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The Arthrotek® Maxfire™ Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

The Arthrotek® Maxfire™ Meniscal Repair Device is a permanent fixation anchor composed of 2-0 Maxbraid™ ultra-high molecular weight polyethylene/polypropylene suture (Teleflex Medical, K040472) covered with two nonresorbable polyester or polyethylene sleeves. The anchors are pre-loaded on to an insertion instrument. The inserter allows for single entry into the joint. Once in the joint, the inserter will pierce the meniscus at the desired location. A pusher within the handle of the inserter allows separate deployment of the anchors, one on each side of the tear. After the second anchor has been deployed, the free ends of suture are gently pulled by the surgeon, drawing the loops into a flat, donut-shaped ring. This anchor sits on the backside of the meniscus. The suture is covered with either a polyester or polyethylene sleeve in order to control the size of the knot thus ensuring that the anchor does not become too small and pull through the meniscal tissue. By tensioning the suture, a sliding knot allows the meniscal tear to be compressed.

This document is a 510(k) summary for the Arthrotek® Maxfire™ Meniscal Repair Device. It details the device's description, intended use, and claims of substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence." However, it does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the non-clinical data).

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

This information is not provided in the document. The testing was non-clinical laboratory testing, not human-read clinical studies.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. The testing was non-clinical laboratory testing, not human-read clinical studies requiring adjudication.

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

No MRMC study was done. The document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone Performance Study:

A standalone study was done in the sense that non-clinical laboratory testing was performed on the device itself. However, this was not an "algorithm only without human-in-the loop performance" study as the device is a physical medical device, not an AI algorithm. The document states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

7. Type of Ground Truth Used:

The ground truth for the non-clinical testing would have been established through a set of predefined performance specifications and engineering standards for medical devices of this type (suture anchors). The results of the non-clinical laboratory tests would then be compared against these established functional and performance requirements to determine if the device was "functional within its intended use."

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device and therefore does not have a "training set" in the context of an AI algorithm.

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

This information is not applicable, as the device is a physical medical device and does not utilize a training set.

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Indications for the 2.8 and 3.5mm LactoScrew® Suture Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow and knee. Specific indications are as follows: Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/tendon repair.

The 2.8 and 3.5mm LactoScrew® Suture Anchors, which are comprised of LactoSorb® resorbable copolymer (85% PLLA/15% PGA), are molded suture anchors used to reattach soft tissue to bone. All 2.8 and 3.5mm LactoScrew® Suture Anchors are pre-loaded with either one or two sutures.

The provided text is a 510(k) summary for the 2.8 and 3.5mm LactoScrew® Suture Anchors. This documentation is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for this specific device is not present in the provided document. The document explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."

It instead relies on "Non-Clinical Testing" which "indicated that the devices were functional within their intended use" and a comparison of technological characteristics to predicate devices.

Summary of available information based on the prompt's request:

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

• Not provided. The document does not specify quantitative acceptance criteria or performance metrics derived from clinical testing for this device. It only states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use."

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

• Not applicable. No clinical test set or data provenance is mentioned.

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. No clinical test set requiring expert ground truth is mentioned.

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

• Not applicable. No clinical test set requiring adjudication is mentioned.

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 physical medical device (suture anchor), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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)

• Not applicable. No clinical ground truth is mentioned. The basis for substantial equivalence was "Non-Clinical Testing" for functionality and comparison to predicate devices.

8. The sample size for the training set

• Not applicable. No training set data is mentioned for this type of device submission.

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

• Not applicable. No training set data or ground truth establishment process is mentioned.

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Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction

Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The design enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.

The provided text describes a 510(k) premarket notification for a medical device called the Hitch™ LactoSorb® Suture Anchor. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined and a device's performance against those criteria is measured using a test set with corresponding ground truth.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, and expert adjudication cannot be extracted from this document as it does not contain information about a clinical or standalone performance study.

