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510(k) Data Aggregation
(44 days)
The Healix BR and Gryphon BR Anchors are intended for:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
The Healix BR and Gryphon BR Anchors are absorbable threaded suture anchors manufactured of "Biocryl Rapide" material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Healix BR Anchor is provided in three sizes: one with an outer diameter of 4.5mm. another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The Gryphon BR Anchor is provided as size 3.0mm. The suture options may or may not include tapered needles to facilitate suture passage through tissue. The Healix BR and Gryphon BR Anchors are currently offered with absorbable Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.
1. Acceptance Criteria and Reported Device Performance:
The document provided does not specify explicit acceptance criteria for device performance based on quantitative metrics. Instead, the "Safety and Performance" section states: "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This implies that the acceptance criteria were met by demonstrating substantial equivalence to pre-existing, legally marketed devices.
Therefore, the table would reflect this:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K071481, K070925, K071177, K032717, K060830) in terms of safety and performance for stated indications. | Demonstrated substantial equivalence to predicate devices based on performance and safety testing. |
2. Sample Size and Data Provenance:
The document does not provide details on the sample size used for any specific tests or studies. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing. The statement is general, referring to "performance and safety testing."
3. Number and Qualifications of Experts for Ground Truth:
This information is not provided in the document. The substantial equivalence claim is against predicate devices, not based on expert-established ground truth on a new dataset.
4. Adjudication Method:
This information is not provided in the document. As no specific "test set" with ground truth established by experts is mentioned, adjudication methods like 2+1 or 3+1 are not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The submission focuses on substantial equivalence to predicate devices rather than direct comparative effectiveness with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
This information is not applicable as the device is a physical bone anchor, not an algorithm or AI-based system. Therefore, an "algorithm only" performance study would not be relevant.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically applied in AI/software evaluation (e.g., expert consensus, pathology, outcome data) is not directly relevant here. The "ground truth" in this context is implicitly the established safety and performance profile of the predicate devices to which this device is compared for substantial equivalence.
8. Sample Size for the Training Set:
This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is a physical bone anchor and does not involve AI or algorithms that require a "training set."
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(112 days)
The KSEA MegaFix®-C Elioabsorbable Composite Interference Screw is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
The KSEA MegaFix®-C Bioabsorbable Composite Interference Screw is a one-time use biodegradable implant, provided to the end user in a sterile condition, and intended for interference fixation of grafts in human cruciate ligament reconstruction. The device is a bioabsorbable composite interference screw which utilizes lactide polymer composite technology to perform the intended use.
The provided text describes the KSEA MegaFix®-C Bioabsorbable Composite Interference Screw, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria. It mentions the device description, indications for use, and technological characteristics, and lists predicate devices, but no performance study details are included.
Therefore, I cannot populate the requested table or answer the specific questions related to a study's methodology, sample sizes, ground truth, or expert involvement.
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(29 days)
The Bioknotless BR Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair 2. SLAP lesion repair; 3. Rotator cuff repair; 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site; 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus; 5. Biceps tenodesis 6. Acromio-clavicular separation; 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment; 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction; 2. Lateral stabilization 3. Medial stabilization at the medial talus site; Foot: Hallux Valgus reconstruction; 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair; 2. Lateral collateral ligament repair; 3. Joint capsule closure to anterior proximal tibia; 4. Posterior oblique ligament or joint capsule to tibia repair; 5. Extra capsular reconstruction / ITB tenodesis; 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER; 1. Bankart repair 2. SLAP lesion repair; 3. Rotator cuff repair; 4. Capsule shift repair (glenoid rim) The Lupine Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair, 2. SLAP lesion repair 3. Rotator cuff repair, 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site, 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, 5. Biceps tenodesis, 6. Acromio-clavicular separation, 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment, 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction, 2. Lateral stabilization 3. Medial stabilization at the medial talus site, Foot: Hallux Valgus reconstruction, 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair, 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia., 4. Posterior oblique ligament or joint capsule to tibia repair, 5. Extra capsular reconstruction / ITB tenodesis, 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER:1. Bankart repair, 2. SLAP lesion repair, 3. Rotator cuff repair, 4. Capsule shift repair (glenoid rim)
Bioknotless BR Anchor / Lupine BR are a preloaded, disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus. The anchor material is changing from absorbable polylactic acid (PLA) in the predicate device to Biocryl Rapide a B-TCP/PLGA biocomposite material in the proposed devise. The anchor is a one piece suture anchor sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
The Bioknotless BR Anchor / Lupine BR Anchor is a medical device for soft tissue repair to bone. The acceptance criteria and supporting study details are as follows:
1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | The device should demonstrate equivalent or superior mechanical properties compared to the predicate device, specifically regarding its ability to withstand forces during soft tissue to bone fixation. This would typically involve metrics such as pull-out strength, insertion torque, and degradation characteristics consistent with its intended use and duration of support. | The submission states: "Bench testing was performed demonstrating that the Bioknotless BR Anchor / Lupine BR Anchor met predetermined acceptance criteria." While specific numerical performance values are not provided in this summary, the FDA's clearance (K070925) indicates that the device's mechanical performance, derived from bench testing, was found to be acceptable and substantially equivalent to the predicate device. The change in material from absorbable polylactic acid (PLA) to Biocryl Rapide (a ß-TCP/PLGA biocomposite) implies that the new material's mechanical and degradation properties were thoroughly evaluated to ensure continued safety and effectiveness for soft tissue to bone fixation. The use of Biocryl Rapid in existing Mitek Milagro Screws (K032717, K060830) for similar indications further supports its proven mechanical suitability. |
| Biocompatibility | The device material must be biocompatible and elicit no unwarranted inflammatory or toxic response in vivo. | While not explicitly detailed as a separate "study" section, the fact that the material (Biocryl Rapid, a ß-TCP/PLGA biocomposite) is "currently used in the Mitek Milagro Screw (K032717, K060830)" implies that its biocompatibility has already been established and accepted by the FDA for similar applications in bone fixation. New biocompatibility testing specific to this device would likely have been conducted and reviewed as part of the overall bench testing, satisfying relevant ISO standards (e.g., ISO 10993 series). |
| Dimensional Equivalence | The dimensions of the anchor should be identical to the predicate device to ensure similar surgical handling and implantation. | The submission explicitly states: "The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus." This indicates that this criterion was met by design. |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "Bench testing was performed". This implies that the test set consisted of a number of physical anchor samples that underwent mechanical and potentially other laboratory tests. However, the specific sample size (e.g., number of anchors tested for pull-out strength, number of samples for degradation studies) is not specified in the provided 510(k) summary.
