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Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:

Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement

Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction

Hip - Capsular Repair (acetabular labral repair)

The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.

The provided text is a 510(k) Summary for the Harpoon® Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices.

Therefore, most of the requested information cannot be extracted from this document.

Here's an assessment based on the available text:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or a reported device performance table as would be expected for a diagnostic or AI device. Instead, it states:

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

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

A test set was not used in the context of performance evaluation against acceptance criteria, as no clinical testing or specific non-clinical performance evaluation against predefined criteria is detailed.

• Sample Size (Test Set): Not applicable, as no dedicated "test set" for performance evaluation is described.
• Data Provenance: Not applicable.

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

Not applicable, as no ground truth was established from expert review for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

This concept is not relevant to the Harpoon® Suture Anchor, which is a physical medical device (suture anchor), not an algorithm or a software device.

7. The type of ground truth used

Not applicable. The "ground truth" concept (e.g., pathology, expert consensus) is typically associated with the evaluation of diagnostic or prognostic devices/algorithms. For a physical device like a suture anchor, "ground truth" would refer to its physical properties and mechanical performance, which were assessed via non-clinical testing. However, the details of how this was established are not provided other than: "Non-clinical laboratory testing was performed to determine substantial equivalence."

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of what the document does provide regarding "proof" of meeting criteria:

The document leverages the concept of substantial equivalence to predicate devices. The "study" that proves the device meets (implicitly, rather than explicitly stated) acceptance criteria is the non-clinical laboratory testing that compared the Harpoon® Suture Anchor to its predicates.

"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."

This implies that the non-clinical tests (e.g., mechanical strength, pull-out force, material biocompatibility, etc. – although not detailed in this summary) demonstrated performance comparable to the predicate devices, thereby supporting the claim that it is "functional within its intended use" and "substantially equivalent." No specific quantitative acceptance criteria or detailed results from these non-clinical tests are included in this 510(k) Summary.

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The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:

Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis

Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Hip
Acetabular labral repair

In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:

Knee
ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction

The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoop™ , a Button or a coreless Sleeve structure, and a passing suture. A ZipLoop™ is constructed from ultra high molecular weight polyethylene (UHMWPE) or polyester. It is passed through the Sleeve or Button, thus creating a soft tissue fixation device that bunches or locks against the bone when deployed.

The Biomet Sleeve and Button Soft Tissue Devices received 510(k) clearance (K071704) based on substantial equivalence to legally marketed predicate devices, rather than through a study demonstrating direct achievement of specific performance acceptance criteria for a novel device. Therefore, the information provided in the document does not include a detailed table of acceptance criteria and reported device performance in the way typically seen for a new technology requiring such validation.

Instead, the submission relied on non-clinical testing and comparison to predicates.

Here's a breakdown based on the provided text:

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

This information is not explicitly available in the provided 510(k) summary. The submission states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is a general statement rather than a detailed report of specific performance metrics against defined acceptance criteria. Without a specific new performance claim, the FDA typically assesses substantial equivalence based on materials, design, and intended use being similar enough to established predicates.

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

• Sample Size for Test Set: Not applicable/not specified. Clinical testing was not provided as a basis for substantial equivalence. The non-clinical testing details are not provided.
• Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing details (e.g., in vitro, cadaveric) are not specified, nor is the country of origin.

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

Not applicable, as no clinical studies requiring expert ground truth establishment for a test set were conducted.

4. Adjudication method for the test set

Not applicable, as no clinical studies requiring adjudication were conducted.

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 fixation device, not an AI-assisted diagnostic or imaging tool.

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

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

7. The type of ground truth used

Not applicable for clinical studies for this submission. For the non-clinical testing, the "ground truth" would implicitly be relevant engineering standards, biomechanical properties, and the established performance of the predicate devices.

8. The sample size for the training set

Not applicable, as no machine learning algorithm was involved.

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

Not applicable, as no machine learning algorithm was involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria, in this context, is the non-clinical testing mentioned in the 510(k) summary. The nature of a 510(k) clearance for this type of device (soft tissue fixation) primarily relies on demonstrating that the new device is substantially equivalent to existing legally marketed predicate devices.

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."

This indicates that Biomet performed tests (likely mechanical, biomechanical, and material characterization tests) to ensure the physical properties and performance characteristics of the Sleeve and Button Soft Tissue Devices were comparable to the predicate devices. The "acceptance criteria" were therefore implicitly that the new device's performance would fall within ranges deemed acceptable and safe, consistent with the performance of the chosen predicate devices, for the stated indications for use.

The predicates listed are:

• Multitak SS Suture System™ (K973015) - Bonutti Research
• BioRaptor™ (K053344) - Smith & Nephew
• Cruciate Ligament Button (PolySuture Button) (K813581) - Biomet Sports Medicine

The "study" was a set of non-clinical tests designed to show that the new device's materials, design, sizing, and ability to perform soft tissue to bone fixation did not raise new questions of safety or effectiveness when compared to these existing devices. The specifics of these tests (e.g., pull-out strength, fatigue testing, material biocompatibility) are not detailed in this summary but would have been part of the full 510(k) submission.

