Search Results

The Hip Spacer with gentamicin preserves the joint space and the length of the affected limb, which results in the maintenance of the entire abductor and stabilizer apparatus of the hip. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Hip Spacer is implanted after the removal of the infected implant, as a regular Hemiarthroplasty. The spacer is inserted into the femoral canal, and a handmade ring of PMMA bone cement with antibiotic may be added to the base of the spacer's neck in order to increase stability. The spacer is kept "in place" until it is replaced by the final prosthesis according to medical criteria. The Hip Spacer must not remain implanted for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Knee Spacer with gentamicin maintains the articular space, the length of the affected limb, and the ligament apparatus of the knee. Its use is indicated for a limited period, in patients who require a Two stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Knee Spacer is placed like a regular arthroplasty, after the removal of the original implant. This knee spacer consists of two independent parts: a tibial plate and a femoral component. The first has a flat base where the femoral component articulates. It is recommended that both components be adapted to the bone by means of a small amount of bone cement with antibiotic. The Knee Spacer must not remain implanted more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Shoulder Spacer with gentamicin preserves joint space and length of the affected limb, resulting in maintenance of the entire shoulder muscle and stabilizer complex. Its use is indicated for a limited period, in patients who require a Two-stage Revision Arthroplasty. A systemic antibiotic therapy should also be prescribed while the spacer remains implanted. The Shoulder Spacer is placed as a hemiarthroplasty after the original implant has been removed. The spacer is inserted into the humeral canal and a ring of bone cement with antibiotic can be added to the base of the neck of the spacer for added stability. The Shoulder Spacer should not remain in place for more than 6 months. Once this period has elapsed, it must be explanted and a permanent device implanted or another appropriate treatment performed.

The Synicem Hip, Knee, and Shoulder Spacers are combination products made from fully formed polymethylmethacrylate (bone cement) with gentamicin. The bone cement is prepared from a powder component and a liquid component. The hip and shoulder spacers contain a stainless steel core of 316L in accordance with ASTM F138. The spacers are temporary implants utilized to maintain the joint space during two-stage revision arthroplasties. The spacer implant is placed as part of the first stage of the two-stage revision when the original prostheses are removed due to joint infection. Once the infection is cleared, the spacers are removed and replaced with a permanent prosthesis as part of the second stage of the revision process. The joint spacers are not intended to be implanted for longer than 6 months. They are a single use device and supplied sterile.

This document is a 510(k) clearance letter for the Synicem Hip, Knee, and Shoulder Spacers. These are medical devices, specifically temporary implants used in two-stage revision arthroplasties following joint infections.

The information provided outlines the substantial equivalence of the Synicem Spacers to previously cleared predicate devices. It describes the device, its intended use, technological characteristics, material composition, sizes, and various performance tests conducted.

However, a critical point to understand is that this document DOES NOT describe an AI/ML-based device. It is a clearance for a traditional medical device (joint spacers). Therefore, many of the requested criteria related to AI/ML systems (such as test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The document focuses on demonstrating that the new Synicem Spacers are "substantially equivalent" to existing, legally marketed predicate devices in terms of safety and effectiveness, based on non-clinical performance testing (mechanical, antibiotic elution), biocompatibility, and MRI safety.

Here's an analysis based on the provided document, addressing the applicable criteria and explicitly stating where information is not available due to the nature of the device:

Device: Synicem Hip Spacer, Synicem Knee Spacer, Synicem Shoulder Spacer
Type of Device: Traditional Medical Device (Non-AI/ML)

Acceptance Criteria and Reported Device Performance

Given that this is a traditional medical device (joint spacer) and not an AI/ML algorithm, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices through various non-clinical performance tests and adherence to relevant standards. There isn't a "performance metric" in the sense of accuracy, sensitivity, or specificity as one would expect for a diagnostic AI.

The acceptance criteria are implicitly met by demonstrating that the Synicem Spacers "met performance requirements and is substantially equivalent to the predicate device" across several categories.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details (Applicability to AI/ML context)

Since this is a non-AI/ML device submission, most of the requested study details pertinent to AI/ML performance validation are not applicable (N/A). The "study" here refers to the non-clinical performance testing done to establish substantial equivalence.

