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510(k) Data Aggregation
(114 days)
Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.
Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.
Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.
Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments.
Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle.
Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle.
Coaxial Biopsy Needle is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle.
All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices. The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These devices cannot be used under MRI.
The provided text is a 510(k) premarket notification for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, and M Biopsy /SureAim Coaxial Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device (K222865) based on design modifications. These modifications include extending indications to breast and muscle tissues, adding a swab component, and introducing new models within existing specifications.
Crucially, this document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software-based AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC). The tests described are primarily related to the physical performance, biocompatibility, and sterility of the biopsy needles themselves, and their ability to obtain tissue samples. The "study" mentioned for the indication extension is an in vivo biopsy sampling from animal to compare the sampling performance.
Therefore, I cannot provide a detailed answer to your request in the format you've specified because the provided document does not contain the information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device per your typical requirements.
Here's what can be extracted and inferred based on the provided document, addressing the points you requested, but with the caveat that it does not fit the typical AI/ML device study format:
Acceptance Criteria and Study for M Biopsy /SureCore and /SureAim Biopsy Needles
The provided document describes the safety and performance testing for a medical device (biopsy needles) which is not an AI/ML device. The "acceptance criteria" and "study" are therefore presented in terms of device functionality, material compatibility, and intended use as a physical instrument, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML systems.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance/Findings |
|---|---|---|
| For Indication Extension (Breast & Muscle) | Biopsy needles can be used on new types of soft tissues (breast and muscle) with comparable sampling performance to the predicate device. | "We conducted in vivo biopsy sampling from animal to compare the sampling performance of the subject devices and comparator devices (K133948 and K171953) , and the results indicated no substantial difference." (This implicitly indicates the performance was acceptable for the new indications, in comparison to an already cleared device). |
| For Addition of Swab - Performance | Performance 1: Tissue strip should be successfully removed from the sampling tank, with no impurities (e.g., dander/exfoliation) in the tissue strip. | |
| Performance 2: After helping take soft tissue, the swab head should be complete, no broken, and no residual tissue strip on the swab head. | "The test results demonstrate that the aged samples complied with the pre-determined acceptance criteria." (This general statement applies to the swab performance specifications after accelerated aging). | |
| For Addition of Swab - Shelf Life | Shelf life: 5 years (maintained physical and chemical performance after simulated aging). | "Accelerated aging was used to simulate the storage of 5 years, then the physical performance tests and chemical performance tests were performed on the accelerated aged samples. The test results demonstrate that the aged samples complied with the pre-determined acceptance criteria." |
| Biocompatibility | All patient-contacting components must be biocompatible according to ISO 10993 applicable parts. (Note: Swab is not patient-contacting, so no biocompatibility test required). | "Biocompatible according to ISO 10993 applicable parts" (Stated as a characteristic, implying it meets this criterion). |
| "Since this component [swab] does not contact with the patient, therefore, biocompatibility test is unnecessary." | ||
| Sterility | SAL of 10-6. The swab component should also be sterile. | "All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6..." |
| "In order to ensure the sterility, the sterility test is carried out and the result meets the requirement." | ||
| Package Validation and Transport | Packaging integrity and maintenance of sterility. | "The swab is packaged in the previous package of Automatic Disposable Biopsy Needle and Semi-automatic Disposable Biopsy Needle without any other modification, therefore, no more test is carried out." (Implies prior validation of the packaging covers the new component). |
| EO/ECH Residuals | Residuals must be within allowable limits according to ISO 10993-7:2008+Amd.1:2019. | "Examination of the EO and ECH residuals have been conducted in accordance with ISO 10993-7:2008+Amd.1:2019 to evaluate whether the sterilized proposed device comply with the above selected allowable limits, and the results meet the requirements." |
| Addition of Product Models | New models must be within previously cleared specifications and not raise new questions of safety or effectiveness. | "Since the models to be added are all within the previous cleared specifications of K222865. Therefore, as this change, no more tests are needed." (Implies compliance by bounding the previously cleared range). |
| General Equivalence | Device is as safe, as effective, and performs as well as legally marketed predicate devices, raising no new questions of safety or effectiveness. | "The conclusions drawn from the comparison and analysis above demonstrate that the proposed subject devices are as safe, as effective, and performs as well as the legally marketed predicate devices and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test. For the in vivo animal study, the sample size is not specified. For the swab performance testing, "aged samples" are mentioned, but the quantity is not detailed.