In essence, for a 510(k) based on substantial equivalence and non-clinical data alone for a device like this, the "acceptance criteria" are that the device performs functionally within its intended use and is comparable enough to predicates that it doesn't require a new PMA.

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Indications for the PEEK Knotless 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 Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair

Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction

Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair

Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement

The PEEK Knotless Anchors are single-use devices.

The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.

The provided text describes a 510(k) premarket notification for "PEEK Knotless Anchors" by Biomet Sports Medicine, Inc. As such, it focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria for a new device and proving its attainment through a dedicated study.

Therefore, many of the requested elements (acceptance criteria, study details, expert involvement, specific ground truth methods, sample sizes for training/test sets, MRMC study details) are not applicable or not explicitly provided in this type of regulatory submission.

Here's an attempt to answer the questions based on the available information:

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

The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating that the new device's technological characteristics are "similar or identical" to predicate devices, and that non-clinical testing showed it to be "functional within its intended use."

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 Test Set: Not applicable. The submission states "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence." This refers to bench testing, not clinical studies with a 'test set' of patient data. The number of samples for the non-clinical tests is not specified.
• Data Provenance: Not applicable. This was non-clinical laboratory testing, not human 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. No clinical test set or human ground truth was established, as it was non-clinical testing.

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

Not applicable. No clinical test set or human adjudication was involved.

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-based device, and no MRMC 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 (suture anchors), not an algorithm or AI system.

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

For the non-clinical testing, the "ground truth" implicitly refers to established engineering and biomechanical principles and design specifications to demonstrate functionality and equivalence. No human-based "ground truth" (like pathology or expert consensus) was used.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable. There is no training set for this type of device.

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The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot. Examples include, but are not limited to:

• Symptomatic acquired flat foot treatment in children and adolescents .
• Symptomatic congenital flexible flat foot .
• Tarsal coalitions when associated with the flatfoot deformity .
• Posterior tibial tendon dysfunction with supple feet .
• Paralytic flat foot .
• Subtalar Instability .
• Severely pronated foot .

The Subtalar Implant is a one-piece device comprised of titanium alloy or PEEK-OPTIMA® intended to be implanted into the sinus tarsi of the implant is available in eight sizes to accommodate a wide range of patient sizes. The device is used to stabilize the subtalar joint by restoring the arch of the foot and block anterior movement of the talus.

This 510(k) summary for the Biomet Subtalar Implant (K071498) primarily relies on non-clinical testing for substantial equivalence and does not include any clinical study data or acceptance criteria related to device performance in terms of diagnostic accuracy or clinical outcomes.

Here's an analysis based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document explicitly states "Non-Clinical Testing: Mechanical testing confirmed that the Subtalar Implant meets the mechanical needs of the subtalar joint and will function within its intended use." This is the only "acceptance criteria" and "performance" described. There are no detailed quantitative metrics provided for these mechanical tests (e.g., specific load endurance, fatigue limits, etc.) within this summary, suggesting these details were likely provided in a separate, more comprehensive test report that was part of the 510(k) submission but not included in this publicly available summary.

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

• Sample Size: Not applicable/Not mentioned for any human diagnostic or clinical performance study. The "test set" refers to the mechanical tests conducted. The number of physical implants or test specimens used for mechanical testing is not specified in this summary.
• Data Provenance: Not applicable for human data. For mechanical testing, the data would be generated in a laboratory setting. No country of origin is specified for the mechanical testing.

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

• Not applicable. There was no human "test set" requiring expert ground truth establishment for diagnostic or clinical performance. The "ground truth" for mechanical testing would be defined by engineering standards and specifications.

4. Adjudication Method for the Test Set

• Not applicable. No human interpretation or adjudication was involved in the mechanical testing.

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

• No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study was conducted or provided for human reader improvement with AI assistance.

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

• No. This device is a physical implant, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

• For the mechanical testing: Engineering specifications and standards. The "ground truth" for mechanical performance is determined by whether the device's physical properties withstand specified forces, fatigue cycles, etc., as per relevant industry or regulatory standards for bone fixation devices.
• For clinical efficacy/safety: Not applicable. No clinical ground truth was established or provided in this submission for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, no training set was used.

Summary of the K071498 Submission's Approach:

The K071498 submission for the Biomet Subtalar Implant relied on demonstrating substantial equivalence to previously legally marketed predicate devices through:

• Comparison of technological characteristics: Materials (titanium alloy or PEEK-OPTIMA®), design, sizing, and indications were stated to be similar or identical to predicates.
• Non-clinical mechanical testing: To ensure the device's physical integrity and functionality.
• Absence of clinical data: The submission did not provide clinical testing data, meaning substantial equivalence was established without a direct clinical comparison of outcomes. This is common for many Class II devices and 510(k) submissions where predicates exist and the technological changes are considered minor or well-understood in terms of clinical impact.

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