1. Sample size used for the test set and the data provenance:

   • N/A. This is not an AI/ML device. The "test set" would refer to the physical samples of the spacers used for mechanical, biocompatibility, and elution testing. The provenance would be the manufacturing site (United Kingdom).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This is not an AI/ML device requiring expert-labeled ground truth data. Performance for this device is based on objective measurements from mechanical and chemical tests, and biological assays.

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

   • N/A. Not applicable for objective non-clinical performance testing of a physical device.

4. 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 is a physical medical device (joint spacer), not an AI system designed to assist human readers. MRMC studies are not relevant.

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

   • N/A. There is no "algorithm" in this device. Its performance is inherent in its physical and chemical properties.

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

   • N/A. The "ground truth" for this device's performance is established by validated engineering and scientific test methods (e.g., ASTM standards for material properties, ISO standards for biocompatibility, gravimetric analysis for elution profiles). It's based on physical measurements and biological reactions, not subjective interpretation requiring "expert consensus" in the diagnostic sense.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device; there is no "training set."

8. How the ground truth for the training set was established:

   • N/A. Not an AI/ML device; no "training set" or "ground truth for training."

Ask a specific question about this device

Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Stimulan Rapid Cure is biodegradable and biocompatible and may be used at an infected site.

To fill a bone void or defect created by:

• . surgery
• . a cyst
• a tumour .
• . osteomyelitis
• . traumatic injury

Stimulan Kit/Stimulan Rapid Cure are indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Stimulan Kit/Stimulan Rapid Cure are biocompatible and may be implanted at an infected site. Stimulan Kit/Stimulan Rapid Cure are presented as a powder and mixing solution which when mixed together form a paste which may be injected, digitally implanted or applied to the mold provided to produce pellets.

This document is a 510(k) premarket notification for the Stimulan Kit/Stimulan Rapid Cure, a bone void filler. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states in section 9, "Clinical performance data was not required as the labelling modifications do not affect the safety and effectiveness of the modified device." This indicates that a new study to assess performance or acceptance criteria was not conducted for this specific submission, as the changes were limited to labeling and did not impact safety or effectiveness.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on existing data and regulatory requirements for labeling modifications, rather than presenting new performance data against acceptance criteria.

Ask a specific question about this device

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.

Ask a specific question about this device

Fortoss® Vital is intended for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.

Fortoss® Vital bone graft substitute is a calcium salt based pre-measured powder and liquid component. The two components are designed to be mixed intraoperatively to produce a homogeneous paste which can then be applied to osseous defects. The product is provided sterile for single patient use. When Fortoss® Vital is placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.

This document is a 510(k) summary for the Fortoss® Vital bone graft substitute. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding acceptance criteria and a study to prove meeting those criteria is not present.

However, I can extract what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the Fortoss® Vital. Instead, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a predicate device. The primary "performance" reported is its equivalence to the predicate in key characteristics.

2. Sample size used for the test set and the data provenance:

• Sample size for the test set: Not provided. The document refers to "Data supplied" and "Documentation provided" but does not specify a test set size for animal or human studies. The nature of a 510(k) submission, especially for a bone graft substitute demonstrating substantial equivalence, often relies on comparing existing data or characteristics to a predicate, rather than conducting new, large-scale clinical trials.
• Data provenance: Not explicitly stated regarding specific studies. The applicant is Biocomposites Ltd, located in Keele, Staffordshire, England. This suggests the data might originate from or be compiled in the UK. The document uses terms like "Non Clinical Testing," implying laboratory or animal studies, but specifics on provenance are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as this submission is not about an AI/ML device that requires expert adjudication for ground truth establishment. It's a medical device (bone graft substitute) submission focused on substantial equivalence.

4. Adjudication method for the test set:

This information is not provided as it's not relevant for this type of medical device 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:

This information is not provided as this device is a bone graft substitute, not an AI/ML diagnostic tool.

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

This information is not provided as this device is a bone graft substitute, not an AI/ML algorithm.

7. The type of ground truth used:

For a bone graft substitute, "ground truth" would typically refer to established biological and material science principles, existing clinical performance data of the predicate, and possibly pre-clinical (e.g., animal model) results. The document states "Data supplied demonstrates that the modified Fortoss® Vital is substantially equivalent to the predicate device." This implies the ground truth is derived from the known characteristics and performance of the predicate device, potentially supported by laboratory testing on the new device verifying these characteristics.