Here's an attempt to address the points based on the provided text, heavily indicating when the information is not present:

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

Explanation: The document does not define specific, quantifiable acceptance criteria for the device's performance (e.g., a certain pull-out strength, a specific failure rate, or a particular clinical outcome threshold). Instead, the basis for approval is "substantial equivalence" to a legally marketed predicate device. The performance is reported as meeting this substantial equivalence through non-clinical testing.

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

• Sample size used for the test set: Not applicable. No clinical or standalone device performance test set is described.
• Data provenance: Not applicable. The "Non-Clinical Testing" mentioned likely refers to bench-top or mechanical tests, not human data. No country of origin is specified for these non-clinical tests.

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. No ground truth was established for a test set as no such clinical or performance study involving human data or expert assessment is described.

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

• Not applicable. No adjudication method is mentioned as there is no human-involved test set requiring expert consensus.

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 device is a suture anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and not mentioned.

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

• No. This device is an implantable medical device, not an algorithm. The "Non-Clinical Testing" could be considered a form of standalone performance assessment in a mechanical sense, but it's not "algorithm only" performance.

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

• Not applicable. For the non-clinical testing, the "ground truth" would likely be engineering specifications, material properties, and mechanical test standards, rather than clinical or expert-derived ground truth.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As there is no training set mentioned, no ground truth for it was established.

Summary:

The provided 510(k) summary is for a traditional medical device (a suture anchor) and primarily relies on demonstrating "substantial equivalence" to a predicate device through non-clinical laboratory testing. It does not involve AI, clinical studies with human participants, expert adjudication, or the establishment of ground truth in the manner that would be relevant for a diagnostic or AI-powered medical device. The information requested regarding acceptance criteria and study methodology is largely absent because the regulatory pathway chosen (510(k) for a device like this) typically focuses on comparative technological characteristics and function rather than detailed clinical performance studies with defined acceptance criteria for novel outcomes.

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Indications for the ALLthread™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair.

The ALLthread™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolice resorbable material, preloaded with #2 polyethylene surgical sutures. The design will enable the anchor to be inserted either without pre-drilling or through a pre-drilled hole.

The provided document is a 510(k) summary for the ALLthread™ LactoSorb® Suture Anchor. It details the device's characteristics and its substantial equivalence to a legally marketed predicate device. However, it explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."

This means that a study proving the device meets specific acceptance criteria based on clinical performance was not performed for this submission. The substantial equivalence was determined through non-clinical laboratory testing.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document.

If this were a document that included such a study, the information would typically be presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: [Number of devices/tests]
• Data Provenance: [e.g., In vitro laboratory testing, Animal study in X species, etc. (Since clinical testing was not done, this would describe the non-clinical test set)].

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

• Not applicable for this type of submission. For clinical studies involving human interpretation or diagnosis, this would usually involve physicians, radiologists, or other specialists.

4. Adjudication Method for the Test Set:

• Not applicable for this type of submission. Adjudication is typically used in clinical trials involving human assessment to resolve discrepancies.

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

• No, an MRMC study was not done. These are highly specific to AI/software performance studies involving human readers.

6. Standalone (Algorithm Only) Performance:

• No, standalone performance was not assessed. This is also specific to AI/software.

7. Type of Ground Truth Used:

• For this submission, the "ground truth" for non-clinical testing would be the established scientific and engineering principles and standards used to evaluate the device's physical and mechanical properties, as well as its biocompatibility. For instance, tensile strength measurements have an objective "ground truth" based on physics.

8. Sample Size for the Training Set:

• Not applicable. This relates to machine learning models, which are not described in this submission.

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

• Not applicable. This also relates to machine learning models.

In summary, based on the provided text, the ALLthread™ LactoSorb® Suture Anchor received its 510(k) clearance based on non-clinical laboratory testing demonstrating substantial equivalence to a predicate device, without the need for clinical testing or establishing specific clinical acceptance criteria.

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Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.

The EZLoc™ Femoral Fixation Device is the same design as the predicate Femoral Hook (EZLoc™), deared in K041261, with additional sizes. The device includes a body, an arm, a passing pin and a pull suture. The implant will be available in three diameters: 5-6mm, 7-8mm and 9-10mm; and five lengths: 15mm, 20mm, 25mm, 30mm and 35mm. The sizes will account for the varying diameters and lengths of the replacement graft and femoral tunnel length. Currently the devices are packaged with a #2 polyethylene suture, but may also be used with any legally marketed, nonresorbable suture.