- Data Provenance: The in vivo animal study data provenance is not specified (e.g., country of origin). The studies are "non-clinical testing" conducted by Canyon Medical Inc. (China). The data for physical/chemical tests (shelflife, EO/ECH residuals) would be from in-house lab testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is not applicable to this submission. The "ground truth" for these physical medical devices is established through engineering and biological testing (e.g., successful tissue sample retrieval, material integrity, sterility, biocompatibility), not through expert clinical consensus on diagnostic images.
4. Adjudication Method for the Test Set
This is not applicable as there is no diagnostic test performance being adjudicated by multiple experts for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted because this is a physical biopsy needle, not a software-based AI/ML device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance evaluation was not done. This is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Physical Performance Bench Testing: Verification that the device can successfully obtain tissue samples, the swab functions as intended (tissue removal, no residue), and the dimensions/mechanics are within specifications.
- Material Testing: Biocompatibility testing (per ISO 10993), sterility testing (per SAL 10-6 requirements), EO/ECH residual testing (per ISO 10993-7).
- Animal Studies: For the extended indications (breast and muscle), performing in vivo biopsy sampling in animals to compare performance with predicate devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This is not applicable.
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(119 days)
The Temno Elite Biopsy System is intended for use in obtaining biopsies from soft tissues such as liver, kidney,breast,prostate, spleen,lung,lymph nodes,thyroid,and various soft tissue masses. It is NOT intended for use in bone.
The Valved Coaxial Introducer Needle and Standard Coaxial Introducer Needles are intended for use as guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney,prostate,spleen, lung,lymph nodes,thyroid, and various soft tissue masses. It is NOT intended for use in bone.
The subject device is a single use full core biopsy device. It is available in several gauge sizes and lengths. The device has printed gauge size indicator that is color coded according to the various gauge sizes (yellow= 20G, pink= 18G, purple= 16 G, green= 14G, and blue=12G. The needles have a protective sheath.
The Temno Elite Biopsy system includes Biopsy device and has the option of including a Valved Coaxial Introducer Needle, or a Standard Coaxial Introducer Needle. The depth stop on both the Valved Coaxial Introducer Needle and the Standard Coaxial Introducer Needle is color coded to match the gauge size of the Temno Elite Biopsy system.
The Temno Elite Biopsy System is supplies sterile and is intended for single use only.
The provided text describes the Temno Elite Biopsy System, which is a medical device. The text focuses on the device's substantial equivalence to predicate devices, its indications for use, and the performance testing conducted to demonstrate its safety and efficacy.
However, the text does not contain any information about acceptance criteria and the study that proves the device meets those acceptance criteria in the context of an AI/human-in-the-loop system, image analysis, or diagnostic accuracy study. The device described is a physical biopsy instrument used for obtaining tissue samples from various soft tissues. The performance data presented refers to bench testing, biocompatibility, and sterilization, which are standard for physical medical devices, not for AI-powered diagnostic tools.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance using AI-specific metrics (e.g., sample size for test/training sets, ground truth establishment for AI, expert consensus, MRMC studies, standalone performance, effect size of human improvement with AI) because the provided document does not pertain to such a device or study.
The document discusses:
- Device: Temno Elite Biopsy System (a physical biopsy instrument)
- Indications for Use: Obtaining biopsies from soft tissues (liver, kidney, breast, prostate, spleen, lung, lymph nodes, thyroid, and various soft tissue masses).
- Acceptance Criteria/Performance Testing: These are related to the physical attributes and safety of the biopsy device itself, such as dimensional verification, tensile strength of joints, adjustable throw accuracy, multiple samples, device visibility, simulated use, biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity), and sterilization standards.
In summary, the provided text does not contain the information needed to answer the prompt regarding AI/imaging-related acceptance criteria and study data.
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