8. The sample size for the training set:

This information is not provided as this is not an AI/ML device that utilizes a training set.

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

This information is not provided as this is not an AI/ML device.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

Dominator TM is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.

Dominator™ is a bioabsorbable device manufactured from a composite mixture of poly-L-lactic acid (PLLA) and calcium phosphate. It may be supplied with sutures with or without pre-attached needles.

The provided text is a 510(k) summary for a medical device (Dominator™ suture anchor) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device that existed before the current regulatory framework.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Type of Device: The Dominator™ is a physical orthopedic implant (suture anchor), not a software algorithm or a diagnostic tool that would typically have performance metrics like those for AI.
• Regulatory Pathway: The 510(k) pathway for medical device clearance in the US primarily relies on demonstrating substantial equivalence, not conducting de novo clinical trials with predefined acceptance criteria and performance metrics in the way a new drug or novel AI diagnostic would.
• Content of Document: The document repeatedly states that "Dominator™ has the exact same intended use and indications as the predicate device" and that "Documentation provided demonstrates that the Dominator™ is substantially equivalent to the legally marketed predicate device and any differences do not raise concerns regarding safety and effectiveness." This doesn't involve setting new performance "acceptance criteria" for the Dominator™ to meet independently, but rather showing it's comparable to an already approved device.
• "Non Clinical Testing": While "Non Clinical Testing" is mentioned, the document only states that it "demonstrates that the Dominator™ is substantially equivalent to the predicate device." It does not provide details of specific tests, methodologies, or results that would allow for an "acceptance criteria" table or a description of a study with sample sizes, ground truth, or expert involvement.

Therefore, I cannot provide the requested information from the given text. The document's purpose is to show equivalence and not to detail a performance study against specific acceptance criteria.

Ask a specific question about this device

The GraftLok™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The GraftLok™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The GraftLok™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

The GraftLok™ ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. GraftLok™ ST Screw is used to provide suspensary fixation femoral fixation during double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.

The GraftLok™ Screw and GraftLok™ ST Screw are cannulated, sterile, single use bone screw manufactured from poly L-lactic acid (PLLA).

This 510(k) premarket notification for the GraftLok™ Screw and GraftLok™ ST Screw does not contain the information requested regarding acceptance criteria and performance studies.

Instead, this document:

• Asserts substantial equivalence: The core claim throughout the document is that the GraftLok™ Screw and GraftLok™ ST Screw are "substantially equivalent" to legally marketed predicate devices. This is a regulatory pathway, not a detailed performance study.
• Focuses on technological characteristics: It states that the devices "have the same technological characteristics" as predicate devices, and any differences "do not raise any concerns regarding safety and effectiveness."
• Mentions "Non Clinical Testing" documentation: It vaguely states, "Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent..." This implies non-clinical testing was conducted, but no details of the tests, their results, or acceptance criteria are provided in the public summary.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document acts as an FDA submission summary, not a detailed study report.

Ask a specific question about this device

The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.

The Bilok®ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.

The Bilok® ST Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).

This submission pertains to a 510(k) premarket notification for a medical device called the Bilok® ST Screw. In 510(k) submissions, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through clinical trials with specific acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria (especially regarding performance metrics like sensitivity, specificity, etc.) is generally not applicable for a 510(k) submission like this one.

Here's a breakdown of why and what information is available in the provided text:

• No specific acceptance criteria or a study proving those criteria are met for performance as a diagnostic device. The 510(k) process relies on demonstrating the new device is as safe and effective as a predicate device already on the market.
• The provided text explicitly states "Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness." This is the core of a 510(k) review.

Let's address each of your points based on the provided document and the nature of a 510(k) for this type of device:

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

• Acceptance Criteria for a 510(k) Submission: The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that "Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device..." This is the "performance" demonstrated for a 510(k) in terms of regulatory approval. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) provided as this is not a diagnostic device and doesn't require such clinical performance data for 510(k) clearance.