This document describes a 510(k) premarket notification for the EZLoc™ Femoral Fixation Device. This is a medical device submission seeking clearance based on substantial equivalence to predicate devices, not a study evaluating device performance against pre-defined acceptance criteria in a clinical setting.

Therefore, the requested information about acceptance criteria, detailed study design, and performance metrics is generally not applicable in the context of this 510(k) summary.

Here's why and what information is available based on the provided text:

• 510(k) Substantial Equivalence: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves showing similar technological characteristics, materials, design, and intended use as the predicate device(s). It does not typically involve proving that the device meets specific, pre-defined quantitative performance acceptance criteria through extensive clinical trials.
• "Non-Clinical Testing" vs. Clinical Trials: The document explicitly states "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This refers to bench testing and material characterization, not a clinical study with patients or human readers.
• "Clinical Testing: None provided as a basis for substantial equivalence.": This directly confirms that no human clinical data was used to support this 510(k) submission.

Given this, I cannot provide the requested information in the format you specified, as those details are typically found in documents describing clinical trials or performance studies that are not part of this specific 510(k) summary.

However, I can extract what is stated in relation to the non-clinical testing:

Relevant Information from the 510(k) Submission:

• Acceptance Criteria/Performance: The submission's non-clinical testing "indicated that the device was functional within its intended use." Specific quantitative acceptance criteria or detailed performance metrics are not provided in this summary. The "acceptance criterion" in this context is the FDA's determination of substantial equivalence to the predicate devices.
• Study That Proves the Device Meets Acceptance Criteria: "Non-clinical laboratory testing was performed to determine substantial equivalence." This testing (presumably mechanical, material, and functional bench tests) supported the claim of substantial equivalence. No details on the methodology, sample sizes, or specific results of these tests are provided in this summary.

Therefore, the table and other requested sections would mostly be marked as "N/A" or "Not Provided in 510(k) Summary".

Here's a breakdown of why each point is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable/Not provided. The "test set" in the context of device performance would refer to clinical study subjects or a specific number of devices tested in a lab. For non-clinical testing, the number of units tested is not disclosed.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. Since no clinical data was submitted, this doesn't apply. For non-clinical lab testing, the location is not specified, but typically conducted in-house or by accredited labs.

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

• Number of Experts: Not applicable. No clinical ground truth was established for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set or human interpretation was involved.

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

• MRMC Study Done: No.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable. This device is a physical fixation device, not an AI diagnostic tool, and no clinical studies were performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Not applicable. This device is a physical fixation device, not an algorithm or software. The "non-clinical testing" could be considered "standalone" in the sense of lab tests without human "in-the-loop" clinical interpretation.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established engineering specifications, material properties, and functional benchmarks derived from predicate devices or established standards.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring training data.

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

• How Ground Truth Was Established: Not applicable.

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The tibial screws and washers are indicated for the following procedures: 1. Anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction 2. Medial collateral ligament repair 3. Lateral collateral ligament repair 4. Posterior oblique ligament repair 5. Iliotibial band tenodesis reconstruction 6. Patellar ligament and tendon repair This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

The Nonresorbable CentraLoo™ Tibial Screws and Washers are a series of the seconding the Same of Sation of Sation to hans Device Deseription: - Ins designed for soft tissue fixation to bone.

The provided text is a 510(k) summary for a medical device called the "Nonresorbable CentraLoc™ Tibial Screw and Washer." It describes the device, its intended use, and claims substantial equivalence to existing legally marketed devices.

Based on the information provided, here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. The submission states "Clinical testing was not necessary." The evaluation was based on mechanical testing and comparison to predicate devices, not on a clinical test set.
• Data Provenance: Not applicable for a clinical test set. The mechanical testing would have been conducted in a laboratory setting, likely in the US, but specific details are not provided.

