable as no training set is described. If referring to the "test results" in general, please refer to the answer for question 7.

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