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

• Not applicable for this 510(k). This device is a bone screw used in surgery. The substantial equivalence argument relies on comparing its design, materials, and mechanical properties to a predicate device, along with non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing). Clinical "test sets" of patients are generally not required for this type of 510(k) submission to demonstrate substantial equivalence.

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. There is no "test set" in the context of clinical images or diagnostic outcomes that requires expert consensus for ground truth for this medical device submission.

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

• Not applicable. No clinical test set requiring adjudication in this context.

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 surgical implant (bone screw), not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Ground Truth for a 510(k) of a Physical Device: For a device like a bone screw, the "ground truth" for demonstrating safety and effectiveness for a 510(k) involves adherence to established standards for materials, biocompatibility, sterilization, and mechanical performance (e.g., tensile strength, fatigue life), as well as comparison to a predicate device with a known history of safe and effective use. This is primarily established through non-clinical laboratory testing and engineering analysis, not clinical outcome data or expert consensus on diagnostic images.

8. The sample size for the training set

• Not applicable. There is no "training set" in the sense of machine learning for this device.

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

• Not applicable. No training set exists for this device in this context.

In summary, this 510(k) submission for the Bilok® ST Screw relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than extensive clinical studies or the establishment of ground truth through expert review of clinical data.

Ask a specific question about this device

The Bilok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place.

The Bilok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

The Bilok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

The Bilok® Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).

The provided documentation for the Bilok® Screw (K071091) does not contain specific acceptance criteria or a detailed study report proving the device meets particular performance metrics beyond substantial equivalence to a predicate device.

Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, which is a common pathway for 510(k) clearance. This means that the device is shown to be as safe and effective as a device already on the market, rather than meeting novel performance criteria through independent testing.

Based on the provided text, here's what can be extracted and inferred regarding the "study" that proves the device meets acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly available in the provided text. The document repeatedly states that "Documentation provided demonstrates that the Bilok® Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness." This implies that the 'acceptance criteria' are implicitly met if substantial equivalence to the predicate is established. Without knowing the predicate device and its specific performance data, no quantitative table can be generated from this document for the Bilok® Screw.

2. Sample size used for the test set and the data provenance: This information is not provided. The document only mentions "Non Clinical Testing" but does not detail the methodology, sample sizes, or provenance of any data used for comparison or testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As no specific test set or data generating study is described, there's no mention of experts establishing ground truth.

4. Adjudication method for the test set: This information is 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 is not applicable. The Bilok® Screw is a bone screw, not an AI-powered diagnostic device. Therefore, MRMC studies with human readers and AI assistance are not relevant to its regulatory submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable. The Bilok® Screw is a physical medical device, not an algorithm.

7. The type of ground truth used: This information is not explicitly provided. Given the nature of a bone screw, "ground truth" would likely relate to biomechanical properties (e.g., pull-out strength, insertion torque, fatigue life) compared against the predicate device. However, the specific type of data (e.g., direct measurement, mechanical testing standards, in-vivo animal studies) isn't detailed. The document only refers to "Non Clinical Testing."

8. The sample size for the training set: This is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: This is not applicable.

In summary of the "Study" mentioned:

The "study" referenced in the document is a "Non Clinical Testing" process that aims to demonstrate "Substantial Equivalence" of the Bilok® Screw to a legally marketed predicate device.

• Acceptance Criteria: Implicitly, the acceptance criterion is that the Bilok® Screw performs at least as well as and shares similar technological characteristics to the predicate device in terms of safety and effectiveness, such that any differences "do not raise any concerns."
• Proof: The "documentation provided" (which is not included in this extract in detail) contains the results of this non-clinical testing.
• Key Phrase: "Documentation provided demonstrates that the Bilok® Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness."

This type of submission often relies on a combination of:

• Material characterization: Ensuring the composite material (calcium phosphate and PLLA) meets specifications and is comparable to materials used in the predicate.
• Biomechanical testing: Comparing properties like insertion torque, pull-out strength, and fatigue resistance of the Bilok® Screw to the predicate device using standardized in-vitro methods.
• Dimensional comparison: Matching the design, dimensions, and cannulation to the predicate device.

Without the actual "documentation provided" mentioned, specific details about exact tests, data, and criteria remain undisclosed in this 510(k) summary.

Ask a specific question about this device