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

• Not applicable. No clinical test set. The determination of substantial equivalence was made by the FDA based on the provided information, which included mechanical testing results and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

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

• Was it done? No. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence for the Nonresorbable CentraLoc™ Tibial Screw and Washer."
• Effect Size: Not applicable as no such study was conducted.

6. Standalone (Algorithm Only) Performance Study

• Was it done? Not applicable. This is a physical medical device (tibial screw and washer), not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

• Not applicable for a clinical ground truth. The "ground truth" for this submission was the established safety and effectiveness of the legally marketed predicate devices, against which the new device's mechanical properties and intended use were compared.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

• Not applicable. This is a physical medical device.

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The Ti-Screw Anchor SP is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction.

Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow Indications - Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee Indications - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

The Ti-Screw Anchor SP consists of a screw tip, a screw body, and an internal cross pin to attach the suture. The screw tip engages the bone while the screw body provides the means to drive the anchor in, and the pin is used to attach the suture to the anchor.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the Ti-Screw Anchor SP, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical mechanical testing.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:

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

   • Acceptance Criteria: Not explicitly stated. The submission relies on substantial equivalence to predicate devices, implying that performance comparable to those devices is the "acceptance criterion" for marketing.
   • Reported Device Performance: Mechanical testing found the Ti - Screw Anchor SP to be substantially equivalent to the predicate Harpoon Suture Anchor and Metal Screw Anchor in terms of mechanical properties. Specific numerical performance metrics or thresholds are not provided in this summary.

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

   • Sample Size: Not specified for the mechanical testing.
   • Data Provenance: Not specified. It's non-clinical testing, likely conducted in a lab environment.

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 is not applicable as there was no clinical testing performed as a basis for substantial equivalence. The "ground truth" for non-clinical mechanical testing would be based on engineering specifications and direct measurements against those specifications.

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

   • Not applicable as there was no clinical testing requiring human adjudication.

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, not an AI software or diagnostic tool that would involve human readers or AI assistance. No clinical testing, let alone an MRMC study, was conducted.

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

   • Not applicable. This device is a surgical implant, not an algorithm.

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

   • For the non-clinical mechanical testing, the ground truth would be the established engineering specifications and physical properties of the materials and design, measured directly. There's no clinical "ground truth" like pathology or outcomes data presented here because no clinical testing was performed.

8. The sample size for the training set

   • Not applicable. No training set is mentioned as this is not a learning algorithm or AI device.

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

   • Not applicable.

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Indications for the Resorbable Interference Screw includes use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following:

Shoulder: Batkart repair, SLAP lesion repair, acromio-clavioular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnat/radial collateral ligament

reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ultar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquus (VMO) muscle advancement.

In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0mm screws are indicated for the following uses:

• 1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
• 2. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
• 3. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.

The 3 mm, 4 mm, 6 mm, 10 mm, 11 mm, and 12 mm as well as the 9 mm x 35 mm Resorbable Interference Screws are an addition to the 7 mm, 8 mm, and 9 mm interference screws already cleared in 510(K) K982497. They are made of the same LactoSorb® material as the predicate devices.

The provided text describes a 510(k) premarket notification for a medical device, the "Resorbable Interference Screw." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive studies.

Therefore, the input document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as typically understood for new device performance claims.

Here's a breakdown of why and what information is present related to equivalency:

Why the requested information is not available in the document:

• Acceptance Criteria and Device Performance: The document does not define specific performance metrics (e.g., tensile strength, degradation rate, biocompatibility standards with defined thresholds) that the "Resorbable Interference Screw" had to meet. Instead, it relies on demonstrating that the new screw is substantially equivalent to existing, legally marketed screws.
• Study Proving Acceptance Criteria: Because specific acceptance criteria with defined thresholds are not provided, there's no study described that "proves" the device meets them in the conventional sense. The "study" mentioned is "Non-Clinical Testing" for substantial equivalence.