Regarding data provenance, the testing was performed as bench testing, meaning it was conducted in a laboratory setting. This is a form of prospective data collection specifically designed to evaluate the physical and mechanical properties of the device before clinical use. The country of origin of the data is not explicitly stated but would typically be the location of the manufacturing and R&D facilities of DePuy Mitek (USA, as inferred from the submitter's address).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of medical device (suture anchor) does not typically involve "experts" establishing a "ground truth" for a "test set" in the way an AI diagnostic algorithm would. For a mechanical device, the "ground truth" is established by objective engineering specifications, material science standards, and established biomechanical testing protocols.
The "experts" involved would be:
- Engineers and material scientists employed by DePuy Mitek who designed the product and established the design specifications and testing protocols.
- Laboratory technicians who conducted the bench tests according to established procedures.
- Regulatory specialists who ensure the testing meets regulatory requirements and standards.
Their qualifications would be relevant engineering, material science, or biological science degrees and experience in medical device development and testing.
4. Adjudication Method for the Test Set
As this is bench testing of a physical device, an "adjudication method" in the context of human interpretation (like 2+1 or 3+1 for imaging studies) is not applicable. The "adjudication" for bench test results involves:
- Comparison to predetermined acceptance criteria: Test results are directly compared against established numerical thresholds (e.g., minimum pull-out strength).
- Verification of methodology: Ensuring that the testing was performed according to validated protocols and standards.
- Statistical analysis: Results are typically analyzed statistically to confirm reliability and meet acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this device. This type of study is typically used for diagnostic devices or AI algorithms where human interpretation of data (e.g., medical images) is involved, and the goal is to assess the impact of the device on human reader performance. The Bioknotless BR Anchor / Lupine BR Anchor is a surgical implant, not a diagnostic tool requiring human interpretation for its primary function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an "algorithm only without human-in-the-loop performance" is not applicable. This phrasing refers to the performance of artificial intelligence or computational algorithms. The Bioknotless BR Anchor / Lupine BR Anchor is a physical medical implant, not an algorithm. Its performance is assessed through bench testing (mechanical, material, and biocompatibility studies) and potentially clinical outcomes for previously approved similar products.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective engineering and material science metrics derived from:
- Established mechanical properties defined by industry standards and internal design specifications (e.g., minimum tensile strength, maximum degradation rate).
- Biocompatibility standards (e.g., ISO 10993 series) for the material.
- Dimensional specifications for the physical anchor.
In short, the ground truth is based on physical and chemical measurements against predefined, objective standards.
8. Sample Size for the Training Set
There is no explicit "training set" mentioned or implied for this device in the context of machine learning or AI. The term "training set" is relevant for AI algorithms that learn from data.
If interpreted loosely as the historical data and experience informing the device's design, then:
- The predicate device (Bioknotless Plus Anchor / Lupine Anchor Plus) serves as a "trained" entity from which the new device derives its substantial equivalence. The design and performance data from this predicate, and other similar devices, implicitly "trained" the design choices for the Bioknotless BR Anchor / Lupine BR Anchor.
- The material Biocryl Rapid has prior use in "Mitek Milagro Screw (K032717, K060830)," which means clinical and bench data from those devices provided a "training set" for the material's properties and safety profile.
9. How the Ground Truth for the Training Set Was Established
Given the interpretation above:
- For the predicate device, its ground truth would have been established through its own bench testing, potentially animal or clinical studies, and successful marketing and clinical use, all demonstrating its safety and effectiveness.
- For the Biocryl Rapid material, the ground truth would have been established through extensive material science testing (mechanical, chemical, degradation), biocompatibility studies (in vitro and in vivo), and documented clinical use in other FDA-cleared devices like the Mitek Milagro Screw.
In essence, the "ground truth" for the "training set" (prior devices and materials) was established through comprehensive scientific and regulatory evaluation over time.
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