Information available related to equivalency:

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

   • Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criterion is that the "Resorbable Interference Screw" must be substantially equivalent to the predicate devices.
     • Predicate Devices:
       • Arthrotek Interference Screw - Arthrotek Inc. (K982497)
       • Soft Tissue Screw and Washer - Arthrotek Inc. (K012572)
       • Resorbable Screw Anchor - Arthrotek Inc. (K012872)
   • Reported Device Performance (as demonstrated for substantial equivalence):
     • Non-Clinical Testing: "Mechanical testing was done on the 3.0 mm Resorbable Interference Screw. This testing indicated that the Resorbable Interference Screw was substantially equivalent to the predicate devices."
     • Materials & Manufacturing: "The Resorbable Interference Screw is made of the same materials, using the same manufacturing processes, and conforming to the same standards as the predicated Arthrotek Interference Screw (K982497)."
     • Intended Use & Indications: The new device shares the same intended use (soft tissue fixation to bone) and expanded indications (specific shoulder, wrist/hand, ankle/foot, elbow, and knee procedures, including ACL/PCL reconstruction) as the predicate devices and prior cleared versions.

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 states "Mechanical testing was done on the 3.0 mm Resorbable Interference Screw." It does not specify the sample size for this mechanical testing.
   • Data provenance (country, retrospective/prospective) is not mentioned.

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

   • Not applicable. This was mechanical testing, not a study requiring expert readers or ground truth established by clinical experts.

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

   • Not applicable. No adjudication method is mentioned as it was mechanical testing.

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 or imaging device. No MRMC study was performed.

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

   • Not applicable. This is not an AI device.

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

   • For the mechanical testing, the "ground truth" would be the established engineering and materials standards (implied by "conforming to the same standards as the predicated Arthrotek Interference Screw") and the performance characteristics of the predicate devices.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this is not a machine learning device.

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

   • Not applicable. There is no mention of a "training set."

Conclusion:

The document focuses on demonstrating substantial equivalence to existing devices through similar materials, manufacturing, intended use, and general performance (indicated by mechanical testing outcome). It explicitly states, "Clinical testing: Clinical testing was not required for these components to support substantial equivalence." This means the device was not subjected to a study designed to meet specific new acceptance criteria in the way a novel, high-risk device or an AI device might be.

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Fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

The Femoral Hook device includes a body and an arm. The body incorporates an eyelet that provides a means to attach the soft tissue grafts. The arm is used to anchor the body to the cortical bone.

The provided document is a 510(k) summary for the Femoral Hook device, which is a soft tissue anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical testing and does not involve an AI/ML component or related studies that would typically require the requested information on acceptance criteria, reader studies, or ground truth establishment relevant to AI performance.

Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluation, which is not applicable here.

Here's what can be extracted and what cannot:

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

Explanation: The document states "Mechanical testing indicated that the Femoral Hook had a greater pull-out strength than the predicate device." However, no specific quantitative acceptance criteria (e.g., "pull-out strength must be X Newtons") or detailed performance measurements (e.g., "Femoral Hook achieved Y Newtons vs. Predicate Device's Z Newtons") are provided in this summary. The primary criterion for substantial equivalence in this context is that the new device performs at least as well as, or better than, the predicate device in relevant mechanical tests.

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

• Sample size for the test set: Not specified in the document. Mechanical testing details are summarized, not fully disclosed.
• Data provenance: Not applicable. This is mechanical testing of a medical device, not a study involving patient data.

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. Ground truth in the context of expert review pertains to AI/ML device evaluation against clinical assessments. This document describes mechanical testing of a physical device.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 refer to expert consensus processes for establishing ground truth in clinical data reviews (e.g., radiology images). This document describes mechanical testing.

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. The document explicitly states: "No clinical testing was provided as a basis for substantial equivalence." A MRMC study is a type of clinical study, often involving human readers and AI.
• Effect size: Not applicable as no such study was conducted.

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 or AI model.

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

• Not Applicable/Intrinsic Property: The "ground truth" for mechanical testing would be the actual physical properties and performance measured under controlled laboratory conditions (e.g., actual pull-out strength, breaking stress). It doesn't rely on expert consensus or pathology in the same way an AI diagnostic device would.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; therefore, there is no training set in the context of machine learning.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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